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

NCT03240874 | Completed Results

• 3 other identifiers: STU002054091R21HD094271-015R21HD094271-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus in Pregnancy

Keywords

Gestational Diabetes; Diabetes Type 2 in Pregnancy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Usage Time of SweetMama Application

  After 2 weeks of enrollment (individual usability phase) and after 8 weeks postpartum (feasibility trial; approximately 18-38 weeks of enrollment)

• Usability Testing of SweetMama Application With the System Usability Scale Survey

  After 2 weeks of enrollment (individual usability phase) and after 8 weeks postpartum (feasibility trial; approximately 18-38 weeks of enrollment)

• Usability Testing of SweetMama Application With the Useful, Satisfaction and Ease of Use Questionnaire

  After 2 weeks of enrollment (individual usability phase) and after 8 weeks postpartum (feasibility trial; approximately 18-38 weeks of enrollment))

• Diabetes Self-efficacy

  After 8 weeks postpartum (approximately 18-38 weeks of enrollment)

• Patient Activation

  After 8 weeks postpartum (approximately 18-38 weeks of enrollment)

Other Outcomes (5)

• Clinical Outcomes of Pregnancy - Percentage of Patients With Hypertensive Disorders of Pregnancy

  After delivery (approximately 10-30 weeks of enrollment)

• Number of Cesarean Deliveries

  After delivery (approximately 10-30 weeks of enrollment)

• Clinical Outcomes of Pregnancy - Neonatal Birthweight

  After delivery (approximately 10-30 weeks of enrollment)

Study Arms (4)

Usability - Focus Group

EXPERIMENTAL

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.

Behavioral: SweetMama Focus Groups

Usability - Individual Testing

EXPERIMENTAL

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.

Behavioral: SweetMama Individual Testing

Feasibility - Pilot Randomized Trial, SweetMama arm

EXPERIMENTAL

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.

Behavioral: SweetMama Feasibility Testing - Pilot Randomized Trial

Feasibility - Pilot Randomized Trial, usual care arm

NO INTERVENTION

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.

Interventions

SweetMama Focus Groups 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 - Focus Group

SweetMama Individual Testing 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.

Usability - Individual Testing

SweetMama Feasibility Testing - Pilot Randomized Trial 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, SweetMama arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• Non-viable pregnancy

Sponsors & Collaborators

• Northwestern University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (8)

• 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.

  PMID: 34839467 BACKGROUND

• 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.

  PMID: 33605158 RESULT

• 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.

  PMID: 34511852 RESULT

• 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.

  PMID: 32627582 RESULT

• 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.

  PMID: 34423677 RESULT

• 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.

  PMID: 32425457 RESULT

• 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.

  PMID: 35389355 RESULT

• 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.

  PMID: 40258264 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Lynn Yee, MD, MPH
• Organization: Northwestern University

lynn.yee@northwestern.edu

312-472-4685

Study Officials

• Lynn M Yee, MD, MPH

  Assistant Professor, Maternal and Fetal Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 7, 2017
• Study Start: August 2, 2017
• Primary Completion: April 9, 2021
• Study Completion: April 9, 2021
• Last Updated: August 5, 2025
• Results First Posted: March 15, 2023

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)