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

NCT07177248 | Completed

• 1 other identifier: ACTIBESE/FONDECYT 2023/1230801
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Activity; Sedentary Behaviors; Exercise; Sleep; Physical Fitness; Health Promotion

Keywords

Physical Activity; Sedentary Behavior; Sleep

Outcome Measures

Primary Outcomes (1)

• Change in children's out-of-school moderate-to-vigorous physical activity (MVPA), min/day

  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.

  Baseline (Weeks 1-3) and Post-intervention (~Week 16)

Secondary Outcomes (8)

• 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)

Study Arms (2)

Experimental: Family-Based Multicomponent Program

EXPERIMENTAL

12-week family-based program combining weekly parent digital guidance (infographics/videos + actionable tips) and three 90-min family sessions (functional training, modified games, outdoor trekking) led by a Physical Education teacher.

Behavioral: Family-Based 12-Week Multicomponent Program

No Intervention: Usual Activities

NO INTERVENTION

Participants continue usual routines; same assessment schedule as the experimental arm.

Interventions

Family-Based 12-Week Multicomponent Program BEHAVIORAL

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.

Also known as: Family Physical Activity Program

Experimental: Family-Based Multicomponent Program

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pontificia Universidad Catolica de Valparaiso: lead
• Agencia Nacional de Investigación y Desarrollo: collaborator

Study Sites (1)

Pontificia Universidad Católica de Valparaíso - School of Physical Education

Viña del Mar, Región de Valparaíso, 2200055, Chile

Location

Related Publications (10)

• Guagliano JM, Armitage SM, Brown HE, Coombes E, Fusco F, Hughes C, Jones AP, Morton KL, van Sluijs EMF. A whole family-based physical activity promotion intervention: findings from the families reporting every step to health (FRESH) pilot randomised controlled trial. Int J Behav Nutr Phys Act. 2020 Sep 22;17(1):120. doi: 10.1186/s12966-020-01025-3.

  PMID: 32962724 BACKGROUND

• Hayes AF. Introduction to Mediation, Moderation, and Conditional Process Analysis: A Regression-Based Approach. 2nd ed. New York: Guilford Press; 2017.

  BACKGROUND

• Zhao X, Lynch JG, Chen Q. Reconsidering Baron and Kenny: Myths and truths about mediation analysis. J Consum Res. 2010;37(2):197-206. https://doi.org/10.1086/651257

  BACKGROUND

• Ortega FB, Ruiz JR, Espana-Romero V, Vicente-Rodriguez G, Martinez-Gomez D, Manios Y, Beghin L, Molnar D, Widhalm K, Moreno LA, Sjostrom M, Castillo MJ; HELENA study group. The International Fitness Scale (IFIS): usefulness of self-reported fitness in youth. Int J Epidemiol. 2011 Jun;40(3):701-11. doi: 10.1093/ije/dyr039. Epub 2011 Mar 24.

  PMID: 21441238 BACKGROUND

• Fairclough SJ, Christian DL, Saint-Maurice PF, Hibbing PR, Noonan RJ, Welk GJ, Dixon PM, Boddy LM. Calibration and Validation of the Youth Activity Profile as a Physical Activity and Sedentary Behaviour Surveillance Tool for English Youth. Int J Environ Res Public Health. 2019 Oct 2;16(19):3711. doi: 10.3390/ijerph16193711.

  PMID: 31581617 BACKGROUND

• Brand C, Zurita-Corvalan N, Batista Lemes V, Villa-Gonzalez E, Aguilar-Farias N, Rodriguez-Rodriguez F. Reliability, reproducibility, and feasibility of youth activity profile (YAP) questionnaire in Chilean children and adolescents. J Sports Sci. 2024 Oct;42(20):1959-1966. doi: 10.1080/02640414.2024.2419278. Epub 2024 Oct 24.

  PMID: 39445725 BACKGROUND

• Saint-Maurice PF, Welk GJ. Validity and Calibration of the Youth Activity Profile. PLoS One. 2015 Dec 2;10(12):e0143949. doi: 10.1371/journal.pone.0143949. eCollection 2015.

  PMID: 26630346 BACKGROUND

• Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

  PMID: 12900694 BACKGROUND

• Tremblay MS, Carson V, Chaput JP. Introduction to the Canadian 24-Hour Movement Guidelines for Children and Youth: An Integration of Physical Activity, Sedentary Behaviour, and Sleep. Appl Physiol Nutr Metab. 2016 Jun;41(6 Suppl 3):iii-iv. doi: 10.1139/apnm-2016-0203. No abstract available.

  PMID: 27306430 BACKGROUND

• Bull FC, Al-Ansari SS, Biddle S, Borodulin K, Buman MP, Cardon G, Carty C, Chaput JP, Chastin S, Chou R, Dempsey PC, DiPietro L, Ekelund U, Firth J, Friedenreich CM, Garcia L, Gichu M, Jago R, Katzmarzyk PT, Lambert E, Leitzmann M, Milton K, Ortega FB, Ranasinghe C, Stamatakis E, Tiedemann A, Troiano RP, van der Ploeg HP, Wari V, Willumsen JF. World Health Organization 2020 guidelines on physical activity and sedentary behaviour. Br J Sports Med. 2020 Dec;54(24):1451-1462. doi: 10.1136/bjsports-2020-102955.

  PMID: 33239350 BACKGROUND

MeSH Terms

Conditions

Motor Activity; Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Fernando Javier Rodríguez-Rodríguez, PhD

  Pontificia Universidad Católica de Valparaíso (PUCV)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Not applicable for this behavioral program; participants and providers were aware of group assignment. Standardized instructions and prespecified analyses were used to reduce bias.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-randomized, two-arm, parallel study conducted in Chilean primary schools. Parent-child dyads were assigned by school-level scheduling/feasibility to either the multicomponent family-based program or usual activities. The intervention combined weekly digital guidance for parents and three family in-person sessions led by a Physical Education teacher. Outcomes were assessed at baseline and post-intervention (\~Week 16). Analyses compare change scores between groups, adjusting for baseline and design features appropriate to non-randomized allocation.

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 16, 2025
• Study Start: May 1, 2023
• Primary Completion: October 31, 2023
• Study Completion: November 30, 2023
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months after the Primary Completion Date and available for 36 months thereafter (extensions considered upon reasonable request).
• Access Criteria: Available to qualified researchers with IRB/ethics approval and a signed Data Use Agreement. Requests should include a brief proposal and analysis plan and be sent to the Principal Investigator. Approved requests will receive access via a secure file transfer or institutional repository. Re-identification attempts and contact with participants/schools are prohibited; citation of the original study is required.

Locations

CL (1)