CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 136 enrolled
Drug / intervention
Family-Based 12-Week Multicomponent Programbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07177248
NCT07177248N/ACompleted

Effects of a 12-Week Multicomponent Intervention on 24-Hour Movement Behaviour and Physical Fitness in Parents and Their Children: A Mediation Analysis

Pontificia Universidad Catolica de Valparaiso·interventional·Posted Sep 16, 2025·Updated Sep 16, 2025

In Brief

A clinical study evaluating Family-Based 12-Week Multicomponent Program for Physical Activity and 5 related conditions. Completed, enrolled 136 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChile

Timeline

N/ACompletedFinished
202420252026
First PostedSep 16, 2025
Enrollment StartMay 1, 2023
Primary CompletionOct 31, 2023
Study CompletionNov 30, 2023
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 10 months ago

Interventions

Family-Based 12-Week Multicomponent Programbehavioral

Weekly digital materials to parents (email/WhatsApp) + three on-site sessions (\~90 min each: functional training; modified games; outdoor trekking); 12 weeks total; delivered by a Physical Education teacher; attendance and delivery logs for fidelity.