- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06070038
A Collaborative Theory-based Intervention to Promote Physical Activity Among Sedentary Parents and Their Children (ProAct)
Study Overview
Status
Intervention / Treatment
Detailed Description
Low levels of physical activity in adult and youth populations are associated with an increased risk of physical and mental health conditions and reduced quality of life. Conversely, regular activity participation is associated with reduced chronic disease risk and better psychological health and well-being. However, studies indicate that most young people and adults do not achieve recommended levels of physical activity. Physical activity participation also tends to decrease throughout childhood, with steep declines observed during adolescence. Consequently, effective means to promote physical activity participation in child and adult populations are needed. While family-based interventions represent a potentially useful environment for delivering behavioural interventions to promote physical activity in both parents and children, few interventions have been applied in this context. Those that have, tend not to have a strong basis in behavioural theory, often focus on short-term change, and are seldom evaluated systematically.
Within this project, we aim to develop an intervention to promote physical activity in low-active parents and their children. Based on previous research, an integrated model based on multiple theories from behavioural science, particularly social psychology, will guide the development of the intervention in the current project. Specifically, the model draws its predictions from two key behavioural theories: self-determination theory (SDT) and the theory of planned behaviour (TPB), two pre-eminent theoretical approaches that have been applied extensively to predict behaviour and guide interventions in health behaviour contexts.
Evidence suggests that a key approach to family-based behavioural interventions aimed at promoting physical activity in young people and their parents should focus on parent-child dyads, as they provide an efficient means to increase physical activity in both parties. Few studies have systematically evaluated the efficacy of behaviour change methods focused specifically on these kinds of dyad in changing physical activity in family-based interventions and further high-quality evidence is needed. Although the proposed integrated model has generally been used as a basis for interventions in individual contexts, it has not hitherto been adopted as a basis for family-based behaviour change interventions focused on dyads, yet is well placed to be adapted to inform such interventions. The model can also be modified to encompass dyad-focused versions of key determinants identified in the model. For example, the model can be modified to include dyad-based self-efficacy perceptions, a family-based revision of the self-efficacy construct in the model, which reflects perceived confidence in performing the target behaviour together with other dyad members and joint appraisal of goal progress.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Keegan Knittle
- Phone Number: +358504698252
- Email: keegan.p.knittle@jyu.fi
Study Locations
-
-
Keski Suomi
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Jyväskylä, Keski Suomi, Finland, 40014
- Recruiting
- The Faculty of Sport and Health Sciences
-
Contact:
- Keegan Knittle
- Phone Number: +358504698252
- Email: keegan.p.knittle@jyu.fi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Parent does not undertake at least 150 minutes of moderate-intensity (or 75 minutes of vigorous-intensity) physical activity each week.
- Child does not undertake at least 60 minutes of moderate-intensity or vigorous-intensity physical activity each day.
- Child is aged between 8 and 12 years old
Exclusion Criteria:
- Parent reports that either they or their child is currently meeting physical activity guidelines at screening.
- Parent states that they or their child has some physical condition that prohibits them from safely participating in physical activity.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Immediate Intervention Group
Immediate intervention group.
Participants assigned to the immediate intervention group will be delivered materials over a three-month period as a series of four zoom hosted workshops, online content, and a social support group.
|
The intervention will be delivered over a three-month period as a series of four zoom hosted workshops, online content, and a moderated social support group.
Zoom workshops will last 45 minutes and will target key constructs from the integrated behavior change model.
Main topics of the workshops are autonomy Supportive parenting (Week 1), goal setting and outcome beliefs (Week 3), physical activity norms (Week 5), and encouraging self-efficacy and maintenance (Week 8).
Following each workshop, participants will receive links to online content that builds on workshop themes, such as messages, worksheets, and reflection tasks.
Throughout the trial, participants will be able to participate in social support chat groups to discuss their progress with other members of the intervention group and intervention facilitators.
|
|
Other: Waitlist Control Group
Wait-List Control Group.
Participants in the follow-up group will be delivered intervention materials following the third data collection timepoint.
|
The intervention will be delivered over a three-month period as a series of four zoom hosted workshops, online content, and a moderated social support group.
Zoom workshops will last 45 minutes and will target key constructs from the integrated behavior change model.
Main topics of the workshops are autonomy Supportive parenting (Week 1), goal setting and outcome beliefs (Week 3), physical activity norms (Week 5), and encouraging self-efficacy and maintenance (Week 8).
Following each workshop, participants will receive links to online content that builds on workshop themes, such as messages, worksheets, and reflection tasks.
Throughout the trial, participants will be able to participate in social support chat groups to discuss their progress with other members of the intervention group and intervention facilitators.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Godin Leisure time physical activity questionnaire
Time Frame: Assessed at pre-intervention, 3 months (i.e., immediately post intervention), 6 months, and 12 months.
|
Self-reported leisure time physical activity as assessed by the Godin Leisure time physical activity questionnaire in all participants.
Score range from 0 upwards, with higher scores indicating more leisure time physical activity.
|
Assessed at pre-intervention, 3 months (i.e., immediately post intervention), 6 months, and 12 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Theory of Planned Behavior - Semantic Differential Attitude Scale
Time Frame: Assessed at baseline, 3 months (immediately post intervention), 6 months, and 12 months.
|
Online questionnaires will be administered to all participants assessing their attitudes towards engaging in leisure time physical activity.
Attitude will be assessed using semantic differential scale items scored between 1 and 5, where higher scores are indicative of a more positive attitude towards engaging in physical activity.
Survey items are drawn from Finnish language scales validated and used in the research team's previous work and available at https://osf.io/rfw2g
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Assessed at baseline, 3 months (immediately post intervention), 6 months, and 12 months.
|
|
Theory of Planned Behavior - Subjective Norms Likert Scale
Time Frame: Assessed at baseline, 3 months (immediately post intervention), 6 months, and 12 months.
|
Online questionnaires will be administered to all participants assessing their subjective norms around engaging in leisure time physical activity.
Subjective norm will be assessed using Likert scale items scored between 1 and 5, where higher scores are indicative of a belief that others would want them to engage in physical activity.
Survey items are drawn from Finnish language scales validated and used in the research team's previous work and available at https://osf.io/rfw2g
|
Assessed at baseline, 3 months (immediately post intervention), 6 months, and 12 months.
|
|
Theory of Planned Behavior - Percieved Behavioral Control Likert Scale
Time Frame: Assessed at baseline, 3 months (immediately post intervention), 6 months, and 12 months.
|
Online questionnaires will be administered to all participants assessing their percieved behavioral control around engaging in leisure time physical activity.
Percieved behavioral control will be assessed using Likert scale items scored between 1 and 5, where higher scores are indicative of a belief that the participant is able to engage in physical activity if they so wished.
Survey items are drawn from Finnish language scales validated and used in the research team's previous work and available at https://osf.io/rfw2g
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Assessed at baseline, 3 months (immediately post intervention), 6 months, and 12 months.
|
|
Theory of Planned Behavior - Intention Likert Scale
Time Frame: Assessed at baseline, 3 months (immediately post intervention), 6 months, and 12 months.
|
Online questionnaires will be administered to all participants assessing their intentions to engage in leisure time physical activity.
Intentions will be assessed using Likert scale items scored between 1 and 5, where higher scores are indicative of participants intentions and willingness to engage in leisure time physical activity in future.
Survey items are drawn from Finnish language scales validated and used in the research team's previous work and available at https://osf.io/rfw2g
|
Assessed at baseline, 3 months (immediately post intervention), 6 months, and 12 months.
|
|
Self-Determination Theory - Autonomous Motivation Likert Scale
Time Frame: Assessed at baseline, 3 months (immediately post intervention), 6 months, and 12 months.
|
Online questionnaires will be administered to all participants assessing their level of autonomous motivation to engage in leisure time physical activity.
Autonomous motivationwill be assessed using Likert scale items scored between 1 and 5, where higher scores are indicative of participants desire to engage in physical activity as they are personally motivated to do so.
Survey items are drawn from Finnish language scales validated and used in the research team's previous work and available at https://osf.io/rfw2g
|
Assessed at baseline, 3 months (immediately post intervention), 6 months, and 12 months.
|
|
Self-Determination Theory - Percieved Autonomy Support Likert Scale
Time Frame: Assessed at baseline, 3 months (immediately post intervention), 6 months, and 12 months.
|
Online questionnaires will be administered to all participants assessing their level of percieved autonomy support for engaging in leisure time physical activity.
Percieved autonomy support will be assessed using Likert scale items scored between 1 and 5, where higher scores are indicative of participants belief that they are provided with an enviroment allowing for choice and self-determination for physical activity.
Survey items are drawn from Finnish language scales validated and used in the research team's previous work and available at https://osf.io/rfw2g
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Assessed at baseline, 3 months (immediately post intervention), 6 months, and 12 months.
|
|
Triaxial Accelerometer Recordings
Time Frame: Assessed at baseline, 3 months (immediately post intervention), 6 months, and 12 months.
|
For participants assigned to the immediate intervention group, device measured physical activity will be assessed alongside self-reported activity levels using triaxial accelerometer such as the Hooke AM13 or similar.
Triaxial accelerometer data will be used to catagorise the amount of time spend engaged in sedentary behaviors, and light, moderate, and vigerous physical activity.
Scores for each sedentary behavior, light physical activity, moderate physical activity, and vigerous physical activity time will be recorded as the average number of minutes each day in which each participant spent engaged in that catagory of activity.
|
Assessed at baseline, 3 months (immediately post intervention), 6 months, and 12 months.
|
|
Focus Group Intervention Evaluation Data - Qualitiative Interview
Time Frame: Assessed at 3 months, immediately post intervention.
|
For participants in the immediate intervention group, the post-intervention (3-months) online questionnaire will include an option for participants to express their interest in attending a 45-minute exit interview on the intervention process.
The interviews will be held via Zoom, and audio recorded to accommodate qualitative thematic analysis.
|
Assessed at 3 months, immediately post intervention.
|
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Resource Use Data
Time Frame: Assessed at 3 months, for the time period covering the intervention.
|
For participants in the immediate intervention group, their utilisation of intervention recources will be recorded in the form of the number of sessions attended, number of online materials accessed, and the number of messages or reactions sent to the whataspp group.
|
Assessed at 3 months, for the time period covering the intervention.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Martin Hagger, University of Jyväskylä
- Principal Investigator: Keegan Knittle, University of Jyväskylä
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
Keywords
Other Study ID Numbers
- 806/13.00.04.00/2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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