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

NCT06802302 | Not Yet Recruiting

• 1 other identifier: PPN2025
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Childhood Obesity Pevention

Keywords

Intervention; Nutrition; Physical activity; Randomized controlled trial; Body fat; School

Outcome Measures

Primary Outcomes (1)

• Mean difference in body Fat (%)

  Body composition will be obtained using electrical bioimpedance RJL Quantum II (Clinton Township, Michigan) following the methodology recommended by the manufacturer. With obtained data (resistance and reactance values in ohms), an equation previously designed to estimate fat-free mass in Mexican children will be used. Fat mass will be obtained by subtracting the kilograms of fat-free mass from the total kilograms of the subject and its percentage with respect to total body weight will be also calculated.

  At 6 months ( from baseline to the end of the study).

Secondary Outcomes (7)

• Mean difference in BMI Z-score

  At 6 months ( from baseline to the end of the study).

• Mean difference in waist circumference

  At 6 months ( from baseline to the end of the study).

• Difference in food consumption

  At 6 months ( from baseline to the end of the study).

• Mean difference in physical activity and sedentary behavior

  At 6 months ( from baseline to the end of the study).

• Mean difference in quality of Life scores

  At 6 months ( from baseline to the end of the study).

Study Arms (3)

NUT-PA group: intervention delivered by advanced nutrition and physical activity students.

EXPERIMENTAL

This group will implement the Planet Nutrition program. Advanced nutrition students will deliver one 1-hour nutrition lesson per week during school hours and will also provide nutrition and health information to parents. Additionally, advanced physical activity students will lead two 1-hour exercise sessions per week at school.

Behavioral: Planet Nutrition Program

PEST-PA group: physical education schoolteachers and physical activity students.

EXPERIMENTAL

This group will implement the Planet Nutrition program. Advanced nutrition students will deliver one 1-hour nutrition lesson per week during school hours and will also provide nutrition and health information to parents. Additionally, advanced physical activity students will lead two 1-hour exercise sessions per week at school.

Behavioral: Planet Nutrition Program

Control group

NO INTERVENTION

The schoolchildren in this group will continue with their regular nutrition and physical activity classes. At the end of the study, they will receive a printed handbook with nutrition recommendations and gain access to the materials from the Planet Nutrition program via a website.

Interventions

Planet Nutrition Program BEHAVIORAL

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.

NUT-PA group: intervention delivered by advanced nutrition and physical activity students.; PEST-PA group: physical education schoolteachers and physical activity students.

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Participating in a similar study.
• Children
• 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).
• A personal condition that prevents conducting physical activity or a condition that parents consider should exclude their child from participating.
• Implementers
• Received 80% of the program training. Satisfactory response to a questionnaire that assessed their knowledge of the program following the training.

Sponsors & Collaborators

• Universidad de Sonora: lead
• Centro de Investigación en Alimentación y Desarrollo A.C.: collaborator
• Instituto Nacional de Geriatria, Mexico: collaborator

Related Publications (12)

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  PMID: 11468499 BACKGROUND

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  BACKGROUND

• 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

  BACKGROUND

• Marfell-Jones M, Olds T, Stewart A, Carter L. International Standards for Anthropometric Assessment. First edit. (ISAK, ed.).; 2006.

  BACKGROUND

• 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 BACKGROUND

• WHO. Growth Reference 5-19 years. BMI-for-age (5-19 years). 2007. https://www.who.int/growthref/en/

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• Ramirez-Rivera DL, Martinez-Contreras T, Villegas-Valle RC, Henry-Mejia G, Quizan-Plata T, Haby MM, Diaz-Zavala RG. Preliminary Results of the Planet Nutrition Program on Obesity Parameters in Mexican Schoolchildren: Pilot Single-School Randomized Controlled Trial. Int J Environ Res Public Health. 2021 Jan 18;18(2):790. doi: 10.3390/ijerph18020790.

  PMID: 33477722 BACKGROUND

• Spiga F, Davies AL, Tomlinson E, Moore TH, Dawson S, Breheny K, Savovic J, Gao Y, Phillips SM, Hillier-Brown F, Hodder RK, Wolfenden L, Higgins JP, Summerbell CD. Interventions to prevent obesity in children aged 5 to 11 years old. Cochrane Database Syst Rev. 2024 May 20;5(5):CD015328. doi: 10.1002/14651858.CD015328.pub2.

  PMID: 38763517 BACKGROUND

• Shamah-Levy T, Gaona-Pineda EB, Cuevas-Nasu L, et al. Prevalence of overweight and obesity in Mexican school-aged children and adolescents. Ensanut 2020-2022. Salud Publica Mex. 2023;65. doi:10.21149/14762

  BACKGROUND

• NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in underweight and obesity from 1990 to 2022: a pooled analysis of 3663 population-representative studies with 222 million children, adolescents, and adults. Lancet. 2024 Mar 16;403(10431):1027-1050. doi: 10.1016/S0140-6736(23)02750-2. Epub 2024 Feb 29.

  PMID: 38432237 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Rolando G Díaz Zavala

  Universidad de Sonora

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Teresita Martínez Contreras, MSc

CONTACT

52 662 289 3793; teresitamartinez@unison.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A nutrition team independent of the recruitment and blinding to the study groups will carry out the measurements. The person that will do the randomly allocation of the schools will be independentof the recruitment and the intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full-time professor

Model Details: Schools that meet the inclusion/exclusion criteria will be randomly assigned to one of three groups: 1) a program implemented by nutrition and physical activity students (NUT-PA group), 2) a program delivered by physical education teachers and physical activity students (PEST-PA group), or 3) a control group.

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: January 31, 2025
• Study Start: January 30, 2025
• Primary Completion: June 13, 2025
• Study Completion: June 13, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share