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

NCT04897945 | Active Not Recruiting DMC

• 2 other identifiers: IRB#20-001558R01DK127733
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Diabetes Prevention; Shared Decision Making

Outcome Measures

Primary Outcomes (1)

• Weight change

  Proportion with \>5% weight loss

  12 months

Secondary Outcomes (3)

• Weight Change

  24 months

• Uptake of DPP lifestyle program or metformin

  6 months

• Health-related quality of life

  6, 12, and 24 months

Study Arms (2)

Shared decision-making with pharmacists

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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.

Interventions

Shared decision-making for diabetes prevention BEHAVIORAL

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.

Shared decision-making with pharmacists

Eligibility Criteria

• Age: 18 Years - 54 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Intermountain Health Care, Inc.: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

University of California, Los Angeles

Los Angeles, California, 90024, United States

Location

Intermountain Healthcare System

Salt Lake City, Utah, 84103, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational; Glucose Intolerance; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia

Study Officials

• Kenrik Duru, MD,MSHS

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Tannaz Moin, MD,MBA,MSHS

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Of Medicine

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 24, 2021
• Study Start: October 12, 2021
• Primary Completion: June 25, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)