Keeping Weight Off: study protocol of an RCT to investigate brain changes associated with mindfulness-based stress reduction

Abstract

IntroductionObesity is a growing epidemic fuelled by unhealthy behaviours and associated with significant comorbidities and financial costs. While behavioural interventions produce clinically meaningful weight loss, weight loss maintenance is challenging. This may partially be due to failure to target stress and emotional reactivity. Mindfulness-based stress reduction (MBSR) reduces stress and emotional reactivity and may be a useful tool for behaviour change maintenance. This study seeks to provide a mechanistic understanding for clinical trials of the benefits of MBSR for weight loss maintenance by examining changes in functional connectivity (FC) and the association of these changes with clinical outcomes.Methods and analysisCommunity-dwelling individuals (n=80) who intentionally lost ≥5% of their body weight in the past year will be recruited and randomised to an MBSR programme or educational control. FC using resting-state functional MRI will be measured at baseline and 8 weeks. Psychological factors, health behaviours, body mass index and waist circumference will be measured at baseline, 8 weeks and 6 months post intervention. A 12-month telephone follow-up will assess self-reported weight. Analyses will characterise FC changes in response to MBSR in comparison with a control condition, assess the relationship between baseline FC status and pre–post MBSR changes in FC and investigate the association of FC change with changes in psychological factors and weight loss maintenance.Ethics and disseminationThe University of Massachusetts Medical School Institutional Review Board has approved this study, Declaration of Helsinki protocols are being followed, and patients will give written informed consent. The Independent Monitoring Committee will monitor protocol adherence. Results from the study will be disseminated to the medical community at conferences and submitted for publication in peer-reviewed journals when the last patient included has been followed up for 12 months.Trial registration numberNCT02189187.

Effects of a new intervention based on the Health at Every Size approach for the management of obesity: The “Health and Wellness in Obesity” study

“…Moreover, the success rate of weight-loss approaches regarding sustainable weight loss, reduction of body fat mass, maintenance of body fat-free mass, and other health benefits (e.g., clinical improvement in blood pressure, lipid profile, physical activity levels, disturbed eating behaviors, self-esteem, and body image) [ 4 , 5 ] is limited. In this context, weight-neutral approaches, such as the Health at Every Size ® approach (HAES ® ), are of increasing interest [ 6 ] (Health at Every Size ® and HAES ® are registered trademarks of the Association for Size Diversity and Health—ASDAH).…”

Keeping weight off: Mindfulness-Based Stress Reduction alters amygdala functional connectivity during weight loss maintenance in a randomized control trial

“… Left half of the figure shows the study phases, while the right half shows the flow of patients and numbers in each group at each of the corresponding study phase. This design is based upon our previously described model [ 22 ]. …”

“…Mindfulness-based interventions have potential utility in weight loss and weight maintenance [ 22 , 23 ]. Mindfulness is defined as the awareness that arises from attending to one’s own internal and external state in the present moment in a non-judgmental way [ 24 ].…”

“…The effectiveness of mindfulness-based interventions, in particular MBSR, for reducing aversive symptoms such as depression and anxiety is well-established [ 29 ]. Given that these symptoms increase the risk of unhealthy behaviors, MBSR may support maintenance of weight loss following successful initiation of health behavior change [ 22 ].…”

“…We previously published our initial exploratory hypotheses and protocol for this randomized controlled trial (RCT) to investigate RS predictors of clinical outcomes following MBSR in the context of weight loss maintenance [ 22 ] (ClinicalTrials.gov NCT02189187). Our primary aim was to characterize RS changes in response to MBSR and the comparison condition.…”