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A Multi-component Program to Reduce Obesity in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00747513
Recruitment Status : Completed
First Posted : September 5, 2008
Last Update Posted : June 1, 2012
Sponsor:
Collaborators:
Rashi Foundation
D-Cure, Israel
Information provided by (Responsible Party):
Sheba Medical Center

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.


Condition or disease Intervention/treatment Phase
Obesity Behavioral: lifestyle program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Multi-component Program to Improve Lifestyle Habits and Reduce Obesity in Children
Study Start Date : September 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : March 2011

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. screen time [ Time Frame: 12 months ]
  2. physical activity [ Time Frame: 12 months ]
  3. breakfast consumption [ Time Frame: 12 months ]
  4. eating family meals [ Time Frame: 12 months ]
  5. number of fruits and vegetables eaten per day [ Time Frame: 12 months ]
  6. drinking water [ Time Frame: 12 months ]
  7. body mass index [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. body fat percentage [ Time Frame: 12 months ]
  2. daily dairy product intake [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00747513


Locations
Show Show 22 study locations
Sponsors and Collaborators
Sheba Medical Center
Rashi Foundation
D-Cure, Israel
Investigators
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Principal Investigator: Liat Lerner-geva, MD PhD Women and Children's Health Research Unit, Gertner Institute, Tel Hashomer, Israel
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Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00747513    
Other Study ID Numbers: SHEBA- 08-5401-LL-CTIL
First Posted: September 5, 2008    Key Record Dates
Last Update Posted: June 1, 2012
Last Verified: May 2012
Keywords provided by Sheba Medical Center:
school
prevention
overweight
children
diet
physical activity
fitness
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms