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Completed

NCT Number: NCT03766256

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

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Key information

Age range

18 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Toluca Lake Health Center, Burbank, California, United States

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shared decision-making with pharmacists

Behavioral

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 outcomes

  1. Choice of evidence-based diabetes prevention (lifestyle change or metformin)

    Time frame: 2 weeks

    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 outcomes

  1. Weight change

    Time frame: 9 months

    Change of weight as measured in the EHR

  2. Systolic blood pressure

    Time frame: 9 months

    Change in systolic blood pressure as measured in the EHR

  3. Decisional conflict

    Time frame: 2 weeks

    Three collaboRATE items that measure decisional conflict

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 6, 2018
Registry last updated
Feb 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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