A Multi-component Program to Reduce Obesity in Children

NCT ID: NCT00747513

Last Updated: 2012-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-03-31

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.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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I

intervention group

Group Type EXPERIMENTAL

lifestyle program

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

5 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rashi Foundation

OTHER

Sponsor Role collaborator

D-Cure, Israel

INDUSTRY

Sponsor Role collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Liat Lerner-geva, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Women and Children's Health Research Unit, Gertner Institute, Tel Hashomer, Israel

Locations

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El Biader

Hura, , Israel

Site Status

El Magad

Hura, , Israel

Site Status

Harel Elementary School

Lod, , Israel

Site Status

Mabuim School

Merhavim, , Israel

Site Status

Merhavim School

Merhavim, , Israel

Site Status

Rothchild School

Or Akiva, , Israel

Site Status

Amirim School

Qiryat Yam, , Israel

Site Status

Miflasim School

Qiryat Yam, , Israel

Site Status

El Gazali

Rahat, , Israel

Site Status

Omar El Hatab

Rahat, , Israel

Site Status

Achva School

Ramla, , Israel

Site Status

Sharet Elementary School

Ramla, , Israel

Site Status

Fikus Preschool

Rosh HaAyin, , Israel

Site Status

Ilanot Preschol

Rosh HaAyin, , Israel

Site Status

Kinor Preschool

Rosh HaAyin, , Israel

Site Status

Meitar Preschool

Rosh HaAyin, , Israel

Site Status

Nevel Preschool

Rosh HaAyin, , Israel

Site Status

Teena Preschool

Rosh HaAyin, , Israel

Site Status

Maimon School

Shlomi, , Israel

Site Status

Hassan Arafe School

Tel Aviv, , Israel

Site Status

Lev Yafo School

Tel Aviv, , Israel

Site Status

Noam School

Tiberias, , Israel

Site Status

Countries

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Israel

Other Identifiers

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SHEBA- 08-5401-LL-CTIL

Identifier Type: -

Identifier Source: org_study_id

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