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A Multi-component Program to Reduce Obesity in Children

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
lifestyle program
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring school, prevention, overweight, children, diet, physical activity, fitness

Eligibility Criteria

5 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • El Biader
  • El Magad
  • Amirim School
  • Miflasim School
  • Harel Elementary School
  • Mabuim School
  • Merhavim School
  • Rothchild School
  • El Gazali
  • Omar El Hatab
  • Achva School
  • Sharet Elementary School
  • Fikus Preschool
  • Ilanot Preschol
  • Kinor Preschool
  • Meitar Preschool
  • Nevel Preschool
  • Teena Preschool
  • Maimon School
  • Hassan Arafe School
  • Lev Yafo School
  • Noam School

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

I

Arm Description

intervention group

Outcomes

Primary Outcome Measures

screen time
physical activity
breakfast consumption
eating family meals
number of fruits and vegetables eaten per day
drinking water
body mass index

Secondary Outcome Measures

body fat percentage
daily dairy product intake

Full Information

First Posted
September 4, 2008
Last Updated
May 31, 2012
Sponsor
Sheba Medical Center
Collaborators
Rashi Foundation, D-Cure, Israel
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1. Study Identification

Unique Protocol Identification Number
NCT00747513
Brief Title
A Multi-component Program to Reduce Obesity in Children
Official Title
A Multi-component Program to Improve Lifestyle Habits and Reduce Obesity in Children
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center
Collaborators
Rashi Foundation, D-Cure, Israel

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
school, prevention, overweight, children, diet, physical activity, fitness

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Experimental
Arm Description
intervention group
Intervention Type
Behavioral
Intervention Name(s)
lifestyle program
Intervention Description
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.
Primary Outcome Measure Information:
Title
screen time
Time Frame
12 months
Title
physical activity
Time Frame
12 months
Title
breakfast consumption
Time Frame
12 months
Title
eating family meals
Time Frame
12 months
Title
number of fruits and vegetables eaten per day
Time Frame
12 months
Title
drinking water
Time Frame
12 months
Title
body mass index
Time Frame
12 months
Secondary Outcome Measure Information:
Title
body fat percentage
Time Frame
12 months
Title
daily dairy product intake
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liat Lerner-geva, MD PhD
Organizational Affiliation
Women and Children's Health Research Unit, Gertner Institute, Tel Hashomer, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
El Biader
City
Hura
Country
Israel
Facility Name
El Magad
City
Hura
Country
Israel
Facility Name
Amirim School
City
Kiryat Yam
Country
Israel
Facility Name
Miflasim School
City
Kiryat Yam
Country
Israel
Facility Name
Harel Elementary School
City
Lod
Country
Israel
Facility Name
Mabuim School
City
Merhavim
Country
Israel
Facility Name
Merhavim School
City
Merhavim
Country
Israel
Facility Name
Rothchild School
City
Or-Akiva
Country
Israel
Facility Name
El Gazali
City
Rahat
Country
Israel
Facility Name
Omar El Hatab
City
Rahat
Country
Israel
Facility Name
Achva School
City
Ramla
Country
Israel
Facility Name
Sharet Elementary School
City
Ramla
Country
Israel
Facility Name
Fikus Preschool
City
Rosh Haayin
Country
Israel
Facility Name
Ilanot Preschol
City
Rosh Haayin
Country
Israel
Facility Name
Kinor Preschool
City
Rosh Haayin
Country
Israel
Facility Name
Meitar Preschool
City
Rosh Haayin
Country
Israel
Facility Name
Nevel Preschool
City
Rosh Haayin
Country
Israel
Facility Name
Teena Preschool
City
Rosh Haayin
Country
Israel
Facility Name
Maimon School
City
Shlomi
Country
Israel
Facility Name
Hassan Arafe School
City
Tel Aviv
Country
Israel
Facility Name
Lev Yafo School
City
Tel Aviv
Country
Israel
Facility Name
Noam School
City
Tiberias
Country
Israel

12. IPD Sharing Statement

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A Multi-component Program to Reduce Obesity in Children

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