Diabetes Mellitus in Pregnancy
Conditions
Keywords
Gestational Diabetes, Diabetes Type 2 in Pregnancy
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.
Interventions
BEHAVIORALSweetMama 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.
BEHAVIORALSweetMama 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.
BEHAVIORALSweetMama 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.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Northwestern University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Identifying Themes on SweetMama Features | 60-90 minutes | 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. |
| Number of Participants Who Used the SweetMama Application | After 8 weeks postpartum (approximately 18-38 weeks of enrollment) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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) | 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. |
| 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)) | 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. |
| Diabetes Self-efficacy | After 8 weeks postpartum (approximately 18-38 weeks of enrollment) | 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 |
| Patient Activation | After 8 weeks postpartum (approximately 18-38 weeks of enrollment) | 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. |
| Difference in Hemoglobin A1c From Enrollment to Delivery | After 8 weeks postpartum (approximately 18-38 weeks of enrollment) | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinical Outcomes of Pregnancy - Number of Babies With Neonatal Hypoglycemia | After delivery (approximately 10-30 weeks of enrollment) | In feasibility testing participants, clinical outcomes include neonatal hypoglycemia, (\<40 mg/dL). |
| Clinical Outcomes of Pregnancy - Number of Babies With Neonatal Intensive Care Unit Admission | After delivery (approximately 10-30 weeks of enrollment) | In feasibility testing participants, clinical outcomes include neonatal intensive care unit admission. |
| Number of Cesarean Deliveries | After delivery (approximately 10-30 weeks of enrollment) | In feasibility testing, the mode of delivery was report as number of cesarean deliveries for SweetMama and usual care participants. |
| Clinical Outcomes of Pregnancy - Percentage of Patients With Hypertensive Disorders of Pregnancy | After delivery (approximately 10-30 weeks of enrollment) | In feasibility testing participants, clinical outcomes include hypertensive disorders of pregnancy. |
| Clinical Outcomes of Pregnancy - Neonatal Birthweight | After delivery (approximately 10-30 weeks of enrollment) | In feasibility testing participants, clinical outcomes include neonatal birthweight. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| 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. | 24 |
| 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. | 30 |
| 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. | 10 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 | 4 | 1 |
Baseline characteristics
| Characteristic | Total | Feasibility - Pilot Randomized Trial, Usual Care Arm | Feasibility - Pilot Randomized Trial, SweetMama Arm | Usability - Focus Group | Usability - Individual Testing |
|---|---|---|---|---|---|
| Age, Continuous | 31.89 Years STANDARD_DEVIATION 5.52 | 31.30 Years STANDARD_DEVIATION 6.91 | 31.35 Years STANDARD_DEVIATION 4.73 | 33 Years STANDARD_DEVIATION 6 | 32.07 Years STANDARD_DEVIATION 5.32 |
| Body Mass Index (BMI) | 39.81 kg/m^2 STANDARD_DEVIATION 10.86 | 36.67 kg/m^2 STANDARD_DEVIATION 9.03 | 42.94 kg/m^2 STANDARD_DEVIATION 12.4 | — | 37.20 kg/m^2 STANDARD_DEVIATION 8.08 |
| Diabetes diagnosis Gestational diabetes | 45 Participants | 7 Participants | 18 Participants | 8 Participants | 12 Participants |
| Diabetes diagnosis Type 2 diabetes | 35 Participants | 3 Participants | 12 Participants | 8 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 25 Participants | 2 Participants | 12 Participants | 2 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 55 Participants | 8 Participants | 18 Participants | 14 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Publicly funded insurance No | 16 Participants | 2 Participants | 5 Participants | 0 Participants | 9 Participants |
| Publicly funded insurance Yes | 64 Participants | 8 Participants | 25 Participants | 16 Participants | 15 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 53 Participants | 8 Participants | 20 Participants | 14 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 20 Participants | 2 Participants | 7 Participants | 2 Participants | 9 Participants |
| Race (NIH/OMB) White | 6 Participants | 0 Participants | 2 Participants | 0 Participants | 4 Participants |
| Region of Enrollment United States | 80 participants | 10 participants | 30 participants | 16 participants | 24 participants |
| Sex: Female, Male Female | 80 Participants | 10 Participants | 30 Participants | 16 Participants | 24 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 10 |
| other Total, other adverse events | 10 / 30 | 4 / 10 |
| serious Total, serious adverse events | 9 / 30 | 2 / 10 |
Outcome results
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.
Time frame: 60-90 minutes
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usability - Individual Testing | Number of Participants Identifying Themes on SweetMama Features | Visual features personalized | 9 Participants |
| Usability - Individual Testing | Number of Participants Identifying Themes on SweetMama Features | Aesthetic appeal | 11 Participants |
| Usability - Individual Testing | Number of Participants Identifying Themes on SweetMama Features | Content organization | 11 Participants |
| Usability - Individual Testing | Number of Participants Identifying Themes on SweetMama Features | Content is practical and helpful | 2 Participants |
| Usability - Individual Testing | Number of Participants Identifying Themes on SweetMama Features | Goal-setting activity | 4 Participants |
| Usability - Individual Testing | Number of Participants Identifying Themes on SweetMama Features | Option to favorite | 3 Participants |
| Usability - Individual Testing | Number of Participants Identifying Themes on SweetMama Features | Interactivity of messages | 1 Participants |
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).
Time frame: After 8 weeks postpartum (approximately 18-38 weeks of enrollment)
Population: Participants assigned to use the SweetMama application or usual care.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usability - Individual Testing | Number of Participants Who Used the SweetMama Application | Retention | 26 Participants |
| Usability - Individual Testing | Number of Participants Who Used the SweetMama Application | Ever used application | 30 Participants |
| Usability - Individual Testing | Number of Participants Who Used the SweetMama Application | Used application at least once/week during pregnancy | 30 Participants |
| Usability - Individual Testing | Number of Participants Who Used the SweetMama Application | Used application at least once/week during postpartum | 26 Participants |
| Feasibility - Pilot Randomized Trial, Usual Care Arm | Number of Participants Who Used the SweetMama Application | Used application at least once/week during postpartum | 0 Participants |
| Feasibility - Pilot Randomized Trial, Usual Care Arm | Number of Participants Who Used the SweetMama Application | Retention | 9 Participants |
| Feasibility - Pilot Randomized Trial, Usual Care Arm | Number of Participants Who Used the SweetMama Application | Used application at least once/week during pregnancy | 0 Participants |
| Feasibility - Pilot Randomized Trial, Usual Care Arm | Number of Participants Who Used the SweetMama Application | Ever used application | 0 Participants |
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
Time frame: After 8 weeks postpartum (approximately 18-38 weeks of enrollment)
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Usability - Individual Testing | Diabetes Self-efficacy | Diabetes self-efficacy Delivery | 4.44 score on a scale |
| Usability - Individual Testing | Diabetes Self-efficacy | Diabetes self-efficacy Postpartum | 4.50 score on a scale |
| Feasibility - Pilot Randomized Trial, Usual Care Arm | Diabetes Self-efficacy | Diabetes self-efficacy Delivery | 3.88 score on a scale |
| Feasibility - Pilot Randomized Trial, Usual Care Arm | Diabetes Self-efficacy | Diabetes self-efficacy Postpartum | 4.50 score on a scale |
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
Time frame: After 8 weeks postpartum (approximately 18-38 weeks of enrollment)
Population: For feasibility testing, N value differs because 1 participant was lost to follow-up in each arm.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usability - Individual Testing | Difference in Hemoglobin A1c From Enrollment to Delivery | Hemoglobin A1c - No change | 3 Participants |
| Usability - Individual Testing | Difference in Hemoglobin A1c From Enrollment to Delivery | Hemoglobin A1c - Worsened by >1% (got higher) | 10 Participants |
| Usability - Individual Testing | Difference in Hemoglobin A1c From Enrollment to Delivery | Hemoglobin A1c - Improved by >1% (lower) | 16 Participants |
| Feasibility - Pilot Randomized Trial, Usual Care Arm | Difference in Hemoglobin A1c From Enrollment to Delivery | Hemoglobin A1c - No change | 2 Participants |
| Feasibility - Pilot Randomized Trial, Usual Care Arm | Difference in Hemoglobin A1c From Enrollment to Delivery | Hemoglobin A1c - Worsened by >1% (got higher) | 1 Participants |
| Feasibility - Pilot Randomized Trial, Usual Care Arm | Difference in Hemoglobin A1c From Enrollment to Delivery | Hemoglobin A1c - Improved by >1% (lower) | 6 Participants |
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.
Time frame: After 8 weeks postpartum (approximately 18-38 weeks of enrollment)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usability - Individual Testing | Patient Activation | Patient activation Delivery | 84.95 score on a scale | Standard Deviation 11.44 |
| Usability - Individual Testing | Patient Activation | Patient activation Postpartum | 88.55 score on a scale | Standard Deviation 8.76 |
| Feasibility - Pilot Randomized Trial, Usual Care Arm | Patient Activation | Patient activation Delivery | 88.31 score on a scale | Standard Deviation 8.24 |
| Feasibility - Pilot Randomized Trial, Usual Care Arm | Patient Activation | Patient activation Postpartum | 93.85 score on a scale | Standard Deviation 4.87 |
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\<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.
Time frame: After 2 weeks of enrollment (individual usability phase) and after 8 weeks postpartum (feasibility trial; approximately 18-38 weeks of enrollment)
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Usability - Individual Testing | Usability Testing of SweetMama Application With the System Usability Scale Survey | 75.00 score on a scale |
| Feasibility - Pilot Randomized Trial, Usual Care Arm | Usability Testing of SweetMama Application With the System Usability Scale Survey | 85.00 score on a scale |
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.
Time frame: After 2 weeks of enrollment (individual usability phase) and after 8 weeks postpartum (feasibility trial; approximately 18-38 weeks of enrollment))
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Usability - Individual Testing | Usability Testing of SweetMama Application With the Useful, Satisfaction and Ease of Use Questionnaire | Usefulness | 83.93 score on a scale |
| Usability - Individual Testing | Usability Testing of SweetMama Application With the Useful, Satisfaction and Ease of Use Questionnaire | Ease of use | 85.71 score on a scale |
| Usability - Individual Testing | Usability Testing of SweetMama Application With the Useful, Satisfaction and Ease of Use Questionnaire | Ease of Learning | 87.50 score on a scale |
| Usability - Individual Testing | Usability Testing of SweetMama Application With the Useful, Satisfaction and Ease of Use Questionnaire | Satisfaction | 85.71 score on a scale |
| Feasibility - Pilot Randomized Trial, Usual Care Arm | Usability Testing of SweetMama Application With the Useful, Satisfaction and Ease of Use Questionnaire | Satisfaction | 82.65 score on a scale |
| Feasibility - Pilot Randomized Trial, Usual Care Arm | Usability Testing of SweetMama Application With the Useful, Satisfaction and Ease of Use Questionnaire | Usefulness | 82.14 score on a scale |
| Feasibility - Pilot Randomized Trial, Usual Care Arm | Usability Testing of SweetMama Application With the Useful, Satisfaction and Ease of Use Questionnaire | Ease of Learning | 91.07 score on a scale |
| Feasibility - Pilot Randomized Trial, Usual Care Arm | Usability Testing of SweetMama Application With the Useful, Satisfaction and Ease of Use Questionnaire | Ease of use | 88.31 score on a scale |
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.
Time frame: After 2 weeks of enrollment (individual usability phase) and after 8 weeks postpartum (feasibility trial; approximately 18-38 weeks of enrollment)
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Usability - Individual Testing | Usage Time of SweetMama Application | 20.5 minutes of SweetMama use |
| Feasibility - Pilot Randomized Trial, Usual Care Arm | Usage Time of SweetMama Application | 48.53 minutes of SweetMama use |
Other Pre-specified
Clinical Outcomes of Pregnancy - Neonatal Birthweight
In feasibility testing participants, clinical outcomes include neonatal birthweight.
Time frame: After delivery (approximately 10-30 weeks of enrollment)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usability - Individual Testing | Clinical Outcomes of Pregnancy - Neonatal Birthweight | 3089.13 grams | Standard Deviation 621.45 |
| Feasibility - Pilot Randomized Trial, Usual Care Arm | Clinical Outcomes of Pregnancy - Neonatal Birthweight | 3042.33 grams | Standard Deviation 656.68 |
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).
Time frame: After delivery (approximately 10-30 weeks of enrollment)
Population: N=9 in the usual care arm due to pregnancy termination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usability - Individual Testing | Clinical Outcomes of Pregnancy - Number of Babies With Neonatal Hypoglycemia | 5 number of babies |
| Feasibility - Pilot Randomized Trial, Usual Care Arm | Clinical Outcomes of Pregnancy - Number of Babies With Neonatal Hypoglycemia | 1 number of babies |
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.
Time frame: After delivery (approximately 10-30 weeks of enrollment)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usability - Individual Testing | Clinical Outcomes of Pregnancy - Number of Babies With Neonatal Intensive Care Unit Admission | 13 number of babies |
| Feasibility - Pilot Randomized Trial, Usual Care Arm | Clinical Outcomes of Pregnancy - Number of Babies With Neonatal Intensive Care Unit Admission | 4 number of babies |
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.
Time frame: After delivery (approximately 10-30 weeks of enrollment)
Population: Participants in the feasibility testing- SweetMama application users and usual care participants
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usability - Individual Testing | Clinical Outcomes of Pregnancy - Percentage of Patients With Hypertensive Disorders of Pregnancy | No | 12 Participants |
| Usability - Individual Testing | Clinical Outcomes of Pregnancy - Percentage of Patients With Hypertensive Disorders of Pregnancy | Yes | 18 Participants |
| Feasibility - Pilot Randomized Trial, Usual Care Arm | Clinical Outcomes of Pregnancy - Percentage of Patients With Hypertensive Disorders of Pregnancy | No | 7 Participants |
| Feasibility - Pilot Randomized Trial, Usual Care Arm | Clinical Outcomes of Pregnancy - Percentage of Patients With Hypertensive Disorders of Pregnancy | Yes | 3 Participants |
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.
Time frame: After delivery (approximately 10-30 weeks of enrollment)
Population: In the usual care arm, 1 missing for pregnancy termination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usability - Individual Testing | Number of Cesarean Deliveries | 16 Participants |
| Feasibility - Pilot Randomized Trial, Usual Care Arm | Number of Cesarean Deliveries | 4 Participants |