A Collaborative Theory-based Intervention to Promote Physical Activity Among Sedentary Parents and Their Children

NCT06070038 | Unknown DMC

• 1 other identifier: 806/13.00.04.00/2023
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

Brief Summary

Insufficient physical activity in children and adults is linked to increased risk of physical and mental health conditions. Parents have an important influence on their children's activity, and preliminary aimed at promoting physical activity suggest the family unit as a potentially efficacious means of delivery. However, there is relatively little research examining the efficacy of family interventions aimed at promoting both parents' and children's physical activity. In addition, many family-based interventions are not guided by behavioral theory known to enhance intervention efficacy and reduce variability, and do not target low-active families. This project will therefore develop and test the efficacy of a theory-based behavioral intervention to increase physical activity engagement in low-active children and their parents. The intervention will adopt a randomized waitlist-controlled design with parents and their children allocated to an intervention group that receives theory-based content targeting changes in key behavioral determinants or to a waitlist control group that receives measurement only. The intervention will be delivered to parent-child dyads in a series of four online meetings with a trained facilitator, accompanied by web-based supporting materials, and a moderated social support online chat group. The primary dependent variable will be parents' and children's leisure time physical activity, and secondary outcomes will be device measured physical activity (intervention group only) and measures of key theory-based determinants of physical activity, including autonomous motivation, attitudes, subjective norms, self-efficacy, intentions, and perceived autonomy support. These outcomes will be measured at baseline and at 3, 6, and 12 months post-baseline. Parents and children allocated to the intervention group are expected to exhibit higher levels of physical activity and behavioral determinants. Intervention effects on physical activity change are expected to be mediated by the theory-based determinants, consistent with psychological theory. The project will contribute to research by testing the efficacy of a unique intervention based on behavioral theory expected to be effective in promoting physical activity in low-active parents and their children, and providing guidelines and materials that practitioners in health promotion and public health can use in campaigns and national strategies to promote physical activity in this population.

Conditions

Inactivity/Low Levels of Exercise; Inactivity, Physical

Keywords

Theory of planned behavior; integrated behavior change model; social cognition; physical activity; sedentarism; self-determination theory

Outcome Measures

Primary Outcomes (1)

• Godin Leisure time physical activity questionnaire

  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 Outcomes (9)

• Theory of Planned Behavior - Semantic Differential Attitude Scale

  Assessed at baseline, 3 months (immediately post intervention), 6 months, and 12 months.

• Theory of Planned Behavior - Subjective Norms Likert Scale

  Assessed at baseline, 3 months (immediately post intervention), 6 months, and 12 months.

• Theory of Planned Behavior - Percieved Behavioral Control Likert Scale

  Assessed at baseline, 3 months (immediately post intervention), 6 months, and 12 months.

• Theory of Planned Behavior - Intention Likert Scale

  Assessed at baseline, 3 months (immediately post intervention), 6 months, and 12 months.

• Self-Determination Theory - Autonomous Motivation Likert Scale

  Assessed at baseline, 3 months (immediately post intervention), 6 months, and 12 months.

Study Arms (2)

Immediate Intervention Group

EXPERIMENTAL

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.

Behavioral: Integrated Behaviour Change Based Intervention Materials

Waitlist Control Group

OTHER

Wait-List Control Group. Participants in the follow-up group will be delivered intervention materials following the third data collection timepoint.

Behavioral: Integrated Behaviour Change Based Intervention Materials

Interventions

Integrated Behaviour Change Based Intervention Materials BEHAVIORAL

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.

Immediate Intervention Group; Waitlist Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Jyvaskyla: lead

Study Sites (1)

The Faculty of Sport and Health Sciences

Jyväskylä, Central Finland, 40014, Finland

RECRUITING

Related Publications (1)

• Phipps D, Green WT, Aho R, Kettunen E, Biddle S, Hamilton K, Laukkanen A, Aunola K, Chan DK, Hankonen N, Hassandra M, Karkkainen T, Kykyri VL, Polet J, Rhodes R, Ruiz MC, Saakslahti A, Schneider J, Toivonen HM, Lintunen T, Hagger M, Knittle K. A Web-Based Physical Activity Promotion Intervention for Inactive Parent-Child Dyads: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Mar 21;13:e55960. doi: 10.2196/55960.

  PMID: 38512336 DERIVED

MeSH Terms

Conditions

Sedentary Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Martin Hagger

  University of Jyvaskyla

  PRINCIPAL INVESTIGATOR

• Keegan Knittle

  University of Jyvaskyla

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keegan Knittle

CONTACT

+358504698252; keegan.p.knittle@jyu.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will consist of a wait list control trial, with one group assigned to receive the intervention immediately, and one group assigned to act as a control group before receiving the intervention after data collection is completed. The model also includes a stopping rule, such that 12-month follow-up data will not be collected if there is no significant effect of the intervention on the primary outcome (i.e. leisure time PA) at the 3-month follow-up.

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: October 6, 2023
• Study Start: September 20, 2023
• Primary Completion: May 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Data will be uploaded following the conclusion of all data collection.
• Access Criteria: Data will be openly available.

Locations

FI (1)