Healthy Eating for Reproductive Health (HERHealth)

This study has been completed.
Sponsor:
Collaborator:
Academy of Nutrition and Dietetics
Information provided by (Responsible Party):
University of South Carolina
ClinicalTrials.gov Identifier:
NCT01509066
First received: January 9, 2012
Last updated: September 18, 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 you 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 you 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
Other: Diet
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Healthy Eating for Reproductive Health (HERHealth)

Resource links provided by NLM:


Further study details as provided by University of South Carolina:

Primary Outcome Measures:
  • Body weight changes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    body weight will be assessed at 0, 3, and 6 months


Secondary Outcome Measures:
  • Pregnancy rates [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    We will measure any occurrences of pregnancy over the course of the study

  • Menstrual cycle length [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    We will measure changes in the length of menstrual cycles over the course of the 6 month study


Enrollment: 18
Study Start Date: January 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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. We will also ask participants to keep foods low in fat and low in glycemic index.
Other: Diet
Dietary approaches for PCOS
Active Comparator: Low-calorie
A low-calorie diet contains all food groups. However, participants will be provided with a calorie goal which should promote weight loss.
Other: Diet
Dietary approaches for PCOS

  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: NCT01509066

Locations
United States, South Carolina
University of South Carolina
Columbia, South Carolina, United States, 29208
Sponsors and Collaborators
University of South Carolina
Academy of Nutrition and Dietetics
Investigators
Principal Investigator: Brie Turner-McGrievy, PhD, MS, RD University of South Carolina
  More Information

Additional Information:
No publications provided

Responsible Party: University of South Carolina
ClinicalTrials.gov Identifier: NCT01509066     History of Changes
Other Study ID Numbers: HERHealth-KA34
Study First Received: January 9, 2012
Last Updated: September 18, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 22, 2014