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

Primary Purpose

Diabetes in Pregnancy, Gestational Diabetes, Texting Interventions

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text Message Intervention
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes in Pregnancy

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital of the University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Routine Care

Text Message Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Healthcare Utilization Measures
Measuring the number of visits to the perinatal evaluation center related to diabetes care and the total number of antepartum hospitalizations.
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.
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

Full Information

First Posted
October 24, 2013
Last Updated
February 19, 2015
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT01973374
Brief Title
Sugar Text: A Randomized Controlled Trial of a Text Message Intervention for Women With Diabetes in Pregnancy
Acronym
Sugar Text
Official Title
Sugar Text: A Randomized Controlled Trial of a Text Message Intervention for Women With Diabetes in Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes in Pregnancy, Gestational Diabetes, Texting Interventions

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Routine Care
Arm Type
No Intervention
Arm Title
Text Message Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Text Message Intervention
Primary Outcome Measure Information:
Title
Patient Satisfaction
Description
Patient satisfaction with the texting intervention as measured by a post-study survey
Time Frame
date of enrollment up to 12 weeks post partum
Title
Compliance with Obstetric and Diabetes Care
Description
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.
Time Frame
OB screening visit through 12 weeks postpartum
Secondary Outcome Measure Information:
Title
Efficacy measures
Description
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
Time Frame
Diabetes diagnosis through 12 weeks postpartum
Title
Healthcare Utilization Measures
Description
Measuring the number of visits to the perinatal evaluation center related to diabetes care and the total number of antepartum hospitalizations.
Time Frame
Screening OB visit through 12 weeks postpartum
Title
Maternal Outcomes
Description
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.
Time Frame
Delivery date through 12 weeks postpartum
Title
Neonatal Outcomes
Description
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
Time Frame
Neonate delivery through 12 weeks postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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