12-Week Family-Based Multicomponent Program to Improve 24-Hour Movement Behaviors in Parents and Children

Not Applicable

Completed

• Conditions: Sedentary Behaviors; Physical Activity; Exercise; Sleep; Physical Fitness; Health Promotion

• Registration Number: NCT07177248
• Lead Sponsor: Pontificia Universidad Catolica de Valparaiso

Brief Summary

This study assessed a 12-week, family-oriented program intended to promote healthier 24-hour movement patterns among school-age children and their parents in Chile. Parent-child pairs volunteered from two private schools and one public school, and schools were used to determine group assignment in a parallel, non-randomized, open-label design.

The intervention blended brief weekly digital guidance for parents (concise infographics/videos and actionable tips sent via email/WhatsApp) with three in-person family sessions (a functional-training class, parent-child modified games, and an outdoor trekking activity) led by a Physical Education teacher with support from school staff. The comparison group continued usual routines and completed the same assessments.

Outcomes were collected at baseline and after the intervention period (post-intervention window around Week 16). The primary outcome was the change in children's out-of-school moderate-to-vigorous physical activity (MVPA) estimated with the Youth Activity Profile-Spain/Latin America version (YAP-SL). Secondary outcomes encompassed children's in-school and weekend MVPA, sedentary time, and sleep duration, as well as parents' MVPA and sedentary time (IPAQ-Short Form) and perceived physical fitness for both parents and children (International Fitness Scale, IFIS). Potential intervention-related adverse events during face-to-face activities and those reported between sessions were monitored.

The institutional ethics committee approved the protocol and the intervention was considered minimal risk. This is a retrospective registration completed after study execution at the request of the sponsor. An exploratory mediation analysis is planned to examine plausible pathways linking the program to changes in MVPA.

Detailed Description

Rationale Low physical activity and prolonged sedentary time in childhood are widespread and linked to unfavorable health and developmental outcomes. Engaging parents as agents of change is a promising strategy to support children's daily movement behaviors across the full 24-hour cycle (physical activity, sedentary time, and sleep). In Latin American school settings, pragmatic, scalable formats that combine short digital prompts with occasional on-site family activities may be feasible and impactful.

Objectives

1. Primary: Determine whether a 12-week multicomponent, family-based program increases children's out-of-school MVPA compared with usual activities.

2. Secondary: Evaluate effects on children's in-school and weekend MVPA, sedentary time, and sleep; parents' MVPA and sedentary time; and perceived physical fitness (parents and children).

3. Exploratory: Conduct a mediation analysis to explore potential pathways (e.g., changes in sedentary time, sleep, or perceived fitness) through which the intervention may influence children's MVPA.

Design and Setting Two-arm, parallel, non-randomized, open-label study conducted in Chilean primary schools. Group assignment was determined at the school level for logistical and feasibility reasons (two private and one public school). Assessments were completed at baseline and post-intervention (\~Week 16).

Participants Eligible units were parent-child pairs recruited through school meetings. Children were primarily 5th-grade students (one school deviated for scheduling reasons). Inclusion required the ability to participate safely in light-to-moderate physical activity and access to email and/or WhatsApp for digital communications. Informed consent (parents) and assent (children) were obtained. Exclusions included medical conditions that would preclude safe participation or concurrent enrollment in another structured physical activity program.

Intervention (summary aligned with TIDieR)

* Format \& Dose: 12 weeks combining weekly digital materials for parents and three on-site family sessions.

* Digital component (Weeks 4-15): Short infographics/videos and practical suggestions were delivered via email/WhatsApp each week (brief educational content early in the week and follow-up prompts later in the week).

* In-person sessions: (i) Functional training class for parents and children (school gym), (ii) modified games session (school gym), and (iii) outdoor trekking activity. Each lasted \~90 minutes and was supervised by a Physical Education teacher with assistance from the school's sports department.

* Implementation timeline (abridged): Week 1 school authorization; Week 2 information sessions and consent/assent; Week 3 baseline questionnaires and anthropometry; Weeks 4-15 digital materials; Weeks 7, 11, and 15 in-person sessions; Week 16 post-test; Week 17 feedback meetings with families and school authorities.

* Adherence \& Fidelity: Delivery logs for digital materials and attendance records for on-site sessions were maintained; activities were adapted to accommodate varied fitness levels.

Comparator Participants in the comparison group maintained their usual activities and were measured on the same schedule as the intervention group.

Outcomes and Measurements

* Primary outcome: Children's out-of-school MVPA (min/day) estimated with the YAP-SL, which uses context-specific items and established calibration procedures to model daily MVPA.

* Secondary outcomes: Children's in-school and weekend MVPA (YAP-SL); sedentary time (hours/day, YAP-SL); sleep duration computed from weekday/weekend bed/wake times (average across the week); parents' MVPA and sedentary time derived from the IPAQ-Short Form; and perceived physical fitness for both parents and children using the International Fitness Scale (IFIS) (higher scores reflect better perceived fitness).

* Safety monitoring: Any intervention-related adverse events (e.g., musculoskeletal complaints, dizziness, falls) were recorded during face-to-face sessions and via parent reports between sessions.

Statistical Approach Primary analyses compare change from baseline to post-intervention between groups, with models adjusted for baseline values and additional covariates as appropriate for the non-randomized design. The mediation analysis will estimate indirect effects along pre-specified behavioral/fitness pathways using established regression-based procedures, recognizing design constraints and measured covariates.

Ethics and Oversight The study received approval from the institutional bioethics committee and adhered to the principles of the Declaration of Helsinki. Given the behavioral nature and low risk of the activities, monitoring was conducted by the research team, with procedures specified for reporting serious events to the PI and the ethics board.

Registration Note This is a retrospective registration finalized after data collection at the sponsor's request.

Study Timeline

• Study Start: 2023-05-01
• Primary Completion: 2023-10-31
• Study Completion: 2023-11-30
• Study First Submitted: 2025-08-29
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-09
• Last Update Submitted: 2025-09-09
• Study First Posted: 2025-09-16
• Last Update Posted: 2025-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

• Parent-child dyad from a participating primary school (child typically in grades 3-6).
• Parent/legal guardian aged ≥18 years; child aged ≥8 years at enrollment.
• Able to take part safely in light-to-moderate physical activity (medical clearance as needed).
• Access to a mobile phone with WhatsApp and/or email for weekly digital materials.
• Signed informed consent from the parent/legal guardian and assent from the child.
• Availability to attend the three scheduled in-person family sessions and complete baseline and post-intervention assessments.

Exclusion Criteria

• Any medical condition, injury, or disability that, in the investigator's judgment, would make participation unsafe or preclude planned activities.
• Current participation in another structured physical activity or lifestyle intervention trial.
• Inability to comply with the study schedule, procedures, or outcome assessments.
• Lack of access to WhatsApp/email for receiving digital materials.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in children's out-of-school moderate-to-vigorous physical activity (MVPA), min/day	Baseline (Weeks 1-3) and Post-intervention (~Week 16)	Daily minutes of MVPA estimated from the Youth Activity Profile-Spain/Latin America version (YAP-SL), using its established calibration procedure to convert item responses into minutes/day; higher values indicate more MVPA.

Secondary Outcome Measures

Name	Time	Method
Change in children's in-school MVPA, min/day	Baseline (Weeks 1-3) and Post-intervention (~Week 16)	Minutes/day of MVPA during school time estimated with YAP-SL calibration; higher = more MVPA.
Change in children's weekend MVPA, min/day	(Weeks 1-3) and Post-intervention (~Week 16)	Minutes/day of MVPA on weekend days derived from YAP-SL; higher = more MVPA.
Change in children's sedentary time, hours/day	Baseline (Weeks 1-3) and Post-intervention (~Week 16)	Average daily sedentary time estimated from YAP-SL items; values expressed in hours/day; lower values indicate less sedentary behavior.
Change in children's sleep duration, hours/day	Baseline (Weeks 1-3) and Post-intervention (~Week 16)	Sleep hours computed from reported bed- and wake-times for weekdays and weekends; weekly average calculated as (weekdayhours×5+weekendhours×2)/7; higher values indicate longer sleep duration.
Change in parents' MVPA, min/week	Baseline (Weeks 1-3) and Post-intervention (~Week 16)	Weekly minutes of MVPA derived from the IPAQ-Short Form, computed as the sum of moderate + vigorous minutes/week in bouts ≥10 min. Per the IPAQ-SF scoring protocol, minutes at each intensity are truncated at 180 min/day to limit outliers; range 0-2 520 min/week; higher values indicate more MVPA.
Change in parents' sedentary time, hours/day	Baseline (Weeks 1-3) and Post-intervention (~Week 16)	Average daily sitting time from the International Physical Activity Questionnaire-Short Form (IPAQ-SF), Sitting item. Reported for a usual weekday and expressed as hours/day; range 0-16 hours/day (equivalently 0-960 min/day). Higher values indicate more sedentary time.
Change in perceived physical fitness (parents and children), IFIS score (1-5)	Baseline (Weeks 1-3) and Post-intervention (~Week 16)	International Fitness Scale (IFIS); five domains rated 1-5. Scores are averaged to obtain a domain-specific perceived fitness score; higher values reflect better perceived fitness.
Participants with intervention-related adverse events	Through study completion (up to 16 weeks).	Count of participants reporting events plausibly related to the program during supervised sessions or between sessions (e.g., musculoskeletal complaints, dizziness, falls); events captured in session logs and via parent reports.

Trial Locations

Locations (1)

Pontificia Universidad Católica de Valparaíso - School of Physical Education; 🇨🇱 Viña del Mar, Región de Valparaíso, Chile