An AI-Powered Lifestyle Intervention vs Human Coaching in the Diabetes Prevention Program: A Randomized Clinical Trial.

IMPORTANCE: Prediabetes is common, yet evidence-based lifestyle interventions are underutilized. OBJECTIVE: To determine whether referral to an exclusively artificial intelligence (AI)-led lifestyle intervention based on the Diabetes Prevention Program (DPP) is noninferior to referral to a human-led DPP in achieving recommended thresholds for weight loss, hemoglobin A1c (HbA1c) reduction, and weekly physical activity among adults with prediabetes and overweight or obesity. DESIGN, SETTING, AND PARTICIPANTS: This phase 3, parallel-group, pragmatic, noninferiority randomized clinical trial was conducted from October 11, 2021, to December 16, 2024 (last follow-up) at 2 US clinical sites in Baltimore, Maryland, and Reading, Pennsylvania. Adults 18 years or older with prediabetes and overweight or obesity were enrolled. INTERVENTIONS: Participants were randomized in a 1:1 ratio to receive either a referral to an AI-powered DPP lifestyle intervention delivered via a mobile app and Bluetooth-enabled digital scale or a referral to a human coach-led DPP lifestyle intervention delivered remotely. Both interventions were delivered independently of the study team over a 12-month period. MAIN OUTCOMES AND MEASURES: The primary outcome was a composite of maintaining an HbA1c less than 6.5% throughout the study and achievement of at least 5% weight loss, at least 4% weight loss plus at least 150 minutes of weekly physical activity (assessed with actigraphy), or an absolute reduction in HbA1c of at least 0.2 percentage points at 12 months. Noninferiority of referral to the AI-led DPP compared with referral to the human-led DPP was prespecified to be determined if the 1-sided 95% CI lower boundary of the risk difference did not cross -15%. RESULTS: A total of 368 participants were included (median [IQR] age, 58 [50-65] years; 71% were female, 27% were Black, 6% were Hispanic, and 61% were White; median [IQR] BMI, 32.3 [28.5-37.1]). After referral, 171 of 183 participants (93.4%) initiated the AI-led DPP and 153 of 185 (82.7%) initiated the human-led DPP. The primary outcome was achieved by 58 of 183 participants (31.7%) in the AI-led DPP group and 59 of 185 (31.9%) in the human-led DPP group (risk difference, -0.2% [1-sided 95% CI, -8.2%]), meeting the criterion for noninferiority. Findings were consistent across individual components of the composite end point and in sensitivity analyses. CONCLUSIONS AND RELEVANCE: Among adults with prediabetes and overweight or obesity, referral to a fully automated AI-led DPP was noninferior to referral to a human-led DPP in achieving a composite outcome based on weight reduction, physical activity, and HbA1c. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05056376.