Healthy Eating for Reproductive Health (HERHealth)
Condition: Polycystic Ovarian Syndrome; Infertility; Obesity; Overweight
MeSH terms: Polycystic Ovary Syndrome; Infertility; Overweight
Study type: Interventional

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.
    

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).
    

Intervention name(s): Diet
Intervention type(s): Other
Intervention description(s): Dietary approaches for PCOS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vegetarian; vegan; low calorie; infertility; PCOS