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Sedentary BehaviorsMAFF-CRTNCT07523945

MAFF-CRT: Reducing Sedentary Behaviour in Children

A study testing Name: MAFF (Methodology for Family Physical Activity) in people with Sedentary Behaviors and Physical Inactivity, run by Instituto Politécnico de Setúbal at 1 site in Portugal.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
Name: MAFF (Methodology for Family Physical Activity)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 sitePortugal
Study dates
30 Nov 2026to 2 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Susana Dr. Garradas, PhD contact

964188877

susana.garradas@ese.ips.pt

Carolina Dr Cabo, Master contact

919564243

carolinaacabo@gmail.com

Portugal1 site
  • Instituto Politécnico de Setúbal

    Setúbal, 2914-504

    Susana Garradas, PhD, 964188877, susana.garradas@ese.ips.pt

    Carolina Alexandra Cabo, Master, 919564243, carolinaacabo@gmail.com

Other trials in Portugal

About this study

Official title: MAFF-CRT: School-to-Home Trial to Reduce Sedentary Behaviour in Children

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.

Read the detailed description

Sedentary behaviour is an independent risk factor for cardiometabolic disease and poor mental health, even among individuals meeting physical activity recommendations. In children, prolonged sitting is associated with impaired metabolic regulation, increased adiposity risk, lower psychological wellbeing and behavioural tracking into adolescence and adulthood. Early intervention targeting sedentary patterns is therefore essential for primary prevention.

Most school-based interventions focus on increasing moderate-to-vigorous physical activity (MVPA) during school hours, with limited transfer to home environments and weak sustainability. Many also require specialised personnel or equipment, limiting scalability and equity.

The MAFF (Methodology for Family Physical Activity) model is grounded in the Socio-Ecological Model and the COM-B framework (Capability, Opportunity, Motivation-Behaviour). It targets:

  • Capability: structured micro-activity routines delivered in class.
  • Opportunity: embedding movement within existing school and home routines.
  • Motivation: intergenerational engagement, social reinforcement and repeated micro-success experiences.

Its innovation lies in the structured school-to-home transfer mechanism and the focus on sedentary behaviour fragmentation through short, repeated movement bouts integrated into daily life.

Preliminary feasibility observations in school settings indicate high acceptability of micro-activity breaks among teachers and students, with minimal curricular disruption. Informal caregiver feedback suggests that structured home challenges are manageable and motivating. These observations support feasibility assumptions.

The trial will be prospectively registered in an international clinical trial registry.

Study Design A cluster randomized controlled trial (CRT) with class-level randomization will be conducted to minimize contamination. Classes will be stratified by school cycle (primary vs preparatory) before allocation.

Approximately eight classes (n≈200 children) will be recruited. The intervention will last 12 weeks, followed by a 3-month follow-up. Parental consent and child assent will be obtained.

Allocation will be performed by an independent researcher using computer-generated random sequences.

Intervention

The MAFF intervention includes:

  1. Two weekly 10-15 minute micro-sessions delivered during school hours.
  2. Two weekly structured home-based movement challenges involving caregivers.
  3. Adherence logging with fortnightly feedback.
  4. Fidelity monitoring using structured checklists. The intervention requires no specialised equipment and minimal curricular disruption. Control classes will continue usual practice.

Outcomes and Measurement

Primary outcomes:

  • Daily sedentary time
  • MVPA

Secondary outcomes:

  • Screen time
  • Sleep (validated scale)
  • Psychological distress (DASS-21)
  • Family cohesion (FACES IV - Portuguese version)
  • Exploratory anthropometrics (BMI percentile; waist circumference) Accelerometry will be collected in a stratified subsample (n≈60) using 7-day wear protocols at baseline and post-intervention (and follow-up if feasible). Valid wear-time criteria will be predefined. Anthropometric assessments will follow standardized procedures conducted by trained assessors.

Process Evaluation A RE-AIM framework will assess reach, adoption, implementation fidelity, dose delivered/received, and maintenance at follow-up. Adherence will be quantified through logs and session tracking.

Statistical Analysis All analyses will follow the intention-to-treat principle. Multilevel mixed-effects models will account for clustering (children nested within classes). Baseline covariates (cycle, sex, socioeconomic status) will be included where appropriate.

Primary analyses will test group × time interaction effects on sedentary time and MVPA. Secondary analyses will examine mediation (family cohesion; adherence) and moderation (sex; school cycle). Sensitivity analyses using multiple imputation will address missing data. Effect sizes and 95% confidence intervals will be reported.

Power Calculation A priori sample size estimation assumed a moderate effect size (Cohen's d = 0.40) for sedentary time reduction, α = 0.05 and power = 0.80. Assuming an intraclass correlation coefficient (ICC) of 0.03 and an average cluster size of 25 students, eight clusters (≈200 participants) provide adequate power. Allowing for 15% attrition, the study remains sufficiently powered under intention-to-treat analysis.

Data Management and Quality Assurance Data will be stored securely in compliance with GDPR. Predefined analysis protocols will be established prior to statistical modelling. Measurement staff will be trained and standardized.

Contribution to the Evidence Base By integrating ecological behavioural theory, cluster randomized design, objective measurement and mediation analysis, this project generates causal evidence on scalable sedentary behaviour reduction strategies in children and strengthens the preventive public health evidence base.

The project directly aligns with preventive health priorities aimed at reducing behavioural risk factors early in life.

Being tested
Name: MAFF (Methodology for Family Physical Activity)
Keywords
sedentary behaviour, physical activity, school-based intervention, family-based intervention, randomized controlled trial
Medical subject headings
Sedentary Behavior, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Name: MAFF (Methodology for Family Physical Activity)Behavioural

    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.

Study groups in NCT07523945
Study groupRoleWhat they receive
MAFF Intervention (School-to-Home Micro-Intervention)ExperimentalParticipants 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.
Receives: Behavioral: Name: MAFF (Methodology for Family Physical Activity)
Control (Usual Practice / Wait-list)No interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (1)
  1. Screen Time

    Screen Time: Self-reported daily screen exposure. Sleep: Assessed using a validated sleep questionnaire. Psychological Distress: Measured using the DASS-21. Family Cohesion: Assessed with FACES IV (Portuguese version). Anthropometrics (Exploratory): BMI percentile and waist circumference. Adherence to Intervention: Based on session attendance and home challenge completion logs.

    Assessment Time Points: Baseline (T0), post-intervention 12 weeks (T1), 3-month follow-up (T2); adherence tracked during intervention.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2026
  2. Study start30 Nov 2026 (estimated)
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion2 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07523945
Sponsor's protocol ID
IPS-CIEQV-MAFF-CRT-2026-01
Other IDs
PS-CIEQV-MAFF-CRT-2026-01
Acronym
MAFF-CRT
Status last verified
Feb 2026
First submitted
4 Apr 2026
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 31761562
  • 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.

    PubMed 10474547
  • 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.

    PubMed 27475271
  • 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.

    PubMed 23450577

Questions about this trial

What is this clinical trial studying?

A study testing Name: MAFF (Methodology for Family Physical Activity) in people with Sedentary Behaviors and Physical Inactivity, run by Instituto Politécnico de Setúbal at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Susana Dr. Garradas, PhD (964188877, susana.garradas@ese.ips.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Daily Sedentary Time (time frame: Baseline (T0), Post-intervention (12 weeks, T1), 3-month follow-up (T2)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07523945, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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