Obesity Science & Practice · Published 2025-12-01 · DOI 10.1002/osp4.70106
ABSTRACT 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 (N = 155; mean ± SD age, 41 ± 11 years; 71% female; BMI, 33.5 ± 4.7 kg/m2) were randomized to either an intervention promoting a Mediterranean‐style low‐carbohydrate diet combined with biofeedback from a handheld breath acetone device or an evidence‐based comparator promoting a calorie‐restricted, low‐fat diet. Participants recorded their daily weights using Bluetooth scales. Weight loss over 48 weeks was analyzed using a linear mixed‐effects model, incorporating all available daily weight measurements from participants who provided at least one follow‐up measurement. 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, p < 0.001). No adverse effects were reported in either group. 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.
Abstract from DOAJ. Public domain (CC0 1.0).
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