A Shared Decision Making Intervention for Diabetes Prevention in Women With a History of Gestational Diabetes Mellitus
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Diabetes Mellitus - Type 2
- Gestational Diabetes Mellitus
- Pre Diabetes
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Single Group AssignmentMasking: Double (Investigator, Outcomes Assessor)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 54 years
- Gender
- Only males
Description
Women with a history of gestational diabetes mellitus (GDM) are at high risk of developing type 2 diabetes (T2DM) but evidence from the Diabetes Prevention Program (DPP) indicates that lifestyle change and metformin use in this population are clinically equivalent, each reducing the incidence of T2D...
Women with a history of gestational diabetes mellitus (GDM) are at high risk of developing type 2 diabetes (T2DM) but evidence from the Diabetes Prevention Program (DPP) indicates that lifestyle change and metformin use in this population are clinically equivalent, each reducing the incidence of T2DM by approximately 50%. Shared decision making (SDM) is an attractive approach in this situation where several options are available. We can use a decision aid to make the decision explicit, describe the available options with equipoise, elicit patient preferences, and help patients make an informed decision that is right for them. To our knowledge, there are no existing studies evaluating SDM for diabetes prevention among women with a history of GDM. Therefore, we aim to test the effectiveness of an RCT evaluating SDM for diabetes prevention on weight loss among overweight/obese women with a history of GDM and hemoglobin A1c between 5.7-6.4%, as well as uptake of lifestyle change and/or metformin use and other patient-reported outcomes (e.g., physical activity, eating patterns, patient activation, health-related quality of life). We will recruit 310 patients from two large health care systems (n=155 from UCLA Health and n=155 from Intermountain Healthcare) who will be randomized to either usual care or in-person shared decision making for diabetes prevention.
Tracking Information
- NCT #
- NCT04897945
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Intermountain Health Care, Inc.
- Investigators
- Principal Investigator: Kenrik Duru, MD,MSHS University of California, Los Angeles Principal Investigator: Tannaz Moin, MD,MBA,MSHS University of California, Los Angeles