School-Based Program On Metabolic Disease

NCT03768245 | Completed

• 1 other identifier: 433.2016
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Body Mass Index; Glucose; Haemoglobin glycosylated; Blood Lipids; Liver Function; Kidney Function; Exercise; Physical activity

Outcome Measures

Primary Outcomes (18)

• Mean Change From Baseline In Body Mass Index At 12 Weeks

  Weight is measured kilograms using a Seca scale. Height is measured in meters cm using a standardized portable stadiometer Microtoise. Weight and height are be combined to report Body mass index (BMI) in kg/m\^2. BMI cut-off points of normal weight, overweight and obesity are used as defined by World Health Organization5.

  Up to 12 weeks

• Mean Change From Baseline In Fasting Glucose Profile At 12 Weeks

  Blood samples are taken in the morning, after a 10-hours fasting to measure glucose in milligrams/decilitres.

  Up to 12 weeks

• Mean Change From Baseline In Fasting Glycated Haemoglobin At 12 Weeks

  Blood samples are taken in the morning, after a 10-hours fasting to glycated haemoglobin in percentage.

  Up to 12 weeks

• Mean Change From Baseline In Fasting Triglycerides At 12 Weeks

  Blood samples are taken in the morning, after a 10-hours fasting to triglycerides in milligrams/decilitres.

  Up to 12 weeks

• Mean Change From Baseline In Fasting Total Cholesterol At 12 Weeks

  Blood samples are taken in the morning, after a 10-hours fasting to total cholesterol in milligrams/decilitres.

  Up to 12 weeks

• Mean Change From Baseline In Fasting High Density Lipoprotein Cholesterol At 12 Weeks

  Blood samples are taken in the morning, after a 10-hours fasting to high density lipoprotein cholesterol in milligrams/decilitres.

  Up to 12 weeks

• Mean Change From Baseline In Fasting Low Density Lipoproteins Cholesterol At 12 Weeks

  Blood samples are taken in the morning, after a 10-hours fasting to low density lipoprotein cholesterol in milligrams/decilitres.

  Up to 12 weeks

• Mean Change From Baseline In Fasting Creatinine At 12 Weeks

  Description Blood samples were taken in the morning, after a 10-hours fasting to measure creatinine in milligrams/decilitres.

  Up to 12 weeks

• Mean Change From Baseline In Fasting Urea At 12 Weeks

  Description Blood samples were taken in the morning, after a 10-hours fasting to measure urea in milligrams/decilitres.

  Up to 12 weeks

• Mean Change From Baseline In Fasting Urea Nitrogen At 12 Weeks

  Blood samples were taken in the morning, after a 10-hours fasting to measure urea in milligrams/decilitres.

  Up to 12 weeks

• Mean Change From Baseline In Fasting Uric Acid At 12 Weeks

  Description Blood samples were taken in the morning, after a 10-hours fasting to measure uric acid in milligrams/decilitres.

  Up to 12 weeks

• Mean Change From Baseline In Fasting Glutamic Oxalacetic Transaminase At 12 Weeks.

  Blood samples were taken in the morning, after a 10-hour fast to measure glutamic oxalacetic transaminase measured in international units/litre (U/L).

  Up to 12 weeks

• Mean Change From Baseline In Fasting Glutamic Pyruvic Transaminase, At 12 Weeks

  Blood samples were taken in the morning, after a 10-hour fast to measure glutamic pyruvic transaminase measured in international units/litre (U/L).

  Up to 12 weeks

• Mean Change From Baseline In Fasting Bilirubin Profile, At 12 Weeks

  Blood samples were taken in the morning, after a 10-hour fast to measure direct, total and indirect bilirubin, measured in milligrams/decilitres.

  Up to 12 weeks

• Mean Change From Baseline In Indirect Of Maximum Oxygen Consumption At 12 Weeks

  The Course-Navette test are used to measure the indirect maximum oxygen consumption measured in milligrams/kilograms/minutes.

  Up to 12 weeks

• Mean Change From Baseline In Speed At 12 Weeks

  Speed is measured in meters/seconds using the 4x10 meters test.

  Up to 12 weeks

• Mean Change From Baseline In Strength-Resistance At 12 Weeks

  Strength-resistance is measured in number of repetition using the abdominal strength test, which consists of recording the maximum number of abdominals in 30 seconds.

  Up to 12 weeks

• Mean Change From Baseline In Power At 12 Weeks

  Power is measured in centimetres, using the long jump test which measures the explosive power of the lower body, and the vertical jump test, measured in centimetres, for measuring changes in leg power.

  Up to 12 weeks

Study Arms (2)

Behaviour

EXPERIMENTAL

Physical activity and the Health Education programs are applied.

Behavioral: Health Education and Physical activity program

Nutrition

ACTIVE COMPARATOR

In this Arm, the the Physical activity, the Health education and Nutrition program are applied.

Behavioral: Health Education and Physical activity program; Dietary Supplement: Nutrition Program

Interventions

Health Education and Physical activity program BEHAVIORAL

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.

Behaviour; Nutrition

Nutrition Program DIETARY_SUPPLEMENT

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.

Nutrition

Eligibility Criteria

• Age: 4 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children from the selected grades and schools.
• Children who voluntarily accept participating in the program.
• Children whose parents must authorize their participation in the program, signing an informed consent document.

You may not qualify if:

• Participants with any incapacity to perform physical activity.

Sponsors & Collaborators

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

Study Sites (1)

Hospital Regional Adolfo Lopez Matelos

Mexico City, Mexico City, 01620, Mexico

Location

Related Publications (1)

• Costa-Urrutia P, Alvarez-Farina R, Abud C, Franco-Trecu V, Esparza-Romero J, Lopez-Morales CM, Rodriguez-Arellano ME, Valle Leal J, Colistro V, Granados J. Effect of multi-component school-based program on body mass index, cardiovascular and diabetes risks in a multi-ethnic study. BMC Pediatr. 2019 Nov 4;19(1):401. doi: 10.1186/s12887-019-1787-x.

  PMID: 31679507 DERIVED

Related Links

• Describe the tests for physical fitness evaluation

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2; Kidney Diseases; Liver Diseases; Motor Activity

Interventions

Food Assistance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Digestive System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Public Assistance; Financing, Government; Financing, Organized; Economics; Health Care Economics and Organizations

Study Officials

• Paula Costa-Urrutia, Ph.D

  Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D

Model Details: 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

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: December 7, 2018
• Study Start: July 1, 2016
• Primary Completion: September 15, 2016
• Study Completion: November 30, 2016
• Last Updated: December 7, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)