Cardiovascular Risk Factors, Body Composition, Fitness Levels And Quality Of Life In Overweight And Obese 8-17 Year Olds
Primary Purpose
Childhood Obesity, Type 2 Diabetes, Hypercholesterolemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Childhood Obesity focused on measuring Pediatric Overweight/Obesity, DEXA, Fitness
Eligibility Criteria
Inclusion Criteria:
- : a) in the 85th percentile Body Mass Index(BMI), standardized for age and gender; b) have hypercholesterolemia as defined as total cholesterol > 170 mg/dl or LDL > 110 mg/dl; and / or c) hypertension as defined as >116/76 for 8-10 year olds, > 120/80 for 10-13 year olds, and >125/890 for 14-17 year olds.
Exclusion Criteria:
- 1) age < 8 or > 17 years; 2) the determination of significant abnormalities on an initial graded exercise test performed by a pediatric cardiologist; 3) past history of chemotherapy or whole-body radiation therapy
Sites / Locations
- Stony Brook University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Exercise
Arm Description
Strength training x 20 sessions (10 weeks) Aerobic exercise core strengthening Running
Outcomes
Primary Outcome Measures
Improved body compositon (decrease in % fat; increase in % lean tissue) using DEXA
Dual energy x-ray absorptiometry - used to assess body composition.
Secondary Outcome Measures
Improved levels of fitness using ACSM guidelines / assessments to measure such constructs of fitness as flexibility, muscle strength, cardiovascular endurance and agility.
ACSM guidelines and measurement were used to assess strength, agility, flexibility, muscle endurance and cardiovascular endurance
Full Information
NCT ID
NCT02024399
First Posted
December 26, 2013
Last Updated
December 26, 2013
Sponsor
Stony Brook University
1. Study Identification
Unique Protocol Identification Number
NCT02024399
Brief Title
Cardiovascular Risk Factors, Body Composition, Fitness Levels And Quality Of Life In Overweight And Obese 8-17 Year Olds
Official Title
Pilot Study of 10 Week Exercise and Nutrition Program for Children Who Are Overweight / Obese.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stony Brook University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This project will address the important area of childhood obesity and the risk of cardiovascular disease associated with obesity. This is a serious health concern since children who are overweight or obese are prone to other medical conditions including high blood pressure, abnormal lipid profiles,and type 2 diabetes. Although exercise and nutrition programs are recommended, evidence for the efficacy of these programs in improving cardiovascular health is lacking.
Specific Aims: a) improve cardiovascular risk factors, b) increase physical fitness levels, c) improve lean body mass, d) enhance QOL of the child e) influence adherence rates to exercise and a healthy lifestyle change both during and beyond the conclusion of the program.
Hypothesis 1a: Compared to baseline and matched controls, children randomized to a 10 week multidisciplinary fitness and nutrition program will show significant improved levels of cardiovascular risk factors.
Specific Aim 2: To determine if a multidisciplinary fitness and nutrition program, when compared with a matched, WLC group will show a change in whole body assessment including a decrease in fat mass, an increase in percent lean body mass, and a decrease in percent body fat, as measured utilizing dual-energy X-ray absorptiometry Hypothesis 2a: Compared to baseline and matched controls, children randomized to a 10 week multidisciplinary fitness and nutrition program will show improved whole body assessments including.
Specific Aim 3:To determine if a multidisciplinary fitness and nutrition program, when compared with a WLC group will show improved levels of fitness. Hypothesis 3a: Compared to baseline and matched controls, children randomized to a 10 week multidisciplinary fitness and nutrition program will show significant improvements in fitness including.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity, Type 2 Diabetes, Hypercholesterolemia, Hypertension
Keywords
Pediatric Overweight/Obesity, DEXA, Fitness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
N/A
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Other
Arm Description
Strength training x 20 sessions (10 weeks) Aerobic exercise core strengthening Running
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Strength training, aerobic exercise and core strengthening, running
Primary Outcome Measure Information:
Title
Improved body compositon (decrease in % fat; increase in % lean tissue) using DEXA
Description
Dual energy x-ray absorptiometry - used to assess body composition.
Time Frame
Baseline, after 10 weeks and after 20 weeks (3 time points)
Secondary Outcome Measure Information:
Title
Improved levels of fitness using ACSM guidelines / assessments to measure such constructs of fitness as flexibility, muscle strength, cardiovascular endurance and agility.
Description
ACSM guidelines and measurement were used to assess strength, agility, flexibility, muscle endurance and cardiovascular endurance
Time Frame
Measured at baseline, after 10 week sand again after 20 weeks.
Other Pre-specified Outcome Measures:
Title
Quality of life as perceived by the children and the parents.
Description
The impact of weight on quality of life was utilized.
Time Frame
Baseline and after 10 weeks and 20 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
: a) in the 85th percentile Body Mass Index(BMI), standardized for age and gender; b) have hypercholesterolemia as defined as total cholesterol > 170 mg/dl or LDL > 110 mg/dl; and / or c) hypertension as defined as >116/76 for 8-10 year olds, > 120/80 for 10-13 year olds, and >125/890 for 14-17 year olds.
Exclusion Criteria:
1) age < 8 or > 17 years; 2) the determination of significant abnormalities on an initial graded exercise test performed by a pediatric cardiologist; 3) past history of chemotherapy or whole-body radiation therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon A Martino, PhD
Organizational Affiliation
Stony Brook University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook University
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Cardiovascular Risk Factors, Body Composition, Fitness Levels And Quality Of Life In Overweight And Obese 8-17 Year Olds
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