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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes Mellitus, Type 2; Gestational Diabetes Mellitus; Pre-diabetes
• Intervention / Treatment: Behavioral: Shared decision-making for diabetes prevention

Detailed 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 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.

• Study Type: Interventional
• Enrollment (Estimated): 310
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 54 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18 years to 54 (Adult)
• Females
• Most recent BMI ≥25 kg/m2 (or >23 if Asian American)
• History of gestational diabetes mellitus based on:
• Diagnostic code ICD10 or 1-hour glucose challenge test > 140 mg/dL, followed by 3-hour glucose tolerance test with TWO or more values. Cut-offs >= i. 95 at 0-hour ii. 180 at 1-hour iii. 155 at 2-hour iv. 140 at 3-hour

• History of prediabetes in prior 36 months defined by either

  1. most recent HbA1c 5.7-6.4% or
  2. most recent FPG 100-125 mg/dL or
  3. prior diabetes diagnostic codes + abnormal labs
• Patient at UCLA or Intermountain Healthcare Systems with provider visit or labs in prior 12 months

Exclusion Criteria:

• Delivery within the last 12 months at randomization
• History of diabetes (i.e., prior HbA1c 6.5% or above, or 2 or more fasting plasma glucose 125 or above, or prior diagnostic code)
• Any anti-glycemic medications or insulin use 12 months prior to randomization
• Most recent eGFR <45 ml/min
• BMI >60 kg/m2 at randomization
• History of any type of weight loss surgery 12 months prior to randomization
• Currently being treated for an eating disorder, such as anorexia or bulimia
• Currently pregnant or planning to get pregnant in the next 12 months
• Completed a prior prediabetes SDM consult anytime
• Currently enrolled OR have ever participated in any CDC certified Diabetes Prevention Program (DPP)
• Inability or concerns about doing >150 minutes of physical activity per week Currently taking a medication called metformin or have been prescribed metformin in the last 12-months
• History of metformin intolerance
• Unable to attend 3 virtual or in-person visits over the next 2 years at UCLA or Intermountain Healthcare
• Non-English primary language

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shared decision-making with pharmacists; Participants randomized to the intervention arm will have an in-person visit to complete the baseline survey, record the participant's weight and receive a pharmacist-coordinated shared decision making intervention. Intervention participants will have follow-up research assessments visits at 6, 12 and 24 months.	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.
No Intervention: Usual Care; Participants randomized to the usual care control arm will have an in-person visit with the research study team to complete the baseline survey and record the participant's weight. These participants will then return to usual care with research assessments at 6, 12 and 24 months follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight change	Proportion with >5% weight loss	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Change	Proportion with >5% weight loss	24 months
Uptake of DPP lifestyle program or metformin	1) Attending at least 9 of 16 of weekly lifestyle change sessions OR 2) Taking metformin (yes/no)	6 months
Health-related quality of life	Short-form (SF-36) measure	6, 12, and 24 months

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• 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

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2021
• Primary Completion (Actual): June 25, 2025
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: May 18, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (Actual): May 24, 2021

Study Record Updates

• Last Update Posted (Actual): July 17, 2025
• Last Update Submitted That Met QC Criteria: July 14, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Diabetes Prevention; Shared Decision Making
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Pregnancy Complications; Glucose Metabolism Disorders; Diabetes, Gestational; Diabetes Mellitus, Type 2; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: IRB#20-001558; R01DK127733 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No