Nutritional Treatment of Overweight Adolescents With Cardiovascular Risk Factors (PowerUp)

Sponsor

Boston Children's Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT00477477

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

Enrollment

Location

Arms

64.1

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is designed to evaluate the efficacy of two diets, a low glycemic load diet and a low saturated fat diet, in the treatment of adolescents with some heart disease risk factors associated with being overweight, such as high blood pressure, pre-diabetes, and cholesterol problems. The objective of the study is to determine which diet improves these risk factors more. The design of the study is a modified feeding study, which requests that the participants eat all and only the food provided by the study for 8 weeks, most days per week. Dietary counseling by phone will continue between 2 and 6 months of the study and the effects of this maintenance period will be assessed at 6 months time.

Condition or Disease	Intervention/Treatment	Phase
Childhood Obesity Dyslipidemia Insulin Resistance Hypertension	Other: Diet Other: Diet	N/A

Detailed Description

The prevalence of obesity and overweight among children is high, and increasing. Metabolic syndrome, a recently recognized consequence of obesity, is known to confer an elevated risk for cardiovascular (CV) disease and diabetes type 2 in adults. The primary treatment for metabolic syndrome is lifestyle modification, including dietary changes. However, little is known about how dietary composition, as distinct from decreased caloric intake and weight loss, alters metabolic syndrome abnormalities in children. Moreover, the optimal pediatric nutritional strategy for prevention and treatment of metabolic syndrome is unknown. The overall goal of this research protocol is to evaluate two nutritional approaches to pediatric metabolic syndrome in post-pubertal overweight adolescents, a low saturated fat diet and a low glycemic load (GL) diet. The design of the protocol is a short-term, modified feeding study that evaluates the efficacy of these two nutritional approaches with equal weight loss goals. Outcome measures will include the percent changes from baseline to the end of the intervention period (8 weeks) in metabolic abnormalities, inflammatory cytokines and adipokines, and non-invasive tests of vascular function. Metabolomic profiles are measured at baseline and 8 weeks in a subset of the participants.

To facilitate compliance and adherence, participants chose from a menu of food choices and food will be delivered to participants homes to supply most of the meals and snacks participants consume. Participants will receive weekly personal nutritional counseling to enhance compliance with frequent phone follow-up. Subsequent to the feeding portion of the intervention, participants are counselled by phone at least on a monthly basis and the effects of this maintenance phase is measured at 6 months.

Study Design

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Nutritional Treatment of Overweight Adolescents With Cardiovascular Risk Factors

Study Start Date :

May 1, 2007

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Low glycemic load diet	Other: Diet Low glycemic load diet prepared/delivered for 8 weeks, and counseled for 4 more months. Daily multivitamin.
Active Comparator: 2 Low fat diet	Other: Diet Low saturated fat diet prepared/delivered for 8 weeks, and counseled for 4 more months. Daily multivitamin.

Arm

Intervention/Treatment

Experimental: 1

Low glycemic load diet

Other: Diet

Low glycemic load diet prepared/delivered for 8 weeks, and counseled for 4 more months. Daily multivitamin.

Active Comparator: 2

Low fat diet

Other: Diet

Low saturated fat diet prepared/delivered for 8 weeks, and counseled for 4 more months. Daily multivitamin.

Outcome Measures

Primary Outcome Measures

Insulin resistance [8 weeks, 6 months]

Secondary Outcome Measures

Inflammation [8 weeks, 6 months]
dyslipidemia [8 weeks, 6 months]
blood pressure [8 weeks, 6 months]
coagulopathy [8 weeks, 6 months]
vascular function [8 weeks, 6 months]
liver function testing [8 weeks, 6 months]
Metabolomic profile [baseline, 8 weeks]
The metabolomic profile of a subset of the participants will be measured at baseline and 8 weeks.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Ages 8 to 17 years old
Overweight, defined as BMI ≥ 85th%tile for age and gender
At least two CV risk factor typical of the metabolic syndrome including insulin resistance, high or borderline blood pressure, low HDL, high TG
Insulin > 10 u/L
Able to attend study visits once a week at participant's home, and eat meals provided by the Children's Hospital CTSA Boston MA as supplied for most meals and snacks
Non-smoker
Able to understand/speak English
Informed consent to participate from a parent or legal guardian. Adolescents must also provide written assent to participate in the study.

Exclusion Criteria:

Pre-existing physician diagnosis of a major medical illness or history of a major medical illness including but not limited to heart, kidney or liver disease, cancer, endocrinopathy including thyroid disorder, genetic syndrome or psychiatric illness, also including vasculitides such as Kawasaki disease or rheumatologic disorder; diabetes type I or II, evidence of severe fatty liver, hypertension requiring pharmacologic treatment, history of or current diagnosis of an major eating disorder
Current or anticipated pregnancy
Weight more than 275 lbs (125 kg)
Abnormalities on initial screening assessment requiring pharmacotherapy urgent treatment, such as familial hyperlipidemia, end organ effects of hypertension, or metabolic abnormalities such as diabetes
Taking any prescription medication or non-prescription substance that affects cholesterol levels, blood pressure, or insulin sensitivity (including but not limited to oral glucocorticoids, oral contraceptives, neuropsychiatric agents, anti-epileptics, HMG-CoA reductase inhibitors, bile acid binding cholesterol transport inhibitors among others) and the use of alcohol or illicit substances.
Anticipated difficulty with participatory requirements of the study including food allergies, significantly restricted food preferences, or other difficulties as assessed by research staff.