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

Primary Purpose

Childhood Obesity, Dyslipidemia, Insulin Resistance

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Diet

About this trial

This is an interventional treatment trial for Childhood Obesity focused on measuring overweight, metabolic syndrome, adolescent, cardiovascular, risk factors, hypertension, dyslipidemia, inflammation, coagulopathy

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept 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.

Sites / Locations

Children's Hospital Boston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Low glycemic load diet

Low fat diet

Outcomes

Primary Outcome Measures

Insulin resistance

Secondary Outcome Measures

Inflammation

dyslipidemia

blood pressure

coagulopathy

vascular function

liver function testing

Metabolomic profile

The metabolomic profile of a subset of the participants will be measured at baseline and 8 weeks.

Full Information

NCT ID

NCT00477477

First Posted

May 22, 2007

Last Updated

October 24, 2014

Sponsor

Boston Children's Hospital

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT00477477

Brief Title

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

Official Title

Nutritional Treatment of Overweight Adolescents With Cardiovascular Risk Factors

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Terminated

Why Stopped

Inadequate enrollment and lack of funds.

Study Start Date

May 2007 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Boston Children's Hospital

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Childhood Obesity, Dyslipidemia, Insulin Resistance, Hypertension

Keywords

overweight, metabolic syndrome, adolescent, cardiovascular, risk factors, hypertension, dyslipidemia, inflammation, coagulopathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Low glycemic load diet

Arm Title

Arm Type

Active Comparator

Arm Description

Low fat diet

Intervention Type

Other

Intervention Name(s)

Diet

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Diet

Intervention Description

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

Primary Outcome Measure Information:

Title

Insulin resistance

Time Frame

8 weeks, 6 months

Secondary Outcome Measure Information:

Title

Inflammation

Time Frame

8 weeks, 6 months

Title

dyslipidemia

Time Frame

8 weeks, 6 months

Title

blood pressure

Time Frame

8 weeks, 6 months

Title

coagulopathy

Time Frame

8 weeks, 6 months

Title

vascular function

Time Frame

8 weeks, 6 months

Title

liver function testing

Time Frame

8 weeks, 6 months

Title

Metabolomic profile

Description

The metabolomic profile of a subset of the participants will be measured at baseline and 8 weeks.

Time Frame

baseline, 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sarah D. de Ferranti

Organizational Affiliation

Boston Children's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Hospital Boston

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

12. IPD Sharing Statement

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

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