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NCT01509066 · ClinicalTrials.gov registry record · NA
Healthy Eating for Reproductive Health (HERHealth)
A NA study, sponsored by University of South Carolina.
- Completed
- Registry status
- NA
- Development phase
- 18
- Enrollment target
NCT01509066: Completed NA study, sponsored by University of South Carolina.
NCT01509066 is a NA study that has completed, run by University of South Carolina. The registered enrollment target is 18 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01509066, a NA study, has completed, sponsored by University of South Carolina.
- COMPLETED
- Registry status
- NA
- Development phase
- 18 participants
- Enrollment target
Study 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.
Primary Outcome
body weight will be assessed at 0, 3, and 6 months
Interventions
- OTHER Diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2012-01 |
| Est. Completion | 2013-06 |
| Phase | NA |
What the finished NCT01509066 record still lists
NCT01509066 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Diet is the first listed.
NCT01509066 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01509066 about?
NCT01509066 is a clinical study titled "Healthy Eating for Reproductive Health (HERHealth)". 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 dieta...
What is the current status of trial NCT01509066?
This trial is currently completed. It is a NA study. The enrollment target is 18 participants. The study started on 2012-01. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01509066?
The interventions under investigation include: Diet (OTHER).
Who is sponsoring clinical trial NCT01509066?
This trial is sponsored by University of South Carolina, which has 157 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01509066's enrollment target sits among peer trials
18 1863rd of 2000 higher than 130 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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