A Multi-component Program to Reduce Obesity in Children
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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 |
- 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 ]
- 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 |
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| Israel | |
| El Biader | |
| Hura, Israel | |
| El Magad | |
| Hura, Israel | |
| Amirim School | |
| Kiryat Yam, Israel | |
| Miflasim 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 | |
| Nevel Preschool | |
| Rosh Haayin, Israel | |
| Kinor Preschool | |
| Rosh Haayin, Israel | |
| Ilanot Preschol | |
| Rosh Haayin, Israel | |
| Meitar Preschool | |
| Rosh Haayin, Israel | |
| Teena Preschool | |
| Rosh Haayin, Israel | |
| Fikus Preschool | |
| Rosh Haayin, Israel | |
| Maimon School | |
| Shlomi, Israel | |
| Lev Yafo School | |
| Tel Aviv, Israel | |
| Hassan Arafe School | |
| Tel Aviv, Israel | |
| Noam School | |
| Tiberias, Israel | |
| 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 June 17, 2013