Effects of a 12-Week Multicomponent Intervention on 24-Hour Movement Behaviour and Physical Fitness in Parents and Their Children: A Mediation Analysis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 136
- Locations
- 2
- Primary Endpoint
- Change in children's out-of-school moderate-to-vigorous physical activity (MVPA), min/day
Study Overview
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
- Primary: Determine whether a 12-week multicomponent, family-based program increases children's out-of-school MVPA compared with usual activities.
- 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).
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Masking Description
Not applicable for this behavioral program; participants and providers were aware of group assignment. Standardized instructions and prespecified analyses were used to reduce bias.
Eligibility Criteria
- Ages
- 8 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Change in children's out-of-school moderate-to-vigorous physical activity (MVPA), min/day
Time Frame: 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 Outcomes
- Change in children's in-school MVPA, min/day(Baseline (Weeks 1-3) and Post-intervention (~Week 16))
- Change in children's weekend MVPA, min/day((Weeks 1-3) and Post-intervention (~Week 16))
- Change in children's sedentary time, hours/day(Baseline (Weeks 1-3) and Post-intervention (~Week 16))
- Change in children's sleep duration, hours/day(Baseline (Weeks 1-3) and Post-intervention (~Week 16))
- Change in parents' MVPA, min/week(Baseline (Weeks 1-3) and Post-intervention (~Week 16))
- Change in parents' sedentary time, hours/day(Baseline (Weeks 1-3) and Post-intervention (~Week 16))
- Change in perceived physical fitness (parents and children), IFIS score (1-5)(Baseline (Weeks 1-3) and Post-intervention (~Week 16))
- Participants with intervention-related adverse events(Through study completion (up to 16 weeks).)