School-Based Program On Metabolic Disease

December 5, 2018 updated by: Paula Costa Urrutia, Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Multi-Component School-Based Program On Obesity and Related Diseases, In A Multi-Ethnic Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
800

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 01620
        • Hospital Regional Adolfo Lopez Matelos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

4 years to 13 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

• Participants with any incapacity to perform physical activity.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Behaviour
Physical activity and the Health Education programs are applied.
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.
ACTIVE_COMPARATOR: Nutrition
In this Arm, the the Physical activity, the Health education and Nutrition program are applied.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline In Body Mass Index At 12 Weeks
Time Frame: Up to 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
Time Frame: Up to 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
Time Frame: Up to 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
Time Frame: Up to 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
Time Frame: Up to 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
Time Frame: Up to 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
Time Frame: Up to 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
Time Frame: Up to 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
Time Frame: Up to 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
Time Frame: Up to 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
Time Frame: Up to 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.
Time Frame: Up to 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
Time Frame: Up to 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
Time Frame: Up to 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
Time Frame: Up to 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
Time Frame: Up to 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
Time Frame: Up to 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
Time Frame: Up to 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Paula Costa-Urrutia, Ph.D, Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 7, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 7, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 433.2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings