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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04897945
• Other study ID #: IRB#20-001558
• Secondary ID: R01DK127733
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2021
• Est. completion date: October 1, 2026

Study information

• Verified date: October 2023
• Source: University of California, Los Angeles
• Contact: Richard Maranon
• Phone: 310-206-4177
• Email: rmaranon[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 310
• Est. completion date: October 1, 2026
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 54 Years

Eligibility

Inclusion Criteria:

• BMI 25 kg/m2 or above (23 or above if Asian American woman)

• History of gestational diabetes mellitus

• 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 prior 12 months

• 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)

• Use of an anti-glycemic medication in prior 12 months

• Last available glomerular filtration rate (eGFR) <45 ml/min

• BMI >60 kg/m2

• Bariatric surgery with prior 12 months

• Active eating disorder

• Currently pregnant or planning to get pregnant in the next 12-24 months

• Completed a prediabetes SDM consult in past

• Currently enrolled in a CDC recognized Diabetes Prevention Program (DPP)

• Inability or concerns about doing >150 minutes of physical activity per week

• History of metformin intolerance

• Non-English primary language

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California
United States	Intermountain Healthcare System	Salt Lake City	Utah

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Los Angeles	Intermountain Health Care, Inc., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight change	Proportion with >5% weight loss	12 months
Secondary	Weight Change	Proportion with >5% weight loss	24 months
Secondary	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
Secondary	Health-related quality of life	Short-form (SF-36) measure	6, 12, and 24 months