Skip to main content
OpenTrials
Completed

NCT Number: NCT03240874

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus in Pregnancy Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SweetMama Focus Groups

Behavioral

Focus groups will assess tool functionality, design, interpretability, and acceptability (initial reaction, attitude, and receptiveness) of SweetMama via qualitative interviewing. The group format will generate feedback on areas that may not be revealed in a one-on-one interview.

SweetMama Individual Testing

Behavioral

Women will be oriented to SweetMama use on their own Android- or Apple-based phones. The goals of this phase are to collect data from diverse users that will (1) confirm that the mobile apps are functioning (not crashing) across a wide range of devices and operating systems, (2) provide basic information about app usage and user satisfaction (3) inform the development of future iterations by analyzing participant characteristics and use, and (4) collect quality assurance data that will allow the research team to refine the applications. Women will use SweetMama for 2 weeks, engage in periodic "check-ins" with the research assistant, and participate in a semi-structured interview upon completion of SweetMama usage.

SweetMama Feasibility Testing - Pilot Randomized Trial

Behavioral

Women will be oriented to SweetMama use on their own Android- or Apple-based phones. The goals of this phase are to collect data from diverse users that will determine acceptability, feasibility, and pilot procedures in anticipation of a fully powered randomized controlled trial. Women will use SweetMama from enrollment (early pregnancy) to up to 8 weeks postpartum, engage in periodic "check-ins" with the research assistant, and participate in surveys and a semi-structured interview upon completion of SweetMama usage.

Primary outcomes

  1. Number of Participants Identifying Themes on SweetMama Features

    Time frame: 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.

  2. Number of Participants Who Used the SweetMama Application

    Time frame: 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 outcomes

  1. Usage Time of SweetMama Application

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

    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.

  2. Usability Testing of SweetMama Application With the System Usability Scale Survey

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

    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.

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

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

    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.

  4. Diabetes Self-efficacy

    Time frame: 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

  5. Patient Activation

    Time frame: 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.

  6. Difference in Hemoglobin A1c From Enrollment to Delivery

    Time frame: 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 outcomes

  1. Clinical Outcomes of Pregnancy - Percentage of Patients With Hypertensive Disorders of Pregnancy

    Time frame: After delivery (approximately 10-30 weeks of enrollment)

    In feasibility testing participants, clinical outcomes include hypertensive disorders of pregnancy.

  2. Number of Cesarean Deliveries

    Time frame: 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.

  3. Clinical Outcomes of Pregnancy - Neonatal Birthweight

    Time frame: After delivery (approximately 10-30 weeks of enrollment)

    In feasibility testing participants, clinical outcomes include neonatal birthweight.

  4. Clinical Outcomes of Pregnancy - Number of Babies With Neonatal Hypoglycemia

    Time frame: After delivery (approximately 10-30 weeks of enrollment)

    In feasibility testing participants, clinical outcomes include neonatal hypoglycemia, (<40 mg/dL).

  5. Clinical Outcomes of Pregnancy - Number of Babies With Neonatal Intensive Care Unit Admission

    Time frame: After delivery (approximately 10-30 weeks of enrollment)

    In feasibility testing participants, clinical outcomes include neonatal intensive care unit admission.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Aug 7, 2017
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.