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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK127733 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Intermountain Health Care, Inc. | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight change | Proportion with >5% weight loss | 12 months |
| 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) |
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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
Patient at UCLA or Intermountain Healthcare Systems with provider visit or labs in prior 12 months
Exclusion Criteria:
Female
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| Name | Affiliation | Role |
|---|---|---|
| Kenrik Duru, MD,MSHS | University of California, Los Angeles | Principal Investigator |
| Tannaz Moin, MD,MBA,MSHS | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90024 | United States | ||
| Intermountain Healthcare System |
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|
| 6 months |
| Health-related quality of life | Short-form (SF-36) measure | 6, 12, and 24 months |
| Salt Lake City |
| Utah |
| 84103 |
| United States |
| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D018149 | Glucose Intolerance |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006943 | Hyperglycemia |
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