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

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ClinicalTrials.gov Identifier: NCT03240874
Recruitment Status : Recruiting
First Posted : August 7, 2017
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Lynn M Yee, Northwestern University

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus in Pregnancy Behavioral: SweetMama Focus Groups Behavioral: SweetMama Individual Testing Behavioral: SweetMama Feasibility Testing - Pilot Randomized Trial Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: SweetMama Usability and Feasibility: Testing of a Novel Technology for Diabetes Education and Support to Pregnant Women
Actual Study Start Date : August 2, 2017
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : July 1, 2020

Arm Intervention/treatment
Experimental: Usability - Focus Group

Mobile Application Usability Testing: SweetMama Focus Groups

Focus groups: Women with a confirmed intrauterine pregnancy or postpartum until 12 weeks after delivery with gestational diabetes mellitus or type 2 diabetes mellitus will be recruited to undergo a single 1-hour focus group.

Behavioral: 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.

Experimental: Usability - Individual Testing

Mobile Application Usability Testing: SweetMama Individual Testing

Individual testing: Women with a confirmed intrauterine pregnancy (any gestational age) or who are up to 4 weeks postpartum, with gestational diabetes mellitus or type 2 diabetes mellitus, will be recruited to use SweetMama for 2 weeks and provide feedback.

Behavioral: 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.

Experimental: Feasibility - Pilot Randomized Trial, SweetMama arm

Mobile Application Feasibility Testing: SweetMama Pilot Trial, SweetMama arm

Women recruited to the pilot RCT phase will enroll in the study upon initiation of prenatal care for diabetes, which could be early in pregnancy at the time of first prenatal visit, or at a later point if they have transferred care to this site. Women randomized to receive SweetMama care will be oriented to use of SweetMama and will then use the intervention (messages, library, goal setting, and appointment reminders) throughout pregnancy and the first 8 weeks postpartum, at which point they will undergo surveys and interviews.

Behavioral: 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.

No Intervention: Feasibility - Pilot Randomized Trial, usual care arm

Mobile Application Feasibility Testing: SweetMama Pilot Trial, usual care arm

Women recruited to the pilot RCT phase will enroll in the study upon initiation of prenatal care for diabetes, which could be early in pregnancy at the time of first prenatal visit, or at a later point if they have transferred care to this site. Women randomized to usual care will be undergo entry and exit surveys (at 6-8 weeks postpartum) but will not interact with SweetMama.




Primary Outcome Measures :
  1. Focus group feedback on SweetMama features [ Time Frame: Study enrollment ]
    Qualitative group interviews will yield information about SweetMama features and participant preferences after use in the usability laboratory

  2. Feasibility - pilot randomized trial [ 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 proportion with 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 Outcome Measures :
  1. Individual user feedback on SweetMama features [ Time Frame: After 2 weeks of enrollment (individual usability phase) and after 8 weeks postpartum (feasibility trial; approximately 18-38 weeks of enrollment) ]
    Qualitative individual interviews will yield information about SweetMama features and participant preferences after use in the field for either 2 weeks or the duration of pregnancy

  2. User interactivity data [ Time Frame: After 2 weeks of enrollment (individual usability phase) and after 8 weeks postpartum (feasibility trial; approximately 18-38 weeks of enrollment) ]
    Investigate user interaction with SweetMama

  3. Usability testing (SUS) [ 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

  4. Usability testing (USE) [ 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

  5. Diabetes self-efficacy [ Time Frame: After 8 weeks postpartum (approximately 18-38 weeks of enrollment) ]
    Diabetes self-efficacy will be 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

  6. Patient activation [ Time Frame: After 8 weeks postpartum (approximately 18-38 weeks of enrollment) ]
    Patient activation will be measured 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

  7. 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


Other Outcome Measures:
  1. Clinical outcomes of pregnancy - proportion 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. Clinical outcomes of pregnancy - mode of delivery [ Time Frame: After delivery (approximately 10-30 weeks of enrollment) ]
    In feasibility testing participants, clinical outcomes include delivery mode.

  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 - proportion of patients 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 - proportion of patients 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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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 smartphone ( for longitudinal testing phase)

Exclusion Criteria:

  • Failure to meet the inclusion criteria above
  • Non-viable pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03240874


Contacts
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Contact: Lynn M Yee, MD, MPH, (312) 472-4685 lynn.yee@northwestern.edu
Contact: Jenise Jackson, MPH jenise@northwestern.edu

Locations
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United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Lynn M Yee, MD, MPH    312-472-4685    lynn.yee@northwestern.edu   
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Lynn M Yee, MD, MPH Assistant Professor, Maternal and Fetal Medicine
  Study Documents (Full-Text)

Documents provided by Lynn M Yee, Northwestern University:

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Responsible Party: Lynn M Yee, Assistant Professor, Division of Maternal-Fetal Medicine Department of Obstetrics and Gynecology, Northwestern University
ClinicalTrials.gov Identifier: NCT03240874    
Other Study ID Numbers: STU00205409
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lynn M Yee, Northwestern University:
Gestational Diabetes
Diabetes Type 2 in Pregnancy
Additional relevant MeSH terms:
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Pregnancy in Diabetics
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications