NCT03648216

Brief Summary

This study will explore the causality between outcomes of subjective well-being and sedentary behavior, through experimentally increasing the sedentary behavior levels of active university students. Half of the eligible participants will receive a behavioral counseling intervention to increase sedentary behavior over one week, while the other half will receive no instructions. After one week, all participants will receive no instructions and continue to wear the inclinometer for another week.

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 Jan 2020

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 27, 2018

Completed
1.4 years until next milestone

Study Start

First participant enrolled

January 7, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2021

Completed
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

1.2 years

First QC Date

August 14, 2018

Last Update Submit

February 29, 2024

Conditions

Keywords

Sedentary BehaviourSubjective Well-BeingUniversity Students

Outcome Measures

Primary Outcomes (4)

  • Change from pre-randomization Subjective Well-Being (Affect) at 1-week post-intervention and 1-week follow-up

    Subjective Well-Being (specifically, affect) will be assessed through the Positive Affect \& Negative Affect Scale (PANAS). The PANAS consists of a number of words that describe different feelings and emotions. Participants indicate the extent to which they feel a particular feeling and emotion over the past week, using a 5-point scale that ranges from 1 "very slightly or not at all" to 5 "extremely". An overall score for both positive and negative affect is calculated by summing up the points for those particular feelings/emotions (e.g., interested for positive affect, distressed for negative affect). Scores for positive affect can range from 10-50, with higher scores representing higher levels of positive affect. Scores for negative affect can range from 10-50, with lower scores representing lower levels of negative affect.

    Baseline, 1-week post-intervention, and 1-week follow-up

  • Change from pre-randomization Subjective Well-Being (Life Satisfaction) at 1-week post-intervention and 1-week follow-up

    Subjective Well-Being (specifically, life satisfaction) will be assessed through the Satisfaction with Life Scale (SWLS); a 5-item scale designed to measure global cognitive judgments of one's life satisfaction. Participants indicate how much they agree or disagree with each of the 5-items over the past week, using a 7-point scale that ranges from 7 "strongly agree" to 1 "strongly disagree". An overall score (from 5 to 35) is calculated through summing the responses to the 5-items. Recommended cutoffs for interpretation are: 5-9, extremely dissatisfied; 10-14, dissatisfied; 15-19, slightly dissatisfied; 20, neutral; 21-25, slightly satisfied; 26-30, satisfied; 31-35, very satisfied.

    Baseline, 1-week post-intervention, and 1-week follow-up

  • Change from pre-randomization Subjective Well-Being (Eudaimonic Well-Being) at 1-week post-intervention and 1-week follow-up

    Subjective Well-Being (Eudaimonic Well-Being) will be assessed through the Subjective Vitality Scale (SVS); a 6- or 7-item scale that assesses the state of feeling alive and alert - to having energy available to the self. For the purposes of this study, the 6-item individual difference level version of the SVS will be utilized. Participants indicate the degree in which a statement/item is true in general in their life, ranging from 1 "not at all" to 7 "very true". An overall score is obtained by averaging the scores for each of the 6-items, with higher scores indicating a greater feeling of vitality.

    Baseline, 1-week post-intervention, and 1-week follow-up

  • Change from pre-randomization Subjective Well-Being at 1-week post-intervention and 1-week follow-up

    Subjective Well-Being will be assessed through the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS). The WEMWBS consists of 14-items that assesses subjective well-being through both hedonic and eudaimonic dimensions of well-being. Participants select the option that best describes their experience with each of the 14-items over the last week (note: the original questionnaire assesses the last two weeks), using a 5-point scale that ranges from 1 "none of the time" to 5 "all of the time". A total score is calculated by summing the 14 individual statement scores. The minimum score is 14 and the maximum is 70, with higher scores indicating greater levels of subjective well-being.

    Baseline, 1-week post-intervention, and 1-week follow-up

Secondary Outcomes (5)

  • Change from pre-randomization self-reported Physical Activity at 1-week post-intervention and 1-week follow-up

    Baseline, 1-week post-intervention, and 1-week follow-up

  • Change from pre-randomization self-reported Sedentary Behaviour at 1-week post-intervention and 1-week follow-up

    Baseline, 1-week post-intervention, and 1-week follow-up

  • Change from pre-randomization Depression at 1-week post-intervention and 1-week follow-up

    Baseline, 1-week post-intervention, and 1-week follow-up

  • Change from pre-randomization Anxiety (State) at 1-week post-intervention and 1-week follow-up

    Baseline, 1-week post-intervention, and 1-week follow-up

  • Change from pre-randomization objectively-measured Sedentary Behaviour at 1-week post-intervention and 1-week follow-up

    Baseline, 1-week post-intervention, and 1-week follow-up

Other Outcomes (6)

  • Age

    Baseline

  • Gender

    Baseline

  • Program of Study

    Baseline

  • +3 more other outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

The intervention group will receive a pedometer and HAPA behavioural counseling with the aim of limiting their daily step count to \<5000 steps per day, over a one week period. Counseling strategies will be grounded in the HAPA model - specifically, creating an action plan and coping strategies for maximizing their daily sedentary behaviour and minimizing steps taken. Strategies may include: driving to locations more often, refraining from physical activity as much as possible, and/or completing tasks in sedentary postures.

Behavioral: HAPA behavioural counseling

Control Group

NO INTERVENTION

The control group will not receive any behavioural intervention or instruction.

Interventions

Behavioural counseling grounded in the Health Action Process Approach (HAPA; i.e., action planning and coping planning) to maximize sedentary behaviour and minimize steps taken.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Full-time student attending Western University
  • Able to read and write in English
  • Self-reporting ≥150 minutes/week of moderate-vigorous physical activity

You may not qualify if:

  • Self-reporting a mental illness
  • Currently having a physical disability that would prevent walking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise and Health Psychology Lab, Western University

London, Ontario, N6A 2G5, Canada

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Harry Prapavessis, PhD

    Western University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Study advertisements and information provided to participants will focus on non-specific behaviour change, in order to mask participants to the purpose of the study.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Upon obtaining consent, eligible participants will complete a week-long baseline period and then will be randomly assigned to either a 1-week intervention or control group, followed by a 1-week follow-up period.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2018

First Posted

August 27, 2018

Study Start

January 7, 2020

Primary Completion

March 17, 2021

Study Completion

March 17, 2021

Last Updated

March 1, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

Upon publication of the research results, IPD will be shared into the Federated Research Data Repository (FRDR)

Shared Documents
STUDY PROTOCOL
Time Frame
Data will become available upon publication of the research results, and will be available for 5 years after depositing.
Access Criteria
Members of the FRDR will be able to access the data.
More information

Locations