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



Status:Not yet recruiting
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 64
Updated:12/8/2018
Start Date:March 1, 2019
End Date:December 31, 2019
Contact:William Lee
Email:wlee@mednet.ucla.edu
Phone:310-794-2298

Use our guide to learn which trials are right for you!

Pilot Study of Pharmacist-Coordinated Implementation of the Diabetes Prevention Program (DPP) for Women With a History of Gestational Diabetes Mellitus (GDM)

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.

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

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.
We found this trial at
20
sites
851 Alma Real Drive
Pacific Palisades, California 90272
?
mi
from
Pacific Palisades, CA
Click here to add this to my saved trials
4323 West Riverside Drive
Burbank, California 91505
?
mi
from
Burbank, CA
Click here to add this to my saved trials
Los Angeles, California 90024
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90024
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90049
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90066
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Santa Monica, California 90401
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
Santa Monica, California 90401
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
Santa Monica, California 90404
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
Santa Monica, California 90404
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
Santa Monica, California 90404
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
Santa Monica, California 90404
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
Santa Monica, California 90404
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
Santa Monica, California 90404
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
Santa Monica, California 90405
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
23388 Mulholland Drive
Woodland Hills, California 91364
?
mi
from
Woodland Hills, CA
Click here to add this to my saved trials
Woodland Hills, California 91367
?
mi
from
Woodland Hills, CA
Click here to add this to my saved trials