Obesity Clinical Trial
Official title:
Multi-Component School-Based Program On Obesity and Related Diseases, In A Multi-Ethnic Study
NCT number | NCT03768245 |
Other study ID # | 433.2016 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2016 |
Est. completion date | November 30, 2016 |
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.
Status | Completed |
Enrollment | 800 |
Est. completion date | November 30, 2016 |
Est. primary completion date | September 15, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Years to 13 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Mexico | Hospital Regional Adolfo Lopez Matelos | Mexico City | Distrito Federal |
Lead Sponsor | Collaborator |
---|---|
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Mean Change From Baseline In Speed At 12 Weeks | Speed is measured in meters/seconds using the 4x10 meters test. | Up to 12 weeks | |
Primary | 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 | |
Primary | 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 |
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