ANíMATE mHealth app for guidance on weight loss in adults with obesity: A randomized controlled trial

Aim To assess the effectiveness of a specific mobile health application (ANíMATE) in promoting weight loss in Spanish adults with obesity. Materials and methods We conducted a 4-month exploratory randomized controlled trial (ClinicalTrials.gov registration number: NCT05236881 ; registration date: January 24, 2022). Thirty-six participants with class I/II obesity were randomized to usual care (3 face-to-face visits) or the intervention group (ANíMATE in addition to 3 face-to-face visits). The primary outcome was total weight loss percentage (%TWL) at 4 months. Secondary outcomes included patient-reported outcome measures, additional weight-related variables, adherence, and satisfaction with the application. Results At 4 months, no differences were observed in the primary outcome, %TWL: 2.73% (0.86; 5.06) in the intervention group versus 1.23% (−0.23; 3.21) in the control group ( P = .283). Differences were also not observed in secondary outcomes, with the exception of physical activity at 4 months, which was higher in the control group (2721 [1049; 5940] vs 923 [−8081; 639] MET-min; P = .020), and the frequency of weekly self-weighing at 2 months, also higher in the control group (76.9% vs 36.4%; P = .042). Mean user satisfaction with the application, evaluated using an ad hoc questionnaire, was high (16.5 out of 20). Conclusions In people with obesity, intervention with the ANíMATE mobile application added to usual care did not demonstrate additional benefits in %TWL, the primary outcome, in a study with limited statistical power. Further long-term research is needed to develop tailored mobile health strategies for weight management interventions that promote active user engagement.