Lifestyle Intervention for African-American Women: A Pilot Study for Women With a Recent History of Gestational Diabetes (The LIFe Study)

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.