Healthy Eating for Reproductive Health (HERHealth)

NCT01509066 | Completed

• 1 other identifier: Pro00014149
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Polycystic Ovarian Syndrome; Infertility; Obesity; Overweight

Keywords

vegetarian; vegan; low calorie; infertility; PCOS

Outcome Measures

Primary Outcomes (1)

• Body weight changes

  body weight will be assessed at 0, 3, and 6 months

  6 months

Secondary Outcomes (2)

• Pregnancy rates

  6 months

• Menstrual cycle length

  6 months

Study Arms (2)

Vegan diet

EXPERIMENTAL

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

Low-calorie

ACTIVE COMPARATOR

A low-calorie diet contains all food groups. However, participants will be provided with a calorie goal which should promote weight loss.

Other: Diet

Interventions

Diet OTHER

Dietary approaches for PCOS

Low-calorie; Vegan diet

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Carolina: lead
• Academy of Nutrition and Dietetics: collaborator

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Infertility; Obesity; Overweight

Interventions

Diet

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Brie Turner-McGrievy, PhD, MS, RD

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 9, 2012
• First Posted: January 12, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: April 18, 2019

Record last verified: 2019-04

Locations

US (1)