Healthy Eating for Reproductive Health: Greenville (HER Health)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01716429
Recruitment Status : Withdrawn (No participants were recruited over the course of the study time period)
First Posted : October 29, 2012
Last Update Posted : September 23, 2013
Greenville Health System
Information provided by (Responsible Party):
University of South Carolina

Brief Summary:
This study will be a 6-month intervention that is examining how different dietary approached may be useful for women with Polycystic Ovarian Syndrome (PCOS) who are attempting pregnancy, particularly by measuring changes in weight. Participants will be randomly assigned to following one of two dietary approaches for weight loss: 1) a low-calorie approach to weight loss (reducing caloric intake by approximately 500 calories per day) or 2) a low-fat, low-glycemic index vegan diet. A vegan diet is one that does not contain any animal products (no meat, fish, poultry, eggs, or dairy) but emphasizes plant-based foods, such as fruits, vegetables, whole grains, and legumes/beans. In addition, this diet will be low-glycemic index, which means the consumer will be asked to favor foods that don't cause a quick rise in blood sugar (for example, favoring oatmeal over cornflakes for breakfast). Participants will receive counseling and supporting materials on the dietary approach the participants are assigned to follow. Both diets are safe and have shown to be effective ways to assist with achieving a healthy weight. The investigators hypothesize that both groups will see improvements in weight and fertility with possible greater improvements seen among participants in the vegan group.

Condition or disease Intervention/treatment Phase
Polycystic Ovarian Syndrome Infertility Obesity Overweight Behavioral: Vegan diet Behavioral: Low calorie diet Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Healthy Eating for Reproductive Health: Greenville
Study Start Date : October 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Low Calorie
Participants in this arm will be instructed on how to reduce their caloric intake and follow a low calorie diet
Behavioral: Low calorie diet
Reduced calorie diet for weight loss
Other Name: Standard diet

Experimental: Vegan diet
Participants in this arm will follow a very low fat diet (~10% kcals from fat) and also a diet that has a low glycemic index and is free of animal products (vegan)
Behavioral: Vegan diet
Vegan dietary approaches for weight loss
Other Name: Vegetarian

Primary Outcome Measures :
  1. Changes in body weight [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Pregnancy rates [ Time Frame: 6 months ]

Other Outcome Measures:
  1. Menstrual cycle length [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Women must meet the following criteria:

have been attempting pregnancy for at least 6 months is not currently pregnant has a clinical diagnosis of PCOS is not on oral medications for insulin resistance (such as metformin) or, if currently on such a medication, has been on the medication at a stable dose for at least 3 months willing not use fertility-enhancing medications over the 6-month study (with the exception of oral medications, such as clomiphene citrate, as directed by their physician) willing to be randomized to either dietary condition and able to make weekly meetings.

Exclusion Criteria:

Participants should not be in this study if they meet any of the following criteria:

have not been diagnoses with polycystic ovarian syndrome have been trying to conceive less than 6 months have a Body Mass Index less than 25 or greater than 45 kg/m2 are currently pregnant are younger than 18 or older than 35 years of age are a smoker are unable to come to the Columbia, SC area at least 3-4 times in a 6 month time period for assessments don't have access to the Internet and a computer don't have access to a scale for self-monitoring weight aren't willing to be randomized to either group have a psychiatric disease, drug or alcohol dependency, or uncontrolled thyroid condition have a major health condition, such as heart conditions, diabetes, and past incidence of stroke unable to receive consent from your doctor to participate if you currently are on blood pressure medications, have issues with dizziness, or have bone or joint issues have an eating disorder currently participating in a weight loss program or taking weight loss medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01716429

United States, South Carolina
Fertility Center of the Carolinas: Greenville Hospital System
Greenville, South Carolina, United States, 29605
Sponsors and Collaborators
University of South Carolina
Greenville Health System
Principal Investigator: Brie Turner-McGrievy, PhD University of South Carolina

Additional Information:
Responsible Party: University of South Carolina Identifier: NCT01716429     History of Changes
Other Study ID Numbers: Pro00019109
First Posted: October 29, 2012    Key Record Dates
Last Update Posted: September 23, 2013
Last Verified: September 2013

Keywords provided by University of South Carolina:
low calorie
weight Loss

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Body Weight
Signs and Symptoms
Genital Diseases, Male
Genital Diseases, Female
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases