Predictors of Success in an Intervention Program for the Treatment of Childhood Obesity
Primary Purpose
Childhood Obesity
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Intervention program for obese children
Sponsored by
About this trial
This is an interventional treatment trial for Childhood Obesity focused on measuring Childhood obesity, Adolescence, Predictors, Success, Intervention program
Eligibility Criteria
Inclusion Criteria:
- Obese / overweight children
Exclusion Criteria:
- Children that has an organic illness that cause obesity
Sites / Locations
- Meir Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
No Intervention
No Intervention
Arm Label
Intervention program
Untreated obese children
Normal weight children
Arm Description
6 months intervention program to lose weight in obese children. Behavioral, emotional, physical, familial and demographic questioners will be fulfilled at the beginning and at the end of the program.
Behavioral, emotional, physical, familial and demographic questioners will be fulfilled twice in a 6 month program.
Behavioral, emotional, physical, familial and demographic questioners will fulfill twice in the 6 month period.
Outcomes
Primary Outcome Measures
Characteristics of the children who succeed in the program
We will use behavioral, emotional, physical, familial and demographic questionnaires to characterize the children taking part in the programs.
The questionnaires: self-efficacy, motivation, depression, parenting style, demographic, environmental.Anthropometric and fitness measurements are performed on a monthly basis .
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01578863
Brief Title
Predictors of Success in an Intervention Program for the Treatment of Childhood Obesity
Official Title
Predictors of Success in a Multidisciplinary Intervention Program for Obese Children and Adolescence
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
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 child health and sports center, at the Meir Medical Center, runs for over 10 years an intervention program to treat obese children. The program includes physical activity, nutritional intervention and behavioral treatment. A similar program exists in the nearby city of Hadera. The aim of the programs is to promote weight loss, encourage physical activity and modify behavior in order to get long term results. The aim of the present study is to try and identify the demographic and behavioral characteristics of children who succeed in the program.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Childhood obesity, Adolescence, Predictors, Success, Intervention program
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
176 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention program
Arm Type
Active Comparator
Arm Description
6 months intervention program to lose weight in obese children. Behavioral, emotional, physical, familial and demographic questioners will be fulfilled at the beginning and at the end of the program.
Arm Title
Untreated obese children
Arm Type
No Intervention
Arm Description
Behavioral, emotional, physical, familial and demographic questioners will be fulfilled twice in a 6 month program.
Arm Title
Normal weight children
Arm Type
No Intervention
Arm Description
Behavioral, emotional, physical, familial and demographic questioners will fulfill twice in the 6 month period.
Intervention Type
Other
Intervention Name(s)
Intervention program for obese children
Other Intervention Name(s)
exercise, nutrition, behavioral
Intervention Description
The program includes physical activity, nutrition intervention and behavioral treatment and lasts for 6 months. The aim of the program is to promote weight loss and physical activity and to promote future healthy lifestyle.
Primary Outcome Measure Information:
Title
Characteristics of the children who succeed in the program
Description
We will use behavioral, emotional, physical, familial and demographic questionnaires to characterize the children taking part in the programs.
The questionnaires: self-efficacy, motivation, depression, parenting style, demographic, environmental.Anthropometric and fitness measurements are performed on a monthly basis .
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Obese / overweight children
Exclusion Criteria:
Children that has an organic illness that cause obesity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Nemet, MD
Organizational Affiliation
Meir Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meir Medical Center
City
Kfar-Saba
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Predictors of Success in an Intervention Program for the Treatment of Childhood Obesity
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