- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03240874
SweetMama: Testing of a Novel Technology for Diabetes Education and Support to Pregnant Women
SweetMama Usability and Feasibility: Testing of a Novel Technology for Diabetes Education and Support to Pregnant Women
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern Memorial Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
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.
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Experimental: 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. |
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.
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Experimental: 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. |
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.
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No Intervention: 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Identifying Themes on SweetMama Features
Time Frame: 60-90 minutes
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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.
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60-90 minutes
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Number of Participants Who Used the SweetMama Application
Time Frame: After 8 weeks postpartum (approximately 18-38 weeks of enrollment)
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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).
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After 8 weeks postpartum (approximately 18-38 weeks of enrollment)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Individual User Feedback on SweetMama Features
Time Frame: After 2 weeks of enrollment (individual usability phase) and after 8 weeks postpartum (feasibility trial; approximately 18-38 weeks of enrollment)
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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.
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After 2 weeks of enrollment (individual usability phase) and after 8 weeks postpartum (feasibility trial; approximately 18-38 weeks of enrollment)
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Usage Time of SweetMama Application
Time Frame: After 2 weeks of enrollment (individual usability phase) and after 8 weeks postpartum (feasibility trial; approximately 18-38 weeks of enrollment)
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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.
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After 2 weeks of enrollment (individual usability phase) and after 8 weeks postpartum (feasibility trial; approximately 18-38 weeks of enrollment)
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Usability Testing of SweetMama Application With the System Usability Scale Survey
Time Frame: After 2 weeks of enrollment (individual usability phase) and after 8 weeks postpartum (feasibility trial; approximately 18-38 weeks of enrollment)
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Usability of SweetMama will be assessed using the System Usability Scale min 0 max 100 1=Acceptable(>70) 2=Marginal(50<SUS<=70) 3=Not Acceptable(<=50) Usability testing of the SweetMama application with System Usability Scale 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)
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Usability Testing of SweetMama Application With the Useful, Satisfaction and Ease of Use Questionnaire
Time Frame: After 2 weeks of enrollment (individual usability phase) and after 8 weeks postpartum (feasibility trial; approximately 18-38 weeks of enrollment))
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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))
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Diabetes Self-efficacy
Time Frame: After 8 weeks postpartum (approximately 18-38 weeks of enrollment)
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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
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After 8 weeks postpartum (approximately 18-38 weeks of enrollment)
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Patient Activation
Time Frame: After 8 weeks postpartum (approximately 18-38 weeks of enrollment)
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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.
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After 8 weeks postpartum (approximately 18-38 weeks of enrollment)
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Difference in Hemoglobin A1c From Enrollment to Delivery
Time Frame: After 8 weeks postpartum (approximately 18-38 weeks of enrollment)
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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
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After 8 weeks postpartum (approximately 18-38 weeks of enrollment)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Outcomes of Pregnancy - Percentage of Patients With Hypertensive Disorders of Pregnancy
Time Frame: After delivery (approximately 10-30 weeks of enrollment)
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In feasibility testing participants, clinical outcomes include hypertensive disorders of pregnancy.
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After delivery (approximately 10-30 weeks of enrollment)
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Number of Cesarean Deliveries
Time Frame: After delivery (approximately 10-30 weeks of enrollment)
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In feasibility testing, the mode of delivery was report as number of cesarean deliveries for SweetMama and usual care participants.
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After delivery (approximately 10-30 weeks of enrollment)
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Clinical Outcomes of Pregnancy - Neonatal Birthweight
Time Frame: After delivery (approximately 10-30 weeks of enrollment)
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In feasibility testing participants, clinical outcomes include neonatal birthweight.
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After delivery (approximately 10-30 weeks of enrollment)
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Clinical Outcomes of Pregnancy - Number of Babies With Neonatal Hypoglycemia
Time Frame: After delivery (approximately 10-30 weeks of enrollment)
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In feasibility testing participants, clinical outcomes include neonatal hypoglycemia, (<40 mg/dL).
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After delivery (approximately 10-30 weeks of enrollment)
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Clinical Outcomes of Pregnancy - Number of Babies With Neonatal Intensive Care Unit Admission
Time Frame: After delivery (approximately 10-30 weeks of enrollment)
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In feasibility testing participants, clinical outcomes include neonatal intensive care unit admission.
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After delivery (approximately 10-30 weeks of enrollment)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lynn M Yee, MD, MPH, Assistant Professor, Maternal and Fetal Medicine
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU00205409
- 1R21HD094271-01 (U.S. NIH Grant/Contract)
- 5R21HD094271-02 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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