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Low-glycemic Load vs. Low-fat Diet for Treating PCOS in Obese Adolescents and Young Adults


N/A
13 Years
21 Years
Open (Enrolling)
Female
Polycystic Ovary Syndrome

Thank you

Trial Information

Low-glycemic Load vs. Low-fat Diet for Treating PCOS in Obese Adolescents and Young Adults


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Bioavailable Testosterone

Outcome Time Frame:

Baseline, 6 months

Safety Issue:

No

Principal Investigator

Cara B. Ebbeling, PhD, MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Hospital Boston

Authority:

United States: Institutional Review Board

Study ID:

10-02-0069

NCT ID:

NCT01079845

Start Date:

July 2010

Completion Date:

Related Keywords:

  • Polycystic Ovary Syndrome
  • Diet
  • Nutrition
  • Adolescent
  • Young Adult
  • Overweight
  • Obesity
  • Polycystic Ovary Syndrome

Name

Location

Children's Hospital Boston Boston, Massachusetts  02115