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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

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

Intervention / Treatment
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* Behavioral: Shared decision-making for diabetes prevention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 54 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shared decision-making with pharmacists<br>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<br>* 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.<br>|
| No Intervention: Usual Care<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Prevention, Shared Decision Making