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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 February 2013 |
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Main ID: |
NCT01079845 |
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Date of registration:
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02/03/2010 |
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Primary sponsor: |
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Public title:
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A Cooking and Eating Study
ACES |
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Scientific title:
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Low-glycemic Load vs. Low-fat Diet for Treating PCOS in Obese Adolescents and Young Adults |
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Date of first enrolment:
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July 2010 |
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Target sample size:
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50 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01079845 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Margaret M Lovesky, MPH, RD |
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Address:
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Telephone:
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617-355-6777 |
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Email:
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margaret.lovesky@childrens.harvard.edu |
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Affiliation:
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Name:
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Cara B. Ebbeling, PhD, MS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Hospital Boston |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of PCOS.
- Aged 13 to 21 years (and living at home with a parent, only for those <18 years old).
- 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, only for
those <18 years old.
- 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.
Age minimum:
13 Years
Age maximum:
21 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Polycystic Ovary Syndrome
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Intervention(s)
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Behavioral: Nutrition Education, Dietary Counseling, and Cooking
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Primary Outcome(s)
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Bioavailable Testosterone
[Time Frame: Baseline, 6 months]
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Secondary Outcome(s)
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Body Weight and Composition
[Time Frame: Baseline, 6 months]
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Cyclicity of Menstrual Periods
[Time Frame: Monthly]
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Insulin Sensitivity and Beta-cell Function
[Time Frame: Baseline, 6 months]
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Other Biochemical and Clinical Signs of Hyperandrogenism
[Time Frame: Baseline, 6 months]
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Quality of Life
[Time Frame: Baseline, 6 months]
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Risk for Cardiovascular Disease
[Time Frame: Baseline, 6 months]
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Secondary ID(s)
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10-02-0069
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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