Texting for Diabetes Success in Pregnancy

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

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.

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes; Pregnancy in Diabetics
• Intervention / Treatment: Behavioral: Texting group

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 Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Texting; Texting group	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Melissa A Simon, MD, MPH, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: July 14, 2017
• First Submitted That Met QC Criteria: August 1, 2017
• First Posted (Actual): August 7, 2017

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Diabetes, Gestational; Pregnancy in Diabetics
• Other Study ID Numbers: STU00084353

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No