Clinical trial NCT03768245: School-Based Program On Metabolic Disease
Official title: Multi-Component School-Based Program On Obesity and Related Diseases, In A Multi-Ethnic Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
Sponsor class: OTHER_GOV
First posted: 2018-12-07
Enrollment: 800
Sex: ALL
Minimum age (years): 4
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Mean Change From Baseline In Body Mass Index At 12 Weeks
timeFrame: Up to 12 weeks
measure: Mean Change From Baseline In Fasting Glucose Profile At 12 Weeks
timeFrame: Up to 12 weeks
measure: Mean Change From Baseline In Fasting Glycated Haemoglobin At 12 Weeks
timeFrame: Up to 12 weeks
measure: Mean Change From Baseline In Fasting Triglycerides At 12 Weeks
timeFrame: Up to 12 weeks
measure: Mean Change From Baseline In Fasting Total Cholesterol At 12 Weeks
timeFrame: Up to 12 weeks
measure: Mean Change From Baseline In Fasting High Density Lipoprotein Cholesterol At 12 Weeks
timeFrame: Up to 12 weeks
measure: Mean Change From Baseline In Fasting Low Density Lipoproteins Cholesterol At 12 Weeks
timeFrame: Up to 12 weeks
measure: Mean Change From Baseline In Fasting Creatinine At 12 Weeks
timeFrame: Up to 12 weeks
measure: Mean Change From Baseline In Fasting Urea At 12 Weeks
timeFrame: Up to 12 weeks
measure: Mean Change From Baseline In Fasting Urea Nitrogen At 12 Weeks
timeFrame: Up to 12 weeks
measure: Mean Change From Baseline In Fasting Uric Acid At 12 Weeks
timeFrame: Up to 12 weeks
measure: Mean Change From Baseline In Fasting Glutamic Oxalacetic Transaminase At 12 Weeks.
timeFrame: Up to 12 weeks
measure: Mean Change From Baseline In Fasting Glutamic Pyruvic Transaminase, At 12 Weeks
timeFrame: Up to 12 weeks
measure: Mean Change From Baseline In Fasting Bilirubin Profile, At 12 Weeks
timeFrame: Up to 12 weeks
measure: Mean Change From Baseline In Indirect Of Maximum Oxygen Consumption At 12 Weeks
timeFrame: Up to 12 weeks
measure: Mean Change From Baseline In Speed At 12 Weeks
timeFrame: Up to 12 weeks
measure: Mean Change From Baseline In Strength-Resistance At 12 Weeks
timeFrame: Up to 12 weeks
measure: Mean Change From Baseline In Power At 12 Weeks
timeFrame: Up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Hospital Regional Adolfo Lopez Matelos
state: Distrito Federal
Study officials:
affiliation: Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
name: Paula Costa-Urrutia, Ph.D
role: STUDY_DIRECTOR
References:
citation: 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.