NCT04116372

Brief Summary

Internet-based health promotion programs have the potential to reach more individuals than in person interventions, without overtaxing healthcare resources. Having a high quality, user-centered web-based program can help maximize user engagement and adherence. Thus, the primary objective of this pilot study is to examine the feasibility and acceptability of a web-based physical activity behavior change program on recently retired and/or empty nest populations. The primary research question is: Is it worthwhile to conduct a larger scale eHealth study targeting empty nest and/or retired populations based on preliminary results and feedback from this pilot study. We will also be examining changes other behavioral indicators related to physical activity as a secondary outcome measure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration 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

October 3, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

October 10, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

2.1 years

First QC Date

October 3, 2019

Last Update Submit

May 17, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Recruitment rate (monthly)

    For the full scale RCT, we are looking for a 1 day per week or 30 min MVPA change which equates to an approximate effect size of d = .35. This equates to roughly 65 per group (130 for a two group trial). If we recruit for 2 years in the large trial (assuming a six month time period for each person in the intervention) we need to be recruiting at least 6 per month. If we decide on a three armed trial, we will need to recruit at least 8 per month.

    4 months

  • Participant retention

    Number of participants who complete both baseline and end of study (10 week) measures. A 80-100% retention rate is indicative of a strong trial (Jackson \& Waters, 2005).

    10 weeks

  • Participant intervention satisfaction/evaluation

    For satisfaction ratings, mean and standard deviations will be calculated for the quantitative satisfaction and evaluation questionnaire. Given that scores of 1 (ex. not helpful, did not use the tools) and 2 (ex. Somewhat helpful, used a little bit of the tools) indicated levels of dissatisfaction, and 3 (ex. Quite helpful, used a bit of the tools) and 4 (ex. Extremely helpful, used a lot of the tools) indicated some sort of satisfaction, a mean score of ≥ 2.5 will be deemed acceptable for recommendation for a full RCT.

    10 weeks

Secondary Outcomes (6)

  • Change in self-reported physical activity from baseline to 10 weeks

    Baseline - 10 weeks

  • Change in physical activity beliefs, attitudes, barriers, and motivation from baseline to 10 weeks.

    Baseline - 10 weeks

  • Change in physical activity behaviour regulation from baseline to 10 weeks.

    Baseline - 10 weeks

  • Change in physical activity habits from baseline to 10 weeks.

    Baseline - 10 weeks

  • Change in physical activity identity from baseline to 10 weeks.

    Baseline - 10 weeks

  • +1 more secondary outcomes

Study Arms (4)

Empty Nest Intervention Group

EXPERIMENTAL

Participants will complete a baseline questionnaire, and receive access to the our online platform for 10 weeks. Completing the online platform is designed to encourage participants to engage in physical activity. At 2 and 5 weeks, a check-in session will occur over the phone. At 10 weeks the participant will be contacted to return to the lab to complete the final questionnaire, and do a wrap up interview. The end-of-trial qualitative interview will evaluate participant satisfaction and feasibility of the intervention. For this reason a lab employee unaffiliated with this study will complete these in person interviews.

Behavioral: Digital Health Online Platform

Retirement Intervention Group

EXPERIMENTAL

Participants will complete a baseline questionnaire, and receive access to the our online platform for 10 weeks. Completing the online platform is designed to encourage participants to engage in physical activity. At 2 and 5 weeks, a check-in session will occur over the phone. At 10 weeks the participant will be contacted to return to the lab to complete the final questionnaire, and do a wrap up interview. The end-of-trial qualitative interview will evaluate participant satisfaction and feasibility of the intervention. For this reason a lab employee unaffiliated with this study will complete these in person interviews.

Behavioral: Digital Health Online Platform

Empty Nest Control Group

NO INTERVENTION

This group will complete baseline and final questionnaires (online or paper). At the end of the study this group will have the option to receive access to the other group's materials (online platform) if they wish, for the 10 week period following the study.

Retirement Control Group

NO INTERVENTION

This group will complete baseline and final questionnaires (online or paper). At the end of the study this group will have the option to receive access to the other group's materials (online platform) if they wish, for the 10 week period following the study.

Interventions

The website has 10 lessons that the participant will gain access to on a weekly basis. Lesson titles are as follows: Lesson 1 - Benefits of Physical Activity on Chronic Disease Lesson 2 - Mental benefits of Physical Activities Lesson 3 - Increasing Self Confidence for Physical Activities Lesson 4 - Learning about your Emotions Lesson 5 - Building Social Support Lesson 6 - Building Physical Activity Opportunity Lesson 7 - Goal Setting and Planning Lesson 8 - Self Monitoring Lesson 9 - Habit Lesson 10 - Identity

Empty Nest Intervention GroupRetirement Intervention Group

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Potential participants will be included if they have either a) recently (within 6 months) retired, or b) experienced children moving out of the familial home. In addition, potential participants must have access to the internet at home, and have a smart phone or home computer that can support the eHealth application we are using. Potential participants must currently be not meeting the physical activity (PA) guidelines (less than 150 minutes of moderate to vigorous aerobic activity). There will be no delimitations to the sample based on socio-economic or ethnic variables.

You may not qualify if:

  • Participants will be excluded from the project if they not have access to the Internet, are unable to speak/read English, are engaging in moderate-to vigorous PA (MVPA) sufficient to meet the PA Guidelines, have an existing chronic medical condition potentially making them at risk of injury or ill health from increasing their physical activity (assessed using the GAQ)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UVIC

Victoria, British Columbia, Canada

Location

Related Publications (1)

  • Jackson N, Waters E; Guidelines for Systematic Reviews in Health Promotion and Public Health Taskforce. Criteria for the systematic review of health promotion and public health interventions. Health Promot Int. 2005 Dec;20(4):367-74. doi: 10.1093/heapro/dai022. Epub 2005 Sep 16.

    PMID: 16169885BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Ryan Rhodes

Study Record Dates

First Submitted

October 3, 2019

First Posted

October 4, 2019

Study Start

October 10, 2019

Primary Completion

November 30, 2021

Study Completion

November 30, 2021

Last Updated

May 18, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations