A Multi-component Program to Reduce Obesity in Children

May 31, 2012 updated by: Sheba Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Hura, Israel
        • El Biader
      • Hura, Israel
        • El Magad
      • Kiryat Yam, Israel
        • Amirim School
      • Kiryat Yam, Israel
        • Miflasim School
      • Lod, Israel
        • Harel Elementary School
      • Merhavim, Israel
        • Mabuim School
      • Merhavim, Israel
        • Merhavim School
      • Or-Akiva, Israel
        • Rothchild School
      • Rahat, Israel
        • El Gazali
      • Rahat, Israel
        • Omar El Hatab
      • Ramla, Israel
        • Achva School
      • Ramla, Israel
        • Sharet Elementary School
      • Rosh Haayin, Israel
        • Fikus Preschool
      • Rosh Haayin, Israel
        • Ilanot Preschol
      • Rosh Haayin, Israel
        • Kinor Preschool
      • Rosh Haayin, Israel
        • Meitar Preschool
      • Rosh Haayin, Israel
        • Nevel Preschool
      • Rosh Haayin, Israel
        • Teena Preschool
      • Shlomi, Israel
        • Maimon School
      • Tel Aviv, Israel
        • Hassan Arafe School
      • Tel Aviv, Israel
        • Lev Yafo School
      • Tiberias, Israel
        • Noam School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 13 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: I
intervention group
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
body fat percentage
Time Frame: 12 months
12 months
daily dairy product intake
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Collaborators

D-Cure, Israel
Rashi Foundation

Investigators

  • Principal Investigator: Liat Lerner-geva, MD PhD, Women and Children's Health Research Unit, Gertner Institute, Tel Hashomer, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

September 4, 2008

First Submitted That Met QC Criteria

September 4, 2008

First Posted (Estimate)

September 5, 2008

Study Record Updates

Last Update Posted (Estimate)

June 1, 2012

Last Update Submitted That Met QC Criteria

May 31, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA- 08-5401-LL-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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