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

Not Applicable

Completed

• Conditions: Diabetes in Pregnancy; Gestational Diabetes; Texting Interventions
• Interventions: Behavioral: Text Message Intervention

• Registration Number: NCT01973374
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-10-24
• Study First Submitted QC: 2013-10-24
• Study First Posted: 2013-10-31
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-19
• Last Update Posted: 2015-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Text Message Intervention	Text Message Intervention	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.

Primary Outcome Measures

Name	Time	Method
Patient Satisfaction	date of enrollment up to 12 weeks post partum	Patient satisfaction with the texting intervention as measured by a post-study survey
Compliance with Obstetric and Diabetes Care	OB screening visit through 12 weeks postpartum	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.

Secondary Outcome Measures

Name	Time	Method
Efficacy measures	Diabetes diagnosis through 12 weeks postpartum	Measuring the proportion of blood glucose values within the target range each week; mean fasting and postprandial blood glucose values measured weekly; change in hemoglobin A1C (for pregestational diabetics) from initiation of care to the third trimester
Maternal Outcomes	Delivery date through 12 weeks postpartum	Measuring the mode of delivery (spontaneous vaginal, operative vaginal, cesarean section), complications of delivery (shoulder dystocia, postpartum hemorrhage, third and fourth degree lacerations), and length of hospital stay.
Healthcare Utilization Measures	Screening OB visit through 12 weeks postpartum	Measuring the number of visits to the perinatal evaluation center related to diabetes care and the total number of antepartum hospitalizations.
Neonatal Outcomes	Neonate delivery through 12 weeks postpartum	Measuring fetal demise; neonatal death; birthweight; large for gestational age; small for gestational age; APGAR scores; umbilical cord blood gas; NICU admission; respiratory distress; hypoglycemia; hyperbilirubinemia; length of hospital stay

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States