| Description: |
Background: Obesity is a chronic, relapsing disease influenced by environmental, lifestyle, biological, and genetic factors, affecting over 1 billion people globally. Treatment for adults typically involves multicomponent lifestyle interventions—diet, physical activity, and behavior change—for at least 6-12 months. However, adherence is often low, and in-person sessions can be time-consuming and costly. Digital therapeutics (DTx), which enhance patient engagement and support long-term outcomes, have proven effective in managing chronic and mental health conditions. DTx offer scalable, evidence-based solutions with the potential to improve obesity management. Objective: The Digital Therapy to Promote Weight Loss in Patients With Obesity by Increasing Their Adherence to Treatment (DEMETRA) study is a prospective, multicenter, pragmatic, randomized, double-arm, single-blind, placebo-controlled trial evaluating the 6-month efficacy of an innovative, multicomponent digital intervention for obesity, which combines dietary, physical activity, and behavioral strategies in people with obesity (primary objective). Secondary objectives were assessing changes in BMI, waist circumference, blood pressure, glucose metabolism, lipid profile, adherence, and factors associated with absolute 6-month weight loss. Methods: The trial was conducted at 2 obesity centers in Italy with 246 participants aged 18-65 years (BMI 30-45 kg/m2), randomly assigned to either the Digital Therapeutics for Obesity (DTxO) app or a placebo app. DTxO offered personalized diet plans, exercise routines, and psycho-behavioral support, while the placebo app only allowed users to log data without feedback. Both groups followed a Mediterranean-style low-calorie diet with an 800 kcal/day deficit. On average, participants used the DTxO app for 42 minutes/day and the placebo app for 35 minutes, primarily for physical activity tracking. Univariable and multivariable generalized linear models were used to assess associations with 6-month absolute weight change ... |