The Role of Exercise and/or Diet in Weight Loss, and Weight Maintenance in Obese Preadolescent Children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Rabin Medical Center
- Enrollment
- 160
- Locations
- 2
- Primary Endpoint
- BMI
Study Overview
Brief Summary
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.
Detailed Description
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:
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The main aim was to determine the roles of exercise and/or diet on weight loss and weight maintenance in obese children.
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Secondary goals were:
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To determine the effects of exercise and/or diet on body composition.
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To determine the effects of exercise and/or diet on leptin and ghrelin that play a role in the regulation of energy balance.
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To determine the effects of exercise and/or diet on metabolic profile, cardiovascular risk factors, and inflammatory markers as fasting glucose,insulin and lipid profile,homocysteine ,adiponectin levels,CRP,and IL-6.
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To determine the role of exercise and/or diet on psychological parameters of obese children.
Study Population
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 11 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Obese preadolescent children 6-11 year-old with BMI> 95th percentile for age and gender.
- •A signed informed consent will be taken from patients and their parents.
- •Agreement to a follow-up of one year.
Exclusion Criteria
- •Cardiac problems (arrhythmia, Congestive heart disease)
- •Uncontrolled hypertension
- •Severe hepatic impairment (liver enzymes above 3 folds the upper normal values)
- •Renal failure
- •Genetic syndromes associated with obesity
- •Presence of untreated hypothyroidism
- •Participation in a clinical study during the last month
Outcomes
Primary Outcomes
BMI
BMI-SDS
BODY FAT PERCENTAGE
WAIST AND HIP CIRCUMFERENCES
Secondary Outcomes
- BLOOD INFLAMATORY MARKERS
- GHRELIN AND LEPTIN LEVELS
- RESTING ENERGY EXPENDITURE
- BLOOD METABOLIC PROFILE
- PSYCHOLOGICAL PARAMETERS