Summary

Eligibility
for females ages 18-54 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCLA
Dates
study started
study ends around
Principal Investigator
by Kenrik Duru, MD,MSHS (ucla)Tannaz Moin, MD,MBA,MSHS (ucla)
Headshot of Tannaz Moin
Tannaz Moin

Description

Summary

Our goal is to test whether shared decision making for diabetes prevention can help women with a history of gestational diabetes mellitus (GDM) who are at high risk of developing type 2 diabetes (T2DM) increase weight loss and adoption of evidence based strategies to lower their risk of incident diabetes.

Details

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. There are no existing studies evaluating SDM for diabetes prevention among women with a history of GDM. Therefore, this study aims 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). The study 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.

Keywords

Gestational Diabetes Mellitus, Pre-diabetes, Diabetes Mellitus, Type 2, Diabetes Prevention, Shared Decision Making, Gestational Diabetes, Diabetes Mellitus, Type 2 Diabetes Mellitus, Prediabetic State, Shared decision-making for diabetes prevention

Eligibility

Locations

  • University of California, Los Angeles
    Los Angeles California 90024 United States
  • Intermountain Healthcare System
    Salt Lake City Utah 84103 United States

Lead Scientists at University of California Health

  • Kenrik Duru, MD,MSHS (ucla)
  • Tannaz Moin, MD,MBA,MSHS (ucla)
    Dr. Moin is an Associate Professor of Medicine in the Divisions of Endocrinology, Diabetes & Metabolism and GIM/HSR at the David Geffen School of Medicine at UCLA. She is also a Core Investigator at the HSR&D Center for the Study of Healthcare Innovation, Implementation & Policy (CSHIIP) and Founding Director of the CSP Network of Dedicated Enrollment Sites (NODES) at the VA Greater Los Angeles.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT04897945
Study Type
Interventional
Participants
Expecting 310 study participants
Last Updated