- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06098716
All in the Family: Promoting Family Function Through Physical Activity (SSHRC-Family)
The goal of this trial is to find out whether adding identity-building and self-regulation training to basic healthy-living education helps families with inactive children (ages 6-12) become more cohesive and physically active. The main question it aims to answer is:
Does the identity + self-regulation + education program improve family cohesion more than (a) self-regulation + education or (b) education alone?
Researchers will compare three groups-identity+self-regulation+education (ID), self-regulation+education (SR), and education-only (ED)-to see which produces the greatest improvements.
Participants will:
- attend three online workshops at baseline plus two booster sessions at 6-week and 3-month with a project coordinator;
- complete online questionnaires at baseline, 6-week, 3-month, and 6-month;
- take part in an exit interview at 6 months.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The primary objective of this study is to test the efficacy of three family physical activity (PA) interventions on a key family functioning outcome-family cohesion-through increased PA in children and parent-child co-PA. Our study tests three intervention conditions: 1) identity (ID; promotion of a PA parenting identities + self-regulation skills + education), 2) self-regulation (SR; promotion of PA parenting self-regulation skills + education) and 3) education (ED; an education about PA control condition). It is hypothesised that (H1): The ID condition will show significantly larger changes in family cohesion compared to the two other conditions after six-months (primary end-point) and (H2): The SR condition will show significantly larger changes in family cohesion compared to the ED control condition after six-months.
There are three secondary objectives for this study. First, this study aims to assess the impact of the three interventions on the remaining family-functioning dimensions-flexibility and organisation-and on behavioural outcomes (child MVPA and parent-child co-PA) at the 6-month end-point. The ID condition is hypothesized to lead to significantly greater increases in family flexibility, family organization, child MVPA and parent-child co-PA compared to the SR and ED conditions after six months (H3), with the SR condition also expected to outperform the ED condition in these PA outcomes (H4).
Second, this study will also investigate whether group differences in child and parent PA and family functioning outcomes can be explained through a mediation model based on the Multi-Process Action Control (M-PAC) framework. It is hypothesized that changes in child MVPA and parent-child co-PA will mediate the relationship between the intervention groups and family functioning outcomes. These changes in PA behaviors are expected to be predicted by alterations in family social identity and parental PA support identity, which will, in turn, be influenced by parental attitudes, perceptions of control (reflective processes), and behavioral self-regulation (regulatory processes) regarding child PA (H5).
Third, the present study will explore the potential moderating effects of seasonal variation, child sex, dual/single-parent status, parent sex and gender, child age, intervention adherence, and the type and format of PA on the primary outcomes across the three intervention conditions. While no specific hypotheses are pre-set for these factors, it is anticipated that participation in PA may decrease during winter due to weather conditions, and single-parent families might face more barriers to parent-child co-PA, leading to lower participation levels. Additionally, the composition and frequency patterns of child MVPA may influence family functioning outcomes differently across the intervention conditions.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sandy Courtnall
- Phone Number: 250 472 5288
- Email: bml@uvic.ca
Study Locations
-
-
British Columbia
-
Victoria, British Columbia, Canada, V8W 2Y2
- Recruiting
- University of Victoria
-
Contact:
- Ryan Rhodes
- Email: rrhodes@uvic.ca
-
Contact:
- Sandy Courtnall
- Email: scourtnal@uvic.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Participants will be at least one parent with at least one child between the ages of 6 and 12 years.
Families (parents and/or guardians and children) residing in Canada. Children that participate in <60 minutes/day of moderate to vigorous physical activity (MVPA).
Exclusion Criteria:
If child is meeting the current physical activity guidelines >=60 minutes a day of moderate to vigorous physical activity per day.
If the participant does not pass the Physical Activity Readiness Questionnaire (PARQ) If children's age falls outside the 6-12 year range
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Education
The Education condition package will consist of Canada's PA guidelines, information about the benefits of child and adult PA, healthy living and a breakdown of ways for the parent to help their child achieve this PA.
|
Information about healthy living (e.g., PA, sleep hygiene and healthy eating)
|
|
Experimental: Self Regulation
The SR condition will receive all of the same education material as the education condition in addition to skill training content (how to plan for family PA) based on our prior family trials.
Families will be instructed to plan for "when," "where," "how," and "what" PA will be performed, and to create back-up plans commensurate with the creation of action and coping planning.
|
How to plan for Family PA
Information about healthy living (e.g., PA, sleep hygiene and healthy eating)
|
|
Experimental: PA Support & Family Social Identity
The ID condition receives the same education and self-regulation content as the other groups, but with additional activities designed to strengthen (i) parents' PA-support identity and (ii) the family's shared PA social identity.
Session 1 involves only the parent(s) and focuses on parental support identity.
The content is based on the behaviour change principles of self-identity theory that should lead to increases in self-identity.
This session's activities include: 1) bringing awareness to the concept of identity and being a role model, 2) an activity on finding the meaning and value of parental support of child PA, 3) an activity on setting prioritization rules around parental support for child PA in comparison to other parenting responsibilities and values (brainstormed), 4) developing an affirmation for parental support self-talk, and 5) planning ways to visually demonstrate the parental support identity for self-categorization (e.g., on social media, pictures in frames).
|
How to plan for Family PA
Information about healthy living (e.g., PA, sleep hygiene and healthy eating)
Exercises that strengthen parents' PA-support identity and a shared active-family identity through values reflection, role-modelling, visualization, and visible "active family" cues.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Family cohesion
Time Frame: Baseline, 6 weeks, 3 months, and 6 months
|
Family cohension will be assessed using FAD & FACES IV subscale = 1 = Strongly Disagree; 2 = Generally Disagree; 3 = Undecided; 4 = Generally Agree; 5 = Strongly Agree
|
Baseline, 6 weeks, 3 months, and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Family functioning outcomes (i.e., family organisation and flexibility)
Time Frame: Baseline, 6 weeks, 3 months, and 6 months
|
Family organisation and flexibility will be assessed using FAD & FACES IV subscale = 1 = Strongly Disagree; 2 = Generally Disagree; 3 = Undecided; 4 = Generally Agree; 5 = Strongly Agree
|
Baseline, 6 weeks, 3 months, and 6 months
|
|
Children's moderate to vigorous physical activity (MVPA)
Time Frame: Baseline, 6 weeks, 3 months, and 6 months
|
Children's physical activity will be quantified by Self Report using Physical Activity Questionnaire for Children (PAQ-C)
|
Baseline, 6 weeks, 3 months, and 6 months
|
|
Parent-child intergenerational activity measured via parent self-report
Time Frame: Baseline, 6 weeks, 3 months, and 6 months
|
For parent-child co-PA, the Godin Leisure-Time Exercise Questionnaire will be used.
|
Baseline, 6 weeks, 3 months, and 6 months
|
|
Parental support and M-PAC Constructs
Time Frame: Baseline, 6 weeks, 3 months, and 6 months
|
Parental support for child PA: 6-item activity-related parenting practices scale Parental support identity: 3-item version of the Exercise Identity Scale Family PA identity: 4-item scale from Doosje, Ellemers 's ingroup identification measure Parental support habits: 4-item version of the Self-Reported Habit Strength Index Behavioral regulation of parental support: 11-item Physical Activity Regulation Scale Perceived capability and perceived opportunity: 7-item perceived control measure Attitude: 6-item affective and instrumental attitude scale Parental intention: 2-item decisional intention and intention strength scale
|
Baseline, 6 weeks, 3 months, and 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ryan Rhodes, PhD, University of Victoria
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 435-2023-0493
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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