NCT03240289

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2013

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 7, 2017

Completed
Last Updated

November 2, 2023

Status Verified

October 1, 2023

Enrollment Period

2 years

First QC Date

July 14, 2017

Last Update Submit

October 31, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction and feedback

    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)

    Up to 42 weeks

Secondary Outcomes (4)

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

    Up to 42 weeks

  • Barriers and facilitators of diabetes self-management

    Study enrollment

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

    Up to 42 weeks

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

    Up to 42 weeks

Study Arms (1)

Texting

OTHER

Texting group

Behavioral: Texting group

Interventions

Texting groupBEHAVIORAL

Women receive text messages to aid in their diabetes self-care tasks during pregnancy; these included appointment reminders, motivational messages, and nutrition/exercise tips.

Texting

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Gestational age greater than 30 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes, GestationalPregnancy in Diabetics

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Melissa A Simon, MD, MPH

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Single arm feasibility and pilot testing study of a curriculum
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2017

First Posted

August 7, 2017

Study Start

December 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

November 2, 2023

Record last verified: 2023-10