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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach

1 country

20 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

10 months study duration

First Submitted

Initial submission to the registry

November 5, 2018

Completed

1 month until next milestone

First Posted

Study publicly available on registry

December 6, 2018

Completed

3 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2019

Completed

Last Updated

February 21, 2020

Status Verified

February 1, 2020

Enrollment Period

10 months

First QC Date

November 5, 2018

Last Update Submit

February 19, 2020

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

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.
2 weeks

Secondary Outcomes (3)

Weight change
9 months
Systolic blood pressure
9 months
Decisional conflict
2 weeks

Study Arms (1)

Shared decision-making with pharmacists

EXPERIMENTAL

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

Interventions

Shared decision-making with pharmacistsBEHAVIORAL

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.

Shared decision-making with pharmacists

Eligibility Criteria

Age18 Years - 64 Years

Sexfemale(Gender-based eligibility)

Gender Eligibility DetailsFemale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

University of California, Los Angeleslead

Study Sites (20)

Toluca Lake Health Center

Burbank, California, 91505, United States

Location

100 Medical Plaza Primary Care Suites 455 & 490

Los Angeles, California, 90024, United States

Location

Internal Medicine Women's Health Clinic Suites 250 & 290

Los Angeles, California, 90024, United States

Location

UCLA Internal Medicine Family Westwood Suite 465

Los Angeles, California, 90024, United States

Location

UCLA Internal Medicine Geriatrics Suite 365 & 420

Los Angeles, California, 90024, United States

Location

CPN Brentwood

Los Angeles, California, 90049, United States

Location

CPN West Washington Internal Medicine

Los Angeles, California, 90066, United States

Location

Pacific Palisades

Pacific Palisades, California, 90272, United States

Location

12th Street Clinic

Santa Monica, California, 90401, United States

Location

Wilshire Office

Santa Monica, California, 90401, United States

Location

CPN Santa Monica 15th Street Family Medicine Practice