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NCT01079845 · ClinicalTrials.gov registry record · NA
A Cooking and Eating Study
A NA study, sponsored by Boston Children's Hospital.
- Terminated
- Registry status
- NA
- Development phase
- 19
- Enrollment target
NCT01079845 is a NA study that was terminated before completion, run by Boston Children's Hospital. The registered enrollment target is 19 participants.
The verdict
NCT01079845, a NA study, was terminated before completion, sponsored by Boston Children's Hospital.
- TERMINATED
- Registry status
- NA
- Development phase
- 19 participants
- Enrollment target
Study Summary
Background. The polycystic ovary syndrome (PCOS) is a complex hormonal disorder that presents in susceptible girls around the time of menarche. Females 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 and young adults with PCOS are insulin resistant and at increased risk for metabolic syndrome and diabetes. The majority of females 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 and young adults 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 and young adults with PCOS. Design. We propose a 6-month study in which 50 obese females with PCOS (ages 13 to 21 years) will be assigned to receive one of two dietary treatments, with the goal of retaining 40 participants. 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). Participants 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 wil
Interventions
- BEHAVIORAL Nutrition Education, Dietary Counseling, and Cooking
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2010-07 |
| Est. Completion | 2013-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01079845
The ClinicalTrials.gov registry entry for NCT01079845 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Nutrition Education, Dietary Counseling, and Cooking is the first listed.
NCT01079845 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01079845 about?
NCT01079845 is a clinical study titled "A Cooking and Eating Study". Background. The polycystic ovary syndrome (PCOS) is a complex hormonal disorder that presents in susceptible girls around the time of menarche. Females with PCOS have high levels of androgens (e.g., testosterone). While cosmetic appearance (excess facial hair and acne) and menstrual disturbances wer...
What is the current status of trial NCT01079845?
This trial is currently terminated. It is a NA study. The enrollment target is 19 participants. The study started on 2010-07. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01079845?
The interventions under investigation include: Nutrition Education, Dietary Counseling, and Cooking (BEHAVIORAL).
Who is sponsoring clinical trial NCT01079845?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
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