Efficacy 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

Abstract

IntroductionLittle 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 analysisA 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 disseminationPositive 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 numberNCT03927534(5/2019).

Effect of the Emory Healthy Kitchen Collaborative on Employee Health Habits and Body Weight: A 12-Month Workplace Wellness Trial

“…An 8-week behavioral intervention program with a focus on mindful eating among overweight and obese premenopausal women showed an improvement in the awareness of hunger cues, decreased reliance on external cues for eating, and increased food enjoyment [ 27 ]. Moreover, a 6-week primary care mindful eating program found significant improvements in emotional eating, mindful eating, and a decrease in eating in response to external cues [ 28 ]. Our study findings suggest that teaching kitchens can similarly be effective in improving eating behaviors, including mindful eating.…”

‘Mindful eating’ for reducing emotional eating in patients with overweight or obesity in primary care settings: A randomized controlled trial

“…The confidentiality of participants was guaranteed and protected by the Spanish Organic Law on Protection of Personal Data and Guarantee of Digital Rights (3/2018 of December 7), and all relevant EU legislation on privacy and data protection. This trial ( ClinicalTrials.gov NCT03927534) was performed in compliance with the study protocol, where more details of the procedures can be found (Morillo‐Sarto et al, 2019 ).…”

“…In this case, the TAU included two interviews with the GP and a nurse, the development of a nutritional plan and some talks on health and nutrition, for a total of 7 sessions, one per week. A more detailed description of this approach can be found elsewhere (Morillo‐Sarto et al, 2019 ).…”

Effects of Mindful Eating and YogaDance among Overweight and Obese Women: An Exploratory Randomized Controlled Trial

“…Two such approaches are mindful eating and YogaDance. Mindful eating has recently attracted much attention in nutrition research [ 6 , 7 ]. In short, mindful eating aims at aligning eating habits with inner hunger and satiety signals rather than counting calories [ 8 , 9 ].…”