Long-Term Weight Loss in Adults With Overweight or Obesity Using a Breath Biofeedback mHealth App: A One-Year Follow-Up of a Randomized Trial.

Background: Long-term weight loss success with dietary interventions is notoriously limited. Mobile health (mHealth) interventions offering personalized dietary guidance combined with real-time biofeedback may enhance long-term adherence and provide a sustainable solution for weight management. Objectives: This study reports the prespecified secondary outcome of weight loss at 48 weeks from a parallel-arm randomized clinical trial (ClinicalTrials.gov: NCT04165707) that aimed to evaluate the long-term effectiveness and sustainability of a Mediterranean-style low-carbohydrate diet delivered via an mHealth application paired with breath biofeedback compared with a calorie-restricted low-fat diet application. Methods: Adults with overweight or obesity ( Results: At 48 weeks, participants using the breath biofeedback mHealth app achieved clinically meaningful weight loss (-9.54 kg, 95% CI: -12.27 to -6.81 kg). In contrast, participants using the low-fat diet app did not achieve statistically significant weight loss (-2.68 kg, 95% CI: -5.49 to 0.14 kg), resulting in a statistically significant between-group difference (-6.9 kg, 95% CI: -10.8 to -2.9, Conclusions: This study demonstrates that a Mediterranean-style diet promoting carbohydrate restriction coupled with biofeedback support delivered via an mHealth app results in clinically meaningful sustained weight loss at 48 weeks. Given its practicality and demonstrated effectiveness, this approach presents a promising non-pharmacological alternative or complement for longer-term weight management.