A Multi-component Program to Reduce Obesity in Children

Not Applicable

Completed

• Conditions: Obesity

• Registration Number: NCT00747513
• Lead Sponsor: Sheba Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-04
• Study First Submitted QC: 2008-09-04
• Study First Posted: 2008-09-05
• Study Start: 2009-09
• Primary Completion: 2010-09
• Study Completion: 2011-03
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-31
• Last Update Posted: 2012-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
body fat percentage	12 months
daily dairy product intake	12 months

Trial Locations

Locations (22)

El Biader; 🇮🇱 Hura, Israel

El Magad; 🇮🇱 Hura, Israel

Amirim School; 🇮🇱 Kiryat Yam, Israel

Miflasim School; 🇮🇱 Kiryat Yam, Israel

Harel Elementary School; 🇮🇱 Lod, Israel

Mabuim School; 🇮🇱 Merhavim, Israel

Merhavim School; 🇮🇱 Merhavim, Israel

Rothchild School; 🇮🇱 Or-Akiva, Israel

El Gazali; 🇮🇱 Rahat, Israel

Omar El Hatab; 🇮🇱 Rahat, Israel

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