Recent GDM Lifestyle Intervention
Condition: Diabetes Mellitus; Diabetes, Gestational
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional

Summary: 
      Women with a history of gestational diabetes (GDM) have a substantially increased risk of
      developing type 2 diabetes. In fact, 50-70% of these women will go on to develop type 2
      diabetes within the 20 years following their GDM-complicated pregnancy. Perceived risk of
      developing type 2 diabetes among women with a history of GDM may be particularly important to
      altering behavior changes associated with reducing risk. Certain populations have lower
      perceived risk of developing type 2 diabetes, despite having a higher prevalence of the
      disease. Specifically, African-Americans have a lower perceived risk of developing type 2
      diabetes compared to whites, despite their more than doubled risk of developing the disease.
      Improvement in awareness of diabetes risk among African-American women at high-risk of
      developing type 2 diabetes, such as those with a history of GDM, could reduce future risk of
      this disease among this group.

      As such, we will conduct a two-armed, pilot randomized controlled trial to evaluate whether a
      postpartum diabetes education intervention, incorporating nutrition, exercise, and diabetes
      risk assessment can improve diabetes risk awareness, diet, and physical activity levels at
      1-year post-pregnancy among African-American women with a recent history of gestational
      diabetes.

      We hypothesize that attendance at a 3-month and 9-month postpartum diabetes education class
      will:

        1. Improve diabetes awareness as measured using the Risk Perception for Developing Diabetes
           among women in the intervention group compared to women in the control group when
           measuring at 3-months postpartum compared to 12-months postpartum

        2. Improve dietary habits and physical activity levels in the intervention group compared
           to the control group when measuring at 3-months postpartum compared to 12-months
           postpartum
    

Detailed description: 
      Study subjects will be recruited from the Brigham and Women's Hospital's (BWH)Diabetes and
      Pregnancy Program. Obstetricians will assist in the study by introducing the study to women
      with gestational diabetes (GDM), who are currently in their third trimester of pregnancy and
      asking the women to which race/ethnicity do they self-identify. Those women who self-identify
      as Black or African-American will be told by their health care provider that a Research
      Assistant from our study would like to speak with them about our study after their
      appointment and that the study is only for research purposes and is not mandatory for their
      treatment or care at BWH, but is on voluntary basis only.

      Our Research Assistant will approach all women who self-identify as African-American and have
      GDM, who are in their third trimester (as identified by the obstetrician). For women who are
      interested in learning more about the study, but do not have time to hear more about it
      during the initial contact, the Research Assistant will obtain their contact information to
      describe the study and discuss the woman's possible participation at a later point in time.

      For those women who have time to learn more about the study immediately following their
      obstetrics appointment at BWH, our Research Assistant will take women into a private room
      within the obstetrics clinic and provide them with general information about the study. If a
      woman is interested, we will ask the woman a set of screening questions to assess their
      eligibility. The screening questions will not include any personal identifying information
      and will only be collected to determine eligibility and response rates. If eligible for
      participation in our study, we will collect the eligible woman's contact information and
      provide the woman with an informed consent form to be reviewed and signed either at that time
      to our Research Assistant or returned to us by mail using a provided stamped, addressed
      envelope within 2 weeks of having received the form. Description of the study, confirmation
      of contact information, administration of the screening questionnaire, and receipt and review
      of consent documents will occur similarly by phone for those women who were not available to
      learn more about the study immediately following their obstetrics visit, but who expressed
      interests in learning more about the study at a later time point.

      Given that women have until 3 months post-pregnancy to be enrolled in our study, we will also
      use a flyer with a detachable card and a brochure to try to recruit women during their 6-week
      postnatal visit, as well as at the time of delivery, during their hospital stay. These
      additional recruitment time points will maximize recruitment efforts. Recruitment at the
      6-week postnatal visit will be similar to that described above for the third trimester clinic
      visit. For those women that we attempt to recruit at the time of delivery, we will have an
      obstetrician notify us of a delivering woman, who has self-identified as African-American and
      had GDM during her recent pregnancy. Our Research Assistant will approach women on the Labor
      and Delivery floor after the woman's delivery. At this time the study will be explained to
      her and the woman will be asked to answer screening questions, if she is interested in the
      study. An informed consent will be provided, if the woman is eligible. The woman can either
      complete the informed consent at that time or return it to our study staff within 2 weeks.

      Upon return of the signed informed consent form, we will enroll the woman in the study and
      randomize her to receive either the study intervention or standard care. We will ensure
      balance in this process through the use of block randomization. At this time point, our
      research assistant will assist with scheduling the woman's 6-week postpartum follow-up visit,
      which is a part of her standard medical care. This assistance with scheduling, will aid in
      making sure that the potential study participant receives her 6-week postpartum diabetes
      screening. If she fails the screening, then she will be notified by a study clinician and
      withdrawn from the study.

      For women who do not return the consent form within 2-weeks of having initially received it
      from our research assistant, we will re-contact the woman to follow-up with her about her
      interest in participating in the study. Eligible women will be re-contacted either by phone
      or e-mail, based on the woman's preferred method of contact, up to three times, to obtain the
      informed consent. After the third unsuccessful re-contact, we will stop attempts to obtain
      the consent form. We will also not re-contact a woman, if they state they are no longer
      interested in the study.

      Again, as a part of enrollment into the study, we will obtain e-mail addresses and mailing
      addresses of our study participants (see Script C1). We will also obtain telephone
      information in order to call or text the woman, if this is her preferred contact method. At
      3-months we will send a secure web link for completion of the 3-months web-based
      questionnaire to be completed by the woman. For women without internet access or those who do
      not wish to complete the questionnaire online, we will mail a paper-version of the
      questionnaire at 3-months postpartum. Likewise, a web link or paper questionnaires will be
      sent at 6-months, 9-months, and 12-months postpartum. If we have not received the completed
      questionnaire, we will contact the study participant by phone to determine whether she
      received the initial questionnaire and if she has any questions. All women enrolled in the
      study (both the intervention group and standard care group) will be asked to complete these
      questionnaires. We will also send a text reminder for those women who listed text as a
      preferred method of contact.

      For those women enrolled in the intervention arm, the research assistant will contact them
      via phone to schedule them for their 3-month and 9-month class to be held at a local
      community centers. Two weeks before the class we will send a reminder card either via e-mail,
      text message, or postal mail. Two days before the class our Research Assistant will contact
      the women by phone to remind them of the class, location, and time. Women will also be
      reminded at this time to bring a favorite recipe to the class.

      The intervention group will attend classes mentioned at the aforementioned centers. Each
      class will take 2-hours and be conducted by a Collaborative Institutional Training Initiative
      (CITI) certified registered nutritionist familiar with working in the GDM population and with
      extensive experience working in the African-American community. Both classes will include a
      cooking demonstration. In addition, the class will include a tour of a local supermarket to
      aid women in identifying healthy food choices. The classes will cover the following material:

      3-month class:

        1. Introductions: Nutritionist/Life coach will introduce herself and will encourage others
           to introduce themselves on a first name basis only.

        2. Overview of class and class guidelines: Nutritionist/Life coach will provide an overview
           of the material to be covered as well as class guidelines

        3. Diabetes Risk Awareness: Focus on diabetes risk factors, as well as symptoms of
           diabetes, and lifestyle factors that can reduce diabetes risk.

        4. Review Weight Loss Goals: Subjects will weigh in at each visit: Discuss the benefit of
           weight loss on the reduction of risk of future type 2 diabetes in the mom.

        5. Good Nutrition, Healthy Plate and Portions: Review portion sizes using handouts. There
           will also be a focus on adding fruits and vegetables, learning about healthy versus
           unhealthy fat, as well as label reading.

        6. Infant feeding: Review/discuss the benefits of breastfeeding for mom and the baby
           including reducing maternal weight retention, and reducing infant and child obesity.
           Review optimal timing of introduction of solid foods and types of foods healthy for your
           child.

        7. Ways to reduce your diabetes risk: Discussion of lifestyle factors that can reduce your
           diabetes risk, including physical activity and sleep.

        8. Exercise Basics: Review options for moderate intensity cardiovascular exercise and
           strength training, including walking and the use of resistance bands, and discuss
           exercise goals.

        9. Making Your Recipes Healthy: Focus on adapting popular recipes, as well as those of
           study participants to make them healthy. Participants will be asked to submit one
           favorite family recipe at the beginning of the study. The group will work together to
           modify all the recipes using healthy substitutions.

       10. Cooking Demonstration: The nutritionist/group teacher will prepare a healthy meal during
           the class time. This will showcase healthy food choices, measuring and food preparation
           skills, as well as methods of cooking. Class participants will be welcomed to partake in
           the meal, once prepared.

      9 month class:

        1. Review of Diabetes and Diabetes Risk Awareness: Review diabetes risk factors, prevention
           measures used to reduce diabetes risk, and signs and symptoms of diabetes.

        2. Review Weight Loss Goals: Subjects will weigh in at this time point and discuss the
           benefits of weight loss on the reduction of risk of future type 2 diabetes in the mom.

        3. Eating Healthy, Healthy Plate and Portions: Review portion sizes using handouts. We will
           re-emphasize the importance of adding fruits and vegetables, and discuss healthy and
           unhealthy fats based on current dietary habits. Also, focus on label reading

        4. Supermarket Smarts, Label reading and Dining Out: Tips for making healthy choices at the
           grocery store. Review how to make healthier choices when dining out, with instruction
           including a sample restaurant menu. In addition, participants will become familiar with
           how to read food labels.

        5. Assessment of barriers to healthy lifestyle: Participants will discuss with
           nutritionist/group teacher issues surrounding healthy eating, barriers to physical
           activity and other healthy lifestyle behaviors associated with reduced risk of diabetes.
           Discussion will focus on solutions to overcoming these barriers.

        6. Cooking Demonstration: The nutritionist/group teacher will provide a prepare and cook a
           health meal during the class time. This will showcase healthy food choices, measuring
           and food preparation skills, as well as methods of cooking. Class participants will be
           welcomed to partake in the meal, once prepared.

      For women in the intervention group, onsite childcare at the Boys and Girls Club will be made
      a possible option through the use of already-certified childcare providers. We will also
      offer women the option of covering childcare at home for 4-hours (to cover commuting time, as
      well as the time for the 2-hour class) per session. Description of this compensation will be
      discussed below. If necessary, women will be allowed to bring their infant children to the
      class to ensure the woman is able to attend.

      Upon completion of the class, the woman will be asked a set of qualitative questions
      regarding the class information and structure to better inform a larger, future intervention.
    

Intervention name(s): Lifestyle and Risk Assessment class
Intervention type(s): Behavioral
Intervention description(s): Classes will be conducted by a CITI-certified Boston Public Health Commission nutritionist, who is a consultant on this project and has previously worked within the Boston African-American community to increase diabetes awareness and reduce diabetes risk. These classes will be held at a local community center to provide maximal accessibility to the women.
The intervention group will attend classes mentioned at the aforementioned centers. Each class will take 2-hours and be conducted by a CITI-certified registered nutritionist with extensive knowledge of working in the African-American community. Both classes will include a cooking demonstration. In addition, the class will include a tour of a local supermarket to aid women in identifying healthy food choices.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Gestational diabetes; Diabetes mellitus; diabetes in pregnancy; diabetes risk; diabetes risk awareness; African-American; Women