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
Santa Monica, California 90404
1984
mi
from 43215
Santa Monica, CA
Click here to add this to my saved trials
4323 West Riverside Drive
Burbank, California 91505
1975
mi
from 43215
Burbank, CA
Click here to add this to my saved trials
Los Angeles, California 90024
1982
mi
from 43215
Los Angeles, CA
Click here to add this to my saved trials
1972
mi
from 43215
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90024
1972
mi
from 43215
Los Angeles, CA
Click here to add this to my saved trials
1972
mi
from 43215
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90049
1972
mi
from 43215
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90066
1972
mi
from 43215
Los Angeles, CA
Click here to add this to my saved trials
851 Alma Real Drive
Pacific Palisades, California 90272
1987
mi
from 43215
Pacific Palisades, CA
Click here to add this to my saved trials
Santa Monica, California 90401
1986
mi
from 43215
Santa Monica, CA
Click here to add this to my saved trials
Santa Monica, California 90401
1986
mi
from 43215
Santa Monica, CA
Click here to add this to my saved trials
1986
mi
from 43215
Santa Monica, CA
Click here to add this to my saved trials
Santa Monica, California 90404
1984
mi
from 43215
Santa Monica, CA
Click here to add this to my saved trials
Santa Monica, California 90404
1985
mi
from 43215
Santa Monica, CA
Click here to add this to my saved trials
Santa Monica, California 90404
1984
mi
from 43215
Santa Monica, CA
Click here to add this to my saved trials
Santa Monica, California 90404
1984
mi
from 43215
Santa Monica, CA
Click here to add this to my saved trials
Santa Monica, California 90404
1984
mi
from 43215
Santa Monica, CA
Click here to add this to my saved trials
Santa Monica, California 90405
1986
mi
from 43215
Santa Monica, CA
Click here to add this to my saved trials
23388 Mulholland Drive
Woodland Hills, California 91364
1990
mi
from 43215
Woodland Hills, CA
Click here to add this to my saved trials
Woodland Hills, California 91367
1988
mi
from 43215
Woodland Hills, CA
Click here to add this to my saved trials