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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes in Pregnancy, Gestational Diabetes, Texting Interventions

Intervention / Treatment
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* Behavioral: Text Message Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women aged 18-50 years Planned delivery at Hospital of the University of Pennsylvania 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Routine Care<br> | |
| Experimental: Text Message Intervention<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy measures | 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 | Diabetes diagnosis through 12 weeks postpartum | 
| Healthcare Utilization Measures | Measuring the number of visits to the perinatal evaluation center related to diabetes care and the total number of antepartum hospitalizations. | Screening OB visit through 12 weeks postpartum | 
| Maternal Outcomes | 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. | Delivery date through 12 weeks postpartum | 
| Neonatal Outcomes | 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 | Neonate delivery through 12 weeks postpartum |