Clinical trial NCT02024399: 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
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Type 2 Diabetes
Hypercholesterolemia
Hypertension
Keywords: Pediatric Overweight/Obesity, DEXA, Fitness
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2013-12-31
Enrollment: 48
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Improved body compositon (decrease in % fat; increase in % lean tissue) using DEXA
timeFrame: Baseline, after 10 weeks and after 20 weeks (3 time points)
Secondary outcomes:
measure: Improved levels of fitness using ACSM guidelines / assessments to measure such constructs of fitness as flexibility, muscle strength, cardiovascular endurance and agility.
timeFrame: Measured at baseline, after 10 week sand again after 20 weeks.
Other outcomes:
measure: Quality of life as perceived by the children and the parents.
timeFrame: Baseline and after 10 weeks and 20 weeks.
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
Study officials:
affiliation: Stony Brook University
name: Sharon A Martino, PhD
role: PRINCIPAL_INVESTIGATOR
References: