NCT07523945

Brief Summary

Children today spend many hours sitting at school and at home, often in front of screens. Prolonged sitting in childhood increases the risk of future health problems such as diabetes, heart disease and poor mental wellbeing. MAFF is a simple school-to-home programme that teaches short, practical movement breaks in the classroom and encourages families to repeat them together at home through structured weekly challenges. Over 12 weeks, we will compare classes using MAFF with classes continuing as usual to assess whether children sit less, move more and improve their wellbeing. If effective, MAFF will provide schools and communities with an easy-to-implement toolkit to promote healthier and more active families.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
24mo left

Started Nov 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
8 months until next milestone

Study Start

First participant enrolled

November 30, 2026

Expected
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2028

Last Updated

April 13, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

April 4, 2026

Last Update Submit

April 5, 2026

Conditions

Sedentary BehaviorsPhysical InactivityChild HealthLifestyle (Sedentary Behavior and Physical Activity)

Keywords

sedentary behaviourphysical activityschool-based interventionfamily-based interventionrandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Daily Sedentary Time

    Daily sedentary time measured via validated self-report instruments and accelerometry (subsample). Moderate-to-vigorous physical activity (MVPA) assessed using validated questionnaires and accelerometry (subsample). Assessment time points: baseline (T0), post-intervention at 12 weeks (T1), and 3-month follow-up (T2).

    Baseline (T0), Post-intervention (12 weeks, T1), 3-month follow-up (T2)

Secondary Outcomes (1)

  • Screen Time

    Baseline (T0), post-intervention at 12 weeks (T1), and 3-month follow-up (T2) for screen time, sleep, psychological distress, family cohesion, and anthropometrics; adherence tracked during the intervention.

Study Arms (2)

MAFF Intervention (School-to-Home Micro-Intervention)

EXPERIMENTAL

Participants will receive a 12-week structured intervention combining school-based and home-based components: Two weekly 10-15 minute micro-activity sessions delivered in the classroom Two weekly structured home-based movement challenges involving caregivers Adherence monitoring through logs Fortnightly feedback to support engagement Fidelity monitoring using structured checklists The intervention focuses on reducing sedentary behaviour by fragmenting prolonged sitting and promoting short bouts of physical activity integrated into daily routines.

Behavioral: Name: MAFF (Methodology for Family Physical Activity)

Control (Usual Practice / Wait-list)

NO INTERVENTION

The control group will continue usual school activities without any structured intervention. Participants will: Complete all assessment timepoints (baseline, post-intervention, follow-up) Not receive the MAFF programme during the study period Post-trial: The MAFF intervention will be offered to control group participants after completion of the study.

Interventions

Name: MAFF (Methodology for Family Physical Activity)BEHAVIORAL

MAFF is a low-cost, scalable behavioural intervention designed to reduce sedentary time and increase physical activity in children through a school-to-home transfer model. It integrates: Structured micro-activity breaks in classroom settings Family-based movement challenges to reinforce behaviour at home Behavioural mechanisms grounded in the COM-B model (capability, opportunity, motivation) Ecological reinforcement through repeated exposure across contexts (school and family) No specialised equipment is required.

MAFF Intervention (School-to-Home Micro-Intervention)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Enrolled in participating Portuguese public schools
  • Written informed consent provided by a parent or legal guardian
  • Assent provided by the child
  • Able to participate in light-to-moderate physical activity as part of normal school activities

You may not qualify if:

  • Medical conditions or physical limitations that contraindicate participation in physical activity
  • Cognitive, developmental, or behavioural conditions that would prevent understanding or adherence to the intervention procedures (as assessed by school staff)
  • Lack of parental/legal guardian consent
  • Concurrent participation in another structured physical activity or behavioural intervention study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Politécnico de Setúbal

Setúbal, 2914-504, Portugal

Location

Related Publications (4)

  • Guthold R, Stevens GA, Riley LM, Bull FC. Global trends in insufficient physical activity among adolescents: a pooled analysis of 298 population-based surveys with 1.6 million participants. Lancet Child Adolesc Health. 2020 Jan;4(1):23-35. doi: 10.1016/S2352-4642(19)30323-2. Epub 2019 Nov 21.

    PMID: 31761562BACKGROUND

  • Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. doi: 10.2105/ajph.89.9.1322.

    PMID: 10474547BACKGROUND

  • Ekelund U, Steene-Johannessen J, Brown WJ, Fagerland MW, Owen N, Powell KE, Bauman A, Lee IM; Lancet Physical Activity Series 2 Executive Committe; Lancet Sedentary Behaviour Working Group. Does physical activity attenuate, or even eliminate, the detrimental association of sitting time with mortality? A harmonised meta-analysis of data from more than 1 million men and women. Lancet. 2016 Sep 24;388(10051):1302-10. doi: 10.1016/S0140-6736(16)30370-1. Epub 2016 Jul 28.

    PMID: 27475271BACKGROUND

  • Dobbins M, Husson H, DeCorby K, LaRocca RL. School-based physical activity programs for promoting physical activity and fitness in children and adolescents aged 6 to 18. Cochrane Database Syst Rev. 2013 Feb 28;2013(2):CD007651. doi: 10.1002/14651858.CD007651.pub2.

    PMID: 23450577BACKGROUND

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Susana Garradas, PhD

    Instituto Politécnico de Setúbal

    PRINCIPAL INVESTIGATOR

  • Carolina A Cabo, Master

    University of Évora

    STUDY DIRECTOR

  • Mário C. Espada, PhD

    Instituto Politécnico de Setúbal

    STUDY DIRECTOR

  • Fernando Santos, PhD

    Instituto Politécnico de Setúbal

    STUDY DIRECTOR

  • Jose A Parraca, PhD

    University of Évora

    STUDY DIRECTOR

Central Study Contacts

Susana Dr. Garradas, PhD

CONTACT

964188877susana.garradas@ese.ips.pt

Carolina Dr Cabo, Master

CONTACT

919564243carolinaacabo@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Cluster randomized controlled trial with parallel assignment, in which schools or classes are allocated to intervention or control groups. The intervention follows a school-to-home approach aimed at reducing sedentary behavior in children, while the control group maintains usual practice.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MAFF-CRT: School-to-Home Trial to Reduce Sedentary Behaviour in Children

Study Record Dates

First Submitted

April 4, 2026

First Posted

April 13, 2026

Study Start (Estimated)

November 30, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

December 2, 2028

Last Updated

April 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

De-identified participant-level data, including daily sedentary time, screen time, moderate-to-vigorous physical activity (MVPA), sleep, psychological distress, family cohesion, and anthropometric measures, will be shared with qualified researchers upon reasonable request after publication of main study results. Data will be provided via a secure repository, and use will require ethical approval and adherence to study guidelines.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
IPD and supporting information will be available after publication of main study results, starting approximately \[Month Year\] and remaining accessible for at least 5 years.
Access Criteria
Qualified researchers with a scientifically valid proposal and ethical approval may request access. Access will include de-identified participant-level data, study protocol and CSR. Data will be shared via a secure repository, with access granted after review by the study team.

Locations

PT(1)