Diabetes Prevention Programming for Women With a History of Gestational Diabetes

Sponsor

Indiana University (Other)

Overall Status

Completed

CT.gov ID

NCT03971838

Collaborator

(none)

117

Enrollment

Location

Arm

Actual Duration (Months)

3.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Behavioral: Positive Outcomes for Women	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

117 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Diabetes Prevention Programming for Women With a History of Gestational Diabetes

Actual Study Start Date :

Jun 1, 2019

Actual Primary Completion Date :

Jun 30, 2022

Actual Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Arm Women with a history of gestational diabetes will be offered 4-6 months of a diabetes prevention program.	Behavioral: Positive Outcomes for Women 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.

Arm

Intervention/Treatment

Experimental: Intervention Arm

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

Behavioral: Positive Outcomes for Women

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.

Outcome Measures

Primary Outcome Measures

Enrollment and participation rates in a diabetes prevention intervention [12 months]
Enrollment and participation rates in a diabetes prevention intervention

Secondary Outcome Measures

HbA1c [12 months]
HbA1c
BMI [12 months]
Height and weight combined to report as BMI

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

History of gestational diabetes in a previous pregnancy
Age 18+

Exclusion Criteria:

·Currently pregnant

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Riley Hospital for Children	Indianapolis	Indiana	United States	46202

Sponsors and Collaborators

Indiana University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tamara S. Hannon, Professor, Indiana University

ClinicalTrials.gov Identifier:

NCT03971838

Other Study ID Numbers:

1812789354

First Posted:

Jun 3, 2019

Last Update Posted:

Aug 3, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes, Gestational

Diabetes Mellitus

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Aug 3, 2022