A Multi-component Program to Reduce Obesity in Children

Study Overview
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Brief Summary
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In an attempt to challenge the increasing prevalence of childhood obesity, many programs have been executed in order to improve childrens' lifestyle. Programs involved either school, family or environmental measures. In most, success was only limited. The purpose of this trial is to examine the ability of a low-cost multi-component program to improve behavioral, diet and activity habits in both school, family and afternoon settings. Ths ultimate goal is to construct and assess a lifestyle modification program that can be implemented in schools and kindergartens on a national level. Participants will be  2,500 children aged 5-12 from 22 kindergartens and elementary schools, divided into control and intervention centers. Teachers and students will be provided with materials in order to perform activities on healthy food and drink choices and habits during the school day. Schools will offer increased physical activity opportunities to children, as will afternoon community centers. Children will be given personal exercise items. Parents will be offered lectures on topics of diet and activity. Diet and activity habits will be assessed by a questionnaire, and height, weight and body fat percentage will be measured before and after the program.

Official Title
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A Multi-component Program to Improve Lifestyle Habits and Reduce Obesity in Children

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: lifestyle program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: schools with lunch served school principal agreement school has 2 weekly PE classes parent and children consent given Exclusion Criteria: consent not given

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 13 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I<br>intervention group | Behavioral: lifestyle program<br>* a comprehensive program designed to encourage healthier food choices and eating habits and increased physical activity among children, by use of school, family and community measures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| screen time |  | 12 months | 
| physical activity |  | 12 months | 
| breakfast consumption |  | 12 months | 
| eating family meals |  | 12 months | 
| number of fruits and vegetables eaten per day |  | 12 months | 
| drinking water |  | 12 months | 
| body mass index |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body fat percentage |  | 12 months | 
| daily dairy product intake |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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school, prevention, overweight, children, diet, physical activity, fitness