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A Shared Decision Making Intervention for Diabetes Prevention in Women With a History of Gestational Diabetes Mellitus

NCT04897945 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2025-07-17

No results posted yet for this study

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.

Conditions

  • Gestational Diabetes Mellitus
  • Pre-diabetes
  • Diabetes Mellitus, Type 2

Interventions

BEHAVIORAL

Shared decision-making for diabetes prevention

Pharmacists and/or nurses will engage patients with history of gestational diabetes mellitus using Healthwise (TM) Decision Tool to help match their personal preferences and values with treatment options, specifically lifestyle change will be referred to a CDC (Center for Disease Control and Prevention) recognized diabetes prevention program (DPP), and pharmacists will coordinate with primary care providers to prescribe metformin for patients interested in this treatment.

Sponsors & Collaborators

  • Intermountain Health Care, Inc.

    collaborator OTHER

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University of California, Los Angeles

    lead OTHER

Principal Investigators

  • Kenrik Duru, MD,MSHS · University of California, Los Angeles

  • Tannaz Moin, MD,MBA,MSHS · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
54 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-12
Primary Completion
2025-06-25
Completion
2026-10-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04897945 on ClinicalTrials.gov