Sugar Text: A Randomized Controlled Trial of a Text Message Intervention for Women With Diabetes in Pregnancy

NCT01973374 | Completed

• 1 other identifier: 817181
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Maternal diabetes in pregnancy can negatively impact fetal well-being and contribute to adverse pregnancy outcomes. Much of the morbidity associated with diabetes in pregnancy can be minimized with tight glucose control. A number of studies in non-pregnant populations have highlighted the feasibility, acceptability and efficacy of text messaging interventions for improving diabetic compliance and control. This study will investigate whether a text messaging intervention is feasible and effective in an urban, diabetic, obstetric clinic and whether this intervention can improve compliance with diabetes care, glucose control and pregnancy outcomes. The study will also assess satisfaction with the intervention itself.

Conditions

Diabetes in Pregnancy; Gestational Diabetes; Texting Interventions

Outcome Measures

Primary Outcomes (2)

• Patient Satisfaction

  Patient satisfaction with the texting intervention as measured by a post-study survey

  date of enrollment up to 12 weeks post partum

• Compliance with Obstetric and Diabetes Care

  Proportion of prenatal visits attended, proportion of assigned blood glucose logs sent to clinic for review, proportion of assigned blood glucose values checked, compliance with attendance at postpartum visit.

  OB screening visit through 12 weeks postpartum

Secondary Outcomes (4)

• Efficacy measures

  Diabetes diagnosis through 12 weeks postpartum

• Healthcare Utilization Measures

  Screening OB visit through 12 weeks postpartum

• Maternal Outcomes

  Delivery date through 12 weeks postpartum

• Neonatal Outcomes

  Neonate delivery through 12 weeks postpartum

Study Arms (2)

Routine Care

NO INTERVENTION

Text Message Intervention

EXPERIMENTAL

The text message intervention group receives usual prenatal and diabetic care in addition to two text messages per week throughout the pregnancy and a reminder text message prior to the postpartum visit. The text message intervention group also fills out a survey about the intervention after delivery.

Behavioral: Text Message Intervention

Interventions

Text Message Intervention BEHAVIORAL

Text Message Intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women aged 18-50 years
• Planned delivery at Hospital of the University of Pennsylvania

You may not qualify if:

• Gestational age greater than 34 weeks at initial visit in the Penn Perinatal Diabetes Program
• Women who are unable to read English as all text messages will be in English
• Women who do not have a cellular phone capable of receiving text messages as this is the study intervention

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Maternal Fetal Medicine, Department of Obstetrics and Gynecology Director, Penn Perinatal Diabetes Program Director, High Risk Clinic at the Helen O. Dickens Center for Women's Health

Study Record Dates

• First Submitted: October 24, 2013
• First Posted: October 31, 2013
• Study Start: January 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: February 20, 2015

Record last verified: 2015-02

Locations

US (1)