Study protocol: Behavioral economics and self-determination theory to change diabetes risk (BEST Change).
Behavioral economics
Diabetes prevention
Randomized controlled trials
Self-determination theory
Journal
Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342
Informations de publication
Date de publication:
01 2023
01 2023
Historique:
received:
14
09
2022
revised:
28
11
2022
accepted:
28
11
2022
pmc-release:
01
01
2024
pubmed:
3
12
2022
medline:
17
1
2023
entrez:
2
12
2022
Statut:
ppublish
Résumé
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. 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. 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.
Sections du résumé
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.
Identifiants
pubmed: 36460265
pii: S1551-7144(22)00364-0
doi: 10.1016/j.cct.2022.107038
pmc: PMC10259647
mid: NIHMS1905385
pii:
doi:
Substances chimiques
Metformin
9100L32L2N
Banques de données
ClinicalTrials.gov
['NCT04902326']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, N.I.H., Extramural
Research Support, U.S. Gov't, Non-P.H.S.
Langues
eng
Sous-ensembles de citation
IM
Pagination
107038Subventions
Organisme : NIDDK NIH HHS
ID : R18 DK122418
Pays : United States
Informations de copyright
Copyright © 2022 Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
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.
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