SweetMama: Testing of a Novel Technology for Diabetes Education and Support to Pregnant Women

Northwestern University

Status: Completed

Conditions: Diabetes Mellitus in Pregnancy

Treatments: Behavioral: SweetMama Feasibility Testing - Pilot Randomized Trial; Behavioral: SweetMama Individual Testing; Behavioral: SweetMama Focus Groups

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03240874

1R21HD094271-01 (U.S. NIH Grant/Contract)

5R21HD094271-02 (U.S. NIH Grant/Contract)

STU00205409

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 18 and older
• Gestational diabetes mellitus or type 2 diabetes mellitus
• English-speaking
• Gestational age
• Focus groups: Confirmed intrauterine pregnancy at least 8 weeks' gestational age or postpartum until 12 weeks after delivery
• Individual testing: Confirmed intrauterine pregnancy prior to 30 weeks' gestational age
• Pilot trial: Confirmed intrauterine pregnancy prior to 30 weeks' gestational age
• Low income, defined as use of publicly-supported insurance for prenatal care or household income <200% of poverty line for family size
• Access to a mobile smartphone ( for longitudinal testing phase)

Exclusion criteria

• Failure to meet the inclusion criteria above
• Non-viable pregnancy

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

Usability - Focus Group

Experimental group

Description:

Mobile Application Usability Testing: SweetMama Focus Groups Focus groups: Women with a confirmed intrauterine pregnancy or postpartum until 12 weeks after delivery with gestational diabetes mellitus or type 2 diabetes mellitus will be recruited to undergo a single 1-hour focus group.

Treatment:

Behavioral: SweetMama Focus Groups

Usability - Individual Testing

Experimental group

Description:

Mobile Application Usability Testing: SweetMama Individual Testing Individual testing: Women with a confirmed intrauterine pregnancy (any gestational age) or who are up to 4 weeks postpartum, with gestational diabetes mellitus or type 2 diabetes mellitus, will be recruited to use SweetMama for 2 weeks and provide feedback.

Treatment:

Behavioral: SweetMama Individual Testing

Feasibility - Pilot Randomized Trial, SweetMama arm

Experimental group

Description:

Mobile Application Feasibility Testing: SweetMama Pilot Trial, SweetMama arm Women recruited to the pilot RCT phase will enroll in the study upon initiation of prenatal care for diabetes, which could be early in pregnancy at the time of first prenatal visit, or at a later point if they have transferred care to this site. Women randomized to receive SweetMama care will be oriented to use of SweetMama and will then use the intervention (messages, library, goal setting, and appointment reminders) throughout pregnancy and the first 8 weeks postpartum, at which point they will undergo surveys and interviews.

Treatment:

Behavioral: SweetMama Feasibility Testing - Pilot Randomized Trial

Feasibility - Pilot Randomized Trial, usual care arm

No Intervention group

Description:

Mobile Application Feasibility Testing: SweetMama Pilot Trial, usual care arm Women recruited to the pilot RCT phase will enroll in the study upon initiation of prenatal care for diabetes, which could be early in pregnancy at the time of first prenatal visit, or at a later point if they have transferred care to this site. Women randomized to usual care will be undergo entry and exit surveys (at 6-8 weeks postpartum) but will not interact with SweetMama.