Randomized Controlled Trial

. 2023 Jan:124:107007.

doi: 10.1016/j.cct.2022.107007. Epub 2022 Nov 13.

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 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: RMadievsky@mednet.ucla.edu.
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: AVVu@mednet.ucla.edu.
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: FICheng@mednet.ucla.edu.
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: JSChon@mednet.ucla.edu.
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: NTurk@mednet.ucla.edu.
⁶ Healthcare Delivery Institute, Office of Research, Intermountain Healthcare, 5026 S. State St, Murray, UT 84107, USA. Electronic address: Ashley.Krueger@imail.org.
⁷ Healthcare Delivery Institute, Office of Research, Intermountain Healthcare, 5026 S. State St, Murray, UT 84107, USA. Electronic address: Jake.Krong@imail.org.
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: RMaranon@mednet.ucla.edu.
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: SJLiu@mednet.ucla.edu.
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: CSHan@mednet.ucla.edu.
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: KCNorris@mednet.ucla.edu.
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: CMangione@mednet.ucla.edu.
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: Jessica.Page@imail.org.
¹⁴ Department of Internal Medicine, Intermountain Healthcare, 5121 Cottonwood St, Murray, UT 84017, USA. Electronic address: Samuel.Thomas@imail.org.
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: KDuru@mednet.ucla.edu.
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: TMoin@mednet.ucla.edu.

PMID: 36384219
PMCID: PMC10642368
DOI: 10.1016/j.cct.2022.107007

Randomized Controlled Trial

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 et al. Contemp Clin Trials. 2023 Jan.

. 2023 Jan:124:107007.

doi: 10.1016/j.cct.2022.107007. Epub 2022 Nov 13.

Authors

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: RMadievsky@mednet.ucla.edu.
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: AVVu@mednet.ucla.edu.
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: FICheng@mednet.ucla.edu.
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: JSChon@mednet.ucla.edu.
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: NTurk@mednet.ucla.edu.
⁶ Healthcare Delivery Institute, Office of Research, Intermountain Healthcare, 5026 S. State St, Murray, UT 84107, USA. Electronic address: Ashley.Krueger@imail.org.
⁷ Healthcare Delivery Institute, Office of Research, Intermountain Healthcare, 5026 S. State St, Murray, UT 84107, USA. Electronic address: Jake.Krong@imail.org.
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: RMaranon@mednet.ucla.edu.
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: SJLiu@mednet.ucla.edu.
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: CSHan@mednet.ucla.edu.
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: KCNorris@mednet.ucla.edu.
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: CMangione@mednet.ucla.edu.
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: Jessica.Page@imail.org.
¹⁴ Department of Internal Medicine, Intermountain Healthcare, 5121 Cottonwood St, Murray, UT 84017, USA. Electronic address: Samuel.Thomas@imail.org.
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: KDuru@mednet.ucla.edu.
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: TMoin@mednet.ucla.edu.

PMID: 36384219
PMCID: PMC10642368
DOI: 10.1016/j.cct.2022.107007

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.

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Figures

**Fig. 3.**
Decision Aid 100-Person Risk Chart for Incident T2DM.

See this image and copyright information in PMC

References

1. Gestational diabetes mellitus, Diabetes Care 26 (Suppl. 1) (2003) S103–S105, 10.2337/diacare.26.2007.S103. - DOI - PubMed
1. National Institute for Health and Care Excellence (NICE), Diabetes in pregnancy: management from preconception to the postnatal period, 2015. - PubMed
1. Bellamy L, Casas JP, Hingorani AD, Williams D, Type 2 diabetes mellitus after gestational diabetes: a systematic review and meta-analysis, Lancet (London, England). 373 (9677) (2009) 1773–1779, 10.1016/S0140-6736(09)60731-5. - DOI - PubMed
1. Kim C, Newton KM, Knopp RH, Gestational diabetes and the incidence of type 2 diabetes: a systematic review, Diabetes Care 25 (10) (2002) 1862–1868, 10.2337/diacare.25.10.1862. - DOI - PubMed
1. American Diabetes Association, Standards of Medical Care in Diabetes 2020, Diabetes Care 43 (Supplement 1) (2020). Available at: https://professional.diabetes.org/content-page/practice-guidelines-resou... (Accessed April 07, 2020).

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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)

Affiliations

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)

Authors

Affiliations

Abstract

Figures

References

Publication types

MeSH terms

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Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

Medical