Clinical trial NCT06802302: Effectiveness of a School-based Obesity Prevention Program on Body Fat At 6 Months of Mexican Children
Official title: Effectiveness of a School-based Obesity Prevention Program on Body Fat At 6 Months of Mexican Children: a Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Childhood Obesity Pevention
Keywords: Intervention
Nutrition
Physical activity
Randomized controlled trial
Body fat
School
Lead sponsor: Universidad de Sonora
Sponsor class: OTHER
Collaborators: name: Centro de Investigación en Alimentación y Desarrollo A.C.
name: Instituto Nacional de Geriatria, Mexico
First posted: 2025-01-31
Enrollment: 240
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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).

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.

Primary outcomes:
measure: Mean difference in body Fat (%)
timeFrame: At 6 months ( from baseline to the end of the study).
Secondary outcomes:
measure: Mean difference in BMI Z-score
timeFrame: At 6 months ( from baseline to the end of the study).
measure: Mean difference in waist circumference
timeFrame: At 6 months ( from baseline to the end of the study).
measure: Difference in food consumption
timeFrame: At 6 months ( from baseline to the end of the study).
measure: Mean difference in physical activity and sedentary behavior
timeFrame: At 6 months ( from baseline to the end of the study).
measure: Mean difference in quality of Life scores
timeFrame: At 6 months ( from baseline to the end of the study).
measure: Mean difference in nutrition knowledge
timeFrame: At 6 months ( from baseline to the end of the study).
measure: Feasibility of the intervention
timeFrame: At 6 months ( from baseline to the end of the study).
Other outcomes:
Locations:
Study officials:
affiliation: Universidad de Sonora
name: Rolando G Díaz Zavala
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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
citation: 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
citation: Marfell-Jones M, Olds T, Stewart A, Carter L. International Standards for Anthropometric Assessment. First edit. (ISAK, ed.).; 2006.
citation: 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.
citation: WHO. Growth Reference 5-19 years. BMI-for-age (5-19 years). 2007. https://www.who.int/growthref/en/
citation: 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
citation: 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
citation: 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.
citation: 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.
citation: 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
citation: 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.