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Complementary medicine
Protocol
Keeping Weight Off: study protocol of an RCT to investigate brain changes associated with mindfulness-based stress reduction
  1. Carl Fulwiler1,
  2. Julia A Siegel2,
  3. Jeroan Allison3,
  4. Milagros C Rosal4,
  5. Judson Brewer1,
  6. Jean A King5
  1. 1Departments of Psychiatry and Medicine and Center for Mindfulness, University of Massachusetts Medical School, Shrewsbury, Massachusetts, USA
  2. 2University of Massachusetts Medical School, Worcester, Massachusetts, USA
  3. 3Department of Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, Massachusetts, USA
  4. 4Department of Medicine, University of Massachusetts Medical School, Worcester, Massachusetts, USA
  5. 5Departments of Psychiatry, Neurology and Radiology, University of Massachusetts Medical School, Worcester, Massachusetts, USA
  1. Correspondence to Dr Carl Fulwiler; carl.fulwiler{at}umassmed.edu

Abstract

Introduction Obesity 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 analysis Community-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 dissemination The 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 number NCT02189187.

  • mindfulness
  • weight loss
  • behavior change maintenance
  • neuroimaging

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2016-012573

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    Footnotes

    • Contributors CF conceptualised the study, and JAK, JA, MCR and JB participated in the study design. CF, JAK, and JAS collected data. CF and JAS wrote and all authors revised the article and approved the final version to be published.

    • Funding The National Center for Complementary and Integrative Health (NCCIH)) provided funding for this trial (grants R34AT006963 and R34 AT006963-01A1 to CF and JAK). The design of this trial was reviewed and approved by NCCIH's Office of Clinical and Regulatory Affairs. Support was also provided by an award from the UMMS Department of Radiology.

    • Disclaimer The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or the UMMS Department of Radiology Advanced MR Imaging Center.

    • Competing interests None declared.

    • Ethics approval University of Massachusetts Medical School Institutional Review Board.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement For investigators expressing interest in data analyses, we will welcome proposals for consideration by the study investigators. If there is no overlap in research interests, necessary data files will be generated and provided, and writing groups identified. We are sensitive to the potential for identification of participants and loss of confidentiality. Consequently, certain sensitive types of data may not be released. However, in these cases analyses may be performed by our group and sent to the investigators for interpretation.