Texting for Diabetes Success in Pregnancy

Gestational Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03240289
• Other study ID #: STU00084353
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: December 2016

Study information

• Verified date: October 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes
• Pregnancy in Diabetics

Intervention

Behavioral:
• Texting group
Women receive text messages to aid in their diabetes self-care tasks during pregnancy; these included appointment reminders, motivational messages, and nutrition/exercise tips.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Barriers and facilitators of diabetes self-management	Qualitative interview of patient experiences regarding having diabetes during pregnancy	Study enrollment
Secondary	Study feasibility (as measured by number of participants retained in the study)	Ability to recruit and retain participants	Up to 42 weeks
Secondary	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