Evaluation of the Planet Nutrition Program on Obesity Parameters in Mexican Schoolchildren

Study Overview
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Brief Summary
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Obesity prevention programs in schools are essential to promoting healthy lifestyles. There are programs with positive effects on obesity parameters, but only a few of them have didactic material for its dissemination. In United States they have effective programs (with materials for their implementation) and some are already being implemented in different schools. In Mexico our study group has developed a program called Planet Nutrition that includes a manual.The main aim of this study is to evaluate the efficacy of the program Planet Nutrition-a nutrition education and behaviour change program- on BMI Z score in school children compared to a control group at 9 weeks. This pilot stud is a randomized controlled trial. The study will be conducted with 41 participants. The primary outcome was the change in the BMI Z score from baseline to 9 weeks. Secondary outcomes were the changes from baseline to 9 weeks in body fat percentage, waist circumference, systolic and diastolic blood pressure, consumption of healthy and unhealthy food, physical activity and sedentary lifestyle, cardiorespiratory capacity and nutrition knowledge. Additionally BMI Z score will be measured at 23 weeks, after the summer vacations. Considering evidence that this period could have a negative impact on children´s weight.

Detailed Description
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Fifth grade students from a public elementary school in Hermosillo, Sonora, Mexico were invited to participate in the program. The nutritionist team of the study made the request face to face in the classrooms. A printed invitation was delivered to be given to schoolchildren parents, in addition to the informed consent and assent along with a data questionnaire. To be included children must be in fifth grade from the chosen school and be between 9 to 12 years old. The exclusion criteria were, having or develop a medical condition, taking medication or having an intervention that affects body weight, having a condition that prevents physical activity (cardiovascular, respiratory, muscular, osteoarticular, etc.) at baseline or during the study, and withdrawal of the consent informed

Official Title
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Evaluation of the Planet Nutrition Program on Obesity Parameters in Mexican Schoolchildren: Pilot Randomized ControlledTrial

Conditions
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Childhood Obesity

Intervention / Treatment
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* Behavioral: Planet Nutrition program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fifth grade students of the chosen school. Having 9 to 12 years old. Exclusion Criteria: Having a condition, taking medication or carrying out an intervention that affects body weight. Condition that impede physical activity including cardiovascular, respiratory, muscular and bone condition. Withdrawal of informed consent and assent. Development of a health problem or taking medication with effect on body weight during the study. Participate in another intervention or treatment for obesity management during the study.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: None (open label)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Planet Nutrition program<br>multidisciplinary school- based program | Behavioral: Planet Nutrition program<br>* - Nutritional education sessions: The study team previously worked on the development of a handbook called Planet Nutrition which contains around 26 topics of nutrition and health. Interns from the Nutritional Sciences Degree of the University of Sonora implemented the sessions. 2 classes of 1 hour were given weekly, adding 18 sessions in total, during regular school hours. The program contemplates the establishment of different objectives. - Physical activity: The classes were designed and implemented by interns from the Bachelor of Physical Culture and Sport from the University of Sonora along with a teacher from the study team. 3 weekly sessions of 1 hour were provided. The activities were held on the schoolyard court during normal school hours, independent of the physical activity classes of the school. - Indirect family participation: Six information brochures with different nutrition and health topics were sent to parents.<br>|
| No Intervention: Control Group<br>Normal curricular classes | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BMI z score | First, the weight and height of the children were measured with a SECA digital scale and a stadiometer (SECA 213). Then, the BMI z score was obtained using the WHO Anthro Plus software, where the values of weight, age, date of birth and sex were considered. | Baseline to 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body fat | A tetrapolar electrical bioimpedance method (BIE) was used to obtain the resistance and reactance values. The measurement was made with the BIE team, RJL Quantum II. To estimate the body fat percentage, a validated equation in Mexican children was used. | Baseline to 9 weeks | 
| Change in waist circumference | The measurement was taken at the umbilical scar level, with the participant standing and on the upper garment (due to the lack of privacy) using a non-stretch tape measure. | Baseline to 9 weeks | 
| Change in the consumption of healthy and unhealthy food | The questionnaire consists of 12 questions about the consumption of healthy foods (fruits, vegetables, cereals, legumes, animal source food, dairy, etc.) and unhealthy (sugary drinks, salty snacks, sweets, pastries, sausages, etc..). The frequency ranges from never to more than twice a day. | Baseline to 9 weeks | 
| Change in auto-reported physical activity and sedentary activities | It was measured by a validated questionnarie for schoolchildren which includes nine questions about the frequency and time spent in physical activity and sedentary activities during the week and weekend. | Baseline to 9 weeks | 
| Change in nutrition knowledge | To assess the learning in the nutritional education sessions, a questionnaire designed by the study team was used. It consisted of 32 questions about nutrition and health. The answers consisted by multiple choice with 4 subsections (A-D) and true or false choices. | Baseline to 9 weeks | 
| Change in systolic and diastolic blood pressure | A digital sphygmomanometer, model Omron HEM-907, was used. Two measurements were made to obtain an average value of systolic and diastolic blood pressure. | Baseline to 9 weeks | 
| Change in cardiorespiratory capacity | It was measured by the Course Navette test to estimate the maxium oxygen consumption (Vo2 Max).The participants traveled a distance of 20 meters round trips, at the rhythm of a recording sound. The test is in one minute stages and the speed increases (0.85 km / h to 0.5 km / h). The participants were stopping when they felt tired. The test was carried out by the physical activity team of the study. | Baseline to 9 weeks | 
| Change in BMI Z score | It will be measured returning from summer vacations, following the same method. | 9 weeks to 21 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention, Obesity, Childhood, School-based Program, Lifestyle, Nutrition Education