Study protocol: Behavioral economics and self-determination theory to change diabetes risk (BEST Change).

Autor: Carter EW; Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America. Electronic address: ewcarter@med.umich.edu., Vadari HS; Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America., Stoll S; Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America., Rogers B; Department of Health Behavior and Health Education, University of Michigan School of Public Health, Ann Arbor, MI, United States of America., Resnicow K; Department of Health Behavior and Health Education, University of Michigan School of Public Health, Ann Arbor, MI, United States of America., Heisler M; Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America; Department of Health Behavior and Health Education, University of Michigan School of Public Health, Ann Arbor, MI, United States of America; VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, United States of America; University of Michigan Institute for Healthcare Policy and Innovation, Ann Arbor, MI, United States of America., Herman WH; Departments of Internal Medicine and Epidemiology, University of Michigan, Ann Arbor, MI, United States of America., Kim HM; VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, United States of America; Consulting for Statistics, Computing and Analytics Research, University of Michigan, Ann Arbor, MI, United States of America., McEwen LN; University of Michigan, Department of Internal Medicine- Metabolism, Endocrinology, and Diabetes, United States of America., Volpp KG; Center for Health Equity Research and Promotion, Philadelphia VA Medical Center, Philadelphia, PA, United States of America; Departments of Medicine and Health Care Management, University of Pennsylvania, Philadelphia, PA, United States of America., Kullgren JT; Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America; VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, United States of America; University of Michigan Institute for Healthcare Policy and Innovation, Ann Arbor, MI, United States of America; Department of Health Management and Policy, University of Michigan School of Public Health, Ann Arbor, MI, United States of America.
Jazyk: angličtina
Zdroj: Contemporary clinical trials [Contemp Clin Trials] 2023 Jan; Vol. 124, pp. 107038. Date of Electronic Publication: 2022 Nov 30.
DOI: 10.1016/j.cct.2022.107038
Abstrakt: Background: The Diabetes Prevention Program (DPP) and metformin can prevent or delay the onset of type 2 diabetes mellitus (T2DM) among patients with prediabetes. Yet, even when these evidence-based strategies are accessible and affordable, uptake is low. Thus, there is a critical need for effective, scalable, and sustainable approaches to increase uptake and engagement in these interventions.
Methods: In this randomized controlled trial, we will test whether financial incentives and automated messaging to promote autonomous motivation for preventing T2DM can increase DPP participation, metformin use, or both among adults with prediabetes. Participants (n = 380) will be randomized to one of four study arms. Control Arm participants will receive usual care and educational text messages about preventing T2DM. Incentives Arm participants will receive the Control Arm intervention plus financial incentives for DPP participation or metformin use. Tailored Messages Arm participants will receive the Control Arm intervention plus tailored messages promoting autonomous motivation for preventing T2DM. Combined Arm participants will receive the Incentives Arm and Tailored Messages Arm interventions plus messages to increase the personal salience of financial incentives. The primary outcome is change in hemoglobin A1c from baseline to 12 months. Secondary outcomes are change in body weight, DPP participation, and metformin use.
Discussion: If effective, these scalable and sustainable approaches to increase patient motivation to prevent T2DM can be deployed by health systems, health plans, and employers to help individuals with prediabetes lower their risk for developing T2DM.
Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Kevin Volpp is the co-owner of the consulting firm VALHealth. Dr. Jeff Kullgren has received consulting fees from SeeChange Health, HealthMine, and the Kaiser Permanente Washington Health Research Institute; and honoraria from the Robert Wood Johnson Foundation, AbilTo, Inc., the Kansas City Area Life Sciences Institute, the American Diabetes Association, the Donaghue Foundation, and the Luxembourg National Research Fund. All other authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2022 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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