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The Role of Exercise and Diet in Weight Loss in Obese Children

The Role of Exercise and/or Diet in Weight Loss, and Weight Maintenance in Obese Preadolescent Children

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00461994
Enrollment
160
Registered
2007-04-18
Start date
2004-04-30
Completion date
2006-12-31
Last updated
2007-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Obesity

Keywords

OBESITY, CHILDREN, METABOLIC PARAMETERS, DIET, EXERCISE

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.

Interventions

BEHAVIORALdiet
BEHAVIORALexercise
BEHAVIORALdiet and exercise

Sponsors

D-Cure, Israel
CollaboratorINDUSTRY
Soroka University Medical Center
CollaboratorOTHER
Rabin Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
BMI
BMI-SDS
BODY FAT PERCENTAGE
WAIST AND HIP CIRCUMFERENCES

Secondary

MeasureTime frame
BLOOD METABOLIC PROFILE
PSYCHOLOGICAL PARAMETERS
BLOOD INFLAMATORY MARKERS
GHRELIN AND LEPTIN LEVELS
RESTING ENERGY EXPENDITURE

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026