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

NCT ID: NCT03240874

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-02
• Study Completion Date: 2021-04-09

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.

Conditions

Diabetes Mellitus in Pregnancy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Usability - Focus Group

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.

Group Type: EXPERIMENTAL

SweetMama Focus Groups

Intervention Type: BEHAVIORAL

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.

Usability - Individual Testing

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.

Group Type: EXPERIMENTAL

SweetMama Individual Testing

Intervention Type: BEHAVIORAL

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.

Feasibility - Pilot Randomized Trial, SweetMama arm

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.

Group Type: EXPERIMENTAL

SweetMama Feasibility Testing - Pilot Randomized Trial

Intervention Type: BEHAVIORAL

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.

Feasibility - Pilot Randomized Trial, usual care arm

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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)

• Non-viable pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lynn M Yee, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor, Maternal and Fetal Medicine

Locations

Northwestern Memorial Hospital

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 34839467 (View on PubMed)

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.

Reference Type: RESULT

PMID: 33605158 (View on PubMed)

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.

Reference Type: RESULT

PMID: 34511852 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32627582 (View on PubMed)

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.

Reference Type: RESULT

PMID: 34423677 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32425457 (View on PubMed)

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.

Reference Type: RESULT

PMID: 35389355 (View on PubMed)

Roytman MV, Lu L, Soyemi E, Leziak K, Niznik CM, Yee LM. Exploring Psychosocial Burdens of Diabetes in Pregnancy and the Feasibility of Technology-Based Support: Qualitative Study. JMIR Diabetes. 2025 Apr 21;10:e53854. doi: 10.2196/53854.

Reference Type: DERIVED

PMID: 40258264 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: Focus Group Usability Testing

View Document

Document Type: Informed Consent Form: Individual Usability Testing

View Document

Other Identifiers

1R21HD094271-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5R21HD094271-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU00205409

Identifier Type: -

Identifier Source: org_study_id