NCT03906942

Brief Summary

Background: Fun For Wellness is an online intervention designed to promote growth in well-being and physical activity by providing confidence-enhancing learning opportunities to participants. Objective: The objective of this feasibility study is to address uncertainties regarding the inclusion of accelerometer-based assessment of physical activity within the Fun For Wellness online intervention among free-living adults with obesity in the United States of America. Method: The study design is a prospective, double-blind, parallel group randomized pilot trial. Discussion: Results are intended to inform the preparation of a future definitive randomized controlled trial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 8, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

November 7, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2020

Completed
Last Updated

September 2, 2020

Status Verified

September 1, 2020

Enrollment Period

5 months

First QC Date

April 3, 2019

Last Update Submit

September 1, 2020

Conditions

Outcome Measures

Primary Outcomes (129)

  • feasibility of accelerometer-based assessment of physical activity (recruitment rate)

    The feasibility of accelerometer-based assessment of physical activity will be assessed with recruitment rate. Recruitment rate will be defined as the percentage of patients who select "yes" when asked if they are interested in determining if they are eligible for participation in this study.

    Week 0

  • feasibility of accelerometer-based assessment of physical activity (eligibility rate)

    The feasibility of accelerometer-based assessment of physical activity will be assessed with eligibility rate. Eligibility rate will be defined as the percentage of interested patients who are presented with the informed consent form.

    Week 0

  • feasibility of accelerometer-based assessment of physical activity (consent rate)

    The feasibility of accelerometer-based assessment of physical activity will be assessed with consent rate. Consent rate will be defined as the percentage of eligible patients who consent to participate in this study.

    Week 0

  • self-efficacy to comply

    Self-efficacy to comply will be measured with a single item at Wave 1 (i.e., How confident are you in your current ability to get yourself to complete at least 30 Fun For Wellness post-introductory challenges within the next four weeks?) \[11\]. Response to the item will form a self-efficacy to comply score with higher values representing greater self-efficacy to comply. The minimum score will be 0. The maximum score will be 4.

    Week 1

  • well-being self-efficacy (interpersonal sub-scale)

    Well-being self-efficacy will be measured at Wave 1 with the 21-item well-being self-efficacy scale \[1,11\]. Responses to the three Likert-scale quantitative items intended to measure the interpersonal sub-scale will be summed at Wave 1 to form an interpersonal sub-scale score at Wave 1 with higher values representing greater interpersonal well-being self efficacy. The minimum score will be 0. The maximum score will be 12.

    Week 1

  • well-being self-efficacy (community sub-scale)

    Well-being self-efficacy will be measured at Wave 1 with the 21-item well-being self-efficacy scale \[1,11\]. Responses to the three Likert-scale quantitative items intended to measure the community sub-scale will be summed at Wave 1 to form a community sub-scale score at Wave 1 with higher values representing greater community well-being self efficacy. The minimum score will be 0. The maximum score will be 12.

    Week 1

  • well-being self-efficacy (occupational sub-scale)

    Well-being self-efficacy will be measured at Wave 1 with the 21-item well-being self-efficacy scale \[1,11\]. Responses to the three Likert-scale quantitative items intended to measure the occupational sub-scale will be summed at Wave 1 to form an occupational sub-scale score at Wave 1 with higher values representing greater occupational well-being self efficacy. The minimum score will be 0. The maximum score will be 12.

    Week 1

  • well-being self-efficacy (physical sub-scale)

    Well-being self-efficacy will be measured at Wave 1 with the 21-item well-being self-efficacy scale \[1,11\]. Responses to the three Likert-scale quantitative items intended to measure the physical sub-scale will be summed at Wave 1 to form a physical sub-scale score at Wave 1 with higher values representing greater physical well-being self efficacy. The minimum score will be 0. The maximum score will be 12.

    Week 1

  • well-being self-efficacy (psychological sub-scale)

    Well-being self-efficacy will be measured at Wave 1 with the 21-item well-being self-efficacy scale \[1,11\]. Responses to the three Likert-scale quantitative items intended to measure the psychological sub-scale will be summed at Wave 1 to form a psychological sub-scale score at Wave 1 with higher values representing greater psychological well-being self efficacy. The minimum score will be 0. The maximum score will be 12.

    Week 1

  • well-being self-efficacy (economic sub-scale)

    Well-being self-efficacy will be measured at Wave 1 with the 21-item well-being self-efficacy scale \[1,11\]. Responses to the three Likert-scale quantitative items intended to measure the economic sub-scale will be summed at Wave 1 to form an economic sub-scale score at Wave 1 with higher values representing greater economic well-being self efficacy. The minimum score will be 0. The maximum score will be 12.

    Week 1

  • well-being self-efficacy (overall sub-scale)

    Well-being self-efficacy will be measured at Wave 1 with the 21-item well-being self-efficacy scale \[1,11\]. Responses to the three Likert-scale quantitative items intended to measure the overall sub-scale will be summed at Wave 1 to form an overall sub-scale score at Wave 1 with higher values representing greater overall well-being self efficacy. The minimum score will be 0. The maximum score will be 12.

    Week 1

  • well-being actions self-efficacy (interpersonal sub-scale)

    Well-being actions self-efficacy will be measured at Wave 1 with the 18-item well-being actions self-efficacy scale \[11\]. Responses to the three Likert-scale quantitative items intended to measure the interpersonal sub-scale will be summed at Wave 1 to form an interpersonal sub-scale score at Wave 1 with higher values representing greater interpersonal well-being actions self efficacy. The minimum score will be 0. The maximum score will be 12.

    Week 1

  • well-being actions self-efficacy (community sub-scale)

    Well-being actions self-efficacy will be measured at Wave 1 with the 18-item well-being actions self-efficacy scale \[11\]. Responses to the three Likert-scale quantitative items intended to measure the community sub-scale will be summed at Wave 1 to form a community sub-scale score at Wave 1 with higher values representing greater community well-being actions self efficacy. The minimum score will be 0. The maximum score will be 12.

    Week 1

  • well-being actions self-efficacy (occupational sub-scale)

    Well-being actions self-efficacy will be measured at Wave 1 with the 18-item well-being actions self-efficacy scale \[11\]. Responses to the three Likert-scale quantitative items intended to measure the occupational sub-scale will be summed at Wave 1 to form an occupational sub-scale score at Wave 1 with higher values representing greater occupational well-being actions self efficacy. The minimum score will be 0. The maximum score will be 12.

    Week 1

  • well-being actions self-efficacy (physical sub-scale)

    Well-being actions self-efficacy will be measured at Wave 1 with the 18-item well-being actions self-efficacy scale \[11\]. Responses to the three Likert-scale quantitative items intended to measure the physical sub-scale will be summed at Wave 1 to form a physical sub-scale score at Wave 1 with higher values representing greater physical well-being actions self efficacy. The minimum score will be 0. The maximum score will be 12.

    Week 1

  • well-being actions self-efficacy (psychological sub-scale)

    Well-being actions self-efficacy will be measured at Wave 1 with the 18-item well-being actions self-efficacy scale \[11\]. Responses to the three Likert-scale quantitative items intended to measure the psychological sub-scale will be summed at Wave 1 to form a psychological sub-scale score at Wave 1 with higher values representing greater psychological well-being actions self efficacy. The minimum score will be 0. The maximum score will be 12.

    Week 1

  • well-being actions self-efficacy (economic sub-scale)

    Well-being actions self-efficacy will be measured at Wave 1 with the 18-item well-being actions self-efficacy scale \[11\]. Responses to the three Likert-scale quantitative items intended to measure the economic sub-scale will be summed at Wave 1 to form an economic sub-scale score at Wave 1 with higher values representing greater economic well-being actions self efficacy. The minimum score will be 0. The maximum score will be 12.

    Week 1

  • subjective well-being (interpersonal sub-scale)

    Subjective well-being will be measured at Wave 1 with the 21-item I COPPE scale \[12\]. Responses to the three Likert-scale quantitative items intended to measure the interpersonal sub-scale will be summed at Wave 1 to form an interpersonal sub-scale score at Wave 1 with higher values representing greater interpersonal well-being. The minimum score will be 0. The maximum score will be 30.

    Week 1

  • subjective well-being (community sub-scale)

    Subjective well-being will be measured at Wave 1 with the 21-item I COPPE scale \[12\]. Responses to the three Likert-scale quantitative items intended to measure the community sub-scale will be summed at Wave 1 to form a community sub-scale score at Wave 1 with higher values representing greater interpersonal well-being. The minimum score will be 0. The maximum score will be 30.

    Week 1

  • subjective well-being (occupational sub-scale)

    Subjective well-being will be measured at Wave 1 with the 21-item I COPPE scale \[12\]. Responses to the three Likert-scale quantitative items intended to measure the occupational sub-scale will be summed at Wave 1 to form an occupational sub-scale score at Wave 1 with higher values representing greater occupational well-being. The minimum score will be 0. The maximum score will be 30.

    Week 1

  • subjective well-being (physical sub-scale)

    Subjective well-being will be measured at Wave 1 with the 21-item I COPPE scale \[12\]. Responses to the three Likert-scale quantitative items intended to measure the physical sub-scale will be summed at Wave 1 to form a physical sub-scale score at Wave 1 with higher values representing greater physical well-being. The minimum score will be 0. The maximum score will be 30.

    Week 1

  • subjective well-being (psychological sub-scale)

    Subjective well-being will be measured at Wave 1 with the 21-item I COPPE scale \[12\]. Responses to the three Likert-scale quantitative items intended to measure the psychological sub-scale will be summed at Wave 1 to form a psychological sub-scale score at Wave 1 with higher values representing greater psychological well-being. The minimum score will be 0. The maximum score will be 30.

    Week 1

  • subjective well-being (economic sub-scale)

    Subjective well-being will be measured at Wave 1 with the 21-item I COPPE scale \[12\]. Responses to the three Likert-scale quantitative items intended to measure the economic sub-scale will be summed at Wave 1 to form an economic sub-scale score at Wave 1 with higher values representing greater economic well-being. The minimum score will be 0. The maximum score will be 30.

    Week 1

  • subjective well-being (overall sub-scale)

    Subjective well-being will be measured at Wave 1 with the 21-item I COPPE scale \[12\]. Responses to the three Likert-scale quantitative items intended to measure the overall sub-scale will be summed at Wave 1 to form an overall sub-scale score at Wave 1 with higher values representing greater overall well-being. The minimum score will be 0. The maximum score will be 30.

    Week 1

  • well-being actions (interpersonal sub-scale)

    Well-being actions will be measured at Wave 1 with the 18-item I COPPE actions scale \[13\]. Responses to the three Likert-scale quantitative items intended to measure the interpersonal sub-scale will be summed at Wave 1 to form an interpersonal sub-scale score at Wave 1 with higher values representing greater interpersonal well-being actions. The minimum score will be 0. The maximum score will be 12.

    Week 1

  • well-being actions (community sub-scale)

    Well-being actions will be measured at Wave 1 with the 18-item I COPPE actions scale \[13\]. Responses to the three Likert-scale quantitative items intended to measure the community sub-scale will be summed at Wave 1 to form a community sub-scale score at Wave 1 with higher values representing greater community well-being actions. The minimum score will be 0. The maximum score will be 12.

    Week 1

  • well-being actions (occupational sub-scale)

    Well-being actions will be measured at Wave 1 with the 18-item I COPPE actions scale \[13\]. Responses to the three Likert-scale quantitative items intended to measure the occupational sub-scale will be summed at Wave 1 to form an occupational sub-scale score at Wave 1 with higher values representing greater occupational well-being actions. The minimum score will be 0. The maximum score will be 12.

    Week 1

  • well-being actions (physical sub-scale)

    Well-being actions will be measured at Wave 1 with the 18-item I COPPE actions scale \[13\]. Responses to the three Likert-scale quantitative items intended to measure the physical sub-scale will be summed at Wave 1 to form a physical sub-scale score at Wave 1 with higher values representing greater physical well-being actions. The minimum score will be 0. The maximum score will be 12.

    Week 1

  • well-being actions (psychological sub-scale)

    Well-being actions will be measured at Wave 1 with the 18-item I COPPE actions scale \[13\]. Responses to the three Likert-scale quantitative items intended to measure the psychological sub-scale will be summed at Wave 1 to form a psychological sub-scale score at Wave 1 with higher values representing greater psychological well-being actions. The minimum score will be 0. The maximum score will be 12.

    Week 1

  • well-being actions (economic sub-scale)

    Well-being actions will be measured at Wave 1 with the 18-item I COPPE actions scale \[13\]. Responses to the three Likert-scale quantitative items intended to measure the economic sub-scale will be summed at Wave 1 to form an economic sub-scale score at Wave 1 with higher values representing greater psychological well-being actions. The minimum score will be 0. The maximum score will be 12.

    Week 1

  • physical activity self-efficacy (job-related vigorous sub-scale)

    Physical activity self-efficacy will be measured at Wave 1 with the 48-item physical activity self-efficacy scale \[11\]. Responses to the six Likert-scale quantitative items intended to measure the job-related vigorous sub-scale will be summed at Wave 1 to form a job-related vigorous sub-scale score at Wave 1 with higher values representing greater physical activity self-efficacy (job-related vigorous). The minimum score will be 0. The maximum score will be 24.

    Week 1

  • physical activity self-efficacy (transportation-related vigorous sub-scale)

    Physical activity self-efficacy will be measured at Wave 1 with the 48-item physical activity self-efficacy scale \[11\]. Responses to the six Likert-scale quantitative items intended to measure the transportation-related vigorous sub-scale will be summed at Wave 1 to form a transportation-related vigorous sub-scale score at Wave 1 with higher values representing greater physical activity self-efficacy (transportation-related vigorous). The minimum score will be 0. The maximum score will be 24.

    Week 1

  • physical activity self-efficacy (domestic and gardening-related vigorous sub-scale)

    Physical activity self-efficacy will be measured at Wave 1 with the 48-item physical activity self-efficacy scale \[11\]. Responses to the six Likert-scale quantitative items intended to measure the domestic and gardening-related vigorous sub-scale will be summed at Wave 1 to form a domestic and gardening-related vigorous sub-scale score at Wave 1 with higher values representing greater physical activity self-efficacy (domestic and gardening-related vigorous). The minimum score will be 0. The maximum score will be 24.

    Week 1

  • physical activity self-efficacy (leisure-related vigorous sub-scale)

    Physical activity self-efficacy will be measured at Wave 1 with the 48-item physical activity self-efficacy scale \[11\]. Responses to the six Likert-scale quantitative items intended to measure the leisure-related vigorous sub-scale will be summed at Wave 1 to form a leisure-related vigorous sub-scale score at Wave 1 with higher values representing greater physical activity self-efficacy (leisure-related vigorous). The minimum score will be 0. The maximum score will be 24.

    Week 1

  • physical activity self-efficacy (job-related moderate sub-scale)

    Physical activity self-efficacy will be measured at Wave 1 with the 48-item physical activity self-efficacy scale \[11\]. Responses to the six Likert-scale quantitative items intended to measure the job-related moderate sub-scale will be summed at Wave 1 to form a job-related moderate sub-scale score at Wave 1 with higher values representing greater physical activity self-efficacy (job-related moderate). The minimum score will be 0. The maximum score will be 24.

    Week 1

  • physical activity self-efficacy (transportation-related moderate sub-scale)

    Physical activity self-efficacy will be measured at Wave 1 with the 48-item physical activity self-efficacy scale \[11\]. Responses to the six Likert-scale quantitative items intended to measure the transportation-related moderate sub-scale will be summed at Wave 1 to form a transportation-related moderate sub-scale score at Wave 1 with higher values representing greater physical activity self-efficacy (transportation-related moderate). The minimum score will be 0. The maximum score will be 24.

    Week 1

  • physical activity self-efficacy (domestic and gardening-related moderate sub-scale)

    Physical activity self-efficacy will be measured at Wave 1 with the 48-item physical activity self-efficacy scale \[11\]. Responses to the six Likert-scale quantitative items intended to measure the domestic and gardening-related moderate sub-scale will be summed at Wave 1 to form a domestic and gardening-related moderate sub-scale score at Wave 1 with higher values representing greater physical activity self-efficacy (domestic and gardening-related moderate). The minimum score will be 0. The maximum score will be 24.

    Week 1

  • physical activity self-efficacy (leisure-related moderate sub-scale)

    Physical activity self-efficacy will be measured at Wave 1 with the 48-item physical activity self-efficacy scale \[11\]. Responses to the six Likert-scale quantitative items intended to measure the leisure-related moderate sub-scale will be summed at Wave 1 to form a leisure-related moderate sub-scale score at Wave 1 with higher values representing greater physical activity self-efficacy (leisure-related moderate). The minimum score will be 0. The maximum score will be 24.

    Week 1

  • Self-efficacy to regulate physical activity

    Self-efficacy to regulate physical activity will be measured at Wave 1 with the 13-item self-efficacy to regulate physical activity scale \[11\]. Responses to the thirteen Likert-scale quantitative items will be summed at Wave 1 to form a a total self-efficacy to regulate physical activity score at Wave 1 with higher values representing greater self-efficacy to regulate physical activity. The minimum score will be 0. The maximum score will be 52.

    Week 1

  • physical activity (Fitbit Zip)

    A commercial-grade (Fitbit Zip) accelerometer will be initialized and attached to an adjustable nylon belt to measure physical activity objectively at Wave 1. Average minutes-per-day of moderate to vigorous physical activity will be determined using the Fitbit application, which uses a proprietary algorithm to estimate fairly active minutes and very active minutes.

    Week 2

  • physical activity (Actigraph wGT3X-BT)

    A research-grade (Actigraph wGT3X-BT) accelerometer will be initialized and attached to an adjustable nylon belt to measure physical activity objectively at Wave 1. Average minutes-per-day of moderate to vigorous physical activity will be calculated based on established cut points (e.g., \> 1952 counts per minute).

    Week 2

  • self-reported physical activity

    Self-reported physical activity will be measured at Wave 1 with the long form of the international physical activity questionnaire \[9,10\]. Average minutes-per-day of moderate to vigorous physical activity will be formed by dividing the sum of the minutes per day (across one week) of minutes-per-day of moderate to vigorous physical activity in the work, transportation, domestic and gardening, and leisure domains by 7 days.

    Week 2

  • feasibility of accelerometer-based assessment of physical activity (participation rate)

    The feasibility of accelerometer-based assessment of physical activity will be assessed with participation rate at Wave 1. Participation rate at Wave 1 will be defined as the percentage of consented patients who provide usable data at Wave 1. Usable data will be defined as: (a) a log sheet with a valid start date is submitted, (b) a monitor is worn for at least 4 days (including one weekend day) with at least 10 hours of valid wear time per day, and (c) no evidence of monitor error (e.g., activity counts \> 20,000 or lengthy strings of repeated activity counts).

    Week 2

  • acceptability of accelerometer-based assessment of physical activity (quantitative)

    The acceptability of accelerometer-based assessment of physical activity will be assessed at Wave 1 with a modified version of an unnamed questionnaire used in previous research \[7,8\]. The 11-item acceptability questionnaire used in this study consists of a mix of both Likert-scale quantitative (6) and open-ended qualitative (5) items. Responses to the five qualitative items will be content analyzed together at Wave 1 to find conceptual themes at Wave 1 with regard to the acceptability of accelerometer-based assessment of physical activity.

    Week 3

  • acceptability of accelerometer-based assessment of physical activity (qualitative)

    The acceptability of accelerometer-based assessment of physical activity will be assessed at Wave 1 with a modified version of an unnamed questionnaire used in previous research \[7,8\]. The 11-item acceptability questionnaire used in this study consists of a mix of both Likert-scale quantitative (6) and open-ended qualitative (5) items. Responses to the six Likert-scale quantitative items will be summed at Wave 1 to form a total acceptability score at Wave 1 with higher values representing greater acceptability. The minimum total acceptability score at Wave 1 will be 6. The maximum total acceptability score at Wave 1 will be 23.

    Week 3

  • well-being self-efficacy (interpersonal sub-scale)

    Well-being self-efficacy will be measured at Wave 2 with the 21-item well-being self-efficacy scale \[1,11\]. Responses to the three Likert-scale quantitative items intended to measure the interpersonal sub-scale will be summed at Wave 2 to form an interpersonal sub-scale score at Wave 2 with higher values representing greater interpersonal well-being self efficacy. The minimum score will be 0. The maximum score will be 12.

    Week 7

  • well-being self-efficacy (community sub-scale)

    Well-being self-efficacy will be measured at Wave 2 with the 21-item well-being self-efficacy scale \[1,11\]. Responses to the three Likert-scale quantitative items intended to measure the community sub-scale will be summed at Wave 2 to form a community sub-scale score at Wave 2 with higher values representing greater community well-being self efficacy. The minimum score will be 0. The maximum score will be 12.

    Week 7

  • well-being self-efficacy (occupational sub-scale)

    Well-being self-efficacy will be measured at Wave 2 with the 21-item well-being self-efficacy scale \[1,11\]. Responses to the three Likert-scale quantitative items intended to measure the occupational sub-scale will be summed at Wave 2 to form an occupational sub-scale score at Wave 2 with higher values representing greater occupational well-being self efficacy. The minimum score will be 0. The maximum score will be 12.

    Week 7

  • well-being self-efficacy (physical sub-scale)

    Well-being self-efficacy will be measured at Wave 2 with the 21-item well-being self-efficacy scale \[1,11\]. Responses to the three Likert-scale quantitative items intended to measure the physical sub-scale will be summed at Wave 2 to form a physical sub-scale score at Wave 2 with higher values representing greater physical well-being self efficacy. The minimum score will be 0. The maximum score will be 12.

    Week 7

  • well-being self-efficacy (psychological sub-scale)

    Well-being self-efficacy will be measured at Wave 2 with the 21-item well-being self-efficacy scale \[1,11\]. Responses to the three Likert-scale quantitative items intended to measure the psychological sub-scale will be summed at Wave 2 to form a psychological sub-scale score at Wave 2 with higher values representing greater psychological well-being self efficacy. The minimum score will be 0. The maximum score will be 12.

    Week 7

  • well-being self-efficacy (economic sub-scale)

    Well-being self-efficacy will be measured at Wave 2 with the 21-item well-being self-efficacy scale \[1,11\]. Responses to the three Likert-scale quantitative items intended to measure the economic sub-scale will be summed at Wave 2 to form an economic sub-scale score at Wave 2 with higher values representing greater economic well-being self efficacy. The minimum score will be 0. The maximum score will be 12.

    Week 7

  • well-being self-efficacy (overall sub-scale)

    Well-being self-efficacy will be measured at Wave 2 with the 21-item well-being self-efficacy scale \[1,11\]. Responses to the three Likert-scale quantitative items intended to measure the overall sub-scale will be summed at Wave 2 to form an overall sub-scale score at Wave 2 with higher values representing greater overall well-being self efficacy. The minimum score will be 0. The maximum score will be 12.

    Week 7

  • well-being actions self-efficacy (interpersonal sub-scale)

    Well-being actions self-efficacy will be measured at Wave 2 with the 18-item well-being actions self-efficacy scale \[11\]. Responses to the three Likert-scale quantitative items intended to measure the interpersonal sub-scale will be summed at Wave 2 to form an interpersonal sub-scale score at Wave 2 with higher values representing greater interpersonal well-being actions self efficacy. The minimum score will be 0. The maximum score will be 12.

    Week 7

  • well-being actions self-efficacy (community sub-scale)

    Well-being actions self-efficacy will be measured at Wave 2 with the 18-item well-being actions self-efficacy scale \[11\]. Responses to the three Likert-scale quantitative items intended to measure the community sub-scale will be summed at Wave 2 to form a community sub-scale score at Wave 2 with higher values representing greater community well-being actions self efficacy. The minimum score will be 0. The maximum score will be 12.

    Week 7

  • well-being actions self-efficacy (occupational sub-scale)

    Well-being actions self-efficacy will be measured at Wave 2 with the 18-item well-being actions self-efficacy scale \[11\]. Responses to the three Likert-scale quantitative items intended to measure the occupational sub-scale will be summed at Wave 2 to form an occupational sub-scale score at Wave 2 with higher values representing greater occupational well-being actions self efficacy. The minimum score will be 0. The maximum score will be 12.

    Week 7

  • well-being actions self-efficacy (physical sub-scale)

    Well-being actions self-efficacy will be measured at Wave 2 with the 18-item well-being actions self-efficacy scale \[11\]. Responses to the three Likert-scale quantitative items intended to measure the physical sub-scale will be summed at Wave 2 to form a physical sub-scale score at Wave 2 with higher values representing greater physical well-being actions self efficacy. The minimum score will be 0. The maximum score will be 12.

    Week 7

  • well-being actions self-efficacy (psychological sub-scale)

    Well-being actions self-efficacy will be measured at Wave 2 with the 18-item well-being actions self-efficacy scale \[11\]. Responses to the three Likert-scale quantitative items intended to measure the psychological sub-scale will be summed at Wave 2 to form a psychological sub-scale score at Wave 2 with higher values representing greater psychological well-being actions self efficacy. The minimum score will be 0. The maximum score will be 12.

    Week 7

  • well-being actions self-efficacy (economic sub-scale)

    Well-being actions self-efficacy will be measured at Wave 2 with the 18-item well-being actions self-efficacy scale \[11\]. Responses to the three Likert-scale quantitative items intended to measure the economic sub-scale will be summed at Wave 2 to form an economic sub-scale score at Wave 2 with higher values representing greater economic well-being actions self efficacy. The minimum score will be 0. The maximum score will be 12.

    Week 7

  • subjective well-being (interpersonal sub-scale)

    Subjective well-being will be measured at Wave 2 with the 21-item I COPPE scale \[12\]. Responses to the three Likert-scale quantitative items intended to measure the interpersonal sub-scale will be summed at Wave 2 to form an interpersonal sub-scale score at Wave 2 with higher values representing greater interpersonal well-being. The minimum score will be 0. The maximum score will be 30.

    Week 7

  • subjective well-being (community sub-scale)

    Subjective well-being will be measured at Wave 2 with the 21-item I COPPE scale \[12\]. Responses to the three Likert-scale quantitative items intended to measure the community sub-scale will be summed at Wave 2 to form a community sub-scale score at Wave 2 with higher values representing greater interpersonal well-being. The minimum score will be 0. The maximum score will be 30.

    Week 7

  • subjective well-being (occupational sub-scale)

    Subjective well-being will be measured at Wave 2 with the 21-item I COPPE scale \[12\]. Responses to the three Likert-scale quantitative items intended to measure the occupational sub-scale will be summed at Wave 2 to form an occupational sub-scale score at Wave 2 with higher values representing greater occupational well-being. The minimum score will be 0. The maximum score will be 30.

    Week 7

  • subjective well-being (physical sub-scale)

    Subjective well-being will be measured at Wave 2 with the 21-item I COPPE scale \[12\]. Responses to the three Likert-scale quantitative items intended to measure the physical sub-scale will be summed at Wave 2 to form a physical sub-scale score at Wave 2 with higher values representing greater physical well-being. The minimum score will be 0. The maximum score will be 30.

    Week 7

  • subjective well-being (psychological sub-scale)

    Subjective well-being will be measured at Wave 2 with the 21-item I COPPE scale \[12\]. Responses to the three Likert-scale quantitative items intended to measure the psychological sub-scale will be summed at Wave 2 to form a psychological sub-scale score at Wave 2 with higher values representing greater psychological well-being. The minimum score will be 0. The maximum score will be 30.

    Week 7

  • subjective well-being (economic sub-scale)

    Subjective well-being will be measured at Wave 2 with the 21-item I COPPE scale \[12\]. Responses to the three Likert-scale quantitative items intended to measure the economic sub-scale will be summed at Wave 2 to form an economic sub-scale score at Wave 2 with higher values representing greater economic well-being. The minimum score will be 0. The maximum score will be 30.

    Week 7

  • subjective well-being (overall sub-scale)

    Subjective well-being will be measured at Wave 2 with the 21-item I COPPE scale \[12\]. Responses to the three Likert-scale quantitative items intended to measure the overall sub-scale will be summed at Wave 2 to form an overall sub-scale score at Wave 2 with higher values representing greater overall well-being. The minimum score will be 0. The maximum score will be 30.

    Week 7

  • well-being actions (interpersonal sub-scale)

    Well-being actions will be measured at Wave 2 with the 18-item I COPPE actions scale \[13\]. Responses to the three Likert-scale quantitative items intended to measure the interpersonal sub-scale will be summed at Wave 2 to form an interpersonal sub-scale score at Wave 2 with higher values representing greater interpersonal well-being actions. The minimum score will be 0. The maximum score will be 12.

    Week 7

  • well-being actions (community sub-scale)

    Well-being actions will be measured at Wave 2 with the 18-item I COPPE actions scale \[13\]. Responses to the three Likert-scale quantitative items intended to measure the community sub-scale will be summed at Wave 2 to form a community sub-scale score at Wave 2 with higher values representing greater community well-being actions. The minimum score will be 0. The maximum score will be 12.

    Week 7

  • well-being actions (occupational sub-scale)

    Well-being actions will be measured at Wave 2 with the 18-item I COPPE actions scale \[13\]. Responses to the three Likert-scale quantitative items intended to measure the occupational sub-scale will be summed at Wave 2 to form an occupational sub-scale score at Wave 2 with higher values representing greater occupational well-being actions. The minimum score will be 0. The maximum score will be 12.

    Week 7

  • well-being actions (physical sub-scale)

    Well-being actions will be measured at Wave 2 with the 18-item I COPPE actions scale \[13\]. Responses to the three Likert-scale quantitative items intended to measure the physical sub-scale will be summed at Wave 2 to form a physical sub-scale score at Wave 2 with higher values representing greater physical well-being actions. The minimum score will be 0. The maximum score will be 12.

    Week 7

  • well-being actions (psychological sub-scale)

    Well-being actions will be measured at Wave 2 with the 18-item I COPPE actions scale \[13\]. Responses to the three Likert-scale quantitative items intended to measure the psychological sub-scale will be summed at Wave 2 to form a psychological sub-scale score at Wave 2 with higher values representing greater psychological well-being actions. The minimum score will be 0. The maximum score will be 12.

    Week 7

  • well-being actions (economic sub-scale)

    Well-being actions will be measured at Wave 2 with the 18-item I COPPE actions scale \[13\]. Responses to the three Likert-scale quantitative items intended to measure the economic sub-scale will be summed at Wave 2 to form an economic sub-scale score at Wave 2 with higher values representing greater psychological well-being actions. The minimum score will be 0. The maximum score will be 12.

    Week 7

  • physical activity self-efficacy (job-related vigorous sub-scale)

    Physical activity self-efficacy will be measured at Wave 2 with the 48-item physical activity self-efficacy scale \[11\]. Responses to the six Likert-scale quantitative items intended to measure the job-related vigorous sub-scale will be summed at Wave 2 to form a job-related vigorous sub-scale score at Wave 2 with higher values representing greater physical activity self-efficacy (job-related vigorous). The minimum score will be 0. The maximum score will be 24.

    Week 7

  • physical activity self-efficacy (transportation-related vigorous sub-scale)

    Physical activity self-efficacy will be measured at Wave 2 with the 48-item physical activity self-efficacy scale \[11\]. Responses to the six Likert-scale quantitative items intended to measure the transportation-related vigorous sub-scale will be summed at Wave 2 to form a transportation-related vigorous sub-scale score at Wave 2 with higher values representing greater physical activity self-efficacy (transportation-related vigorous). The minimum score will be 0. The maximum score will be 24.

    Week 7

  • physical activity self-efficacy (domestic and gardening-related vigorous sub-scale)

    Physical activity self-efficacy will be measured at Wave 2 with the 48-item physical activity self-efficacy scale \[11\]. Responses to the six Likert-scale quantitative items intended to measure the domestic and gardening-related vigorous sub-scale will be summed at Wave 2 to form a domestic and gardening-related vigorous sub-scale score at Wave 2 with higher values representing greater physical activity self-efficacy (domestic and gardening-related vigorous). The minimum score will be 0. The maximum score will be 24.

    Week 7

  • physical activity self-efficacy (leisure-related vigorous sub-scale)

    Physical activity self-efficacy will be measured at Wave 2 with the 48-item physical activity self-efficacy scale \[11\]. Responses to the six Likert-scale quantitative items intended to measure the leisure-related vigorous sub-scale will be summed at Wave 2 to form a leisure-related vigorous sub-scale score at Wave 2 with higher values representing greater physical activity self-efficacy (leisure-related vigorous). The minimum score will be 0. The maximum score will be 24.

    Week 7

  • physical activity self-efficacy (job-related moderate sub-scale)

    Physical activity self-efficacy will be measured at Wave 2 with the 48-item physical activity self-efficacy scale \[11\]. Responses to the six Likert-scale quantitative items intended to measure the job-related moderate sub-scale will be summed at Wave 2 to form a job-related moderate sub-scale score at Wave 2 with higher values representing greater physical activity self-efficacy (job-related moderate). The minimum score will be 0. The maximum score will be 24.

    Week 7

  • physical activity self-efficacy (transportation-related moderate sub-scale)

    Physical activity self-efficacy will be measured at Wave 2 with the 48-item physical activity self-efficacy scale \[11\]. Responses to the six Likert-scale quantitative items intended to measure the transportation-related moderate sub-scale will be summed at Wave 2 to form a transportation-related moderate sub-scale score at Wave 2 with higher values representing greater physical activity self-efficacy (transportation-related moderate). The minimum score will be 0. The maximum score will be 24.

    Week 7

  • physical activity self-efficacy (domestic and gardening-related moderate sub-scale)

    Physical activity self-efficacy will be measured at Wave 2 with the 48-item physical activity self-efficacy scale \[11\]. Responses to the six Likert-scale quantitative items intended to measure the domestic and gardening-related moderate sub-scale will be summed at Wave 2 to form a domestic and gardening-related moderate sub-scale score at Wave 2 with higher values representing greater physical activity self-efficacy (domestic and gardening-related moderate). The minimum score will be 0. The maximum score will be 24.

    Week 7

  • physical activity self-efficacy (leisure-related moderate sub-scale)

    Physical activity self-efficacy will be measured at Wave 2 with the 48-item physical activity self-efficacy scale \[11\]. Responses to the six Likert-scale quantitative items intended to measure the leisure-related moderate sub-scale will be summed at Wave 2 to form a leisure-related moderate sub-scale score at Wave 2 with higher values representing greater physical activity self-efficacy (leisure-related moderate). The minimum score will be 0. The maximum score will be 24.

    Week 7

  • Self-efficacy to regulate physical activity

    Self-efficacy to regulate physical activity will be measured at Wave 2 with the 13-item self-efficacy to regulate physical activity scale \[11\]. Responses to the thirteen Likert-scale quantitative items will be summed at Wave 2 to form a a total self-efficacy to regulate physical activity score at Wave 2 with higher values representing greater self-efficacy to regulate physical activity. The minimum score will be 0. The maximum score will be 52.

    Week 7

  • physical activity (Actigraph wGT3X-BT)

    A research-grade (Actigraph wGT3X-BT) accelerometer will be initialized and attached to an adjustable nylon belt to measure physical activity objectively at Wave 2. Average minutes-per-day of moderate to vigorous physical activity will be calculated based on established cut points (e.g., \> 1952 counts per minute).

    Week 8

  • self-reported physical activity

    Self-reported physical activity will be measured at Wave 2 with the long form of the international physical activity questionnaire \[9,10\]. Average minutes-per-day of moderate to vigorous physical activity will be formed by dividing the sum of the minutes per day (across one week) of minutes-per-day of moderate to vigorous physical activity in the work, transportation, domestic and gardening, and leisure domains by 7 days.

    Week 8

  • physical activity (Fitbit Zip)

    A commercial-grade (Fitbit Zip) accelerometer will be initialized and attached to an adjustable nylon belt to measure physical activity objectively at Wave 2. Average minutes-per-day of moderate to vigorous physical activity will be determined using the Fitbit application, which uses a proprietary algorithm to estimate fairly active minutes and very active minutes.

    Week 8

  • feasibility of accelerometer-based assessment of physical activity (participation rate)

    The feasibility of accelerometer-based assessment of physical activity will be assessed with participation rate at Wave 2. Participation rate at Wave 2 will be defined as the percentage of consented patients who provide usable data at Wave 2. Usable data will be defined as: (a) a log sheet with a valid start date is submitted, (b) a monitor is worn for at least 4 days (including one weekend day) with at least 10 hours of valid wear time per day, and (c) no evidence of monitor error (e.g., activity counts \> 20,000 or lengthy strings of repeated activity counts).

    Week 8

  • feasibility of accelerometer-based assessment of physical activity (retention rate)

    The feasibility of accelerometer-based assessment of physical activity will be assessed with retention rate at Wave 2. Retention rate at Wave 2 will be defined as the percentage of consented patients who provide usable data at Wave 1 and Wave 2. Usable data will be defined as: (a) a log sheet with a valid start date is submitted, (b) a monitor is worn for at least 4 days (including one weekend day) with at least 10 hours of valid wear time per day, and (c) no evidence of monitor error (e.g., activity counts \> 20,000 or lengthy strings of repeated activity counts).

    Week 8

  • acceptability of accelerometer-based assessment of physical activity (quantitative)

    The acceptability of accelerometer-based assessment of physical activity will be assessed at Wave 2 with a modified version of an unnamed questionnaire used in previous research \[7,8\]. The 11-item acceptability questionnaire used in this study consists of a mix of both Likert-scale quantitative (6) and open-ended qualitative (5) items. Responses to the six Likert-scale quantitative items will be summed at Wave 2 to form a total acceptability score at Wave 2 with higher values representing greater acceptability. The minimum total acceptability score at Wave 2 will be 6. The maximum total acceptability score at Wave 2 will be 23.

    Week 9

  • acceptability of accelerometer-based assessment of physical activity (qualitative)

    The acceptability of accelerometer-based assessment of physical activity will be assessed at Wave 2 with a modified version of an unnamed questionnaire used in previous research \[7,8\]. The 11-item acceptability questionnaire used in this study consists of a mix of both Likert-scale quantitative (6) and open-ended qualitative (5) items. Responses to the five qualitative items will be content analyzed together at Wave 2 to find conceptual themes at Wave 2 with regard to the acceptability of accelerometer-based assessment of physical activity.

    Week 9

  • well-being self-efficacy (interpersonal sub-scale)

    Well-being self-efficacy will be measured at Wave 3 with the 21-item well-being self-efficacy scale \[1,11\]. Responses to the three Likert-scale quantitative items intended to measure the interpersonal sub-scale will be summed at Wave 3 to form an interpersonal sub-scale score at Wave 2 with higher values representing greater interpersonal well-being self efficacy. The minimum score will be 0. The maximum score will be 12.

    Week 11

  • well-being self-efficacy (community sub-scale)

    Well-being self-efficacy will be measured at Wave 3 with the 21-item well-being self-efficacy scale \[1,11\]. Responses to the three Likert-scale quantitative items intended to measure the community sub-scale will be summed at Wave 3 to form a community sub-scale score at Wave 3 with higher values representing greater community well-being self efficacy. The minimum score will be 0. The maximum score will be 12.

    Week 11

  • well-being self-efficacy (occupational sub-scale)

    Well-being self-efficacy will be measured at Wave 3 with the 21-item well-being self-efficacy scale \[1,11\]. Responses to the three Likert-scale quantitative items intended to measure the occupational sub-scale will be summed at Wave 3 to form an occupational sub-scale score at Wave 3 with higher values representing greater occupational well-being self efficacy. The minimum score will be 0. The maximum score will be 12.

    Week 11

  • well-being self-efficacy (physical sub-scale)

    Well-being self-efficacy will be measured at Wave 3 with the 21-item well-being self-efficacy scale \[1,11\]. Responses to the three Likert-scale quantitative items intended to measure the physical sub-scale will be summed at Wave 3 to form a physical sub-scale score at Wave 3 with higher values representing greater physical well-being self efficacy. The minimum score will be 0. The maximum score will be 12.

    Week 11

  • well-being self-efficacy (psychological sub-scale)

    Well-being self-efficacy will be measured at Wave 3 with the 21-item well-being self-efficacy scale \[1,11\]. Responses to the three Likert-scale quantitative items intended to measure the psychological sub-scale will be summed at Wave 3 to form a psychological sub-scale score at Wave 3 with higher values representing greater psychological well-being self efficacy. The minimum score will be 0. The maximum score will be 12.

    Week 11

  • well-being self-efficacy (economic sub-scale)

    Well-being self-efficacy will be measured at Wave 3 with the 21-item well-being self-efficacy scale \[1,11\]. Responses to the three Likert-scale quantitative items intended to measure the economic sub-scale will be summed at Wave 3 to form an economic sub-scale score at Wave 3 with higher values representing greater economic well-being self efficacy. The minimum score will be 0. The maximum score will be 12.

    Week 11

  • well-being self-efficacy (overall sub-scale)

    Well-being self-efficacy will be measured at Wave 3 with the 21-item well-being self-efficacy scale \[1,11\]. Responses to the three Likert-scale quantitative items intended to measure the overall sub-scale will be summed at Wave 3 to form an overall sub-scale score at Wave 3 with higher values representing greater overall well-being self efficacy. The minimum score will be 0. The maximum score will be 12.

    Week 11

  • well-being actions self-efficacy (interpersonal sub-scale)

    Well-being actions self-efficacy will be measured at Wave 3 with the 18-item well-being actions self-efficacy scale \[11\]. Responses to the three Likert-scale quantitative items intended to measure the interpersonal sub-scale will be summed at Wave 3 to form an interpersonal sub-scale score at Wave 3 with higher values representing greater interpersonal well-being actions self efficacy. The minimum score will be 0. The maximum score will be 12.

    Week 11

  • well-being actions self-efficacy (community sub-scale)

    Well-being actions self-efficacy will be measured at Wave 3 with the 18-item well-being actions self-efficacy scale \[11\]. Responses to the three Likert-scale quantitative items intended to measure the community sub-scale will be summed at Wave 3 to form a community sub-scale score at Wave 3 with higher values representing greater community well-being actions self efficacy. The minimum score will be 0. The maximum score will be 12.

    Week 11

  • well-being actions self-efficacy (occupational sub-scale)

    Well-being actions self-efficacy will be measured at Wave 3 with the 18-item well-being actions self-efficacy scale \[11\]. Responses to the three Likert-scale quantitative items intended to measure the occupational sub-scale will be summed at Wave 3 to form an occupational sub-scale score at Wave 3 with higher values representing greater occupational well-being actions self efficacy. The minimum score will be 0. The maximum score will be 12.

    Week 11

  • well-being actions self-efficacy (physical sub-scale)

    Well-being actions self-efficacy will be measured at Wave 3 with the 18-item well-being actions self-efficacy scale \[11\]. Responses to the three Likert-scale quantitative items intended to measure the physical sub-scale will be summed at Wave 3 to form a physical sub-scale score at Wave 3 with higher values representing greater physical well-being actions self efficacy. The minimum score will be 0. The maximum score will be 12.

    Week 11

  • well-being actions self-efficacy (psychological sub-scale)

    Well-being actions self-efficacy will be measured at Wave 3 with the 18-item well-being actions self-efficacy scale \[11\]. Responses to the three Likert-scale quantitative items intended to measure the psychological sub-scale will be summed at Wave 3 to form a psychological sub-scale score at Wave 3 with higher values representing greater psychological well-being actions self efficacy. The minimum score will be 0. The maximum score will be 12.

    Week 11

  • well-being actions self-efficacy (economic sub-scale)

    Well-being actions self-efficacy will be measured at Wave 3 with the 18-item well-being actions self-efficacy scale \[11\]. Responses to the three Likert-scale quantitative items intended to measure the economic sub-scale will be summed at Wave 3 to form an economic sub-scale score at Wave 3 with higher values representing greater economic well-being actions self efficacy. The minimum score will be 0. The maximum score will be 12.

    Week 11

  • subjective well-being (interpersonal sub-scale)

    Subjective well-being will be measured at Wave 3 with the 21-item I COPPE scale \[12\]. Responses to the three Likert-scale quantitative items intended to measure the interpersonal sub-scale will be summed at Wave 3 to form an interpersonal sub-scale score at Wave 3 with higher values representing greater interpersonal well-being. The minimum score will be 0. The maximum score will be 30.

    Week 11

  • subjective well-being (community sub-scale)

    Subjective well-being will be measured at Wave 3 with the 21-item I COPPE scale \[12\]. Responses to the three Likert-scale quantitative items intended to measure the community sub-scale will be summed at Wave 3 to form a community sub-scale score at Wave 3 with higher values representing greater interpersonal well-being. The minimum score will be 0. The maximum score will be 30.

    Week 11

  • subjective well-being (occupational sub-scale)

    Subjective well-being will be measured at Wave 3 with the 21-item I COPPE scale \[12\]. Responses to the three Likert-scale quantitative items intended to measure the occupational sub-scale will be summed at Wave 3 to form an occupational sub-scale score at Wave 3 with higher values representing greater occupational well-being. The minimum score will be 0. The maximum score will be 30.

    Week 11

  • subjective well-being (physical sub-scale)

    Subjective well-being will be measured at Wave 3 with the 21-item I COPPE scale \[12\]. Responses to the three Likert-scale quantitative items intended to measure the physical sub-scale will be summed at Wave 3 to form a physical sub-scale score at Wave 3 with higher values representing greater physical well-being. The minimum score will be 0. The maximum score will be 30.

    Week 11

  • subjective well-being (psychological sub-scale)

    Subjective well-being will be measured at Wave 3 with the 21-item I COPPE scale \[12\]. Responses to the three Likert-scale quantitative items intended to measure the psychological sub-scale will be summed at Wave 3 to form a psychological sub-scale score at Wave 3 with higher values representing greater psychological well-being. The minimum score will be 0. The maximum score will be 30.

    Week 11

  • subjective well-being (economic sub-scale)

    Subjective well-being will be measured at Wave 3 with the 21-item I COPPE scale \[12\]. Responses to the three Likert-scale quantitative items intended to measure the economic sub-scale will be summed at Wave 3 to form an economic sub-scale score at Wave 3 with higher values representing greater economic well-being. The minimum score will be 0. The maximum score will be 30.

    Week 11

  • subjective well-being (overall sub-scale)

    Subjective well-being will be measured at Wave 3 with the 21-item I COPPE scale \[12\]. Responses to the three Likert-scale quantitative items intended to measure the overall sub-scale will be summed at Wave 3 to form an overall sub-scale score at Wave 3 with higher values representing greater overall well-being. The minimum score will be 0. The maximum score will be 30.

    Week 11

  • well-being actions (interpersonal sub-scale)

    Well-being actions will be measured at Wave 3 with the 18-item I COPPE actions scale \[13\]. Responses to the three Likert-scale quantitative items intended to measure the interpersonal sub-scale will be summed at Wave 3 to form an interpersonal sub-scale score at Wave 3 with higher values representing greater interpersonal well-being actions. The minimum score will be 0. The maximum score will be 12.

    Week 11

  • well-being actions (community sub-scale)

    Well-being actions will be measured at Wave 3 with the 18-item I COPPE actions scale \[13\]. Responses to the three Likert-scale quantitative items intended to measure the community sub-scale will be summed at Wave 3 to form a community sub-scale score at Wave 3 with higher values representing greater community well-being actions. The minimum score will be 0. The maximum score will be 12.

    Week 11

  • well-being actions (occupational sub-scale)

    Well-being actions will be measured at Wave 3 with the 18-item I COPPE actions scale \[13\]. Responses to the three Likert-scale quantitative items intended to measure the occupational sub-scale will be summed at Wave 3 to form an occupational sub-scale score at Wave 3 with higher values representing greater occupational well-being actions. The minimum score will be 0. The maximum score will be 12.

    Week 11

  • well-being actions (physical sub-scale)

    Well-being actions will be measured at Wave 3 with the 18-item I COPPE actions scale \[13\]. Responses to the three Likert-scale quantitative items intended to measure the physical sub-scale will be summed at Wave 3 to form a physical sub-scale score at Wave 3 with higher values representing greater physical well-being actions. The minimum score will be 0. The maximum score will be 12.

    Week 11

  • well-being actions (psychological sub-scale)

    Well-being actions will be measured at Wave 3 with the 18-item I COPPE actions scale \[13\]. Responses to the three Likert-scale quantitative items intended to measure the psychological sub-scale will be summed at Wave 3 to form a psychological sub-scale score at Wave 3 with higher values representing greater psychological well-being actions. The minimum score will be 0. The maximum score will be 12.

    Week 11

  • well-being actions (economic sub-scale)

    Well-being actions will be measured at Wave 3 with the 18-item I COPPE actions scale \[13\]. Responses to the three Likert-scale quantitative items intended to measure the economic sub-scale will be summed at Wave 3 to form an economic sub-scale score at Wave 3 with higher values representing greater psychological well-being actions. The minimum score will be 0. The maximum score will be 12.

    Week 11

  • physical activity self-efficacy (job-related vigorous sub-scale)

    Physical activity self-efficacy will be measured at Wave 3 with the 48-item physical activity self-efficacy scale \[11\]. Responses to the six Likert-scale quantitative items intended to measure the job-related vigorous sub-scale will be summed at Wave 3 to form a job-related vigorous sub-scale score at Wave 3 with higher values representing greater physical activity self-efficacy (job-related vigorous). The minimum score will be 0. The maximum score will be 24.

    Week 11

  • physical activity self-efficacy (domestic and gardening-related vigorous sub-scale)

    Physical activity self-efficacy will be measured at Wave 3 with the 48-item physical activity self-efficacy scale \[11\]. Responses to the six Likert-scale quantitative items intended to measure the domestic and gardening-related vigorous sub-scale will be summed at Wave 3 to form a domestic and gardening-related vigorous sub-scale score at Wave 3 with higher values representing greater physical activity self-efficacy (domestic and gardening-related vigorous). The minimum score will be 0. The maximum score will be 24.

    Week 11

  • physical activity self-efficacy (transportation-related vigorous sub-scale)

    Physical activity self-efficacy will be measured at Wave 3 with the 48-item physical activity self-efficacy scale \[11\]. Responses to the six Likert-scale quantitative items intended to measure the transportation-related vigorous sub-scale will be summed at Wave 3 to form a transportation-related vigorous sub-scale score at Wave 3 with higher values representing greater physical activity self-efficacy (transportation-related vigorous). The minimum score will be 0. The maximum score will be 24.

    Week 11

  • physical activity self-efficacy (leisure-related vigorous sub-scale)

    Physical activity self-efficacy will be measured at Wave 3 with the 48-item physical activity self-efficacy scale \[11\]. Responses to the six Likert-scale quantitative items intended to measure the leisure-related vigorous sub-scale will be summed at Wave 3 to form a leisure-related vigorous sub-scale score at Wave 3 with higher values representing greater physical activity self-efficacy (leisure-related vigorous). The minimum score will be 0. The maximum score will be 24.

    Week 11

  • physical activity self-efficacy (job-related moderate sub-scale)

    Physical activity self-efficacy will be measured at Wave 3 with the 48-item physical activity self-efficacy scale \[11\]. Responses to the six Likert-scale quantitative items intended to measure the job-related moderate sub-scale will be summed at Wave 3 to form a job-related moderate sub-scale score at Wave 3 with higher values representing greater physical activity self-efficacy (job-related moderate). The minimum score will be 0. The maximum score will be 24.

    Week 11

  • physical activity self-efficacy (transportation-related moderate sub-scale)

    Physical activity self-efficacy will be measured at Wave 3 with the 48-item physical activity self-efficacy scale \[11\]. Responses to the six Likert-scale quantitative items intended to measure the transportation-related moderate sub-scale will be summed at Wave 3 to form a transportation-related moderate sub-scale score at Wave 3 with higher values representing greater physical activity self-efficacy (transportation-related moderate). The minimum score will be 0. The maximum score will be 24.

    Week 11

  • physical activity self-efficacy (domestic and gardening-related moderate sub-scale)

    Physical activity self-efficacy will be measured at Wave 3 with the 48-item physical activity self-efficacy scale \[11\]. Responses to the six Likert-scale quantitative items intended to measure the domestic and gardening-related moderate sub-scale will be summed at Wave 3 to form a domestic and gardening-related moderate sub-scale score at Wave 3 with higher values representing greater physical activity self-efficacy (domestic and gardening-related moderate). The minimum score will be 0. The maximum score will be 24.

    Week 11

  • physical activity self-efficacy (leisure-related moderate sub-scale)

    Physical activity self-efficacy will be measured at Wave 3 with the 48-item physical activity self-efficacy scale \[11\]. Responses to the six Likert-scale quantitative items intended to measure the leisure-related moderate sub-scale will be summed at Wave 3 to form a leisure-related moderate sub-scale score at Wave 3 with higher values representing greater physical activity self-efficacy (leisure-related moderate). The minimum score will be 0. The maximum score will be 24.

    Week 11

  • Self-efficacy to regulate physical activity

    Self-efficacy to regulate physical activity will be measured at Wave 3 with the 13-item self-efficacy to regulate physical activity scale \[11\]. Responses to the thirteen Likert-scale quantitative items will be summed at Wave 3 to form a a total self-efficacy to regulate physical activity score at Wave 3 with higher values representing greater self-efficacy to regulate physical activity. The minimum score will be 0. The maximum score will be 52.

    Week 11

  • physical activity (Fitbit Zip)

    A commercial-grade (Fitbit Zip) accelerometer will be initialized and attached to an adjustable nylon belt to measure physical activity objectively at Wave 3. Average minutes-per-day of moderate to vigorous physical activity will be determined using the Fitbit application, which uses a proprietary algorithm to estimate fairly active minutes and very active minutes.

    Week 12

  • physical activity (Actigraph wGT3X-BT)

    A research-grade (Actigraph wGT3X-BT) accelerometer will be initialized and attached to an adjustable nylon belt to measure physical activity objectively at Wave 3. Average minutes-per-day of moderate to vigorous physical activity will be calculated based on established cut points (e.g., \> 1952 counts per minute).

    Week 12

  • self-reported physical activity

    Self-reported physical activity will be measured at Wave 3 with the long form of the international physical activity questionnaire \[9,10\]. Average minutes-per-day of moderate to vigorous physical activity will be formed by dividing the sum of the minutes per day (across one week) of minutes-per-day of moderate to vigorous physical activity in the work, transportation, domestic and gardening, and leisure domains by 7 days.

    Week 12

  • feasibility of accelerometer-based assessment of physical activity (participation rate)

    The feasibility of accelerometer-based assessment of physical activity will be assessed with participation rate at Wave 3. Participation rate at Wave 1 will be defined as the percentage of consented patients who provide usable data at Wave 3. Usable data will be defined as: (a) a log sheet with a valid start date is submitted, (b) a monitor is worn for at least 4 days (including one weekend day) with at least 10 hours of valid wear time per day, and (c) no evidence of monitor error (e.g., activity counts \> 20,000 or lengthy strings of repeated activity counts).

    Week 12

  • feasibility of accelerometer-based assessment of physical activity (retention rate)

    The feasibility of accelerometer-based assessment of physical activity will be assessed with retention rate at Wave 3. Retention rate at Wave 3 will be defined as the percentage of consented patients who provide usable data at Wave 1, Wave 2, and Wave 3. Usable data will be defined as: (a) a log sheet with a valid start date is submitted, (b) a monitor is worn for at least 4 days (including one weekend day) with at least 10 hours of valid wear time per day, and (c) no evidence of monitor error (e.g., activity counts \> 20,000 or lengthy strings of repeated activity counts).

    Week 12

  • acceptability of accelerometer-based assessment of physical activity (quantitative)

    The acceptability of accelerometer-based assessment of physical activity will be assessed at Wave 3 with a modified version of an unnamed questionnaire used in previous research \[7,8\]. The 11-item acceptability questionnaire used in this study consists of a mix of both Likert-scale quantitative (6) and open-ended qualitative (5) items. Responses to the six Likert-scale quantitative items will be summed at Wave 3 to form a total acceptability score at Wave 3 with higher values representing greater acceptability. The minimum total acceptability score at Wave 3 will be 6. The maximum total acceptability score at Wave 3 will be 23.

    Week 13

  • acceptability of accelerometer-based assessment of physical activity (qualitative)

    The acceptability of accelerometer-based assessment of physical activity will be assessed at Wave 3 with a modified version of an unnamed questionnaire used in previous research \[7,8\]. The 11-item acceptability questionnaire used in this study consists of a mix of both Likert-scale quantitative (6) and open-ended qualitative (5) items. Responses to the five qualitative items will be content analyzed together at Wave 3 to find conceptual themes at Wave 3 with regard to the acceptability of accelerometer-based assessment of physical activity.

    Week 13

Study Arms (2)

Fun For Wellness (FFW)

EXPERIMENTAL

Participants assigned to the FFW group (i.e., FFW participants) will proceed through the pre-operative program provided by the center and will be given 4 weeks of 24 hr access to the FFW online intervention during data collection for this study. Intervention participants will: 1) watch original videos with vignettes performed by professional actors; 2) read and/or watch mini-lectures that teach skills for behavior change; 3) engage in self-reflection exercises, 4) play original interactive games related to vignettes and mini-lectures; 5) interact with other FFW users via chat room functions and; 6) watch funny narrated video clips about well-being and/or physical activity.

Behavioral: Fun For Wellness (FFW)

Usual Care (UC)

NO INTERVENTION

Participants assigned to the UC group (i.e., UC participants) will proceed through the pre-operative weight management program provided by the center.

Interventions

FFW consists of videos, games, and content in the form of 152 BET I CAN challenges \[1\]. Behavior challenges are intended to increase a participant's capabilities to set a goal and to create positive habits. Emotion challenges are intended to increase a participant's capabilities to cope with negative emotions and to cultivate positive emotions. Thought challenges are intended to increase a participant's capabilities to challenge negative assumptions and to create a new narrative for their life. Interaction challenges are intended to increase a participant's capabilities to communicate and connect with others. Context challenges are intended to increase a participant's capabilities to read cues and to change cues in the environment. Awareness challenges are intended to increase a participant's capabilities to know herself/himself and to know the issue. Next steps challenges are intended to increase a participant's capabilities to make a plan and to stick with a plan.

Fun For Wellness (FFW)

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Individual is at least 18 years old but not older than 64 years old. Individual has a body mass index (BMI) ≥ 25.00 kg/m2. Individual has access to a technological device (e.g., computer) that can access the online intervention.
  • Individual is not simultaneously enrolled in another program promoting either well-being or physical activity.
  • Individual is willing to comply with instructions for physical activity monitoring.

You may not qualify if:

  • Individual is less than 18 years old or older than 64 years old. Individual has a body mass index (BMI) \< 25.00. Individual does not have access to a technological device (e.g., computer) that can access the online intervention.
  • Individual is simultaneously enrolled in another program promoting either well-being or physical activity.
  • Individual is unwilling to comply with instructions for physical activity monitoring.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sparrow Health System Bariatric Services

East Lansing, Michigan, 48823-2946, United States

Location

Related Publications (14)

  • Myers ND, Prilleltensky I, Prilleltensky O, McMahon A, Dietz S, Rubenstein CL. Efficacy of the Fun For Wellness Online Intervention to Promote Multidimensional Well-Being: a Randomized Controlled Trial. Prev Sci. 2017 Nov;18(8):984-994. doi: 10.1007/s11121-017-0779-z.

    PMID: 28303422BACKGROUND
  • Bandura A. Self-efficacy: the exercise of control. New York: Freeman; 1997.

    BACKGROUND
  • Myers ND, Dietz S, Prilleltensky I, Prilleltensky O, McMahon A, Rubenstein CL, Lee S. Efficacy of the Fun For Wellness Online Intervention to Promote Well-Being Actions: A Secondary Data Analysis. Games Health J. 2018 Aug;7(4):225-239. doi: 10.1089/g4h.2017.0132. Epub 2018 Apr 30.

    PMID: 29708773BACKGROUND
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  • ClinicalTrials.gov: Well-Being and Physical Activity Study. https://clinicaltrials.gov/ct2/show/NCT 03194854 Accessed 9 January 2019.

    BACKGROUND
  • Prilleltensky I, Dietz S, Prilleltensky O, Myers ND, Rubenstein CL, Jin Y, et al. Assessing multidimensional well-being: development and validation of the I COPPE scale. J Community Psychol. 2015;43:199-226.

    BACKGROUND
  • Rubenstein CL. Assessing actions and feelings related to multidimensional well-being: validation of the I COPPE actions and feelings scales. 2017. https://scholarlyrepository.miami.edu/oa_dissertations/1942. Accessed 1 July 2018.

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  • Myers ND, Lee S, Bateman AG, Prilleltensky I, Clevenger KA, Pfeiffer KA, Dietz S, Prilleltensky O, McMahon A, Brincks AM. Accelerometer-based assessment of physical activity within the Fun For Wellness online behavioral intervention: protocol for a feasibility study. Pilot Feasibility Stud. 2019 May 31;5:73. doi: 10.1186/s40814-019-0455-0. eCollection 2019.

MeSH Terms

Interventions

Health

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

  • Nicholas D Myers, Ph.D.

    Michigan State University

    PRINCIPAL INVESTIGATOR
  • Isaac Prilleltensky, Ph.D.

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants, center staff, and research staff will be blinded to participant group assignment.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to either the Fun For Wellness (FFW) group or the Usual Care (i.e., UC) group by the code programmed within the FFW website that is specified to achieve a 1:1 group (i.e., nFFW = 15, nUC = 15) assignment. Participants assigned to the UC group (i.e., UC participants) will proceed through the pre-operative weight management program provided by the center. Participants assigned to the FFW group (i.e., FFW participants) will proceed through the pre-operative program provided by the center and will be given 4 weeks (i.e., Week 3 through Week 6) of 24 hr access to the FFW online intervention during data collection for this study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 3, 2019

First Posted

April 8, 2019

Study Start

November 7, 2019

Primary Completion

April 2, 2020

Study Completion

April 2, 2020

Last Updated

September 2, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations