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Diabetes Prevention Programming for Women With a History of Gestational Diabetes

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ClinicalTrials.gov Identifier: NCT03971838
Recruitment Status : Active, not recruiting
First Posted : June 3, 2019
Last Update Posted : August 25, 2021
Sponsor:
Information provided by (Responsible Party):
Tamara S. Hannon, 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: Positive Outcomes for Women Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : June 1, 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


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.





Primary Outcome Measures :
  1. Enrollment and participation rates in a diabetes prevention intervention [ Time Frame: 12 months ]
    Enrollment and participation rates in a diabetes prevention intervention


Secondary Outcome Measures :
  1. HbA1c [ Time Frame: 12 months ]
    HbA1c

  2. BMI [ Time Frame: 12 months ]
    Height and weight combined to report as BMI



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

·Currently pregnant


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03971838


Locations
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United States, Indiana
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
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Responsible Party: Tamara S. Hannon, Professor, Indiana University
ClinicalTrials.gov Identifier: NCT03971838    
Other Study ID Numbers: 1812789354
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: August 25, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications