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NCT Number: NCT00461994

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

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.

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Key information

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Soroka Medical Center, Beersheba, Israel

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About this study

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:

  • The main aim was to determine the roles of exercise and/or diet on weight loss and weight maintenance in obese children.
  • Secondary goals were:
  • To determine the effects of exercise and/or diet on body composition.
  • To determine the effects of exercise and/or diet on leptin and ghrelin that play a role in the regulation of energy balance.
  • 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.
  • To determine the role of exercise and/or diet on psychological parameters of obese children.

Study Population

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 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet

Behavioral

Exercise

Behavioral

Diet and Exercise

Behavioral

Primary outcomes

  1. BMI

  2. BMI-SDS

  3. BODY FAT PERCENTAGE

  4. WAIST AND HIP CIRCUMFERENCES

Secondary outcomes

  1. BLOOD METABOLIC PROFILE

  2. BLOOD INFLAMATORY MARKERS

  3. GHRELIN AND LEPTIN LEVELS

  4. RESTING ENERGY EXPENDITURE

  5. PSYCHOLOGICAL PARAMETERS

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Collaborators

  • D-Cure, Israel
  • Soroka University Medical Center

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2006
First posted
Apr 18, 2007
Registry last updated
Apr 18, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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