Intervention Study for Overweight and Obese Kindergarten Children

This study has been withdrawn prior to enrollment.

(We were not successful in raising money for this project)

Sponsor:

Information provided by (Responsible Party):

Meir Medical Center

ClinicalTrials.gov Identifier:

NCT01285063

First received: December 7, 2010

Last updated: February 20, 2013

Last verified: February 2013

History of Changes

Purpose

The goal of the this study is to create an interdisciplinary program which includes intervention in the fields of nutrition, physical activity and behavior in order to treat obesity and overweight among kindergarten children and to examine the influence of such program on the BMI,BMI%, physical fitness, knowledge and preferences in the said fields among the participants.

Condition	Intervention
Overweight Obesity Physical Fitness	Other: Multidisciplinary intervention: physical activity, dietary instructions and behavioral treatment.

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Combined Physical Activity and Diet Intervention for the Treatment of Overweight and Obesity in Kindergarten Children

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Obesity

U.S. FDA Resources

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:

reduction of the BMI percentage among the participants in comparison to the control group. [ Time Frame: every 2 weeks. ] [ Designated as safety issue: No ]
height, weight, BMI and BMI percentage will be documented after each meeting with the dietitian.

Secondary Outcome Measures:

Improvement in the physical fitness of the participants in comparison to the control group. [ Time Frame: Day 1 and after 3 months. ] [ Designated as safety issue: No ]
"Back and forth" running test for a 10m distance.
Positive change in the knowledge and preferences of the participants in the fields of nutrition and physical activity in comparison to the control group. [ Time Frame: Day 1 and after 3 months. ] [ Designated as safety issue: No ]
"Nutrition and physical activity knowledge and preferences" questionnaire. The questionnaire is an instrument to evaluate the knowledge and preferences of children in the ages of 4-8 in the fields of nutrition and physical activity.

Enrollment:	0
Study Start Date:	January 2013
Estimated Study Completion Date:	February 2014
Estimated Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: physical activiy & nutrition 25 kindergarten children in the ages of 4-6 who defined as suffering from overweigh (BMI percentage 85-95) or obesity (above BMI percentage 95). Non-generalization criteria: children who suffer from obesity due to organic disease or children who take medicine which may influence body weight (e.g., steroids) will be excluded from the research.	Other: Multidisciplinary intervention: physical activity, dietary instructions and behavioral treatment. 3 months intervention. Nutritious plan: includes 6 meetings of the child and his or her parents with a dietician from the center. Physical activity: physical trainings of 60 minutes each will be held twice a week. behavioral treatment: all the participants will take part it a 45 minutes meeting of movement therapy once a week. The goal of such meeting is to strengthen nutritious and physical activity habits and to assimilate positive change in the participants' lifestyle.

Arms

Assigned Interventions

Experimental: physical activiy & nutrition

25 kindergarten children in the ages of 4-6 who defined as suffering from overweigh (BMI percentage 85-95) or obesity (above BMI percentage 95).

Non-generalization criteria: children who suffer from obesity due to organic disease or children who take medicine which may influence body weight (e.g., steroids) will be excluded from the research.

Other: Multidisciplinary intervention: physical activity, dietary instructions and behavioral treatment.

3 months intervention. Nutritious plan: includes 6 meetings of the child and his or her parents with a dietician from the center.

Physical activity: physical trainings of 60 minutes each will be held twice a week.

behavioral treatment: all the participants will take part it a 45 minutes meeting of movement therapy once a week. The goal of such meeting is to strengthen nutritious and physical activity habits and to assimilate positive change in the participants' lifestyle.

Show Detailed Description

Eligibility

Ages Eligible for Study:	4 Years to 6 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

children in ages of 4-6 who defined as suffering from overweigh (BMI percentage 85-95) or obesity (above BMI percentage 95).

Exclusion Criteria:

children who suffer from obesity due to organic disease or children who take medicine which may influence body weight (e.g., steroids) will be excluded from the research.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01285063

Locations

Israel
the sports and health center for children and youth at "Meir" medical center
Kfar Sava, Israel

Sponsors and Collaborators

Meir Medical Center

Investigators

Study Chair:

Tali Sinai, Dr

The hebrew university, Jerusalem

More Information

No publications provided

Responsible Party:	Meir Medical Center
ClinicalTrials.gov Identifier:	NCT01285063 History of Changes
Other Study ID Numbers:	Mc01162010ctil
Study First Received:	December 7, 2010
Last Updated:	February 20, 2013
Health Authority:	Israel: Health Ministry Pharmaceuital Administration

Keywords provided by Meir Medical Center:

overweight
obesity
physical fitness
kinder garden
preschool

Additional relevant MeSH terms:

Obesity
Overweight
Overnutrition

Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013

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