Efficacy of a School-based Obesity Prevention Program in Mexican Schoolchildren: Cluster Randomized Controlled Trial

NCT05461703 | Unknown

• 1 other identifier: PNP02
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

There is evidence that obesity prevention programs show positive effects on obesity and lifestyle parameters. However, the effect of the programs delivered by different implementers is unknown, and in Mexico, the available studies present methodological limitations. The aim of this study is to evaluate the feasibility and efficacy of a school-based obesity prevention program implemented by nutrition and physical activity advanced students compared to a control group and implemented by school teachers compared to a control group of Mexican schoolchildren. This is a cluster randomized controlled trial. Schoolchildren from different public schools in Hermosillo , Sonora will be invited to participate. The schools will be randomly assigned to one option:1) the Planet Nutrition Program (PPN) delivered by advanced students, 2) PPN by school teachers, or 3) a control group. A 6-month pilot study with a follow-up at 8 months (after the summer holidays), followed by a definitive study with a follow-up at 8 and 12 months will be conducted.The intervention will consist of nutrition education sessions, physical activity, and the provision of nutrition information for parents. The BMI Z-score, body fat, other obesity, and lifestyle parameters will be evaluated at baseline and at the end of the study. A mixed effects model will be used to evaluate the differences between the groups. The investigators expect that the program could be a model of obesity prevention with a high potential for dissemination in Mexican schools.

Conditions

Pediatric Obesity

Keywords

Obesity prevention; School-based program; Nutrition education; Physical activity; Cluster randomized controlled trial

Outcome Measures

Primary Outcomes (6)

• Retention assessed by the number of participants/schools that complete the study (more information in the description).

  This variable will be obtained with the number of schools and participants that complete the final measurements of the study. At 6 months, retention of participants and schools \>80% will be considered excellent, \>50-80 moderate, and \<50 low retention.

  At 6 months

• Adherence evaluated with the number of sessions attended by the participants (more information in the description).

  It will be evaluated with the number of attended sessions by schoolchildren and parents of the intervention groups. At 6 months, the attendance at program activities \>80 will be considered excellent, \>50-80 moderate, and \<50 low attendance.

  At 6 months.

• Fidelity evaluated with the number of sessions provided by the implementers (more information in the description).

  This will be evaluated with a questionnaire to ask implementers about the number of sessions and workshops implemented. Excellent fidelity to the study activities will be considered when ≥ 60% of the program is delivered, \<60-40% moderate, and \<40 % low.

  At 6 months.

• Acceptability of the intervention assessed by a questionnaire of the research team (information in the description).

  The variable will be obtained with a questionnaire designed by the research group (not validated), applied to the children and parents of the intervention groups to qualify the program and materials. Also, to know about the benefits obtained with the program. A questionnaire will be provided to implementers to indicate their acceptance of the program and barriers to provide the sessions. It will be considered as good acceptance with a score of \> 8-10 points, moderate acceptance \> 5-8 points, and low acceptance ≤5 points.

  At 6 months.

• Change in the BMI Z-score

  It will be the primary outcome for the definitive study. The BMI Z-score will be obtaining with the weight, height, gender and date of birth of the children, using the "Anthro Plus" software, which utilize the WHO reference tables (WHO,2007). The change in the outcome will be obtained by subtracting the value obtained at the final measurement from the baseline value.

  Baseline, at 6 months, 8 months (after summer holidays), and for the definitive trial: baseline, 6 months, 8 months and after the 12 months of follow-up.

• Change in Body fat

  It will be the primary outcome for the definitive study. The tetrapolalar electrical bioimpedance method will be used to obtain the resistance and reactance values. The measurement will be carried out with a bioimpedance electrical equipment, RJL Quantum II, following the methodology used by Ramírez et al. With the data obtained, an equation designed to estimate fat-free mass in Mexican children will be used (Ramírez et al,2012). The change in the outcome will be obtained by subtracting the value obtained at the final measurement from the baseline value.

  Baseline, at 6 months, 8 months (after summer holidays), and for the definitive trial: baseline, 6 months, 8 months and after the 12 months of follow-up.

Secondary Outcomes (7)

• Change in Weight

  Baseline, at 6 months and 8 months (after summer holidays), and for the definitive trial: baseline, 6 months, and after the 8 months and 12 months of follow-up.

• Change in Waist circumference

  Baseline and 6 months.

• Change in Relative fat mass

  Baseline and 6 months.

• Change in Food consumption

  Baseline and 6 months.

• Change in Physical activity and sedentary behavior

  Baseline and 6 months.

Study Arms (3)

Planet Nutrition Program (PNP) implemented by nutrition and physical activity advanced students

EXPERIMENTAL

The PNP consists of: Nutrition education sessions: Nutrition advanced students of the University of Sonora will provide 1 face-to-face group class of one hour per week. The PNP handbook will be used to bring the different topics and dynamics to reinforce learning. The program will be focused on establishing some health-related goals. Physical activity sessions: Three classes of 1 hour per week will be implemented by physical activity advanced students of the University of Sonora, independent of the school's curricular physical activity classes. A physical activity handbook designed by the study team will be used. Children will work on developing different skills. Parents participation: They will receive one printed brochure with nutrition topics weekly. Also, they will be asked for their Facebook user (to create a private group) or the email to upload the information of the brochure and other didactic materials. Nutrition students will be in charge of providing the information.

Behavioral: Planet Nutrition Program

Planet Nutrition (PNP) implemented by school teachers

EXPERIMENTAL

The PNP consists of: Nutrition education sessions: Fourth grade school teachers will provide 1 face-to-face group class of one hour per week. The PNP handbook will be used to bring the different topics and dynamics to reinforce learning. The program will be focused on establishing some health-related goals. Physical activity sessions: Three classes of 1 hour per week will be implemented by physical activity advanced students of the University of Sonora, independent of the school's curricular physical activity classes. A physical activity handbook designed by the study team will be used. Children will work on developing different skills. Parents participation: They will receive one printed brochure with nutrition topics weekly. Also, they will be asked for their Facebook user (to create a private group) or the email and upload the information of the brochure and other didactic materials. School teachers will be in charge of providing the information.

Behavioral: Planet Nutrition Program

Control Group

NO INTERVENTION

Scholars of this group will continue with their normal school nutrition and physical activity classes. At the end of the study they will have access to the program materials through a web page.

Interventions

Planet Nutrition Program BEHAVIORAL

It is a 6-month school-based obesity prevention program that includes: nutrition education sessions, physical activity and family participation.

Planet Nutrition (PNP) implemented by school teachers; Planet Nutrition Program (PNP) implemented by nutrition and physical activity advanced students

Eligibility Criteria

• Age: 9 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Schools:
• school directors and teachers wish to participate.
• availability of space for physical activity classes.
• the school has at least 20 children per 4th-grade group.
• Schoolchildren:
• be a 4th grade student (9 to 11 years old).
• Implemeters:
• receive 80% of the program training.
• respond satisfactorily to a questionnaire that tests knowledge of the program

You may not qualify if:

• Schools: participating in another similar study.
• Schoolchildren: Having a personal condition that prevents physical activity or a condition that parents consider should not involve the child.

Sponsors & Collaborators

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

Study Sites (1)

Public Schools

Hermosillo, Sonora, Mexico

RECRUITING

Related Publications (27)

• World Health Organization (WHO). Obesity and Overweight. [Internet]. 2018 [cited 2019 Oct 10]. Available from: https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight

  BACKGROUND

• NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in body-mass index, underweight, overweight, and obesity from 1975 to 2016: a pooled analysis of 2416 population-based measurement studies in 128.9 million children, adolescents, and adults. Lancet. 2017 Dec 16;390(10113):2627-2642. doi: 10.1016/S0140-6736(17)32129-3. Epub 2017 Oct 10.

  PMID: 29029897 BACKGROUND

• Shamah-Levy T, Vielma-Orozco E, Heredia-Hernández O, Romero-Martínez M, Mojica-Cuevas J C-NL, Santaella-Castell JA R-DJ. Encuesta Nacional de Salud y Nutrición 2018-19: Resultados Nacionales. [Internet]. Cuernavaca, México; 2020. Available from: https://ensanut.insp.mx/encuestas/ensanut2018/informes.php

  BACKGROUND

• Obesity Evidence Hub. Obesity trends in children globally [Internet]. 2021 [cited 2021 Nov 20]. Available from: https://www.obesityevidencehub.org.au/collections/trends/children-global-context

  BACKGROUND

• Sharma V, Coleman S, Nixon J, Sharples L, Hamilton-Shield J, Rutter H, Bryant M. A systematic review and meta-analysis estimating the population prevalence of comorbidities in children and adolescents aged 5 to 18 years. Obes Rev. 2019 Oct;20(10):1341-1349. doi: 10.1111/obr.12904. Epub 2019 Jul 24.

  PMID: 31342672 BACKGROUND

• Lambrinou CP, Androutsos O, Karaglani E, Cardon G, Huys N, Wikstrom K, Kivela J, Ko W, Karuranga E, Tsochev K, Iotova V, Dimova R, De Miguel-Etayo P, M Gonzalez-Gil E, Tamas H, Jancso Z, Liatis S, Makrilakis K, Manios Y; Feel4Diabetes-study group. Effective strategies for childhood obesity prevention via school based, family involved interventions: a critical review for the development of the Feel4Diabetes-study school based component. BMC Endocr Disord. 2020 May 6;20(Suppl 2):52. doi: 10.1186/s12902-020-0526-5.

  PMID: 32370795 BACKGROUND

• WHO. Population-based approaches to childhood obesity prevention [Internet]. Geneva, Switzerland; 2012. Available from: https://www.who.int/dietphysicalactivity/childhood/WHO_new_childhoodobesity_PREVENTION_27nov_HR_PRINT_OK.pdf

  BACKGROUND

• Pulimeno M, Piscitelli P, Colazzo S, Colao A, Miani A. School as ideal setting to promote health and wellbeing among young people. Health Promot Perspect. 2020 Nov 7;10(4):316-324. doi: 10.34172/hpp.2020.50. eCollection 2020.

  PMID: 33312927 BACKGROUND

• Brown T, Moore TH, Hooper L, Gao Y, Zayegh A, Ijaz S, Elwenspoek M, Foxen SC, Magee L, O'Malley C, Waters E, Summerbell CD. Interventions for preventing obesity in children. Cochrane Database Syst Rev. 2019 Jul 23;7(7):CD001871. doi: 10.1002/14651858.CD001871.pub4.

  PMID: 31332776 BACKGROUND

• Singhal J, Herd C, Adab P, Pallan M. Effectiveness of school-based interventions to prevent obesity among children aged 4 to 12 years old in middle-income countries: A systematic review and meta-analysis. Obes Rev. 2021 Jan;22(1):e13105. doi: 10.1111/obr.13105. Epub 2020 Jul 28.

  PMID: 32725780 BACKGROUND

• Aceves-Martins M, Lopez-Cruz L, Garcia-Botello M, Gutierrez-Gomez YY, Moreno-Garcia CF. Interventions to Prevent Obesity in Mexican Children and Adolescents: Systematic Review. Prev Sci. 2022 May;23(4):563-586. doi: 10.1007/s11121-021-01316-6. Epub 2021 Nov 2.

  PMID: 34725762 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

• Ramírez-Rivera DL, Martínez-Contreras T, Henry-Mejia G, Ruelas AL, Quizán-Plata T, Esparza-Romero J, Díaz-Zavala RG. 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 durante la pandemia por COVID-19. Rev Esp Nutr Hum Diet 2021;25.

  BACKGROUND

• Diaz-Zavala RG, Castro-Cantu MF, Valencia ME, Alvarez-Hernandez G, Haby MM, Esparza-Romero J. Effect of the Holiday Season on Weight Gain: A Narrative Review. J Obes. 2017;2017:2085136. doi: 10.1155/2017/2085136. Epub 2017 Jul 4.

  PMID: 28744374 BACKGROUND

• Franckle R, Adler R, Davison K. Accelerated weight gain among children during summer versus school year and related racial/ethnic disparities: a systematic review. Prev Chronic Dis. 2014 Jun 12;11:E101. doi: 10.5888/pcd11.130355.

  PMID: 24921899 BACKGROUND

• Fernandez ME, Ruiter RAC, Markham CM, Kok G. Intervention Mapping: Theory- and Evidence-Based Health Promotion Program Planning: Perspective and Examples. Front Public Health. 2019 Aug 14;7:209. doi: 10.3389/fpubh.2019.00209. eCollection 2019.

  PMID: 31475126 BACKGROUND

• Murimi MW, Moyeda-Carabaza AF, Nguyen B, Saha S, Amin R, Njike V. Factors that contribute to effective nutrition education interventions in children: a systematic review. Nutr Rev. 2018 Aug 1;76(8):553-580. doi: 10.1093/nutrit/nuy020.

  PMID: 29800311 BACKGROUND

• Universidad de Guadalaja. Pedirá AMFEN regular apertura de escuelas de Nutrición en México [Internet]. 2021. Available from: http://www.cualtos.udg.mx/noticia/pedira-amfen-regular-apertura-de-escuelas-de-nutricion-en-mexico.

  BACKGROUND

• El País. Universidades que imparten Deportes [Internet]. 2021. Available from: https://elpais.com/especiales/2015/carreras-mexico/carrera/universidad/deportes.html

  BACKGROUND

• Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239.

  PMID: 27777223 BACKGROUND

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

  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

• Gibson R. Principles of Nutritional Assessment. New York: Oxford University Press; 1990.

  BACKGROUND

• Woolcott OO, Bergman RN. Relative Fat Mass as an estimator of whole-body fat percentage among children and adolescents: A cross-sectional study using NHANES. Sci Rep. 2019 Oct 24;9(1):15279. doi: 10.1038/s41598-019-51701-z.

  PMID: 31649287 BACKGROUND

• Shamah-Levy T, Cuevas-Nasu L, Rivera-Dommarco J, Hernández-Ávila M. Encuesta Nacional de Salud y Nutrición de Medio Camino 2016. (ENSANUT MC 2016) [Internet]. 2016. Available from: gob.mx/salud/documentos/encuesta-nacional-de-salud-y-nutricion-de-medio-camino-2016.

  BACKGROUND

• 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 [Internet]. 2014. Available from: http://www.hbsc.org

  BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Pediatric Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Rolando G Díaz Zavala, PhD

  Universidad de Sonora

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rolando G Díaz Zavala, PhD

CONTACT

6622592250; giovanni.diaz@unison.mx

Diana L Ramírez Rivera, MSc

CONTACT

a214207064@unison.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The person in charge of the allocation of the schools will be blinded. The outcome assessors will also be blinded to the group allocation of the schools.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full-time professor and researcher

Model Details: This is a cluster randomized controlled trial. The study will be conducted in two phases. The first will be a 6-month pilot study with a follow-up at 8 months (after the summer holidays) and the second a definitive study of 6 months with a follow-up at 8 and 12 months. The study will consist of three parallel, three-arm groups with a 1:1:1 allocation ratio.

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 18, 2022
• Study Start: December 5, 2022
• Primary Completion: June 1, 2023
• Study Completion: November 1, 2024
• Last Updated: February 2, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)