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

This study has been terminated.
(Inadequate enrollment and lack of funds.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sarah D. de Ferranti, Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00477477
First received: May 22, 2007
Last updated: March 6, 2012
Last verified: March 2012
  Purpose

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 Intervention
Childhood Obesity
Dyslipidemia
Insulin Resistance
Hypertension
Other: Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nutritional Treatment of Overweight Adolescents With Cardiovascular Risk Factors

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Insulin resistance [ Time Frame: 8 weeks, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inflammation [ Time Frame: 8 weeks, 6 months ] [ Designated as safety issue: No ]
  • dyslipidemia [ Time Frame: 8 weeks, 6 months ] [ Designated as safety issue: No ]
  • blood pressure [ Time Frame: 8 weeks, 6 months ] [ Designated as safety issue: No ]
  • coagulopathy [ Time Frame: 8 weeks, 6 months ] [ Designated as safety issue: No ]
  • vascular function [ Time Frame: 8 weeks, 6 months ] [ Designated as safety issue: No ]
  • liver function testing [ Time Frame: 8 weeks, 6 months ] [ Designated as safety issue: No ]
  • Metabolomic profile [ Time Frame: baseline, 8 weeks ] [ Designated as safety issue: No ]
    The metabolomic profile of a subset of the participants will be measured at baseline and 8 weeks.


Enrollment: 27
Study Start Date: May 2007
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477477

Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Children's Hospital Boston
Investigators
Principal Investigator: Sarah D. de Ferranti Children's Hospital Boston
  More Information

No publications provided

Responsible Party: Sarah D. de Ferranti, Assistant Professor, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00477477     History of Changes
Other Study ID Numbers: 07-01-0020, K23HL085308
Study First Received: May 22, 2007
Last Updated: March 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
overweight
metabolic syndrome
adolescent
cardiovascular
risk factors
hypertension
dyslipidemia
inflammation
coagulopathy

Additional relevant MeSH terms:
Hypertension
Dyslipidemias
Overweight
Insulin Resistance
Pediatric Obesity
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Body Weight
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Obesity
Overnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on September 22, 2014