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Completed

NCT Number: NCT03240289

Texting for Diabetes Success in Pregnancy

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.

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Key information

Conditions

Gestational Diabetes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Pregnancy in Diabetics Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Texting group

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.

Primary outcomes

  1. Patient satisfaction and feedback

    Time frame: 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 outcomes

  1. Diabetes self-efficacy (Measured using the Diabetes Empowerment Scale-Short Form)

    Time frame: Up to 42 weeks

    Assessment of diabetes self-efficacy. Survey takes place after 35 weeks gestation and before discharge after delivery (postpartum day 2)

  2. Barriers and facilitators of diabetes self-management

    Time frame: Study enrollment

    Qualitative interview of patient experiences regarding having diabetes during pregnancy

  3. Study feasibility (as measured by number of participants retained in the study)

    Time frame: Up to 42 weeks

    Ability to recruit and retain participants

  4. Diabetes self-efficacy (Measured using the Perceived Diabetes Self-Management Scale)

    Time frame: Up to 42 weeks

    Assessment of diabetes self-efficacy. Survey takes place after 35 weeks gestation and before discharge after delivery (postpartum day 2)

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Aug 7, 2017
Registry last updated
Nov 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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