Trial Outcomes & Findings for SweetMama: Testing of a Novel Technology for Diabetes Education and Support to Pregnant Women (NCT NCT03240874)
NCT ID: NCT03240874
Last Updated: 2025-08-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
60-90 minutes
Results posted on
2025-08-05
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
24
|
30
|
10
|
|
Overall Study
COMPLETED
|
16
|
22
|
26
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
4
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
4
|
1
|
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Usability - Focus Group
n=16 Participants
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.
|
Usability - Individual Testing
n=24 Participants
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.
|
Feasibility - Pilot Randomized Trial, SweetMama Arm
n=30 Participants
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.
|
Feasibility - Pilot Randomized Trial, Usual Care Arm
n=10 Participants
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.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
33 Years
STANDARD_DEVIATION 6 • n=16 Participants
|
32.07 Years
STANDARD_DEVIATION 5.32 • n=24 Participants
|
31.35 Years
STANDARD_DEVIATION 4.73 • n=30 Participants
|
31.30 Years
STANDARD_DEVIATION 6.91 • n=10 Participants
|
31.89 Years
STANDARD_DEVIATION 5.52 • n=80 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=16 Participants
|
24 Participants
n=24 Participants
|
30 Participants
n=30 Participants
|
10 Participants
n=10 Participants
|
80 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=16 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=16 Participants
|
9 Participants
n=24 Participants
|
12 Participants
n=30 Participants
|
2 Participants
n=10 Participants
|
25 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=16 Participants
|
15 Participants
n=24 Participants
|
18 Participants
n=30 Participants
|
8 Participants
n=10 Participants
|
55 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=16 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=16 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=16 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=16 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=16 Participants
|
11 Participants
n=24 Participants
|
20 Participants
n=30 Participants
|
8 Participants
n=10 Participants
|
53 Participants
n=80 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=16 Participants
|
4 Participants
n=24 Participants
|
2 Participants
n=30 Participants
|
0 Participants
n=10 Participants
|
6 Participants
n=80 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=16 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=16 Participants
|
9 Participants
n=24 Participants
|
7 Participants
n=30 Participants
|
2 Participants
n=10 Participants
|
20 Participants
n=80 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=16 Participants
|
24 participants
n=24 Participants
|
30 participants
n=30 Participants
|
10 participants
n=10 Participants
|
80 participants
n=80 Participants
|
|
Diabetes diagnosis
Gestational diabetes
|
8 Participants
n=16 Participants
|
12 Participants
n=24 Participants
|
18 Participants
n=30 Participants
|
7 Participants
n=10 Participants
|
45 Participants
n=80 Participants
|
|
Diabetes diagnosis
Type 2 diabetes
|
8 Participants
n=16 Participants
|
12 Participants
n=24 Participants
|
12 Participants
n=30 Participants
|
3 Participants
n=10 Participants
|
35 Participants
n=80 Participants
|
|
Publicly funded insurance
Yes
|
16 Participants
n=16 Participants
|
15 Participants
n=24 Participants
|
25 Participants
n=30 Participants
|
8 Participants
n=10 Participants
|
64 Participants
n=80 Participants
|
|
Publicly funded insurance
No
|
0 Participants
n=16 Participants
|
9 Participants
n=24 Participants
|
5 Participants
n=30 Participants
|
2 Participants
n=10 Participants
|
16 Participants
n=80 Participants
|
|
Body Mass Index (BMI)
|
—
|
37.20 kg/m^2
STANDARD_DEVIATION 8.08 • n=24 Participants • 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.
|
42.94 kg/m^2
STANDARD_DEVIATION 12.40 • n=30 Participants • 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.
|
36.67 kg/m^2
STANDARD_DEVIATION 9.03 • n=10 Participants • 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.
|
39.81 kg/m^2
STANDARD_DEVIATION 10.86 • n=64 Participants • 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.
|
PRIMARY outcome
Timeframe: 60-90 minutesPopulation: 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.
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.
Outcome measures
| Measure |
Usability - Individual Testing
n=16 Participants
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.
|
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.
|
|---|---|---|
|
Number of Participants Identifying Themes on SweetMama Features
Visual features personalized
|
9 Participants
|
—
|
|
Number of Participants Identifying Themes on SweetMama Features
Aesthetic appeal
|
11 Participants
|
—
|
|
Number of Participants Identifying Themes on SweetMama Features
Content organization
|
11 Participants
|
—
|
|
Number of Participants Identifying Themes on SweetMama Features
Content is practical and helpful
|
2 Participants
|
—
|
|
Number of Participants Identifying Themes on SweetMama Features
Goal-setting activity
|
4 Participants
|
—
|
|
Number of Participants Identifying Themes on SweetMama Features
Option to "favorite"
|
3 Participants
|
—
|
|
Number of Participants Identifying Themes on SweetMama Features
Interactivity of messages
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: After 8 weeks postpartum (approximately 18-38 weeks of enrollment)Population: Participants assigned to use the SweetMama application or usual care.
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).
Outcome measures
| Measure |
Usability - Individual Testing
n=30 Participants
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.
|
Feasibility - Pilot Randomized Trial, Usual Care Arm
n=10 Participants
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.
|
|---|---|---|
|
Number of Participants Who Used the SweetMama Application
Retention
|
26 Participants
|
9 Participants
|
|
Number of Participants Who Used the SweetMama Application
Ever used application
|
30 Participants
|
0 Participants
|
|
Number of Participants Who Used the SweetMama Application
Used application at least once/week during pregnancy
|
30 Participants
|
0 Participants
|
|
Number of Participants Who Used the SweetMama Application
Used application at least once/week during postpartum
|
26 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Usability - Individual Testing
n=23 Participants
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.
|
Feasibility - Pilot Randomized Trial, Usual Care Arm
n=30 Participants
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.
|
|---|---|---|
|
Usage Time of SweetMama Application
|
20.5 minutes of SweetMama use
Interval 11.53 to 27.93
|
48.53 minutes of SweetMama use
Interval 23.53 to 69.9
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Usability - Individual Testing
n=22 Participants
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.
|
Feasibility - Pilot Randomized Trial, Usual Care Arm
n=28 Participants
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.
|
|---|---|---|
|
Usability Testing of SweetMama Application With the System Usability Scale Survey
|
75.00 score on a scale
Interval 60.0 to 87.5
|
85.00 score on a scale
Interval 70.0 to 88.75
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Usability - Individual Testing
n=22 Participants
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.
|
Feasibility - Pilot Randomized Trial, Usual Care Arm
n=28 Participants
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.
|
|---|---|---|
|
Usability Testing of SweetMama Application With the Useful, Satisfaction and Ease of Use Questionnaire
Usefulness
|
83.93 score on a scale
Interval 64.29 to 94.64
|
82.14 score on a scale
Interval 71.43 to 85.71
|
|
Usability Testing of SweetMama Application With the Useful, Satisfaction and Ease of Use Questionnaire
Ease of use
|
85.71 score on a scale
Interval 83.12 to 97.4
|
88.31 score on a scale
Interval 84.42 to 94.81
|
|
Usability Testing of SweetMama Application With the Useful, Satisfaction and Ease of Use Questionnaire
Ease of Learning
|
87.50 score on a scale
Interval 85.71 to 100.0
|
91.07 score on a scale
Interval 85.71 to 100.0
|
|
Usability Testing of SweetMama Application With the Useful, Satisfaction and Ease of Use Questionnaire
Satisfaction
|
85.71 score on a scale
Interval 69.39 to 100.0
|
82.65 score on a scale
Interval 73.47 to 93.88
|
SECONDARY outcome
Timeframe: 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.
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
Outcome measures
| Measure |
Usability - Individual Testing
n=28 Participants
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.
|
Feasibility - Pilot Randomized Trial, Usual Care Arm
n=10 Participants
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.
|
|---|---|---|
|
Diabetes Self-efficacy
Diabetes self-efficacy Delivery
|
4.44 score on a scale
Interval 4.13 to 4.88
|
3.88 score on a scale
Interval 3.75 to 4.63
|
|
Diabetes Self-efficacy
Diabetes self-efficacy Postpartum
|
4.50 score on a scale
Interval 4.13 to 4.88
|
4.50 score on a scale
Interval 4.13 to 4.75
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Usability - Individual Testing
n=28 Participants
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.
|
Feasibility - Pilot Randomized Trial, Usual Care Arm
n=10 Participants
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.
|
|---|---|---|
|
Patient Activation
Patient activation Delivery
|
84.95 score on a scale
Standard Deviation 11.44
|
88.31 score on a scale
Standard Deviation 8.24
|
|
Patient Activation
Patient activation Postpartum
|
88.55 score on a scale
Standard Deviation 8.76
|
93.85 score on a scale
Standard Deviation 4.87
|
SECONDARY outcome
Timeframe: 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.
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
Outcome measures
| Measure |
Usability - Individual Testing
n=29 Participants
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.
|
Feasibility - Pilot Randomized Trial, Usual Care Arm
n=9 Participants
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.
|
|---|---|---|
|
Difference in Hemoglobin A1c From Enrollment to Delivery
Hemoglobin A1c - No change
|
3 Participants
|
2 Participants
|
|
Difference in Hemoglobin A1c From Enrollment to Delivery
Hemoglobin A1c - Worsened by >1% (got higher)
|
10 Participants
|
1 Participants
|
|
Difference in Hemoglobin A1c From Enrollment to Delivery
Hemoglobin A1c - Improved by >1% (lower)
|
16 Participants
|
6 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: After delivery (approximately 10-30 weeks of enrollment)Population: Participants in the feasibility testing- SweetMama application users and usual care participants
In feasibility testing participants, clinical outcomes include hypertensive disorders of pregnancy.
Outcome measures
| Measure |
Usability - Individual Testing
n=30 Participants
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.
|
Feasibility - Pilot Randomized Trial, Usual Care Arm
n=10 Participants
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.
|
|---|---|---|
|
Clinical Outcomes of Pregnancy - Percentage of Patients With Hypertensive Disorders of Pregnancy
No
|
12 Participants
|
7 Participants
|
|
Clinical Outcomes of Pregnancy - Percentage of Patients With Hypertensive Disorders of Pregnancy
Yes
|
18 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: After delivery (approximately 10-30 weeks of enrollment)Population: In the usual care arm, 1 missing for pregnancy termination.
In feasibility testing, the mode of delivery was report as number of cesarean deliveries for SweetMama and usual care participants.
Outcome measures
| Measure |
Usability - Individual Testing
n=30 Participants
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.
|
Feasibility - Pilot Randomized Trial, Usual Care Arm
n=9 Participants
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.
|
|---|---|---|
|
Number of Cesarean Deliveries
|
16 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
In feasibility testing participants, clinical outcomes include neonatal birthweight.
Outcome measures
| Measure |
Usability - Individual Testing
n=31 Participants
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.
|
Feasibility - Pilot Randomized Trial, Usual Care Arm
n=9 Participants
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.
|
|---|---|---|
|
Clinical Outcomes of Pregnancy - Neonatal Birthweight
|
3089.13 grams
Standard Deviation 621.45
|
3042.33 grams
Standard Deviation 656.68
|
OTHER_PRE_SPECIFIED outcome
Timeframe: After delivery (approximately 10-30 weeks of enrollment)Population: N=9 in the usual care arm due to pregnancy termination.
In feasibility testing participants, clinical outcomes include neonatal hypoglycemia, (\<40 mg/dL).
Outcome measures
| Measure |
Usability - Individual Testing
n=30 Participants
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.
|
Feasibility - Pilot Randomized Trial, Usual Care Arm
n=9 Participants
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.
|
|---|---|---|
|
Clinical Outcomes of Pregnancy - Number of Babies With Neonatal Hypoglycemia
|
5 number of babies
|
1 number of babies
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
In feasibility testing participants, clinical outcomes include neonatal intensive care unit admission.
Outcome measures
| Measure |
Usability - Individual Testing
n=31 Participants
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.
|
Feasibility - Pilot Randomized Trial, Usual Care Arm
n=9 Participants
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.
|
|---|---|---|
|
Clinical Outcomes of Pregnancy - Number of Babies With Neonatal Intensive Care Unit Admission
|
13 number of babies
|
4 number of babies
|
Adverse Events
Feasibility - Pilot Randomized Trial, SweetMama Arm
Serious events: 9 serious events
Other events: 10 other events
Deaths: 0 deaths
Feasibility - Pilot Randomized Trial, Usual Care Arm
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Feasibility - Pilot Randomized Trial, SweetMama Arm
n=30 participants at risk
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.
|
Feasibility - Pilot Randomized Trial, Usual Care Arm
n=10 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Unanticipated hospital admission requiring medical or surgical intervention for life-threatening eve
|
3.3%
1/30 • Number of events 1 • 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.
|
0.00%
0/10 • 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.
|
|
Hepatobiliary disorders
Unanticipated hospital admission requiring medical or surgical intervention for life-threatening eve
|
3.3%
1/30 • Number of events 1 • 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.
|
0.00%
0/10 • 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.
|
|
Renal and urinary disorders
Unanticipated hospital admission requiring medical or surgical intervention for life-threatening eve
|
3.3%
1/30 • Number of events 1 • 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.
|
0.00%
0/10 • 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.
|
|
Pregnancy, puerperium and perinatal conditions
Preterm birth <34 weeks of gestation
|
6.7%
2/30 • Number of events 2 • 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.
|
10.0%
1/10 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Unanticipated hospital admission requiring medical or surgical intervention for life-threatening eve
|
6.7%
2/30 • Number of events 2 • 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.
|
0.00%
0/10 • 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.
|
|
Pregnancy, puerperium and perinatal conditions
Unanticipated hospital admission requiring medical or surgical intervention for life-threatening eve
|
6.7%
2/30 • Number of events 2 • 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.
|
10.0%
1/10 • Number of events 1 • 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.
|
|
Pregnancy, puerperium and perinatal conditions
Neonatal intensive care unit admission for pressor support, ventilator support, or anti-seizure medi
|
3.3%
1/30 • Number of events 1 • 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.
|
0.00%
0/10 • 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.
|
|
Pregnancy, puerperium and perinatal conditions
Maternal intensive care unit admission
|
3.3%
1/30 • Number of events 1 • 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.
|
0.00%
0/10 • 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.
|
Other adverse events
| Measure |
Feasibility - Pilot Randomized Trial, SweetMama Arm
n=30 participants at risk
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.
|
Feasibility - Pilot Randomized Trial, Usual Care Arm
n=10 participants at risk
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.
|
|---|---|---|
|
Endocrine disorders
Hospital admission requiring medical intervention or observation for a diabetes-related indication
|
13.3%
4/30 • Number of events 7 • 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.
|
30.0%
3/10 • Number of events 3 • 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.
|
|
Pregnancy, puerperium and perinatal conditions
Preterm birth ≥34 weeks of gestation
|
30.0%
9/30 • Number of events 9 • 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.
|
10.0%
1/10 • Number of events 1 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place