Clinical trial NCT00747513: A Multi-component Program to Reduce Obesity in Children
Official title: A Multi-component Program to Improve Lifestyle Habits and Reduce Obesity in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: school
prevention
overweight
children
diet
physical activity
fitness
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Rashi Foundation
name: D-Cure, Israel
First posted: 2008-09-05
Enrollment: 3600
Sex: ALL
Minimum age (years): 5
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: screen time
timeFrame: 12 months
measure: physical activity
timeFrame: 12 months
measure: breakfast consumption
timeFrame: 12 months
measure: eating family meals
timeFrame: 12 months
measure: number of fruits and vegetables eaten per day
timeFrame: 12 months
measure: drinking water
timeFrame: 12 months
measure: body mass index
timeFrame: 12 months
Secondary outcomes:
measure: body fat percentage
timeFrame: 12 months
measure: daily dairy product intake
timeFrame: 12 months
Other outcomes:
Locations:
city: Hura
country: Israel
facility: El Biader
city: Hura
country: Israel
facility: El Magad
city: Kiryat Yam
country: Israel
facility: Amirim School
city: Kiryat Yam
country: Israel
facility: Miflasim School
city: Lod
country: Israel
facility: Harel Elementary School
city: Merhavim
country: Israel
facility: Mabuim School
city: Merhavim
country: Israel
facility: Merhavim School
city: Or-Akiva
country: Israel
facility: Rothchild School
city: Rahat
country: Israel
facility: El Gazali
city: Rahat
country: Israel
facility: Omar El Hatab
city: Ramla
country: Israel
facility: Achva School
city: Ramla
country: Israel
facility: Sharet Elementary School
city: Rosh Haayin
country: Israel
facility: Fikus Preschool
city: Rosh Haayin
country: Israel
facility: Ilanot Preschol
city: Rosh Haayin
country: Israel
facility: Kinor Preschool
city: Rosh Haayin
country: Israel
facility: Meitar Preschool
city: Rosh Haayin
country: Israel
facility: Nevel Preschool
city: Rosh Haayin
country: Israel
facility: Teena Preschool
city: Shlomi
country: Israel
facility: Maimon School
city: Tel Aviv
country: Israel
facility: Hassan Arafe School
city: Tel Aviv
country: Israel
facility: Lev Yafo School
city: Tiberias
country: Israel
facility: Noam School
Study officials:
affiliation: Women and Children's Health Research Unit, Gertner Institute, Tel Hashomer, Israel
name: Liat Lerner-geva, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: