AUTHOR=Giusti Laura , Bianchini Valeria , Aggio Annalisa , Mammarella Silvia , Salza Anna , Necozione Stefano , Alunno Alessia , Ferri Claudio , Casacchia Massimo , Roncone Rita TITLE=Twelve-month outcomes in overweight/obese users with mental disorders following a multi-element treatment including diet, physical activity, and positive thinking: The real-world “An Apple a Day” controlled trial JOURNAL=Frontiers in Psychiatry VOLUME=Volume 13 - 2022 YEAR=2022 URL=https://www.frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2022.903759 DOI=10.3389/fpsyt.2022.903759 ISSN=1664-0640 ABSTRACT=Overweight and obesity and metabolic diseases are not often prevented, identified, or adequately treated among persons with mental illness. The present study aimed to evaluate the 12-month effectiveness of a real-world weight loss transdiagnostic intervention in overweight/obese participants affected by mental disorders under psychopharmacological treatment. We conducted a real-world, controlled, pragmatic outpatient trial. We recruited and consecutively allocated 58 overweight/obese adults under psychopharmacological treatment from a mental health outpatient unit and 48 overweight/obese adults from a hypertension and cardiovascular prevention outpatient unit, and assigned them to an intervention or treatment usual as condition (TAU) enriched by lifestyle advice. Participants in both intervention groups took part in a diet programme (the modified OMNIHeart dietary protocol) and monitoring of regular aerobic activity. A brief group programme (‘An Apple a Day’ Metacognitive Training, Apple-MCT) was added in the intervention group of participants affected by mental disorders. The primary outcome was weight loss. Secondary outcomes included anthropometric, clinical, and metabolic variables. Psychopathology and health-related quality of life were also evaluated in the psychiatric sample. At 12 months, both intervention groups showed a more marked mean decrease in weight (6.7 kg, SD: 3.57) than the TAU group (0.32 kg, SD: 1.96). Both intervention groups exhibited a statistically significant difference in the proportion of participants who lost 5% (59.3%) or 10% (25.4%) of their baseline weight compared to those included in the TAU groups who lost 5% (7.7%) or 10% (0%) of their baseline weight; 92.3% of TAU participants recorded less than 5% weight loss versus the intervention groups (15.3%). Compared to when the study began, in the intervention groups, at 12 months, the mean changes revealed a statistically significant decline in total cholesterol, triglycerides, low-density lipoprotein cholesterol, fasting glucose levels, and a positive HDLc concentration increase compared with the control groups. Furthermore, the participants affected by mental disorders included in the intervention group reported improved health-related quality of life. Our findings suggest the need to implement integrated interventions based on a modified OMNIHeart dietary protocol, physical activity, and modification of cognitive style in overweight/obese users with mental disorders.