A Multi-component Program to Reduce Obesity in Children
A Multi-component Program to Improve Lifestyle Habits and Reduce Obesity in Children
1 other identifier
interventional
3,600
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Sep 2009
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2008
CompletedFirst Posted
Study publicly available on registry
September 5, 2008
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedJune 1, 2012
May 1, 2012
1 year
September 4, 2008
May 31, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
screen time
12 months
physical activity
12 months
breakfast consumption
12 months
eating family meals
12 months
number of fruits and vegetables eaten per day
12 months
drinking water
12 months
body mass index
12 months
Secondary Outcomes (2)
body fat percentage
12 months
daily dairy product intake
12 months
Study Arms (1)
I
EXPERIMENTALintervention group
Interventions
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 Criteria
You may qualify if:
- schools with lunch served
- school principal agreement
- school has 2 weekly PE classes
- parent and children consent given
You may not qualify if:
- consent not given
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sheba Medical Centerlead
- Rashi Foundationcollaborator
- D-Cure, Israelcollaborator
Study Sites (22)
El Biader
Hura, Israel
El Magad
Hura, Israel
Harel Elementary School
Lod, Israel
Mabuim School
Merhavim, Israel
Merhavim School
Merhavim, Israel
Rothchild School
Or Akiva, Israel
Amirim School
Qiryat Yam, Israel
Miflasim School
Qiryat Yam, 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, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Liat Lerner-geva, MD PhD
Women and Children's Health Research Unit, Gertner Institute, Tel Hashomer, Israel
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2008
First Posted
September 5, 2008
Study Start
September 1, 2009
Primary Completion
September 1, 2010
Study Completion
March 1, 2011
Last Updated
June 1, 2012
Record last verified: 2012-05