Shared Decision Making in Diabetes Prevention for Women With a History of GDM
Primary Purpose
Gestational Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Shared decision-making with pharmacists
Sponsored by
About this trial
This is an interventional prevention trial for Gestational Diabetes
Eligibility Criteria
Inclusion Criteria:
- Overweight or obese (BMI >25 or >23 if Asian American)
- at least 6 weeks post-partum
- 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
Sites / Locations
- Toluca Lake Health Center
- 100 Medical Plaza Primary Care Suites 455 & 490
- Internal Medicine Women's Health Clinic Suites 250 & 290
- UCLA Internal Medicine Family Westwood Suite 465
- UCLA Internal Medicine Geriatrics Suite 365 & 420
- CPN Brentwood
- CPN West Washington Internal Medicine
- Pacific Palisades
- 12th Street Clinic
- Wilshire Office
- CPN Santa Monica 15th Street Family Medicine Practice
- CPN/Santa Monica Parkside
- Santa Moica Bay Physicians/20th Street 10th Floor
- Santa Monica Bay Physicians Plaza
- Santa Monica Bay Physicians/20th Street 3rd Floor
- Santa Monica Internal Medicine
- UCLA Family Health Clinic
- Santa Moica Bay Physicians Ocean Park
- Jack H. Skirball Health Center
- CPN Woodland Hills Practice
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Shared decision-making with pharmacists
Arm Description
Pharmacist-coordinated shared decision making about treatment for history of gestational diabetes mellitus (lifestyle change and/or metformin), using a decision tool
Outcomes
Primary Outcome Measures
Choice of evidence-based diabetes prevention (lifestyle change or metformin)
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
Weight change
Change of weight as measured in the EHR
Systolic blood pressure
Change in systolic blood pressure as measured in the EHR
Decisional conflict
Three collaboRATE items that measure decisional conflict
Full Information
NCT ID
NCT03766256
First Posted
November 5, 2018
Last Updated
February 19, 2020
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT03766256
Brief Title
Shared Decision Making in Diabetes Prevention for Women With a History of GDM
Official Title
Pilot Study of Pharmacist-Coordinated Implementation of the Diabetes Prevention Program (DPP) for Women With a History of Gestational Diabetes Mellitus (GDM)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
December 28, 2019 (Actual)
Study Completion Date
December 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Shared decision-making with pharmacists
Arm Type
Experimental
Arm Description
Pharmacist-coordinated shared decision making about treatment for history of gestational diabetes mellitus (lifestyle change and/or metformin), using a decision tool
Intervention Type
Behavioral
Intervention Name(s)
Shared decision-making with pharmacists
Intervention Description
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 Measure Information:
Title
Choice of evidence-based diabetes prevention (lifestyle change or metformin)
Description
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.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Weight change
Description
Change of weight as measured in the EHR
Time Frame
9 months
Title
Systolic blood pressure
Description
Change in systolic blood pressure as measured in the EHR
Time Frame
9 months
Title
Decisional conflict
Description
Three collaboRATE items that measure decisional conflict
Time Frame
2 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Overweight or obese (BMI >25 or >23 if Asian American)
at least 6 weeks post-partum
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
Facility Information:
Facility Name
Toluca Lake Health Center
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
100 Medical Plaza Primary Care Suites 455 & 490
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Internal Medicine Women's Health Clinic Suites 250 & 290
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
UCLA Internal Medicine Family Westwood Suite 465
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
UCLA Internal Medicine Geriatrics Suite 365 & 420
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
CPN Brentwood
City
Los Angeles
State/Province
California
ZIP/Postal Code
90049
Country
United States
Facility Name
CPN West Washington Internal Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90066
Country
United States
Facility Name
Pacific Palisades
City
Pacific Palisades
State/Province
California
ZIP/Postal Code
90272
Country
United States
Facility Name
12th Street Clinic
City
Santa Monica
State/Province
California
ZIP/Postal Code
90401
Country
United States
Facility Name
Wilshire Office
City
Santa Monica
State/Province
California
ZIP/Postal Code
90401
Country
United States
Facility Name
CPN Santa Monica 15th Street Family Medicine Practice
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
CPN/Santa Monica Parkside
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Santa Moica Bay Physicians/20th Street 10th Floor
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Santa Monica Bay Physicians Plaza
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Santa Monica Bay Physicians/20th Street 3rd Floor
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Santa Monica Internal Medicine
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
UCLA Family Health Clinic
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Santa Moica Bay Physicians Ocean Park
City
Santa Monica
State/Province
California
ZIP/Postal Code
90405
Country
United States
Facility Name
Jack H. Skirball Health Center
City
Woodland Hills
State/Province
California
ZIP/Postal Code
91364
Country
United States
Facility Name
CPN Woodland Hills Practice
City
Woodland Hills
State/Province
California
ZIP/Postal Code
91367
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
36384219
Citation
Madievsky R, Vu A, Cheng F, Chon J, Turk N, Krueger A, Krong J, Maranon R, Liu S, Han CS, Norris KC, Mangione C, Page J, Thomas S, Duru OK, Moin T. A randomized controlled trial of a shared decision making intervention for diabetes prevention for women with a history of gestational diabetes mellitus: The Gestational diabetes Risk Attenuation for New Diabetes (GRAND study). Contemp Clin Trials. 2023 Jan;124:107007. doi: 10.1016/j.cct.2022.107007. Epub 2022 Nov 13.
Results Reference
derived
Learn more about this trial
Shared Decision Making in Diabetes Prevention for Women With a History of GDM
We'll reach out to this number within 24 hrs