Healthy Eating for Reproductive Health: Greenville (HER Health)

This study has been withdrawn prior to enrollment.
(No participants were recruited over the course of the study time period)
Sponsor:
Collaborator:
Greenville Hospital System University Medical Center
Information provided by (Responsible Party):
University of South Carolina
ClinicalTrials.gov Identifier:
NCT01716429
First received: October 25, 2012
Last updated: September 19, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Polycystic Ovarian Syndrome
Infertility
Obesity
Overweight
Behavioral: Vegan diet
Behavioral: Low calorie diet
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Healthy Eating for Reproductive Health: Greenville

Resource links provided by NLM:


Further study details as provided by University of South Carolina:

Primary Outcome Measures:
  • Changes in body weight [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pregnancy rates [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Menstrual cycle length [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: October 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01716429

Locations
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 Hospital System University Medical Center
Investigators
Principal Investigator: Brie Turner-McGrievy, PhD University of South Carolina
  More Information

Additional Information:
No publications provided

Responsible Party: University of South Carolina
ClinicalTrials.gov Identifier: NCT01716429     History of Changes
Other Study ID Numbers: Pro00019109
Study First Received: October 25, 2012
Last Updated: September 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Carolina:
vegetarian
vegan
low calorie
weight Loss
infertility
PCOS

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

ClinicalTrials.gov processed this record on July 23, 2014