A Multi-component Program to Reduce Obesity in Children

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00747513
• Other study ID #: SHEBA- 08-5401-LL-CTIL
• Status: Completed
• Phase: N/A
• First received: September 4, 2008
• Last updated: May 31, 2012
• Start date: September 2009
• Est. completion date: March 2011

Study information

• Verified date: May 2012
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3600
• Est. completion date: March 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 13 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity

Intervention

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.

Locations

Country	Name	City	State
Israel	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	Achva School	Ramla
Israel	Sharet Elementary School	Ramla
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	Rosh Haayin
Israel	Maimon School	Shlomi
Israel	Hassan Arafe School	Tel Aviv
Israel	Lev Yafo School	Tel Aviv
Israel	Noam School	Tiberias

Sponsors (3)

Lead Sponsor	Collaborator
Sheba Medical Center	D-Cure, Israel, Rashi Foundation

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	screen time		12 months	No
Primary	physical activity		12 months	No
Primary	breakfast consumption		12 months	No
Primary	eating family meals		12 months	No
Primary	number of fruits and vegetables eaten per day		12 months	No
Primary	drinking water		12 months	No
Primary	body mass index		12 months	No
Secondary	body fat percentage		12 months	No
Secondary	daily dairy product intake		12 months	No