000087749 001__ 87749 000087749 005__ 20231215090951.0 000087749 0247_ $$2doi$$a10.1136/bmjopen-2019-031327 000087749 0248_ $$2sideral$$a115876 000087749 037__ $$aART-2019-115876 000087749 041__ $$aeng 000087749 100__ $$aMorillo Sarto, Héctor$$uUniversidad de Zaragoza 000087749 245__ $$aEfficacy of a mindful-eating programme to reduce emotional eating in patients suffering from overweight or obesity in primary care settings: a cluster-randomised trial protocol 000087749 260__ $$c2019 000087749 5060_ $$aAccess copy available to the general public$$fUnrestricted 000087749 5203_ $$aIntroduction Little is known about the applicability of mindfulness-based interventions in Spanish adults with overweight/obesity. The objective of the present study protocol is to describe the methods that will be used in a cluster randomised trial (CRT) that aims to evaluate the effectiveness of a mindfulness eating (ME) programme to reduce emotional eating (EE) in adults with overweight/obesity in primary care (PC) settings. Methods and analysis A CRT will be conducted with approximately 76 adults with overweight/obesity from four PC health centres (clusters) in the city of Zaragoza, Spain. Health centres matched to the average per capita income of the assigned population will be randomly allocated into two groups: ME +treatment as usual (TAU)'' and TAU alone''. The ME programme will be composed of seven sessions delivered by a clinical psychologist, and TAU will be offered by general practitioners. The primary outcome will be EE measured by the Dutch Eating Behaviour Questionnaire (DEBQ) at post test as primary endpoint. Other outcomes will be external and restrained eating (DEBQ), binge eating (Bulimic Investigatory Test Edinburgh), eating disorder (Eating Attitude Test), anxiety (General Anxiety Disorder-7), depression (Patient Health Questionnaire-9), mindful eating (Mindful Eating Scale), dispositional mindfulness (Five Facet Mindfulness Questionnaire) and self-compassion (Self-Compassion Scale). Anthropometric measures, vital signs and blood tests will be taken. A primary intention-to-treat analysis on EE will be conducted using linear mixed models. Supplementary analyses will include secondary outcomes and 1-year follow-up measures; adjusted models controlling for sex, weight status and levels of anxiety and depression; the complier average causal effect of treatment; and the clinical significance of improvements. Ethics and dissemination Positive results of this study may have a significant impact on one of the most important current health-related problems. Approval was obtained from the Ethics Committee of the Regional Authority. The results will be submitted to peer-reviewed journals, and reports will be sent to participants. 000087749 536__ $$9info:eu-repo/grantAgreement/ES/DGA/B17-17R$$9info:eu-repo/grantAgreement/ES/ISCIII/RD16-0007-0005 000087749 540__ $$9info:eu-repo/semantics/openAccess$$aby-nc$$uhttp://creativecommons.org/licenses/by-nc/3.0/es/ 000087749 590__ $$a2.496$$b2019 000087749 591__ $$aMEDICINE, GENERAL & INTERNAL$$b52 / 165 = 0.315$$c2019$$dQ2$$eT1 000087749 592__ $$a1.247$$b2019 000087749 593__ $$aMedicine (miscellaneous)$$c2019$$dQ1 000087749 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion 000087749 700__ $$0(orcid)0000-0002-2116-9257$$aBarceló-Soler, Alberto 000087749 700__ $$0(orcid)0000-0003-2088-4272$$aHerrera-Mercadal, Paola$$uUniversidad de Zaragoza 000087749 700__ $$aPantilie, Bianca 000087749 700__ $$0(orcid)0000-0003-4842-0453$$aNavarro-Gil, Mayte$$uUniversidad de Zaragoza 000087749 700__ $$0(orcid)0000-0002-3797-4218$$aGarcía-Campayo, Javier$$uUniversidad de Zaragoza 000087749 700__ $$0(orcid)0000-0001-5677-1662$$aMontero-Marín, Jesús 000087749 7102_ $$14009$$2730$$aUniversidad de Zaragoza$$bDpto. Psicología y Sociología$$cÁrea Psicología Básica 000087749 7102_ $$11007$$2745$$aUniversidad de Zaragoza$$bDpto. Medicina, Psiqu. y Derm.$$cArea Psiquiatría 000087749 7102_ $$14009$$2735$$aUniversidad de Zaragoza$$bDpto. Psicología y Sociología$$cÁrea Psicolog.Evolut.Educac 000087749 773__ $$g9, 11 (2019), e031327 1-17$$pBMJ Open$$tBMJ Open$$x2044-6055 000087749 85641 $$uhttps://bmjopen.bmj.com/content/9/11/e031327$$zTexto completo de la revista 000087749 8564_ $$s452266$$uhttps://zaguan.unizar.es/record/87749/files/texto_completo.pdf$$yVersión publicada 000087749 8564_ $$s155854$$uhttps://zaguan.unizar.es/record/87749/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada 000087749 909CO $$ooai:zaguan.unizar.es:87749$$particulos$$pdriver 000087749 951__ $$a2023-12-15-08:58:01 000087749 980__ $$aARTICLE