SweetMama: Testing of a Novel Technology for Diabetes Education and Support to Pregnant Women
Condition: Diabetes Mellitus in Pregnancy
MeSH terms: Pregnancy in Diabetics; Diabetes Mellitus
Study type: Interventional

Summary: 
      Diabetes during pregnancy is a challenging clinical situation requiring substantial patient
      engagement. The investigators have developed a novel early-phase tool, called SweetMama, that
      incorporates educational, motivational and supportive elements to positively impact maternal
      health behaviors. This phase of work involves develop an optimized version of SweetMama via a
      2-step sequential process of in-depth usability and feasibility testing. First the
      investigators will conduct focus groups and individual usability testing followed by
      refinement of SweetMama based on participant input. Next, the investigators will conduct
      feasibility testing via a pilot randomized trial to determine acceptability, feasibility, and
      pilot procedures for a fully powered larger trial.
    

Detailed description: 
      In prior work, the investigators created a text messaging curriculum that was well-received
      by patients for diabetes-related education and support during pregnancy. The team has now
      drawn upon these earlier phases to develop a mobile health behavior tool to educate and
      support low-income, minority pregnant women with Gestational Diabetes Mellitus and Type 2
      Diabetes Mellitus. This "first-of-its-kind" mHealth platform for pregnant women with GDM or
      T2DM is called SweetMama. SweetMama is a theory-driven application that delivers an
      interactive, goal-oriented educational and motivational diabetes-focused curriculum.
      SweetMama currently functions as a user-friendly application in which participants are
      delivered curriculum messages and have the opportunity to receive novel educational,
      motivational, or supportive content when desired by patients; they additionally have the
      opportunity to view library content and receive support with goal-setting.

      To perform usability testing, the investigators will first conduct focus groups with 10-20
      low-income pregnant women with diabetes to evaluate tool functionality, design, and
      interpretability. The investigators will then conduct a phase of individual usability testing
      with 20 women, who will use SweetMama for 2 weeks followed by qualitative (interviews) and
      quantitative (questionnaires and user interaction data) assessments of tool satisfaction and
      use.

      Next, to perform feasibility testing, the investigators will recruit approximately 40
      low-income pregnant women with diabetes to be randomized to either usual care or SweetMama
      care, from the beginning of their enrollment at this clinical site for diabetes-specific
      prenatal care through the first 8 weeks postpartum. Randomization will be unbalanced to favor
      receipt of the intervention. Participants will undergo surveys and interviews at multiple
      time points, and those who are randomized to experience SweetMama will undergo an exit
      interview. Outcomes will include retention, treatment adherence, functionality of the tool,
      and user interactivity with the tool. The expected outcome of the pilot RCT phase is a better
      understanding of feasibility of a SweetMama trial via field testing.
    

Intervention name(s): SweetMama Focus Groups; SweetMama Individual Testing; SweetMama Feasibility Testing - Pilot Randomized Trial
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Focus groups will assess tool functionality, design, interpretability, and acceptability (initial reaction, attitude, and receptiveness) of SweetMama via qualitative interviewing. The group format will generate feedback on areas that may not be revealed in a one-on-one interview.; Women will be oriented to SweetMama use on their own Android- or Apple-based phones. The goals of this phase are to collect data from diverse users that will (1) confirm that the mobile apps are functioning (not crashing) across a wide range of devices and operating systems, (2) provide basic information about app usage and user satisfaction (3) inform the development of future iterations by analyzing participant characteristics and use, and (4) collect quality assurance data that will allow the research team to refine the applications. Women will use SweetMama for 2 weeks, engage in periodic "check-ins" with the research assistant, and participate in a semi-structured interview upon completion of SweetMama usage.; Women will be oriented to SweetMama use on their own Android- or Apple-based phones. The goals of this phase are to collect data from diverse users that will determine acceptability, feasibility, and pilot procedures in anticipation of a fully powered randomized controlled trial. Women will use SweetMama from enrollment (early pregnancy) to up to 8 weeks postpartum, engage in periodic "check-ins" with the research assistant, and participate in surveys and a semi-structured interview upon completion of SweetMama usage.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Two phases of study:
Usability testing - focus groups followed by individual usability testing (single arm)
Feasibility testing - pilot randomized controlled trial of SweetMama care versus usual care
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Gestational Diabetes; Diabetes Type 2 in Pregnancy