Clinical trial NCT03766256: 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
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2018-12-06
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Choice of evidence-based diabetes prevention (lifestyle change or metformin)
timeFrame: 2 weeks
Secondary outcomes:
measure: Weight change
timeFrame: 9 months
measure: Systolic blood pressure
timeFrame: 9 months
measure: Decisional conflict
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Burbank
country: United States
facility: Toluca Lake Health Center
state: California
city: Los Angeles
country: United States
facility: 100 Medical Plaza Primary Care Suites 455 & 490
state: California
city: Los Angeles
country: United States
facility: Internal Medicine Women's Health Clinic Suites 250 & 290
state: California
city: Los Angeles
country: United States
facility: UCLA Internal Medicine Family Westwood Suite 465
state: California
city: Los Angeles
country: United States
facility: UCLA Internal Medicine Geriatrics Suite 365 & 420
state: California
city: Los Angeles
country: United States
facility: CPN Brentwood
state: California
city: Los Angeles
country: United States
facility: CPN West Washington Internal Medicine
state: California
city: Pacific Palisades
country: United States
facility: Pacific Palisades
state: California
city: Santa Monica
country: United States
facility: 12th Street Clinic
state: California
city: Santa Monica
country: United States
facility: Wilshire Office
state: California
city: Santa Monica
country: United States
facility: CPN Santa Monica 15th Street Family Medicine Practice
state: California
city: Santa Monica
country: United States
facility: CPN/Santa Monica Parkside
state: California
city: Santa Monica
country: United States
facility: Santa Moica Bay Physicians/20th Street 10th Floor
state: California
city: Santa Monica
country: United States
facility: Santa Monica Bay Physicians Plaza
state: California
city: Santa Monica
country: United States
facility: Santa Monica Bay Physicians/20th Street 3rd Floor
state: California
city: Santa Monica
country: United States
facility: Santa Monica Internal Medicine
state: California
city: Santa Monica
country: United States
facility: UCLA Family Health Clinic
state: California
city: Santa Monica
country: United States
facility: Santa Moica Bay Physicians Ocean Park
state: California
city: Woodland Hills
country: United States
facility: Jack H. Skirball Health Center
state: California
city: Woodland Hills
country: United States
facility: CPN Woodland Hills Practice
state: California
Study officials:
References:
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.