A Multi-component Program to Reduce Obesity in Children
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|ClinicalTrials.gov Identifier: NCT00747513|
Recruitment Status : Completed
First Posted : September 5, 2008
Last Update Posted : June 1, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Behavioral: lifestyle program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-component Program to Improve Lifestyle Habits and Reduce Obesity in Children|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||March 2011|
Behavioral: lifestyle program
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.
- screen time [ Time Frame: 12 months ]
- physical activity [ Time Frame: 12 months ]
- breakfast consumption [ Time Frame: 12 months ]
- eating family meals [ Time Frame: 12 months ]
- number of fruits and vegetables eaten per day [ Time Frame: 12 months ]
- drinking water [ Time Frame: 12 months ]
- body mass index [ Time Frame: 12 months ]
- body fat percentage [ Time Frame: 12 months ]
- daily dairy product intake [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00747513
|Principal Investigator:||Liat Lerner-geva, MD PhD||Women and Children's Health Research Unit, Gertner Institute, Tel Hashomer, Israel|