School-Based Program On Metabolic Disease

Summary

Mexico occupies the first place worldwide in childhood obesity. Its urban and indigenous communities present different levels of westernization which have triggered different epidemiological diseases. This study aims to treat and prevent obesity and related diseases. A school-based multi-component intervention program is developed in three ethnic groups with varying levels of westernization: Mestizos, Seris and Yaquis. Measurements are obtained to evaluate obesity, cardiovascular, diabetes risk, hepatic and renal function, and physical fitness. The intervention consists on Physical Activity (PA), Health Education (HE) and Nutrition (NP) programs carried out in six urban (Mestizo ethnic group) and indigenous schools (Seri and Yaqui ethnic groups). A total of 800 participants were part of the PA and HE programs (Education Arm), and 117 of them were also part of the NP program (Nutrition Arm). Measurement differences, after and before treatments are used to assess the intervention effect by age, sex, ethnicity, nutritional status, and treatments. Expanded access is not applicable to this study. The Government's Secretary of Education does not allow developing a plan to share individual data of participants.

Conditions

• Obesity
• Diabetes Mellitus, Type 2
• Cardiovascular Function
• Kidney Diseases
• Liver Diseases
• Physical Fitness

Interventions

BEHAVIORAL

Health Education and Physical activity program

Its objective is to empower children on healthy lifestyle, addressing four main topics: nutrition (i.e. healthy food, hydration), adequate quantities of food, physical activity, and self-monitoring. The program is implemented in the classroom through workshops planned and conducted by psychologists and nutritionists. A total of 12 workshops are planned, to be conducted once a week, and lasting 50 minutes each. The Physical activity program objective is to develop an active scholar environment, and consists of a moderate-vigorous activity, five days a week. The activities are divided into two types: (a) in the school backyard for 60 minutes, three times a week, and (b) in the classroom two days a week, for 15 minutes three times a day, adding up to 45 minutes daily.

DIETARY_SUPPLEMENT

Nutrition Program

Its objective is to maintain lean mass, decrease fat mass and ensure mineral vitamins and fatty acids intake, maintain proper growth under National Specific Action Program: Food and Activity4. From total energy, a fat intake of 25-35%, carbohydrate intake of 45-65%, protein intake of 10-30%, and total calories are adjusted according to age. The Nutrition program consists of three meals: breakfast, a snack for a mid-morning playtime, and lunch at school. Food is prepared daily following sanitary and quality standards of Mexican official regulation. Breakfast is served 40 minutes before starting class time, lunch is served 40 minutes before leaving school.

Sponsors & Collaborators

• Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

  lead OTHER_GOV

Principal Investigators

• Paula Costa-Urrutia, Ph.D · Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

4 Years

Max Age

13 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-07-01

Primary Completion

2016-09-15

Completion

2016-11-30

Countries

• Mexico

Study Locations