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

NCT02024399 | Completed DMC

• 1 other identifier: 87468
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Obesity; Type 2 Diabetes; Hypercholesterolemia; Hypertension

Keywords

Pediatric Overweight/Obesity, DEXA, Fitness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Improved levels of fitness using ACSM guidelines / assessments to measure such constructs of fitness as flexibility, muscle strength, cardiovascular endurance and agility.

  Measured at baseline, after 10 week sand again after 20 weeks.

Other Outcomes (1)

• Quality of life as perceived by the children and the parents.

  Baseline and after 10 weeks and 20 weeks.

Study Arms (1)

Exercise

OTHER

Strength training x 20 sessions (10 weeks) Aerobic exercise core strengthening Running

Other: Exercise

Interventions

Exercise OTHER

Strength training, aerobic exercise and core strengthening, running

Exercise

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• : 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.

You may not qualify if:

• \) 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

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

Stony Brook University

Stony Brook, New York, 11790, United States

Location

MeSH Terms

Conditions

Pediatric Obesity; Diabetes Mellitus, Type 2; Hypercholesterolemia; Hypertension; Obesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sharon A Martino, PhD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2013
• First Posted: December 31, 2013
• Study Start: August 1, 2004
• Primary Completion: August 1, 2005
• Study Completion: August 1, 2005
• Last Updated: December 31, 2013

Record last verified: 2013-12

Locations

US (1)