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Sponsors and Collaborators: |
Rabin Medical Center D CURE- advancing diabetes care to cure. Pediatric Endocrine unit, Soroka medical center. |
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Information provided by: | Rabin Medical Center |
ClinicalTrials.gov Identifier: | NCT00461994 |
A 3-arms randomized prospective intervention study to determine the roles of exercise and/or diet on weight loss and weight maintenance in obese preadolescent children 6-11 year-old with BMI> 95th percentile for age and gender. Children were randomly allocated into three groups. The first group underwent an exercise program, the second one underwent both an exercise program and a diet program and the third underwent a diet program alone.
The total duration of the intervention is 12 weeks followed by a period of 9 months of follow-up. The effects of the different intervention on weight loss and weight maintenance,body composition, on hormonal components that regulate the caloric balance, on metabolic profile and cardiovascular risk factors and on psychological parameters were also determined.
Condition | Intervention |
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Pediatric Obesity |
Behavioral: diet Behavioral: exercise Behavioral: diet and exercise |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | The Role of Exercise and/or Diet in Weight Loss, and Weight Maintenance in Obese Preadolescent Children |
Estimated Enrollment: | 160 |
Study Start Date: | April 2004 |
Study Completion Date: | December 2006 |
A 3-arms randomized prospective intervention study including 161 patients in order to determine the roles of exercise and/or diet on weight loss and weight maintenance in obese preadolescent children 6-11 year-old with BMI> 95th percentile for age and gender. The study recruited patients from 2 endocrine clinics.
Objectives:
Secondary goals were:
Study Population
Inclusion Criteria
Exclusion Criteria
The first group underwent an exercise program, the second one underwent both an exercise program and a diet program and the third underwent a diet program alone.
On the first visit of the study, at the end of the intervention (12 weeks) and at the end of the follow-up period (1 year) the following had been checked:
Weight, Height, Body impedance, Waist and hip circumferences, Skin-folds, Blood pressure, Basal Metabolic Rate (evaluated by a metabolic monitor), and blood samples for: Blood count, Liver function, Renal function, Fasting Lipid, glucose and insulin,CRP, IL-6, TSH, free T4, Homocysteine, Adiponectin, Leptin and Ghrelin. Also at these point of time every patient underwent a psychosocial evaluation with life style questioners.
Safety:There were no complications with these modes of treatment.
Ages Eligible for Study: | 6 Years to 11 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Israel | |
Schneider Children's Medical Center | |
Petah-Tikva, Israel, 49202 | |
Soroka Medical Center | |
Beer-Sheva, Israel |
Principal Investigator: | Moshe Phillip, Prof, MD | Schneider Children Medical Center |
Study ID Numbers: | rmc003189CTil |
Study First Received: | April 17, 2007 |
Last Updated: | April 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00461994 |
Health Authority: | Israel: Ministry of Health |
OBESITY CHILDREN METABOLIC PARAMETERS DIET EXERCISE |
Body Weight Signs and Symptoms Obesity Weight Loss |
Body Weight Changes Nutrition Disorders Overweight Overnutrition |