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Completed

NCT Number: NCT00747513

A Multi-component Program to Reduce Obesity in Children

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.

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Key information

Age range

5 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

El Biader, Hura, Israel

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lifestyle program

Behavioral

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 outcomes

  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 outcomes

  1. body fat percentage

    Time frame: 12 months

  2. daily dairy product intake

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Collaborators

  • D-Cure, Israel
  • Rashi Foundation

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Sep 5, 2008
Registry last updated
Jun 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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