Multi-Component School-Based Program On Obesity and Related Diseases, In A Multi-Ethnic Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline In Fasting Creatinine At 12 Weeks
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Participants with any incapacity to perform physical activity.
研究组 & 干预措施
Behaviour
Physical activity and the Health Education programs are applied.
干预措施: Health Education and Physical activity program (Behavioral)
Nutrition
In this Arm, the the Physical activity, the Health education and Nutrition program are applied.
干预措施: Health Education and Physical activity program (Behavioral)
Nutrition
In this Arm, the the Physical activity, the Health education and Nutrition program are applied.
干预措施: Nutrition Program (Dietary Supplement)
结局指标
主要结局
Mean Change From Baseline In Fasting Creatinine At 12 Weeks
时间窗: Up to 12 weeks
Description Blood samples were taken in the morning, after a 10-hours fasting to measure creatinine in milligrams/decilitres.
Mean Change From Baseline In Fasting Urea At 12 Weeks
时间窗: Up to 12 weeks
Description Blood samples were taken in the morning, after a 10-hours fasting to measure urea in milligrams/decilitres.
Mean Change From Baseline In Speed At 12 Weeks
时间窗: Up to 12 weeks
Speed is measured in meters/seconds using the 4x10 meters test.
Mean Change From Baseline In Fasting Low Density Lipoproteins Cholesterol At 12 Weeks
时间窗: Up to 12 weeks
Blood samples are taken in the morning, after a 10-hours fasting to low density lipoprotein cholesterol in milligrams/decilitres.
Mean Change From Baseline In Fasting Uric Acid At 12 Weeks
时间窗: Up to 12 weeks
Description Blood samples were taken in the morning, after a 10-hours fasting to measure uric acid in milligrams/decilitres.
Mean Change From Baseline In Fasting Glutamic Pyruvic Transaminase, At 12 Weeks
时间窗: 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).
Mean Change From Baseline In Body Mass Index At 12 Weeks
时间窗: 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.
Mean Change From Baseline In Fasting Glucose Profile At 12 Weeks
时间窗: Up to 12 weeks
Blood samples are taken in the morning, after a 10-hours fasting to measure glucose in milligrams/decilitres.
Mean Change From Baseline In Fasting Glycated Haemoglobin At 12 Weeks
时间窗: Up to 12 weeks
Blood samples are taken in the morning, after a 10-hours fasting to glycated haemoglobin in percentage.
Mean Change From Baseline In Fasting Triglycerides At 12 Weeks
时间窗: Up to 12 weeks
Blood samples are taken in the morning, after a 10-hours fasting to triglycerides in milligrams/decilitres.
Mean Change From Baseline In Fasting Total Cholesterol At 12 Weeks
时间窗: Up to 12 weeks
Blood samples are taken in the morning, after a 10-hours fasting to total cholesterol in milligrams/decilitres.
Mean Change From Baseline In Fasting High Density Lipoprotein Cholesterol At 12 Weeks
时间窗: Up to 12 weeks
Blood samples are taken in the morning, after a 10-hours fasting to high density lipoprotein cholesterol in milligrams/decilitres.
Mean Change From Baseline In Fasting Urea Nitrogen At 12 Weeks
时间窗: Up to 12 weeks
Blood samples were taken in the morning, after a 10-hours fasting to measure urea in milligrams/decilitres.
Mean Change From Baseline In Fasting Glutamic Oxalacetic Transaminase At 12 Weeks.
时间窗: 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).
Mean Change From Baseline In Fasting Bilirubin Profile, At 12 Weeks
时间窗: 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.
Mean Change From Baseline In Indirect Of Maximum Oxygen Consumption At 12 Weeks
时间窗: Up to 12 weeks
The Course-Navette test are used to measure the indirect maximum oxygen consumption measured in milligrams/kilograms/minutes.
Mean Change From Baseline In Power At 12 Weeks
时间窗: 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.
Mean Change From Baseline In Strength-Resistance At 12 Weeks
时间窗: 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.
次要结局
未报告次要终点
研究者
Paula Costa Urrutia
Ph.D
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado