<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01716429</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00019109</org_study_id>
    <nct_id>NCT01716429</nct_id>
  </id_info>
  <brief_title>Healthy Eating for Reproductive Health: Greenville</brief_title>
  <acronym>HER Health</acronym>
  <official_title>Healthy Eating for Reproductive Health: Greenville</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Prisma Health-Upstate</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of South Carolina</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will be a 6-month intervention that is examining how different dietary approached&#xD;
      may be useful for women with Polycystic Ovarian Syndrome (PCOS) who are attempting pregnancy,&#xD;
      particularly by measuring changes in weight. Participants will be randomly assigned to&#xD;
      following one of two dietary approaches for weight loss: 1) a low-calorie approach to weight&#xD;
      loss (reducing caloric intake by approximately 500 calories per day) or 2) a low-fat,&#xD;
      low-glycemic index vegan diet. A vegan diet is one that does not contain any animal products&#xD;
      (no meat, fish, poultry, eggs, or dairy) but emphasizes plant-based foods, such as fruits,&#xD;
      vegetables, whole grains, and legumes/beans. In addition, this diet will be low-glycemic&#xD;
      index, which means the consumer will be asked to favor foods that don't cause a quick rise in&#xD;
      blood sugar (for example, favoring oatmeal over cornflakes for breakfast). Participants will&#xD;
      receive counseling and supporting materials on the dietary approach the participants are&#xD;
      assigned to follow. Both diets are safe and have shown to be effective ways to assist with&#xD;
      achieving a healthy weight. The investigators hypothesize that both groups will see&#xD;
      improvements in weight and fertility with possible greater improvements seen among&#xD;
      participants in the vegan group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study involves two groups. You will be randomly assigned to one of these groups (i.e.&#xD;
      you do not have a choice for group assignment) which means your group will be assigned to you&#xD;
      by chance. Both groups will receive information on a dietary approach aimed at losing weight.&#xD;
&#xD;
      One group will receive instruction on a low-calorie approach to weight loss (reducing caloric&#xD;
      intake by approximately 500 calories per day). The other group will be instructed to follow a&#xD;
      low-fat, low-glycemic index vegan diet. A vegan diet is one that does not contain any animal&#xD;
      products (no meat, fish, poultry, eggs, or dairy) but emphasizes plant-based foods, such as&#xD;
      fruits, vegetables, whole grains, and legumes/beans. In addition, this will be a low-glycemic&#xD;
      index diet, which means you will be asked to favor foods that don't cause a quick rise in&#xD;
      blood sugar (for example, choosing oatmeal over cornflakes for breakfast).&#xD;
&#xD;
      Below are the steps in the study:&#xD;
&#xD;
      If you are accepted into the study, you will come to the study site (Fertility Center of the&#xD;
      Carolinas in Greenville) to learn more about the study and complete your consent form. If you&#xD;
      live outside the Columbia, SC area (more than a 60 mile drive), you may complete the study&#xD;
      orientation process over the phone and Web. You will be mailed a consent form to sign and&#xD;
      return to the study coordinator. This study will involve 3-4 in-person visits to the&#xD;
      Fertility Center of the Carolinas office, each lasting approximately 1.5 to 2 hours.&#xD;
&#xD;
      You will complete some questionnaires that measure your diet and physical activity levels on&#xD;
      a computer at home or other location where you have computer/internet access.&#xD;
&#xD;
      You will come back for a meeting to have your weight measured. You will then be randomly&#xD;
      assigned to one of the two groups: calorie controlled group or vegan diet group. You will&#xD;
      receive a one-hour overview of the diet you have been assigned to and be provided with&#xD;
      materials on this diet.&#xD;
&#xD;
      During the study, we will ask you to complete a weekly questionnaire which will assess if you&#xD;
      are following the diet, your weight, and ask for information on your menstrual cycle. This&#xD;
      will take approximately 5 minutes to complete.&#xD;
&#xD;
      You will be provided individualized feedback each week via e-mail on your progress, along&#xD;
      with a weekly lesson on the topic for the week.&#xD;
&#xD;
      You will have access to a group website (a private Facebook group) that will provide group&#xD;
      support. Participation using this group is optional.&#xD;
&#xD;
      You will be provided with test strips to monitor ovulation each month and pregnancy tests (1&#xD;
      per month) to monitor pregnancy status. You will report these results to us via online&#xD;
      survey.&#xD;
&#xD;
      Study personnel will host a weekly 30 minute webinar for your diet group online. This will&#xD;
      take place after work time on a weekday. Make-up sessions by phone during the work day will&#xD;
      be available.&#xD;
&#xD;
      At 3 months, you will be asked to complete another set of questionnaires from home and return&#xD;
      to our study site for your weight measurement.&#xD;
&#xD;
      You will continue the study for the next 3 months. At study completion (6 months), you will&#xD;
      complete the last set of questionnaires (online). Also, you will come to a follow-up&#xD;
      assessment to be weighed and to receive your incentive for participating ($10 +$5/month of&#xD;
      each menstrual cycle data submitted for a total of $25 possible).&#xD;
&#xD;
      Participants in both groups will be asked to take a daily prenatal vitamin (or other reliable&#xD;
      source of vitamin B-12) over the course of the study.&#xD;
&#xD;
      During the study, we will ask you to keep your physical activity levels constant (keep your&#xD;
      levels the same as what you were doing at study entry).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No participants were recruited over the course of the study time period&#xD;
  </why_stopped>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in body weight</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pregnancy rates</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Menstrual cycle length</measure>
    <time_frame>6 months</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Polycystic Ovarian Syndrome</condition>
  <condition>Infertility</condition>
  <condition>Obesity</condition>
  <condition>Overweight</condition>
  <arm_group>
    <arm_group_label>Low Calorie</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this arm will be instructed on how to reduce their caloric intake and follow a low calorie diet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vegan diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Vegan diet</intervention_name>
    <description>Vegan dietary approaches for weight loss</description>
    <arm_group_label>Vegan diet</arm_group_label>
    <other_name>Vegetarian</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Low calorie diet</intervention_name>
    <description>Reduced calorie diet for weight loss</description>
    <arm_group_label>Low Calorie</arm_group_label>
    <other_name>Standard diet</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Women must meet the following criteria:&#xD;
&#xD;
        have been attempting pregnancy for at least 6 months is not currently pregnant has a&#xD;
        clinical diagnosis of PCOS is not on oral medications for insulin resistance (such as&#xD;
        metformin) or, if currently on such a medication, has been on the medication at a stable&#xD;
        dose for at least 3 months willing not use fertility-enhancing medications over the 6-month&#xD;
        study (with the exception of oral medications, such as clomiphene citrate, as directed by&#xD;
        their physician) willing to be randomized to either dietary condition and able to make&#xD;
        weekly meetings.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants should not be in this study if they meet any of the following criteria:&#xD;
&#xD;
        have not been diagnoses with polycystic ovarian syndrome have been trying to conceive less&#xD;
        than 6 months have a Body Mass Index less than 25 or greater than 45 kg/m2 are currently&#xD;
        pregnant are younger than 18 or older than 35 years of age are a smoker are unable to come&#xD;
        to the Columbia, SC area at least 3-4 times in a 6 month time period for assessments don't&#xD;
        have access to the Internet and a computer don't have access to a scale for self-monitoring&#xD;
        weight aren't willing to be randomized to either group have a psychiatric disease, drug or&#xD;
        alcohol dependency, or uncontrolled thyroid condition have a major health condition, such&#xD;
        as heart conditions, diabetes, and past incidence of stroke unable to receive consent from&#xD;
        your doctor to participate if you currently are on blood pressure medications, have issues&#xD;
        with dizziness, or have bone or joint issues have an eating disorder currently&#xD;
        participating in a weight loss program or taking weight loss medications&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brie Turner-McGrievy, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of South Carolina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fertility Center of the Carolinas: Greenville Hospital System</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2013</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>April 16, 2019</last_update_submitted>
  <last_update_submitted_qc>April 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of South Carolina</investigator_affiliation>
    <investigator_full_name>Brie Turner-McGrievy</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>vegetarian</keyword>
  <keyword>vegan</keyword>
  <keyword>low calorie</keyword>
  <keyword>weight Loss</keyword>
  <keyword>infertility</keyword>
  <keyword>PCOS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polycystic Ovary Syndrome</mesh_term>
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01716429
org study id: Pro00019109
nct id: NCT01716429
lead sponsor: 
collaborator: 
has dmc: No
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.
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. Both groups will receive information on a dietary approach aimed at losing 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 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 will be a low-glycemic
      index diet, which means you will be asked to favor foods that don't cause a quick rise in
      blood sugar (for example, choosing 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 (Fertility Center of the
      Carolinas in Greenville) to learn more about the study and complete your consent form. If you
      live outside the Columbia, SC area (more than a 60 mile drive), you may complete the study
      orientation process over the phone and Web. You will be mailed a consent form to sign and
      return to the study coordinator. This study will involve 3-4 in-person visits to the
      Fertility Center of the Carolinas office, each lasting approximately 1.5 to 2 hours.

      You will complete some questionnaires that measure your diet and physical activity levels on
      a computer at home or other location where you have computer/internet access.

      You will come back for a meeting to have your weight 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 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 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 measurement.

      You will continue the study for the next 3 months. At study completion (6 months), you will
      complete the last set of questionnaires (online). Also, you will come to a follow-up
      assessment to be weighed and to receive your incentive for participating ($10 +$5/month of
      each menstrual cycle data submitted for a total of $25 possible).

      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).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes in body weight
time frame: 6 months
measure: Pregnancy rates
time frame: 6 months
measure: Menstrual cycle length
time frame: 6 months
arm group label: Low Calorie
arm group type: Active Comparator
description: Participants in this arm will be instructed on how to reduce their caloric intake and follow a low calorie diet
arm group label: Vegan diet
arm group type: Experimental
description: 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)
intervention type: Behavioral
intervention name: Vegan diet
description: Vegan dietary approaches for weight loss
arm group label: Vegan diet
other name: Vegetarian
intervention type: Behavioral
intervention name: Low calorie diet
description: Reduced calorie diet for weight loss
arm group label: Low Calorie
other name: Standard diet
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Brie Turner-McGrievy, PhD
role: Principal Investigator
affiliation: University of South Carolina
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of South Carolina
investigator full name: Brie Turner-McGrievy
investigator title: Assistant Professor
mesh term: Polycystic Ovary Syndrome
mesh term: Infertility
mesh term: Overweight