Introduction 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.
Trial registration number NCT03927534 (5/2019).
- primary care
- mindful eating
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Collaborators Dharamsala Institute of Mindfulness and Psychotherapy, Zaragoza (Spain).
Contributors HMS, JG-C, JM-M, and MN-G participated in the design and planning of the intervention evaluated here. HMS, JM-M and JG-C coordinated all the processes. JM-M designed the methods section and statistical analyses protocol. AB-S was in charge of the protocol registration. JM-M and HMS prepared the first draft of the manuscript. PH-M and BP collaborated in the editing of the final manuscript. All authors have read and corrected draft versions and approved the final version of this document.
Funding The project received funding from the DGA group (B17-17R) and the Network for Prevention and Health Promotion in Primary Care (REDIAPP) grant from the Carlos III Health Institute of the Spanish Ministry of Economy and Competitiveness, cofinanced by European Union ERDF funds (RD16/0007/0005). The funding sources have no influence on the study design; collection, management, analysis and interpretation of the data; writing of the report and the decision to submit the report for publication; and they will have no authority over any of these activities in the trial development.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval Approval was obtained from the Ethics Committee of the corresponding regional authority (CEICA Aragon, Spain registry number PI19/086).
Provenance and peer review Not commissioned; externally peer reviewed.
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