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Healthy Eating for Reproductive Health (HERHealth)

Phase 1/Phase 2
18 Years
35 Years
Open (Enrolling)
Polycystic Ovarian Syndrome, Infertility, Obesity, Overweight

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Trial Information

Healthy Eating for Reproductive Health (HERHealth)

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

- willing to be randomized to either dietary condition and able to make weekly

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Body weight changes

Outcome Description:

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

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Brie Turner-McGrievy, PhD, MS, RD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of South Carolina


United States: Institutional Review Board

Study ID:




Start Date:

January 2012

Completion Date:

June 2013

Related Keywords:

  • Polycystic Ovarian Syndrome
  • Infertility
  • Obesity
  • Overweight
  • vegetarian
  • vegan
  • low calorie
  • infertility
  • PCOS
  • Infertility
  • Obesity
  • Polycystic Ovary Syndrome
  • Overweight



University of South CarolinaColumbia, South Carolina  29203