Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00461994
Status:
COMPLETED
Last Update Posted:
2007-04-18
First Post:
2007-04-17
Brief Title:
The Role of Exercise and Diet in Weight Loss in Obese Children
Sponsor:
Rabin Medical Center
Organization:
Rabin Medical Center
Study Overview
Official Title:
The Role of Exercise andor Diet in Weight Loss and Weight Maintenance in Obese Preadolescent Children
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A 3-arms randomized prospective intervention study to determine the roles of exercise andor 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 maintenancebody composition on hormonal components that regulate the caloric balance on metabolic profile and cardiovascular risk factors and on psychological parameters were also determined
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 maintenancebody 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 andor 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 andor diet on weight loss and weight maintenance in obese children
2 Secondary goals were
1 To determine the effects of exercise andor diet on body composition
2 To determine the effects of exercise andor diet on leptin and ghrelin that play a role in the regulation of energy balance
3 To determine the effects of exercise andor diet on metabolic profile cardiovascular risk factors and inflammatory markers as fasting glucoseinsulin and lipid profilehomocysteine adiponectin levelsCRPand IL-6
4 To determine the role of exercise andor 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 insulinCRP 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
SafetyThere were no complications with these modes of treatment
Objectives
1 The main aim was to determine the roles of exercise andor diet on weight loss and weight maintenance in obese children
2 Secondary goals were
1 To determine the effects of exercise andor diet on body composition
2 To determine the effects of exercise andor diet on leptin and ghrelin that play a role in the regulation of energy balance
3 To determine the effects of exercise andor diet on metabolic profile cardiovascular risk factors and inflammatory markers as fasting glucoseinsulin and lipid profilehomocysteine adiponectin levelsCRPand IL-6
4 To determine the role of exercise andor 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 insulinCRP 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
SafetyThere were no complications with these modes of treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None