Texting for Diabetes Success in Pregnancy

Study Overview
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Brief Summary
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Diabetes during pregnancy can be a challenging circumstance requiring extensive patient learning and self-care. The purpose of this study is to develop and pilot test a patient-centered diabetes education and self-care tool using text messaging to provide supportive messaging and education to underserved women with a pregnancy complicated by diabetes.

Detailed Description
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Low-income, pregnant women in the Chicago area are frequently affected by obesity or diabetes. The addition of a disease in pregnancy amplifies the requirements for optimal self-care during pregnancy. This load of information poses a significant burden, particularly for women with additional socioeconomic barriers to self-care. Preliminary work suggests patients must overcome a number of social, psychological, and knowledge-based barriers to achieve successful diabetic control in pregnancy. This project involves development and preliminary evaluation of a patient-centered education and self-care tool for use with women whose pregnancies are complicated by diabetes. The study begins with development of a text messaging curriculum to provide motivational and educational support. We will use a one-way, non-interactive text-based educational platform to provide supportive and educational messages to a cohort of 40 women with diabetes. Women receive 3-5 text messages per week until delivery. The goal is to develop a program that can be expanded to a clinical trial in which perinatal outcomes are assessed. The primary outcome is patient satisfaction and opinions about the texting program, as measured via a qualitative interview upon study completion. Participants underwent an enrollment survey to assess health literacy/numeracy, diabetes self-efficacy, diabetes knowledge, personality, and social hassles. They underwent a baseline in-depth one-on-one interview focusing on barriers to successful self-care with pregnancy and diabetes. Follow-up surveys and an exit interview elicited information about their opinions of the texting program. Additional goals included determining feasibility for future expansion as a trial.

Official Title
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Use of Text Messaging to Reduce Barriers to Self-care for Low-income Pregnant Women With Diabetes

Conditions
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Gestational Diabetes, Pregnancy in Diabetics

Intervention / Treatment
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* Behavioral: Texting group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant English-speaking Have gestational diabetes mellitus, type 2 diabetes mellitus, or type 1 diabetes mellitus Age 18 years or older Access to a phone that can receive text messages Exclusion Criteria: Gestational age greater than 30 weeks Women not meeting the above inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm feasibility and pilot testing study of a curriculum
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Texting<br>Texting group | Behavioral: Texting group<br>* Women receive text messages to aid in their diabetes self-care tasks during pregnancy; these included appointment reminders, motivational messages, and nutrition/exercise tips.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction and feedback | A single qualitative interview of patient perspectives and areas for improvement in the text messaging program. Interview takes place between 35 weeks gestation and discharge after delivery (postpartum day 2) | Up to 42 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes self-efficacy (Measured using the Diabetes Empowerment Scale-Short Form) | Assessment of diabetes self-efficacy. Survey takes place after 35 weeks gestation and before discharge after delivery (postpartum day 2) | Up to 42 weeks | 
| Barriers and facilitators of diabetes self-management | Qualitative interview of patient experiences regarding having diabetes during pregnancy | Study enrollment | 
| Study feasibility (as measured by number of participants retained in the study) | Ability to recruit and retain participants | Up to 42 weeks | 
| Diabetes self-efficacy (Measured using the Perceived Diabetes Self-Management Scale) | Assessment of diabetes self-efficacy. Survey takes place after 35 weeks gestation and before discharge after delivery (postpartum day 2) | Up to 42 weeks |