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Completed

NCT Number: NCT03971838

Diabetes Prevention Programming for Women With a History of Gestational Diabetes

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

·Currently pregnant

Treatment and study plan

Positive Outcomes for Women

Behavioral

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.

  • 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 outcomes

  1. Enrollment and participation rates in a diabetes prevention intervention

    Time frame: 12 months

    Enrollment and participation rates in a diabetes prevention intervention

Secondary outcomes

  1. HbA1c

    Time frame: 12 months

    HbA1c

  2. BMI

    Time frame: 12 months

    Height and weight combined to report as BMI

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jun 3, 2019
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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