Clinical trial NCT03240874: SweetMama: Testing of a Novel Technology for Diabetes Education and Support to Pregnant Women
Official title: SweetMama Usability and Feasibility: Testing of a Novel Technology for Diabetes Education and Support to Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus in Pregnancy
Keywords: Gestational Diabetes
Diabetes Type 2 in Pregnancy
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2017-08-07
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two phases of study:

1. Usability testing - focus groups followed by individual usability testing (single arm)
2. Feasibility testing - pilot randomized controlled trial of SweetMama care versus usual care
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Identifying Themes on SweetMama Features
timeFrame: 60-90 minutes
measure: Number of Participants Who Used the SweetMama Application
timeFrame: After 8 weeks postpartum (approximately 18-38 weeks of enrollment)
Secondary outcomes:
measure: Individual User Feedback on SweetMama Features
timeFrame: After 2 weeks of enrollment (individual usability phase) and after 8 weeks postpartum (feasibility trial; approximately 18-38 weeks of enrollment)
measure: Usage Time of SweetMama Application
timeFrame: After 2 weeks of enrollment (individual usability phase) and after 8 weeks postpartum (feasibility trial; approximately 18-38 weeks of enrollment)
measure: Usability Testing of SweetMama Application With the System Usability Scale Survey
timeFrame: After 2 weeks of enrollment (individual usability phase) and after 8 weeks postpartum (feasibility trial; approximately 18-38 weeks of enrollment)
measure: Usability Testing of SweetMama Application With the Useful, Satisfaction and Ease of Use Questionnaire
timeFrame: After 2 weeks of enrollment (individual usability phase) and after 8 weeks postpartum (feasibility trial; approximately 18-38 weeks of enrollment))
measure: Diabetes Self-efficacy
timeFrame: After 8 weeks postpartum (approximately 18-38 weeks of enrollment)
measure: Patient Activation
timeFrame: After 8 weeks postpartum (approximately 18-38 weeks of enrollment)
measure: Difference in Hemoglobin A1c From Enrollment to Delivery
timeFrame: After 8 weeks postpartum (approximately 18-38 weeks of enrollment)
Other outcomes:
measure: Clinical Outcomes of Pregnancy - Percentage of Patients With Hypertensive Disorders of Pregnancy
timeFrame: After delivery (approximately 10-30 weeks of enrollment)
measure: Number of Cesarean Deliveries
timeFrame: After delivery (approximately 10-30 weeks of enrollment)
measure: Clinical Outcomes of Pregnancy - Neonatal Birthweight
timeFrame: After delivery (approximately 10-30 weeks of enrollment)
measure: Clinical Outcomes of Pregnancy - Number of Babies With Neonatal Hypoglycemia
timeFrame: After delivery (approximately 10-30 weeks of enrollment)
measure: Clinical Outcomes of Pregnancy - Number of Babies With Neonatal Intensive Care Unit Admission
timeFrame: After delivery (approximately 10-30 weeks of enrollment)
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Assistant Professor, Maternal and Fetal Medicine
name: Lynn M Yee, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gomez H, DiTosto JD, Niznik CM, Yee LM. Understanding Food Security as a Social Determinant of Diabetes-Related Health during Pregnancy. Am J Perinatol. 2023 Jun;40(8):825-832. doi: 10.1055/s-0041-1740194. Epub 2021 Nov 28.
citation: Leziak K, Birch E, Jackson J, Strohbach A, Niznik C, Yee LM. Identifying Mobile Health Technology Experiences and Preferences of Low-Income Pregnant Women with Diabetes. J Diabetes Sci Technol. 2021 Sep;15(5):1018-1026. doi: 10.1177/1932296821993175. Epub 2021 Feb 19.
citation: Jackson J, Leziak K, Niznik CM, Yee LM. Health Care Providers' Utilization of and Perspectives on Mobile Health Technology for Diabetes and Pregnancy Support. Diabetes Spectr. 2021 Aug;34(3):257-267. doi: 10.2337/ds20-0040. Epub 2021 Mar 9.
citation: Yee LM, Leziak K, Jackson J, Strohbach A, Saber R, Niznik CM, Simon MA. Patient and Provider Perspectives on a Novel Mobile Health Intervention for Low-Income Pregnant Women With Gestational or Type 2 Diabetes Mellitus. J Diabetes Sci Technol. 2021 Sep;15(5):1121-1133. doi: 10.1177/1932296820937347. Epub 2020 Jul 5.
citation: Steinberg JR, Yeh C, Jackson J, Saber R, Niznik CM, Leziak K, Yee LM. Optimizing Engagement in an mHealth Intervention for Diabetes Support During Pregnancy: the Role of Baseline Patient Health and Behavioral Characteristics. J Diabetes Sci Technol. 2022 Nov;16(6):1466-1472. doi: 10.1177/19322968211035441. Epub 2021 Aug 22.
citation: Yee LM, Leziak K, Jackson J, Niznik CM, Simon MA. Health Care Providers' Perspectives on Barriers and Facilitators to Care for Low-Income Pregnant Women With Diabetes. Diabetes Spectr. 2020 May;33(2):190-200. doi: 10.2337/ds19-0044.
citation: Birch EM, Leziak K, Jackson J, Dahl E, Niznik CM, Yee LM. Content Quality of YouTube Videos About Gestational Diabetes: Systematic Evaluation. JMIR Diabetes. 2022 Apr 7;7(2):e30156. doi: 10.2196/30156.