Cardiovascular Risk Factors, Body Composition, Fitness Levels And Quality Of Life In Overweight And Obese 8-17 Year Olds

Pilot Study of 10 Week Exercise and Nutrition Program for Children Who Are Overweight / Obese.

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Type 2 Diabetes; Childhood Obesity; Hypercholesterolemia
• Intervention / Treatment: Other: Exercise

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Stony Brook, New York, United States, 11790
      • Stony Brook University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Exercise; Strength training x 20 sessions (10 weeks) Aerobic exercise core strengthening Running	Other: Exercise; Strength training, aerobic exercise and core strengthening, running

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improved body compositon (decrease in % fat; increase in % lean tissue) using DEXA	Dual energy x-ray absorptiometry - used to assess body composition.	Baseline, after 10 weeks and after 20 weeks (3 time points)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Measured at baseline, after 10 week sand again after 20 weeks.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life as perceived by the children and the parents.	The impact of weight on quality of life was utilized.	Baseline and after 10 weeks and 20 weeks.

Collaborators and Investigators

• Sponsor: Stony Brook University
• Investigators: Principal Investigator: Sharon A Martino, PhD, Stony Brook University

Study record dates

Study Major Dates

• Study Start: August 1, 2004
• Primary Completion (Actual): August 1, 2005
• Study Completion (Actual): August 1, 2005

Study Registration Dates

• First Submitted: December 26, 2013
• First Submitted That Met QC Criteria: December 26, 2013
• First Posted (Estimate): December 31, 2013

Study Record Updates

• Last Update Posted (Estimate): December 31, 2013
• Last Update Submitted That Met QC Criteria: December 26, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Pediatric Overweight/Obesity, DEXA, Fitness
• Additional Relevant MeSH Terms: Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Obesity; Pediatric Obesity; Overweight; Hypercholesterolemia
• Other Study ID Numbers: 87468