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Not yet recruiting NCT06802302

Effectiveness of a School-based Obesity Prevention Program on Body Fat At 6 Months of Mexican Children

No phase Interventional Childhood Obesity Pevention

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Planet Nutrition Program.
Who it may be relevant to
Registry conditions: Childhood Obesity Pevention. Basic parameters: 9 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effectiveness of a School-based Obesity Prevention Program on Body Fat At 6 Months of Mexican Children: a Cluster Randomized Controlled Trial

Overview

School-based programs are an essential strategy for preventing obesity, yet the most effective way to implement them remains unclear. This study aims to evaluate the effectiveness of a school-based obesity prevention program, delivered by different implementers, in comparison to a control group, focusing on body fat reduction in Mexican children. This is a cluster randomized controlled trial. Approximately six public elementary schools (240 children) in Hermosillo, Mexico, will be invited to participate. Schools will be randomly assigned to one of three groups: a program implemented by advanced undergraduate students in Nutrition and Physical Activity (NUT-PA), a program implemented by Physical Education teachers and Physical Activity students (PEST-PA), or a control group. The intervention will consist of a 6-month obesity prevention program that includes nutrition education, physical activity sessions, and parent participation. The control group will continue with their regular school activities. The primary outcome will be the difference in body fat percentage at 6 months between the NUT-PA group and the control group, as well as between the PEST-PA group and the control group. Secondary outcomes will include BMI Z-score, waist circumference, and various lifestyle parameters. A mixed-effects linear analysis will be conducted using an intention-to-treat approach.

Detailed description

This is a cluster randomized controlled trial with three parallel groups and a 1:1:1 allocation ratio. The current protocol represents the definitive phase of the study, which was previously registered and approved in clinical trials (NCT05461703). The project has been approved by the Research Ethics Committee of the Nursing Department at the Universidad de Sonora (EPD-007-2022).

Interventions

  • Behavioral Planet Nutrition Program
    The intervention in this study will be the same for both intervention groups, both based on the previously designed and tested "Planet Nutrition" Program (PNP). The program components include: nutrition education lessons (one 1-hour session per week), physical activity classes (two 1-hour sessions per week), and nutrition information for parents. The intervention will be implemented from February to June 2025.

Primary outcome measures

  • Mean difference in body Fat (%) [Time frame: At 6 months ( from baseline to the end of the study).]
Secondary outcome measures (7)
  • Mean difference in BMI Z-score [Time frame: At 6 months ( from baseline to the end of the study).]
  • Mean difference in waist circumference [Time frame: At 6 months ( from baseline to the end of the study).]
  • Difference in food consumption [Time frame: At 6 months ( from baseline to the end of the study).]
  • Mean difference in physical activity and sedentary behavior [Time frame: At 6 months ( from baseline to the end of the study).]
  • Mean difference in quality of Life scores [Time frame: At 6 months ( from baseline to the end of the study).]
  • Mean difference in nutrition knowledge [Time frame: At 6 months ( from baseline to the end of the study).]
  • Feasibility of the intervention [Time frame: At 6 months ( from baseline to the end of the study).]

Eligibility criteria

Schools

Inclusion criteria

  • School principals, 4th- and 5th- grade teachers willing to participate, availability of space for physical activity classes, and groups with a minimum of 20 students.

Exclusion criteria

  • Participating in a similar study.

Children

Inclusion criteria

  • To be a 4th or 5th grade student (9 to 12 years) in one of the participating schools. To be eligible for this study, parents and children will be required to sign an informed consent and assent form, respectively, and had to complete anthropometric measurements (children) and lifestyle questionnaires (parents).

Exclusion criteria

  • A personal condition that prevents conducting physical activity or a condition that parents consider should exclude their child from participating.

Implementers

Inclusion criteria

-Received 80% of the program training. Satisfactory response to a questionnaire that assessed their knowledge of the program following the training.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006. PMID 11468499
  • Currie C, Inchley J, Molcho M, Lenzi M, Veselska Z, Wild F. Health Behaviour in School-Aged Children (HBSC) Study Protocol: Background , Methodology and Mandatory Items for the 2013/14 Survey.; 2014. http://www.hbsc.org
  • Shamah-Levy T, Vielma-Orozco E, Heredia-Hernández O, Romero-Martínez M, Mojica-Cuevas J CNL, Santaella-Castell JA RDJ. Encuesta Nacional de Salud y Nutrición 2018-19: Resultados Nacionales.; 2020. Accessed September 4, 2020. https://ensanut.insp.mx/encuestas/ensanut2018/informes.php
  • Marfell-Jones M, Olds T, Stewart A, Carter L. International Standards for Anthropometric Assessment. First edit. (ISAK, ed.).; 2006.
  • Ramirez E, Valencia ME, Bourges H, Espinosa T, Moya-Camarena SY, Salazar G, Aleman-Mateo H. Body composition prediction equations based on deuterium oxide dilution method in Mexican children: a national study. Eur J Clin Nutr. 2012 Oct;66(10):1099-103. doi: 10.1038/ejcn.2012.89. Epub 2012 Jul 18. PMID 22805494
  • WHO. Growth Reference 5-19 years. BMI-for-age (5-19 years). 2007. https://www.who.int/growthref/en/
  • Ramírez Rivera DL, Martínez Contreras T, Villegas Valle RC, et al. Effectiveness of a school-based obesity prevention program on the BMI Z-score and body fat at 6 months in Mexican children: study protocol of a cluster randomized controlled trial. Biotecnia. 2023;25(3):71-78. doi:10.18633/biotecnia.v25i3.2074
  • Ramírez-Rivera DL, Martínez-Contreras Teresita, Henry-Mejia Gricelda, et al. Efecto de una intervención en línea de cambio en el estilo de vida sobre el puntaje zIMC de escolares mexicanos: protocolo de ensayo controlado aleatorizado piloto cegado a evaluadores

Identifiers

NCT: NCT06802302 · PPN2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗