Texting for Diabetes Success in Pregnancy

Not Applicable

Completed

• Conditions: Pregnancy in Diabetics; Gestational Diabetes
• Interventions: Behavioral: Texting group

• Registration Number: NCT03240289
• Lead Sponsor: Northwestern University

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-12
• Primary Completion: 2015-12
• Study Completion: 2016-12
• Study First Submitted: 2017-07-14
• Study First Submitted QC: 2017-08-01
• Study First Posted: 2017-08-07
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 33

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

Read More

Exclusion Criteria

• Gestational age greater than 30 weeks
• Women not meeting the above inclusion criteria

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Texting	Texting group	Texting group

Primary Outcome Measures

Name	Time	Method
Patient satisfaction and feedback	Up to 42 weeks	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)

Secondary Outcome Measures

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