Healthy Eating for Reproductive Health (HERHealth)

Completed · Not applicable

Conditions studied: Polycystic Ovarian Syndrome, Infertility, Obesity, Overweight

In brief

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.

Key facts

Study ID

NCT01509066

Run by

University of South Carolina

People needed

18

Starts

2012-01-01

Expected to finish

2013-06-01

Last updated by the study team

2019-04-18

Who can join

Age: 18 and older, up to 35. Sex: female. Healthy volunteers: accepted.

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
• currently participating in a weight loss program or taking weight loss medications

Where it is running

• University of South Carolina — Columbia, South Carolina, United States

Full record on ClinicalTrials.gov

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