Polycystic Ovarian SyndromeHERHealthNCT01509066
Healthy Eating for Reproductive Health (HERHealth)
A study testing Diet in people with Polycystic Ovarian Syndrome and Infertility, run by University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovarian Syndrome, Infertility, Obesity
- What is being tested?
- Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29208
About this study
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.
Read the detailed description
This study involves two groups. You will be randomly assigned to one of these groups (i.e. you do not have a choice for group assignment) which means your group will be assigned to you by chance, like flipping a coin. Both groups will be assigned to receive information on a dietary approach to lose weight. One group will receive instruction on a low-calorie approach to weight loss (reducing caloric intake by approximately 500 calories per day). The other group will be instructed on how to follow 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). Below are the steps in the study:
- If you are accepted into the study, you will come to the study site (USC School of Public Health) to learn more about the study and complete your consent form. If you live outside the Columbia, SC area (more than a 6o mile drive), then you may complete orientation to the study over the phone and Web. You will then be mailed a consent form which we will discuss over the phone. You can then sign the consent form (keeping one copy for yourself and having a witness sign it as well) and mail it back. Once that is received by study personnel, a copy with a research personnel's signature will be mailed back to you. You may then begin the study.
- This study will involve 3-4 in-person visits to the School of Public Health at USC's Columbia campus, each lasting less than 2 hours each.
- You will then complete some questionnaires that will measure your diet and physical activity levels at home from a computer.
- You will come back for a meeting to have your weight, height, waist, and hip circumference measured. You will then be randomly assigned to one of the two groups: calorie controlled group or vegan diet group. You will receive a one-hour overview of the diet you have been assigned to and be provided with materials on this diet.
- During the study, we will ask you to complete a weekly questionnaire which will assess if you are following the diet, your weight, and ask for information on your menstrual cycle. This will take approximately 5 minutes to complete.
- You will then be provided individualized feedback each week via e-mail on your progress, along with a weekly lesson on the topic for the week.
- You will also have access to a group website (a private Facebook group) that will provide group support. Participation using this group is optional.
- You will be provided with test strips to monitor ovulation each month and pregnancy tests (1 per month) to monitor pregnancy status. You will report these results to us via online survey.
- Study personnel will host a weekly 30 minute webinar for your diet group online. This will take place after work time on a weekday. Make-up sessions by phone during the work day will be available.
- At 3 months, you will be asked to complete another set of questionnaires from home and return to our study site for your weight, waist, and hip circumference measurements. You will receive a $10 incentive for completing the 3-month assessment. You will also receive a $5 incentive each month that you provide your menstrual cycle data (using the test strips) and pregnancy tests results-which you will receive at the 3 month meeting (for a total of $25 possible at month 3).
- You will then continue the study for the next 3 months.
- At study completion (6 months), you will complete the last set of questionnaire (online from home). Also, you will come to a follow-up assessment to be weighed, have your waist and hip circumference measured, and to receive your incentive for participating ($10 +$5/month of each menstrual cycle data submitted for a total of $25 possible).
- If you become pregnant during the course of the study, you will be advised to consult your care provider. Because this is a weight loss study, we cannot allow continued participation but would like to record your weight measurement and other questionnaire data prior to study discontinuation. If you choose to continue to follow your assigned dietary approach, we can provide information on the diet to your physician, who can advise you on how to proceed.
- Participants in both groups will be asked to take a daily prenatal vitamin (or other reliable source of vitamin B-12) over the course of the study.
- During the study, we will ask you to keep your physical activity levels constant (keep your levels the same as what you were doing at study entry).
- Conditions
- Polycystic Ovarian Syndrome, Infertility, Obesity, Overweight
- Being tested
- Diet
- Keywords
- vegetarian, vegan, low calorie, infertility, PCOS
- Medical subject headings
- Polycystic Ovary Syndrome, Infertility, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
Dietary approaches for PCOS
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight changes
body weight will be assessed at 0, 3, and 6 months
Measured: 6 months
Secondary outcomes (2)
Pregnancy rates
We will measure any occurrences of pregnancy over the course of the study
Measured: 6 months
Menstrual cycle length
We will measure changes in the length of menstrual cycles over the course of the 6 month study
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovarian SyndromeStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Academy of Nutrition and Dietetics
- Responsible party
- Principal investigator, Brie Turner-McGrievy, University of South Carolina
- Investigators
- Brie Turner-McGrievy, PhD, MS, RD, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509066
- Sponsor's protocol ID
- Pro00014149
- Acronym
- HERHealth
- Status last verified
- Apr 2019
- First submitted
- 9 Jan 2012
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Eating for Reproductive Health (HERHealth)
- ClinicalTrials.gov ID
- NCT01509066
- Acronym / sponsor ID
- HERHealth / Pro00014149
- Conditions
- Polycystic Ovarian Syndrome, Infertility, Obesity, Overweight
- Keywords
- vegetarian, vegan, low calorie, infertility, PCOS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- Academy of Nutrition and Dietetics
- Study start
- Jan 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 12 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study involves two groups. You will be randomly assigned to one of these groups (i.e. you do not have a choice for group assignment) which means your group will be assigned to you by chance, like flipping a coin. Both groups will be assigned to receive information on a dietary approach to lose weight. One group will receive instruction on a low-calorie approach to weight loss (reducing caloric intake by approximately 500 calories per day). The other group will be instructed on how to follow 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). Below are the steps in the study:
- If you are accepted into the study, you will come to the study site (USC School of Public Health) to learn more about the study and complete your consent form. If you live outside the Columbia, SC area (more than a 6o mile drive), then you may complete orientation to the study over the phone and Web. You will then be mailed a consent form which we will discuss over the phone. You can then sign the consent form (keeping one copy for yourself and having a witness sign it as well) and mail it back. Once that is received by study personnel, a copy with a research personnel's signature will be mailed back to you. You may then begin the study.
- This study will involve 3-4 in-person visits to the School of Public Health at USC's Columbia campus, each lasting less than 2 hours each.
- You will then complete some questionnaires that will measure your diet and physical activity levels at home from a computer.
- You will come back for a meeting to have your weight, height, waist, and hip circumference measured. You will then be randomly assigned to one of the two groups: calorie controlled group or vegan diet group. You will receive a one-hour overview of the diet you have been assigned to and be provided with materials on this diet.
- During the study, we will ask you to complete a weekly questionnaire which will assess if you are following the diet, your weight, and ask for information on your menstrual cycle. This will take approximately 5 minutes to complete.
- You will then be provided individualized feedback each week via e-mail on your progress, along with a weekly lesson on the topic for the week.
- You will also have access to a group website (a private Facebook group) that will provide group support. Participation using this group is optional.
- You will be provided with test strips to monitor ovulation each month and pregnancy tests (1 per month) to monitor pregnancy status. You will report these results to us via online survey.
- Study personnel will host a weekly 30 minute webinar for your diet group online. This will take place after work time on a weekday. Make-up sessions by phone during the work day will be available.
- At 3 months, you will be asked to complete another set of questionnaires from home and return to our study site for your weight, waist, and hip circumference measurements. You will receive a $10 incentive for completing the 3-month assessment. You will also receive a $5 incentive each month that you provide your menstrual cycle data (using the test strips) and pregnancy tests results-which you will receive at the 3 month meeting (for a total of $25 possible at month 3).
- You will then continue the study for the next 3 months.
- At study completion (6 months), you will complete the last set of questionnaire (online from home). Also, you will come to a follow-up assessment to be weighed, have your waist and hip circumference measured, and to receive your incentive for participating ($10 +$5/month of each menstrual cycle data submitted for a total of $25 possible).
- If you become pregnant during the course of the study, you will be advised to consult your care provider. Because this is a weight loss study, we cannot allow continued participation but would like to record your weight measurement and other questionnaire data prior to study discontinuation. If you choose to continue to follow your assigned dietary approach, we can provide information on the diet to your physician, who can advise you on how to proceed.
- Participants in both groups will be asked to take a daily prenatal vitamin (or other reliable source of vitamin B-12) over the course of the study.
- During the study, we will ask you to keep your physical activity levels constant (keep your levels the same as what you were doing at study entry).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vegan diet | Experimental | Other: DietA 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. |
| Low-calorie | Active comparator | Other: DietA low-calorie diet contains all food groups. However, participants will be provided with a calorie goal which should promote weight loss. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Women must meet the following criteria:
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DietDietary approaches for PCOS | Other | Low-calorie, Vegan diet |
Primary outcome
Body weight changes
Time frame: 6 months
body weight will be assessed at 0, 3, and 6 months
2 secondary outcomes
Pregnancy rates
Time frame: 6 months
Menstrual cycle length
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brie Turner-McGrievy, PhD, MS, RD principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet in people with Polycystic Ovarian Syndrome and Infertility, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight changes (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.