Texting for Diabetes Success in Pregnancy

NCT ID: NCT03240289

Last Updated: 2023-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2016-12-31

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.

Conditions

Gestational Diabetes; Pregnancy in Diabetics

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Texting

Texting group

Group Type: OTHER

Texting group

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melissa A Simon, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Other Identifiers

STU00084353

Identifier Type: -

Identifier Source: org_study_id