The impact of positive social reinforcement on time-to-attrition from the Diabetes Prevention Program in college students at high risk for Type II Diabetes: a study protocol for a phase 3, multicenter, cluster randomized trial

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A. Bhandari
A. Concha-Mejia
A. Vasquez
A. Peralta
A. Rivera
G. Vallejos
H. Lu
J. Cardoso-Mourao
L. Assad
L. Handal
L. Kirihara
M. DeCain
M. Deger
M. Jimenez
M. Schulz
N. Mazariegos
N.V. Racu
N. Rincon
P. Parra
S. Arroub
S. Kalmadka
S. Olagun
V. Balbuena

Abstract

Introduction: The prevalence of type 2 diabetes mellitus (T2DM) in young adults has increased considerably in the past
decade. Evidence shows that lifestyle modification programs such as the Diabetes Prevention Program (DPP) are
effective in improving health behaviors and lowering the risk of diabetes. DPP follow-up studies have found that a lack
of retention can reduce the effectiveness of such programs. Adding a positive social reinforcement platform is a novel
strategy to provide educational resources to facilitate lifestyle changes. However, evidence regarding the effect of
positive social reinforcement as a theory-based strategy to prolong retention within the DPP is limited. The current study
protocol aims to evaluate the efficacy of the online Prevent Diabetes® Program, including a Positive Inter@ctiOn forum
on time-to-attrition from the DPP among college students at high risk for T2DM.
Methods: This study protocol is a phase 3, multicenter, double-blinded, cluster-randomized, superiority, controlled trial
conducted in West Virginia, Alabama, and Mississippi. Four hundred eigclthty college students will be centrally
randomized in a cluster-wise 1:1 ratio to the online Prevent Diabetes® Program integrated with the Positive Inter@ctiOn
forum or to the online Prevent Diabetes® Program alone for 12 months. The primary outcome is time-to-attrition from
the DPP.
Discussion: Successful completion of the study will provide valuable information on whether implementing theory-based
health behavior strategies can improve the retention of participants in the online DPP and contribute to enhancing DPP
effectiveness.

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How to Cite
Bhandari, A., Concha-Mejia, A., Vasquez, A., Peralta, A., Rivera, A., Vallejos, G., Lu, H., Cardoso-Mourao, J., Assad, L., Handal, L., Kirihara, L., DeCain, M., Deger, M., Jimenez, M., Schulz, M., Mazariegos, N., Racu, N., Rincon, N., Parra, P., Arroub, S., Kalmadka, S., Olagun, S., & Balbuena, V. (2022). The impact of positive social reinforcement on time-to-attrition from the Diabetes Prevention Program in college students at high risk for Type II Diabetes: a study protocol for a phase 3, multicenter, cluster randomized trial. Principles and Practice of Clinical Research, 8(2). https://doi.org/10.21801/ppcrj.2022.82.1
Section
Clinical Research Design