A Multi-component Program to Reduce Obesity in Children

This study has been completed.
Sponsor:
Collaborators:
Rashi Foundation
D-Cure
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00747513
First received: September 4, 2008
Last updated: May 31, 2012
Last verified: May 2012
  Purpose

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 Intervention
Obesity
Behavioral: lifestyle program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Multi-component Program to Improve Lifestyle Habits and Reduce Obesity in Children

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • screen time [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • physical activity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • breakfast consumption [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • eating family meals [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • number of fruits and vegetables eaten per day [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • drinking water [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • body mass index [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • body fat percentage [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • daily dairy product intake [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 3600
Study Start Date: September 2009
Study Completion Date: March 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   5 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00747513

Locations
Israel
El Magad
Hura, Israel
El Biader
Hura, Israel
Miflasim School
Kiryat Yam, Israel
Amirim School
Kiryat Yam, Israel
Harel Elementary School
Lod, Israel
Merhavim School
Merhavim, Israel
Mabuim School
Merhavim, Israel
Rothchild School
Or-Akiva, Israel
Omar El Hatab
Rahat, Israel
El Gazali
Rahat, Israel
Achva School
Ramla, Israel
Sharet Elementary School
Ramla, Israel
Fikus Preschool
Rosh Haayin, Israel
Kinor Preschool
Rosh Haayin, Israel
Ilanot Preschol
Rosh Haayin, Israel
Nevel Preschool
Rosh Haayin, Israel
Teena Preschool
Rosh Haayin, Israel
Meitar Preschool
Rosh Haayin, Israel
Maimon School
Shlomi, Israel
Lev Yafo School
Tel Aviv, Israel
Hassan Arafe School
Tel Aviv, Israel
Noam School
Tiberias, Israel
Sponsors and Collaborators
Sheba Medical Center
Rashi Foundation
D-Cure
Investigators
Principal Investigator: Liat Lerner-geva, MD PhD Women and Children's Health Research Unit, Gertner Institute, Tel Hashomer, Israel
  More Information

No publications provided

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00747513     History of Changes
Other Study ID Numbers: SHEBA- 08-5401-LL-CTIL
Study First Received: September 4, 2008
Last Updated: May 31, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
school
prevention
overweight
children
diet
physical activity
fitness

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014