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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21HD094271-01 | U.S. NIH Grant/Contract | View source | |
| 5R21HD094271-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Feasibility - Pilot Randomized Trial, usual care arm | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Number of Cesarean Deliveries |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lynn M Yee, MD, MPH | Assistant Professor, Maternal and Fetal Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34839467 | Background | 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. | |
| 33605158 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. 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. |
| FG002 | 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. 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The usability and feasibility phases did not occur at the same time so age was not analyzed together. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Focus group participants with confirmed diagnosis of Gestational Diabetes or Type 2 Diabetes. We recorded the identified themes and the number of participants who expressed each theme. | Posted | Count of Participants | Participants | 60-90 minutes |
|
from participant enrollment to after 8 weeks postpartum (approximately 18-38 weeks of enrollment)
Study specific adverse events definitions were created based on FDA criteria. All events were unrelated to the study. The usability phase and feasibility phases were conducted separately and adverse events were not monitored at all for the usability phase and not included in this section. Adverse events were assessed for only participants related to the prenatal and postpartum periods which include events related to the labor and delivery or the immediate postpartum hospitalization.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unanticipated hospital admission requiring medical or surgical intervention for life-threatening eve | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospital admission requiring medical intervention or observation for a diabetes-related indication | Endocrine disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lynn Yee, MD, MPH | Northwestern University | 312-472-4685 | lynn.yee@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 19, 2019 | Jul 22, 2022 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Focus Group Usability Testing | Jun 30, 2017 | Sep 26, 2022 | ICF_003.pdf |
| ICF | No | No | Yes | Informed Consent Form: Individual Usability Testing | Jun 30, 2017 | Sep 26, 2022 | ICF_004.pdf |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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Two phases of study:
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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. |
|
| 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. |
|
| 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. |
|
| 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 | 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) |
| 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)) |
| 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) |
| 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) |
| 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) |
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) |
| Clinical Outcomes of Pregnancy - Neonatal Birthweight | In feasibility testing participants, clinical outcomes include neonatal birthweight. | After delivery (approximately 10-30 weeks of enrollment) |
| 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) |
| 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) |
| 34511852 | 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. |
| 32627582 | 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. |
| 34423677 | 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. |
| 32425457 | 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. |
| 35389355 | 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. |
| 40258264 | Derived | 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. |
| BG001 | 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. 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. |
| BG002 | 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. 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Diabetes diagnosis | Count of Participants | Participants |
|
| Publicly funded insurance | Count of Participants | Participants |
|
| Body Mass Index (BMI) | For the usability phase qualitative (interviews) and quantitative (questionnaires and user interaction data) were collected. The focus group, individual usability testing, and feasibility pilot phase were analyzed separately. BMI was collected for the individual usability phase and the feasibility phase. BMI was not collected for the usability focus group. No demographics were collected to determine BMI. | BMI was collected for the individual usability phase and the feasibility phase. For the usability focus group, no participants were analyzed for BMI and no data was collected. | Mean | Standard Deviation | kg/m^2 |
|
|
|
| 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). | Participants assigned to use the SweetMama application or usual care. | Posted | Count of Participants | Participants | After 8 weeks postpartum (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. | Participants enrolled to engage with the SweetMama application in both Aim 1 and Aim 2. For usability testing, N= 23 because one participant never opened the application which removes the participant from the analysis population of this outcome. | Posted | Median | Inter-Quartile Range | minutes of SweetMama use | 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\ | In the individual usability phase, 22 participants completed the USE Questionnaire; 2 missing for non-user of application and loss to follow-up. In the feasibility phase, 28 participants completed the USE Questionnaire; 2 missing for loss to follow-up and did not deliver at site hospital. | Posted | Median | Inter-Quartile Range | score on a scale | 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. | In the individual usability phase, 22 participants completed the USE Questionnaire; 2 missing for non-user of application and loss to follow-up. In the feasibility phase, 28 participants completed the USE Questionnaire; 2 missing for loss to follow-up and did not deliver at site hospital. | Posted | Median | Inter-Quartile Range | score on a scale | 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 | In SweetMama arm, 28 completed the Diabetes self-efficacy measure at delivery; 2 missing for loss to follow-up and not delivered at site hospital. In the SweetMama arm, 27 completed Diabetes self-efficacy measure postpartum; 3 missing for not delivered at site hospital and 2 lost to follow-up. In the usual care arm, 9 completed Diabetes self-efficacy measure postpartum; 1 missing for pregnancy termination. | Posted | Median | Inter-Quartile Range | score on a scale | 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. | In SweetMama arm, 28 completed Patient Activation Measure at delivery; 2 missing for 1 lost to follow-up and 1 participant not delivered at site hospital. In the SweetMama arm, 27 completed Patient Activation Measure postpartum; 3 missing for 1 participant not delivered at site hospital and 2 lost to follow-up. In the usual care arm, 9 complete Patient Activation Measure postpartum; 1 missing for pregnancy termination. | Posted | Mean | Standard Deviation | score on a scale | 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 | For feasibility testing, N value differs because 1 participant was lost to follow-up in each arm. | Posted | Count of Participants | Participants | After 8 weeks postpartum (approximately 18-38 weeks of enrollment) |
|
|
|
| Other Pre-specified | Clinical Outcomes of Pregnancy - Percentage of Patients With Hypertensive Disorders of Pregnancy | In feasibility testing participants, clinical outcomes include hypertensive disorders of pregnancy. | Participants in the feasibility testing- SweetMama application users and usual care participants | Posted | Count of Participants | Participants | After delivery (approximately 10-30 weeks of enrollment) |
|
|
|
| Other Pre-specified | Number of Cesarean Deliveries | In feasibility testing, the mode of delivery was report as number of cesarean deliveries for SweetMama and usual care participants. | In the usual care arm, 1 missing for pregnancy termination. | Posted | Count of Participants | Participants | After delivery (approximately 10-30 weeks of enrollment) |
|
|
|
| Other Pre-specified | Clinical Outcomes of Pregnancy - Neonatal Birthweight | In feasibility testing participants, clinical outcomes include neonatal birthweight. | SweetMama application participants and usual care participants. N=31 in SweetMama arm due to one set of twins. N=9 in the usual care arm due to pregnancy termination. | Posted | Mean | Standard Deviation | grams | After delivery (approximately 10-30 weeks of enrollment) |
|
|
|
| Other Pre-specified | Clinical Outcomes of Pregnancy - Number of Babies With Neonatal Hypoglycemia | In feasibility testing participants, clinical outcomes include neonatal hypoglycemia, (<40 mg/dL). | N=9 in the usual care arm due to pregnancy termination. | Posted | Number | number of babies | After delivery (approximately 10-30 weeks of enrollment) |
|
|
|
| Other Pre-specified | 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. | SweetMama application participants and usual care participants. N=31 in SweetMama arm due to one set of twins. N=9 in the usual care arm due to pregnancy termination. | Posted | Number | number of babies | After delivery (approximately 10-30 weeks of enrollment) |
|
|
|
| 0 |
| 30 |
| 9 |
| 30 |
| 10 |
| 30 |
| EG001 | 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. | 0 | 10 | 2 | 10 | 4 | 10 |
|
| Unanticipated hospital admission requiring medical or surgical intervention for life-threatening eve | Hepatobiliary disorders | Non-systematic Assessment |
|
| Unanticipated hospital admission requiring medical or surgical intervention for life-threatening eve | Renal and urinary disorders | Non-systematic Assessment |
|
| Preterm birth <34 weeks of gestation | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Unanticipated hospital admission requiring medical or surgical intervention for life-threatening eve | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Unanticipated hospital admission requiring medical or surgical intervention for life-threatening eve | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Neonatal intensive care unit admission for pressor support, ventilator support, or anti-seizure medi | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment | Only participants of infants with neonatal intensive care unit admission for pressor support, ventilator support, or anti-seizure medicine are considered as having adverse events. NICU admissions for other reasons were not considered in this section |
|
| Maternal intensive care unit admission | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Preterm birth ≥34 weeks of gestation | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
Not provided
Not provided
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Type 2 diabetes |
|
| No |
|
| Used application at least once/week during pregnancy |
|
| Used application at least once/week during postpartum |
|
| Ease of Learning |
|
| Satisfaction |
|
| Diabetes self-efficacy Postpartum |
|
|
| Patient activation Postpartum |
|
|
| Hemoglobin A1c - Improved by >1% (lower) |
|