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

Diabetes Mellitus in Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03240874
• Other study ID #: STU00205409
• Secondary ID: 1R21HD094271-015
• Status: Completed
• Phase: N/A
• Start date: August 2, 2017
• Est. completion date: April 9, 2021

Study information

• Verified date: November 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 9, 2021
• Est. primary completion date: April 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus in Pregnancy
• Pregnancy in Diabetics

Intervention

Behavioral:
• SweetMama Focus Groups
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.
• SweetMama Individual Testing
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.
• SweetMama Feasibility Testing - Pilot Randomized Trial
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.

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View 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. — View 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 — View 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 — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical Outcomes of Pregnancy - Percentage of Patients With Hypertensive Disorders of Pregnancy	In feasibility testing participants, clinical outcomes include hypertensive disorders of pregnancy.	After delivery (approximately 10-30 weeks of enrollment)
Other	Number of Cesarean Deliveries	In feasibility testing, the mode of delivery was report as number of cesarean deliveries for SweetMama and usual care participants.	After delivery (approximately 10-30 weeks of enrollment)
Other	Clinical Outcomes of Pregnancy - Neonatal Birthweight	In feasibility testing participants, clinical outcomes include neonatal birthweight.	After delivery (approximately 10-30 weeks of enrollment)
Other	Clinical Outcomes of Pregnancy - Number of Babies With Neonatal Hypoglycemia	In feasibility testing participants, clinical outcomes include neonatal hypoglycemia, (<40 mg/dL).	After delivery (approximately 10-30 weeks of enrollment)
Other	Clinical Outcomes of Pregnancy - Number of Babies With Neonatal Intensive Care Unit Admission	In feasibility testing participants, clinical outcomes include neonatal intensive care unit admission.	After delivery (approximately 10-30 weeks of enrollment)
Primary	Number of Participants Identifying Themes on SweetMama Features	Participants completed qualitative group interviews to yield information about SweetMama features and participant preferences after use in the usability laboratory. The identified themes are outlined, and the criteria used to determine the outcome measure is the number of participants who endorsed each theme related to SweetMama features.	60-90 minutes
Primary	Number of Participants Who Used the SweetMama Application	Feasibility will be assessed as both ability to recruit and retain participants and as a percentage of active SweetMama use. Feasibility targets for study retention will be set at 80% retention; the feasibility target for SweetMama adoption will be 80% active use (at least weekly interaction with SweetMama content).	After 8 weeks postpartum (approximately 18-38 weeks of enrollment)
Secondary	Individual User Feedback on SweetMama Features	For the usability phase, qualitative individual interviews will yield information about SweetMama features and participant preferences after use in the field for after 2 weeks of enrollment. For the feasibility phase, qualitative individual interviews will yield information about SweetMama features and participant preferences after use in the field after 8 weeks postpartum.	After 2 weeks of enrollment (individual usability phase) and after 8 weeks postpartum (feasibility trial; approximately 18-38 weeks of enrollment)
Secondary	Usage Time of SweetMama Application	User interaction with the SweetMama application for the total usage time of the application in minutes was assessed at two timepoints. In the individual usability phase, total usage time of the application was evaluated after 2 weeks of enrollment. In the feasibility phase, total usage time of the application was evaluated after 8 weeks postpartum. The reported number is minutes of use which is a total number of minutes of usage time after 2 weeks of enrollment and after 8 weeks postpartum.	After 2 weeks of enrollment (individual usability phase) and after 8 weeks postpartum (feasibility trial; approximately 18-38 weeks of enrollment)
Secondary	Usability Testing of SweetMama Application With the System Usability Scale Survey	Usability of SweetMama will be assessed using the System Usability Scale min 0 max 100; 1=Acceptable(>70) 2=Marginal(50	After 2 weeks of enrollment (individual usability phase) and after 8 weeks postpartum (feasibility trial; approximately 18-38 weeks of enrollment)
Secondary	Usability Testing of SweetMama Application With the Useful, Satisfaction and Ease of Use Questionnaire	Usability of SweetMama will be assessed using the Usefulness, Satisfaction and Ease of Use (USE) Questionnaire. The higher the participant scored means the participant did better.; Usefulness: (sum(use_1 - use_8)/56)*100, range from 14.29 to 100 Satisfaction: (sum(use_24-use_30)/49)*100, range from 14.29 to 100 Ease of Use (USE): (sum(use_9-use_19)/77)*100, range from 14.29 to 100 Usability testing of the SweetMama application was assessed at two timepoints. In the individual usability phase, usability testing was evaluated after 2 weeks of enrollment. In the feasibility phase, usability testing was evaluated after 8 weeks postpartum.	After 2 weeks of enrollment (individual usability phase) and after 8 weeks postpartum (feasibility trial; approximately 18-38 weeks of enrollment))
Secondary	Diabetes Self-efficacy	Diabetes self-efficacy measured via patient-reported outcomes (Diabetes Empowerment Scale), which is scored from 8 to 40 (sum of individual items), where higher total scores indicate higher self-efficacy	After 8 weeks postpartum (approximately 18-38 weeks of enrollment)
Secondary	Patient Activation	Patient activation measured patient engagement in healthcare via patient-reported outcomes (Patient Activation Measure), which is scored from 0 to 100 (sum of all scores, scaled to a 0-100-point system), where higher scores indicate greater activation.	After 8 weeks postpartum (approximately 18-38 weeks of enrollment)
Secondary	Difference in Hemoglobin A1c From Enrollment to Delivery	Hemoglobin A1c will be assessed as a continuous measure reflecting the difference from enrollment to final. A1c before delivery, we controlled for A1c at enrollment and week difference	After 8 weeks postpartum (approximately 18-38 weeks of enrollment)