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Shared Decision Making in Diabetes Prevention for Women With a History of GDM

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ClinicalTrials.gov Identifier: NCT03766256
Recruitment Status : Not yet recruiting
First Posted : December 6, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Kenrik Duru, University of California, Los Angeles

Brief Summary:
Gestational diabetes mellitus (GDM) is a risk factor for the development of Type 2 diabetes. Lifestyle change and metformin are equally effective in preventing diabetes in patients with a history of GDM, so these women should choose a strategy based on their preferences and values, which may vary by race/ethnicity. This proposal will engage 32 women in shared decision making about diabetes prevention.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Behavioral: Shared decision-making with pharmacists Not Applicable

Detailed Description:

The Diabetes Prevention Program (DPP) demonstrated that intensive lifestyle change and metformin both prevent or delay Type 2 diabetes (T2DM), but uptake of either approach has been minimal. The research team is implementing a shared decision-making (SDM) intervention for diabetes prevention funded by the National Institute of Diabetes and Digestive and Kidney Disease (NIDDK; R18 DK105464). In this clinic-based pragmatic trial, the Prediabetes Informed Decisions and Education (PRIDE) study, pharmacists engage patients with prediabetes in evidence-based diabetes prevention using an SDM framework. The research team reached the recruitment goal (n=350) more than 15 months ahead of schedule and enrolled 1.5 times the number of projected participants (n=515), including 56% from racial/ethnic minority groups. PRIDE has been highly successful in treatment engagement, as 85% of participants chose either lifestyle change or metformin. Furthermore, among patients who have reached 12-month follow-up, PRIDE participants as a group have lost more weight than matched controls (-5.2 lbs. vs. -0.29 lbs., p<0.001).

PRIDE targets both men and women with prediabetes. Only five PRIDE participants had a history of gestational diabetes mellitus (GDM) during a prior pregnancy. GDM is more common among minority women and a history of a GDM diagnosis is one of the most significant risk factors for incident type 2 diabetes, increasing the risk of developing T2DM upwards of sevenfold. The research team is planning to pilot an SDM intervention for women with a history of GDM. This project would advance a patient-centered approach to increase uptake of both evidence-based diabetes prevention strategies among the subgroup of minority women at the highest risk of progression to T2DM.

In the proposed project, the research team plans to enroll women with a history of GDM in a pilot study, tracking their choice of diabetes prevention strategy and their weight change over time. Importantly, the pilot will enable the research team to estimate the sample size for a future, multi-center study to engage women with a history of GDM in SDM for diabetes prevention. The project's specific aim is as follows:

In a pilot study, to deliver the tailored intervention to a diverse sample of 32 women with a history of GDM and hemoglobin A1c from 5.7-6.4% who have not yet developed Type 2 diabetes, with a sample divided equally between whites, African Americans, Latinas and Asian Americans


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pilot Study of Pharmacist-Coordinated Implementation of the Diabetes Prevention Program (DPP) for Women With a History of Gestational Diabetes Mellitus (GDM)
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Shared decision-making with pharmacists
Pharmacist-coordinated shared decision making about treatment for history of gestational diabetes mellitus (lifestyle change and/or metformin), using a decision tool
Behavioral: Shared decision-making with pharmacists
Pharmacist will engage patient 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) approved diabetes prevention program, and pharmacists will coordinate with primary care providers to prescribe metformin for patients interested in this treatment.




Primary Outcome Measures :
  1. Choice of evidence-based diabetes prevention (lifestyle change or metformin) [ Time Frame: 2 weeks ]
    One of four participant decisions: 1) choosing to attend a Centers for Disease Control and Prevention (CDC)-certified diabetes prevention program, 2) choosing to start metformin as diabetes prevention, 3) choosing both the diabetes prevention program and metformin, 4) choosing NOT to start either the diabetes prevention program or start metformin.


Secondary Outcome Measures :
  1. Weight change [ Time Frame: 9 months ]
    Change of weight as measured in the EHR

  2. Systolic blood pressure [ Time Frame: 9 months ]
    Change in systolic blood pressure as measured in the EHR

  3. Decisional conflict [ Time Frame: 2 weeks ]
    Three collaboRATE items that measure decisional conflict



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Overweight or obese (BMI >25 or >23 if Asian American), at least 6 weeks post-partum, and have a history of gestational diabetes mellitus

Exclusion Criteria:

  • Currently pregnant, not a UCLA Health patient, any history of a Type 2 diabetes diagnosis, based on billing codes, laboratory values, or taking any antiglycemic medications.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03766256


Contacts
Contact: William Lee 310-794-2298 wlee@mednet.ucla.edu
Contact: Arturo Gongora 310-794-3217 agongora@mednet.ucla.edu

Locations
United States, California
Toluca Lake Health Center
Burbank, California, United States, 91505
100 Medical Plaza Primary Care Suites 455 & 490
Los Angeles, California, United States, 90024
Internal Medicine Women's Health Clinic Suites 250 & 290
Los Angeles, California, United States, 90024
UCLA Internal Medicine Family Westwood Suite 465
Los Angeles, California, United States, 90024
UCLA Internal Medicine Geriatrics Suite 365 & 420
Los Angeles, California, United States, 90024
CPN Brentwood
Los Angeles, California, United States, 90049
CPN West Washington Internal Medicine
Los Angeles, California, United States, 90066
Pacific Palisades
Pacific Palisades, California, United States, 90272
12th Street Clinic
Santa Monica, California, United States, 90401
Wilshire Office
Santa Monica, California, United States, 90401
CPN Santa Monica 15th Street Family Medicine Practice
Santa Monica, California, United States, 90404
CPN/Santa Monica Parkside
Santa Monica, California, United States, 90404
Santa Moica Bay Physicians/20th Street 10th Floor
Santa Monica, California, United States, 90404
Santa Monica Bay Physicians Plaza
Santa Monica, California, United States, 90404
Santa Monica Bay Physicians/20th Street 3rd Floor
Santa Monica, California, United States, 90404
Santa Monica Internal Medicine
Santa Monica, California, United States, 90404
UCLA Family Health Clinic
Santa Monica, California, United States, 90404
Santa Moica Bay Physicians Ocean Park
Santa Monica, California, United States, 90405
Jack H. Skirball Health Center
Woodland Hills, California, United States, 91364
CPN Woodland Hills Practice
Woodland Hills, California, United States, 91367
Sponsors and Collaborators
University of California, Los Angeles

Responsible Party: Kenrik Duru, Professor of Medicine, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03766256     History of Changes
Other Study ID Numbers: IRB#18-001058
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications