Intervention Study for Overweight and Obese Kindergarten Children
Primary Purpose
Overweight, Obesity, Physical Fitness
Status
Withdrawn
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Multidisciplinary intervention: physical activity, dietary instructions and behavioral treatment.
Sponsored by

About this trial
This is an interventional treatment trial for Overweight focused on measuring overweight, obesity, physical fitness, kinder garden, preschool
Eligibility 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.
Sites / Locations
- the sports and health center for children and youth at "Meir" medical center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
physical activiy & nutrition
Arm Description
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.
Outcomes
Primary Outcome Measures
reduction of the BMI percentage among the participants in comparison to the control group.
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.
"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.
"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.
Full Information
NCT ID
NCT01285063
First Posted
December 7, 2010
Last Updated
February 20, 2013
Sponsor
Meir Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01285063
Brief Title
Intervention Study for Overweight and Obese Kindergarten Children
Official Title
Combined Physical Activity and Diet Intervention for the Treatment of Overweight and Obesity in Kindergarten Children
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Withdrawn
Why Stopped
We were not successful in raising money for this project
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
February 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
Subjects, goals and objective:
Obesity is the most common chronic children disease of the modern era. The number of children who suffer from obesity is increasing to scales of epidemic. The frequency of obesity among kindergarten children (ages of 2-5) in the United States is approximately 14%, whereas among children of those ages in the center of Israel there is a risk of 25% to obesity and overweight.
Obesity is not only a cosmetic problem but also constitutes the #1 risk factor for common medical problems, such as: hyperlipidemia, high blood pressure, glucose intolerance, type 2 diabetes, arteriosclerosis, asthma, orthopaedic problems and psychological problems. A comprehensive review that was recently published showed that among fat children, intensive intervention programs which include nutrition consulting, physical training and behavioral change are the most effective to treat obesity.
Children who suffer from obesity have a greater risk to become fat adults and the older the child the greater the risk becomes. Therefore, it is highly important to treat such obesity in the youngest age possible. Moreover, along with the change of nutritious preferences, a great emphasize should be given to physical activity in order to reduce the BMI percentage and improve the physical fitness.
The goal of the paper 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.
Place: The intervention program will be held in the sports and health center for children and youth at "Meir" medical center.
The intervention group: 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.
The control group: 25 kindergarten children in similar ages who defined as suffering from overweigh (BMI percentage 85-95) or obesity (above BMI percentage 95) and who do not participate in any intervention program.
The research plan Nutritious plan: includes 6 personal meetings, 30-45 minutes each, of the child and his parents with a dietician from the center. The meetings will include nutritious evaluation and will focus on nutritious education.
Physical activity: physical trainings of 45 minutes each will be held twice a week and be guided by a qualified trainer. In order to encourage the participants to take responsibility for the process, the children will be asked to further practice during the weeks and conduct little assignments which will be given by the trainer.
Additionally, all the participants will take part it a 45 minutes meeting of movement therapy once a week. Such meeting will be held by a qualified trainer. The goal of such meeting is to strengthen nutritious and physical activity habits and to assimilate positive change in the participants' lifestyle.
Evaluation index: height, weight, BMI and BMI percentage,"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.
Evaluation of physical fitness: "back and forth" running test for a 10m distance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity, Physical Fitness
Keywords
overweight, obesity, physical fitness, kinder garden, preschool
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
physical activiy & nutrition
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Multidisciplinary intervention: physical activity, dietary instructions and behavioral treatment.
Intervention Description
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.
Primary Outcome Measure Information:
Title
reduction of the BMI percentage among the participants in comparison to the control group.
Description
height, weight, BMI and BMI percentage will be documented after each meeting with the dietitian.
Time Frame
every 2 weeks.
Secondary Outcome Measure Information:
Title
Improvement in the physical fitness of the participants in comparison to the control group.
Description
"Back and forth" running test for a 10m distance.
Time Frame
Day 1 and after 3 months.
Title
Positive change in the knowledge and preferences of the participants in the fields of nutrition and physical activity in comparison to the control group.
Description
"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.
Time Frame
Day 1 and after 3 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tali Sinai, Dr
Organizational Affiliation
The hebrew university, Jerusalem
Official's Role
Study Chair
Facility Information:
Facility Name
the sports and health center for children and youth at "Meir" medical center
City
Kfar Sava
Country
Israel
12. IPD Sharing Statement
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Intervention Study for Overweight and Obese Kindergarten Children
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