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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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02024399
Enrollment
48
Registered
2013-12-31
Start date
2004-08-31
Completion date
2005-08-31
Last updated
2013-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Obesity, Hypercholesterolemia, Hypertension, Type 2 Diabetes

Keywords

Pediatric Overweight/Obesity, DEXA, Fitness

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.

Interventions

OTHERExercise

Strength training, aerobic exercise and core strengthening, running

Sponsors

Stony Brook University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Improved body compositon (decrease in % fat; increase in % lean tissue) using DEXABaseline, after 10 weeks and after 20 weeks (3 time points)Dual energy x-ray absorptiometry - used to assess body composition.

Secondary

MeasureTime frameDescription
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.ACSM guidelines and measurement were used to assess strength, agility, flexibility, muscle endurance and cardiovascular endurance

Other

MeasureTime frameDescription
Quality of life as perceived by the children and the parents.Baseline and after 10 weeks and 20 weeks.The impact of weight on quality of life was utilized.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026