• Jeffrey A Katula, Emily V Dressler, Carol A Kittel, Lea N Harvin, Fabio A Almeida, Kathryn E Wilson, Tzeyu L Michaud, Gwenndolyn C Porter, Fabiana A Brito, Cody L Goessl, Carolyn B Jasik, SweetCynthia M CastroCMCMedical Affairs, Omada Health, Inc., San Francisco, California., Robert Schwab, and Paul A Estabrooks.
• Department of Health & Exercise Science, Wake Forest University, Winston-Salem, North Carolina. Electronic address: katulaj@wfu.edu.
• Am J Prev Med. 2022 Apr 1; 62 (4): 567-577.

IntroductionIn light of the need to expand the reach and access of clinically proven digital Diabetes Prevention Programs (d-DPPs) and the need for rigorous evidence of effectiveness, the purpose of this study was to determine the effectiveness of a digital Diabetes Prevention Program for improving weight, HbA1c, and cardiovascular risk factors among people with prediabetes compared to enhanced standard care plus waitlist control.Study DesignThis was a single-blind RCT among participants at risk of developing type 2 diabetes and included 12 months of follow-up.Setting/ParticipantsA total of 599 volunteer patients with prediabetes were recruited primarily through electronic medical records and primary care practices.InterventionParticipants were randomized to either a d-DPP (n=299) or a single-session small-group diabetes-prevention education class (n=300) focused on action planning for weight loss. The d-DPPs consisted of 52 weekly sessions, lifestyle coaching, virtual peer support, and behavior tracking tools.Main Outcome MeasuresThe primary outcome was a change in HbA1c from baseline to 12 months using intent-to-treat analyses. On the basis of multiple comparisons of endpoints, 95% CIs are presented and 2-sided p<0.025 was required for statistical significance. Secondary outcomes included body weight and cardiovascular disease risk factors.ResultsAmong 599 randomized participants (mean age=55.4 years, 61.4% women), 483 (80%) completed the study. The d-DPPs produced significantly greater reductions in HbA1c (0.08%, 95% CI= -0.12, -0.03) and percentage change in body weight (-5.5% vs -2.1%, p<0.001) at 12 months. A greater proportion of the d-DPPs group achieved a clinically significant weight loss ≥5% (43% vs 21%, p<0.001), and more participants shifted from prediabetes to normal HbA1c range (58% vs 48%, p=0.04). Engagement in d-DPPs was significantly related to improved HbA1c and weight loss.ConclusionsThis d-DPPs demonstrated clinical effectiveness and has significant potential for widespread dissemination and impact, particularly considering the growing demand for telemedicine in preventive healthcare services.Trial RegistrationThis study is registered at www.Clinicaltrialsgov (ClinicalTrials.gov Identifier: NCT03312764).Copyright © 2021 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

24 keywords...

hide…