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)

Ruth Madievsky; Amanda Vu; Felicia Cheng; Janet Chon; Norman Turk; Ashley Krueger; Jacob Krong; Richard Maranon; Sandra Liu; Christina S Han; Keith C Norris; Carol Mangione; Jessica Page; Samuel Thomas; O Kenrik Duru; Tannaz Moin

doi:10.1016/j.cct.2022.107007

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.

Authors

Ruth Madievsky¹, Amanda Vu², Felicia Cheng³, Janet Chon⁴, Norman Turk⁵, Ashley Krueger⁶, Jacob Krong⁷, Richard Maranon⁸, Sandra Liu⁹, Christina S Han¹⁰, Keith C Norris¹¹, Carol Mangione¹², Jessica Page¹³, Samuel Thomas¹⁴, O Kenrik Duru¹⁵, Tannaz Moin¹⁶

Affiliations

¹ Department of Medicine, Division of General Internal Medicine-Health Services Research, University of California, 1100 Glendon Ave STE 850, Los Angeles, CA 90024, USA. Electronic address: [email protected].
² Department of Medicine, Division of General Internal Medicine-Health Services Research, University of California, 1100 Glendon Ave STE 850, Los Angeles, CA 90024, USA. Electronic address: [email protected].
³ Department of Medicine, Division of General Internal Medicine-Health Services Research, University of California, 1100 Glendon Ave STE 850, Los Angeles, CA 90024, USA. Electronic address: [email protected].
⁴ Department of Medicine, Division of General Internal Medicine-Health Services Research, University of California, 1100 Glendon Ave STE 850, Los Angeles, CA 90024, USA. Electronic address: [email protected].
⁵ Department of Medicine, Division of General Internal Medicine-Health Services Research, University of California, 1100 Glendon Ave STE 850, Los Angeles, CA 90024, USA. Electronic address: [email protected].
⁶ Healthcare Delivery Institute, Office of Research, Intermountain Healthcare, 5026 S. State St, Murray, UT 84107, USA. Electronic address: [email protected].
⁷ Healthcare Delivery Institute, Office of Research, Intermountain Healthcare, 5026 S. State St, Murray, UT 84107, USA. Electronic address: [email protected].
⁸ Department of Medicine, Division of General Internal Medicine-Health Services Research, University of California, 1100 Glendon Ave STE 850, Los Angeles, CA 90024, USA. Electronic address: [email protected].
⁹ Department of Medicine, Division of General Internal Medicine-Health Services Research, University of California, 1100 Glendon Ave STE 850, Los Angeles, CA 90024, USA. Electronic address: [email protected].
¹⁰ Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of California, 200 Medical Plaza, Suite 430, Los Angeles, CA 90095, USA. Electronic address: [email protected].
¹¹ Department of Medicine, Division of General Internal Medicine-Health Services Research, University of California, David Geffen School of Medicine at UCLA, 1100 Glendon Ave STE 850, Los Angeles, CA 90024, USA. Electronic address: [email protected].
¹² Department of Medicine, Division of General Internal Medicine-Health Services Research, University of California, David Geffen School of Medicine at UCLA, 1100 Glendon Ave STE 850, Los Angeles, CA 90024, USA; Jonathan and Karin Fielding School of Public Health, University of California, Los Angeles, CA, USA. Electronic address: [email protected].
¹³ Department of Maternal-Fetal Medicine, Intermountain Healthcare. Department of Maternal-Fetal Medicine, University of Utah Health, 8th Ave & C St E, Salt Lake City, UT 84143, USA. Electronic address: [email protected].
¹⁴ Department of Internal Medicine, Intermountain Healthcare, 5121 Cottonwood St, Murray, UT 84017, USA. Electronic address: [email protected].
¹⁵ Department of Medicine, Division of General Internal Medicine-Health Services Research, University of California, David Geffen School of Medicine at UCLA, 1100 Glendon Ave STE 850, Los Angeles, CA 90024, USA. Electronic address: [email protected].
¹⁶ Department of Medicine, Division of General Internal Medicine-Health Services Research, University of California, 1100 Glendon Ave STE 850, Los Angeles, CA 90024, USA; HSR&D Center for the Study of Healthcare Innovation, Implementation & Policy, VA Greater Los Angeles Healthcare System, Los Angeles, CA 90073, USA; Department of Medicine, Division of Endocrinology, Diabetes & Metabolism, UCLA, Los Angeles, CA 90024, USA. Electronic address: [email protected].

Abstract

Background: Gestational diabetes mellitus (GDM) is a risk factor for the development of type 2 diabetes. Metformin and lifestyle change through a Diabetes Prevention Program (DPP) are equally effective in preventing diabetes in patients with a GDM history, so women can choose a strategy based on their preferences. This study aims to test whether shared decision making (SDM) can help women with a history of GDM increase adoption of evidence-based strategies and lose weight to lower their risk of incident diabetes in real-world settings.

Methods: This pragmatic randomized controlled trial (RCT) will test the effectiveness of SDM for diabetes prevention among 310 overweight/obese women with a history of GDM and prediabetes from two large health care systems (n = 155 from UCLA Health and n = 155 from Intermountain Healthcare). The primary outcome is the proportion of participants who lose ≥5% body weight at 12 months. Secondary outcomes include uptake of DPP and/or metformin and other patient-reported outcomes such as patient activation and health-related quality of life. Rates of GDM in a subsequent pregnancy will be an exploratory outcome. A descriptive analysis of costs related to SDM implementation will also be conducted.

Conclusion: This is the first RCT to examine the effectiveness of SDM on weight loss, lifestyle change and/or metformin use, and other patient-reported outcomes in participants with a GDM history at risk of developing diabetes.

Trial registration: ClinicalTrials.gov, NCT03766256. Registered on 6 December 2018.

Keywords: Decision aid; Gestational diabetes; Prediabetes; Shared decision making; Type 2 diabetes.

Publication types

Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

Decision Making, Shared
Diabetes Mellitus, Type 2* / complications
Diabetes Mellitus, Type 2* / prevention & control
Diabetes, Gestational* / prevention & control
Female
Humans
Metformin* / therapeutic use
Obesity / complications
Pregnancy

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)

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Abstract

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