Clinical trial NCT00461994: The Role of Exercise and Diet in Weight Loss in Obese Children
Official title: The Role of Exercise and/or Diet in Weight Loss, and Weight Maintenance in Obese Preadolescent Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Keywords: OBESITY
CHILDREN
METABOLIC PARAMETERS
DIET
EXERCISE
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
Collaborators: name: D-Cure, Israel
name: Soroka University Medical Center
First posted: 2007-04-18
Enrollment: 160
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

1. The main aim was to determine the roles of exercise and/or diet on weight loss and weight maintenance in obese children.
2. Secondary goals were:

   1. To determine the effects of exercise and/or diet on body composition.
   2. To determine the effects of exercise and/or diet on leptin and ghrelin that play a role in the regulation of energy balance.
   3. 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.
   4. To determine the role of exercise and/or diet on psychological parameters of obese children.

Study Population

Inclusion Criteria

1. Obese preadolescent children 6-11 year-old with BMI\> 95th percentile for age and gender.
2. A signed informed consent will be taken from patients and their parents.
3. Agreement to a follow-up of one year.

Exclusion Criteria

1. Cardiac problems (arrhythmia, Congestive heart disease)
2. Uncontrolled hypertension
3. Severe hepatic impairment (liver enzymes above 3 folds the upper normal values)
4. Renal failure
5. Genetic syndromes associated with obesity
6. Presence of untreated hypothyroidism
7. Participation in a clinical study during the last month methods Children fulfilling the inclusion and exclusion criteria were randomly allocated into one of 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Obese preadolescent children 6-11 year-old with BMI\> 95th percentile for age and gender.
2. A signed informed consent will be taken from patients and their parents.
3. Agreement to a follow-up of one year.

Exclusion Criteria:

1. Cardiac problems (arrhythmia, Congestive heart disease)
2. Uncontrolled hypertension
3. Severe hepatic impairment (liver enzymes above 3 folds the upper normal values)
4. Renal failure
5. Genetic syndromes associated with obesity
6. Presence of untreated hypothyroidism
7. Participation in a clinical study during the last month

Primary outcomes:
measure: BMI
measure: BMI-SDS
measure: BODY FAT PERCENTAGE
measure: WAIST AND HIP CIRCUMFERENCES
Secondary outcomes:
measure: BLOOD METABOLIC PROFILE
measure: BLOOD INFLAMATORY MARKERS
measure: GHRELIN AND LEPTIN LEVELS
measure: RESTING ENERGY EXPENDITURE
measure: PSYCHOLOGICAL PARAMETERS
Other outcomes:
Locations:
city: Beer-Sheva
country: Israel
facility: Soroka Medical Center
city: Petah-Tikva
country: Israel
facility: Schneider Children's Medical Center
Study officials:
affiliation: Schneider Children Medical Center
name: Moshe Phillip, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References: