Diabetes Prevention Programming for Women With a History of Gestational Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Behavioral: Positive Outcomes for Women

• Registration Number: NCT03971838
• Lead Sponsor: Indiana University

Brief Summary

The purpose of this study is to offer women with a history of gestational diabetes access to diabetes prevention programming; their children 10 and older can participate.

Detailed Description

The purpose of this study is to offer women with a history of gestational diabetes access to diabetes prevention programming; their children 10 and older can participate. There are two potential types of participants:

1. Women and their children 10+ can consent to participate in the diabetes prevention programming offered through Dr. Hannon's center (called Encourage). Researchers will collect data at three time points, baseline, 4-6 months, and 12 months.

2. Instead of participating in Encourage, women may participate in other diabetes prevention programming/weight management programming offered by other entities. Researchers will consent these women into the study to complete 3 data collection points, baseline, 4-6 months, and 12 months. Additionally, researchers will consent women to obtain data from their chosen program. For instance, if a woman chooses to do a Diabetes Prevention Program through the YMCA, researchers will ask women to self report their weekly attendance and weight.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-05-24
• Study First Submitted QC: 2019-05-30
• Study Start: 2019-06-01
• Study First Posted: 2019-06-03
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 117

Inclusion Criteria

• History of gestational diabetes in a previous pregnancy
• Age 18+

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Exclusion Criteria

·Currently pregnant

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Positive Outcomes for Women	Women with a history of gestational diabetes will be offered 4-6 months of a diabetes prevention program.

Primary Outcome Measures

Name	Time	Method
Enrollment and participation rates in a diabetes prevention intervention	12 months	Enrollment and participation rates in a diabetes prevention intervention

Secondary Outcome Measures

Name	Time	Method
HbA1c	12 months	HbA1c
BMI	12 months	Height and weight combined to report as BMI

Trial Locations

Locations (1)

Riley Hospital for Children; 🇺🇸 Indianapolis, Indiana, United States