Healthy Eating for Reproductive Health: Greenville (HER Health)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: Dietary Intervention |
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 |
- Changes in body weight [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Pregnancy rates [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Menstrual cycle length [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 35 |
| Study Start Date: | October 2012 |
| Estimated Primary Completion Date: | October 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: Dietary Intervention
Other Names:
|
|
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: Dietary Intervention
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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| United States, South Carolina | |
| Fertility Center of the Carolinas: Greenville Hospital System | Recruiting |
| Greenville, South Carolina, United States, 29605 | |
| Contact: Brie Turner-McGrievy, PhD, MS, RD 803-777-3932 brie@sc.edu | |
| Principal Investigator: Paul Miller, MD | |
More Information
Additional Information:
No publications provided
| Responsible Party: | Brie Turner-McGrievy, Assistant Professor, University of South Carolina |
| ClinicalTrials.gov Identifier: | NCT01716429 History of Changes |
| Other Study ID Numbers: | Pro00019109 |
| Study First Received: | October 25, 2012 |
| Last Updated: | October 31, 2012 |
| 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 May 19, 2013