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Adolescent Cooking and Eating Study - NCT01079845-02115(Clinical Trial 566748)



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City:  Boston
State:  
MA
Zip Code: 02115
Conditions: Polycystic Ovary Syndrome
Purpose: Background. The polycystic ovary syndrome (PCOS) is a complex hormonal disorder that presents in susceptible girls around the time of menarche. Girls with PCOS have high levels of androgens (e.g., testosterone). While cosmetic appearance (excess facial hair and acne) and menstrual disturbances were once considered the primary concerns, emerging data indicate that many adolescents with PCOS are insulin resistant and at increased risk for metabolic syndrome and diabetes. The majority of girls with PCOS are obese, and excess body fat amplifies the severity of the syndrome. Dietary intervention is considered an important component of treatment for PCOS. However, a consensus statement regarding optimal nutrient composition for treating adolescents with PCOS has not been published because data are lacking to provide a foundation for such a statement. Recognizing increased risk for diabetes in patients with PCOS, many practitioners employ a low-fat diet as prescribed in the Diabetes Prevention Program (DPP) for weight loss and control of symptoms. Objective and Hypothesis. The purpose of this research study is to compare different diets for treating PCOS. We hypothesize that a low-glycemic load diet - designed to lower blood levels of glucose and insulin - will be more beneficial than a low-fat diet in obese adolescents with PCOS. Design. We propose a 6-month study in which 50 obese girls with PCOS (ages 13 to 17 years) will be assigned to receive one of two dietary treatments. Group assignment will be at random. One of the treatments will be a low-glycemic load diet, and the other treatment will be a low-fat diet (modeled after the DPP diet). Girls in both groups will receive individual nutrition education and dietary counseling with a registered dietitian (clinic visits, telephone calls) and cooking workshops with a chef. The purpose of the cooking workshops will be to enhance compliance with diet prescriptions, beyond what can be achieved by nutrition education and dietary counseling in a conventional clinic setting. The primary outcome will be bioavailable testosterone (form of testosterone that causes symptoms of PCOS). Secondary outcomes will include other blood tests to evaluate further high androgen levels (total testosterone, free testosterone, sex hormone binding globulin, dehydroepiandrosterone sulfate), clinical signs of high androgen levels (excess facial hair, acne), glucose tolerance and risk for diabetes (determined by blood sugar and insulin measurements), risk for cardiovascular disease (based on blood cholesterol and C-reactive protein levels and blood pressure), body fat percentage and distribution (measured using state-of-the-art dual energy x-ray absorptiometry and waist circumference), menstrual cyclicity, and health-related quality of life (evaluated by questionnaire).
Study summary:
Criteria: Inclusion Criteria: - Diagnosis of PCOS. - Aged 13 to 17 years (and living at home with a parent). - Body mass index (BMI) at or above the 85th percentile. - Access to a working telephone. - At least one parent willing and able to participate in the intervention. - Residing in predominately one household (no more than one weekend every two weeks in a secondary household). - Medical clearance from the physician who is treating PCOS. Exclusion Criteria: - Physician diagnosis of a major medical illness or eating disorder. - Fasting blood glucose at or above 126 mg/dL, indicating diabetes mellitus. - Chronic use of any medication that may affect study outcomes. - Current smoking. - Physical, mental, or cognitive handicaps that prevent participation. - Sister participating in the study.
Study is available at: Children's Hospital Boston
Boston, MA 02115
United States

Primary Contact:
Margaret M Lovesky, MPH, RD
Email: margaret.lovesky@childrens.harvard.edu
Phone: 617-355-6777
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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