AI-Assisted Lifestyle Intervention vs. Tirzepatide for Obesity and New Type 2 Diabetes Management

The global prevalence of obesity and type 2 diabetes (T2D) continues to rise, posing significant public health challenges. In China, over half of adults with diabetes also experience overweight or obesity, underscoring the critical need for effective weight management strategies in this population. Current standard-of-care often involves lifestyle modifications, which can be difficult to sustain, and pharmacological interventions like GLP-1R/GIPR agonists such as tirzepatide, which are highly effective but may have cost or accessibility barriers. This trial addresses the gap by evaluating whether an AI-assisted intensive lifestyle intervention can offer comparable benefits to tirzepatide, providing a potentially scalable and accessible alternative.

This multicenter randomized controlled trial will enroll adults aged 18 to 65 years with a BMI of 28 to <40 kg/m² and newly diagnosed type 2 diabetes, who have not used glucose-lowering medications in the past 3 months. Participants will be randomly assigned to one of three groups: an AI-assisted intensive lifestyle intervention group, a tirzepatide treatment group, or a standard lifestyle management control group. The intervention period is planned for 52 weeks, followed by a 12-week post-intervention follow-up. The primary endpoint is the percentage change in body weight at week 52.

As this is a trial design, specific efficacy and safety data are not yet available, and no findings have been reported. However, the study is designed to rigorously assess several key outcomes. The primary outcome will be the percentage change in body weight at week 52. Secondary outcomes planned for evaluation include comprehensive measures of glycemic control, such as HbA1c levels, fasting plasma glucose, and continuous glucose monitoring (CGM) metrics. Body composition changes, including fat mass and lean mass, will also be assessed. Furthermore, the trial will monitor other metabolic outcomes and meticulously collect safety data across all three intervention arms. The comparative effectiveness of the AI-assisted lifestyle intervention versus tirzepatide and standard care will be determined upon completion of the study.