School-Based Program On Metabolic Disease
Condition: Obesity; Diabetes Mellitus, Type 2; Cardiovascular Function; Kidney Diseases; Liver Diseases; Physical Fitness
MeSH terms: Liver Diseases; Kidney Diseases; Obesity; Diabetes Mellitus, Type 2
Study type: Interventional

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.
    

Detailed description: 
      Participants from one preschool and 5 primary schools are included in the study. Participants
      are children between 5 and 12 years old from Sonora State, North of Mexico. Four urban
      schools of Mexican-Mestizos (from Hermosillo, capital city) and two indigenous schools, Seris
      (from Punta Chueca) and Yaquis (from Bahía de Lobos), participate in the program. Urban
      schools are randomly selected. Indigenous schools are hard to access, thus Seris and Yaquis
      school are chosen based on higher accessibility, and all grades from those schools (from
      first to sixth) are included. The intervention program consists of implementing Health
      Education, Nutrition and Physical Activity programs, and also parent involvement activities.
      All nutritionists, psychologists, and physical education teachers are prepared for their
      lessons during two weeks before the project implementation by the developers of the project
      (PCU and RA), who also supervise them. The intervention program is split into two Arms; the
      Education Arm, which is applied to all participants, and the Nutrition Arm, which includes
      the Health Education, the Physical Activity and also the Nutrition programs. The Nutrition
      program is randomly applied just in the Mestizo group, i.e. schools and grade are randomly
      allocated in Nutrition program. Anthropogenic and biochemical measurements are collected
      before (Measurements 1, M1) and after (Measurements 2, M2) treatments. Anthropogenic
      measurements are taken to all participants, while biochemical are randomly taken to 320
      participants (includes all form Nutrition Arm). M1 and M2 are taken by the same team.
      Intervention effect is measured as the difference between M2 and M1, calculated as the
      difference (Dif) in M=M2-M1. Thus, negative DifM values indicate a decrease in the variable
      measured after the intervention, while positive DifM values indicate an increase in the
      variable. To assess the effect of age, sex, ethnic group (Mestizos, Seris, Yaquis),
      treatments (T1, T2) and nutritional status (Normal weight, Overweight+Obesity) in DifM (i.e.
      DifBMI), we perform Generalized Linear Models (GLMs) with Gaussian distribution(1). The
      initial model contains all single effects and all possible interactions of such explanatory
      variables. GLM simplification is done by stepwise deletion of the least significant terms.
      Subsequent models were generated by the stepwise removal of non-significant terms, and
      assessing each simplification with the Akaike information criterion (AIC) using the ΔAIC > 2
      criterion(2). All models considered are subjected to the customary residual analyses and show
      a satisfactory fit (results not shown). All statistical analyses are carried out in R(3).
    

Intervention name(s): Health Education and Physical activity program; Nutrition Program
Intervention type(s): Behavioral; Dietary Supplement
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The intervention program is split into two groups of participants which receive two deferments treatments (Arms); treatment (Arm 1) is applied to all participants (n=800), while treatment 2 (Arm 2) is randomly applied just in the Mestizo group (n=117), i.e. schools and grade are randomly allocated in Arm 2
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Body Mass Index; Glucose; Haemoglobin glycosylated; Blood Lipids; Liver Function; Kidney Function; Exercise; Physical activity