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Diabetes Prevention Programming for Women With a History of Gestational Diabetes

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Positive Outcomes for Women

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

History of gestational diabetes in a previous pregnancy
Age 18+

Exclusion Criteria:

·Currently pregnant

Sites / Locations

Riley Hospital for Children

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Arm

Arm Description

Women with a history of gestational diabetes will be offered 4-6 months of a diabetes prevention program.

Outcomes

Primary Outcome Measures

Enrollment and participation rates in a diabetes prevention intervention

Secondary Outcome Measures

HbA1c

BMI

Height and weight combined to report as BMI

Full Information

NCT ID

NCT03971838

First Posted

May 24, 2019

Last Updated

August 2, 2022

Sponsor

Indiana University

1. Study Identification

Unique Protocol Identification Number

NCT03971838

Brief Title

Diabetes Prevention Programming for Women With a History of Gestational Diabetes

Official Title

Diabetes Prevention Programming for Women With a History of Gestational Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

June 1, 2019 (Actual)

Primary Completion Date

June 30, 2022 (Actual)

Study Completion Date

June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indiana University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

117 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention Arm

Arm Type

Experimental

Arm Description

Women with a history of gestational diabetes will be offered 4-6 months of a diabetes prevention program.

Intervention Type

Behavioral

Intervention Name(s)

Positive Outcomes for Women

Intervention Description

Women and their children 10+ can consent to participate in the diabetes prevention programming offered through the research center. We 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.

Primary Outcome Measure Information:

Title

Enrollment and participation rates in a diabetes prevention intervention

Description

Enrollment and participation rates in a diabetes prevention intervention

Time Frame

12 months

Secondary Outcome Measure Information:

Title

HbA1c

Description

HbA1c

Time Frame

12 months

Title

BMI

Description

Height and weight combined to report as BMI

Time Frame

12 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: History of gestational diabetes in a previous pregnancy Age 18+ Exclusion Criteria: ·Currently pregnant

Facility Information:

Facility Name

Riley Hospital for Children

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

Undecided

Learn more about this trial

Diabetes Prevention Programming for Women With a History of Gestational Diabetes

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