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

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.

SUBMITTER: Fulwiler C

PROVIDER: S-EPMC5168503 | biostudies-literature | 2016 Nov

REPOSITORIES: biostudies-literature

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

Fulwiler Carl C Siegel Julia A JA Allison Jeroan J Rosal Milagros C MC Brewer Judson J King Jean A JA

BMJ open 20161130 11

<h4>Introduction</h4>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 see ...[more]

PMID: 27903561

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Project description:The young adult years have been recognized as an influential period for excess weight gain. Non-traditional students and those attending 2-year community colleges are at particularly high risk for a range of adverse weight-related outcomes.Choosing Healthy Options in College Environments and Settings was an RCT with students randomly assigned into a control or intervention condition after baseline assessment. The study was designed to evaluate if a 24-month weight-gain prevention intervention reduces the expected increase in BMI and overweight prevalence in young adults attending 2-year colleges. Two cohorts were recruited, corresponding to the fall and spring semesters. Data collection occurred at four time points for each cohort, with baseline occurring in fall 2011 for Cohort 1 and spring 2012 for Cohort 2. The 24-month follow-up occurred in fall 2013 for Cohort 1 and spring 2014 for Cohort 2. Data analysis occurred in 2015-2016.This research was conducted with 441 students from three community colleges in Minnesota.The 24-month intervention began with a 1-credit college course on healthy weight behaviors. A social networking and social support website was introduced as part of the course and participation encouraged for the duration of the trial.Changes in BMI, weight, body fat percentage, waist circumference, and weight status were assessed.Retention of the cohorts at 24 months was 83.4%. There was not a statistically significant difference in BMI between conditions at the end of the trial. However, there was a statically significant difference in the prevalence of overweight/obesity between treatment conditions at 24 months. Also, participants randomized to the intervention who were overweight or obese at baseline were more than three times as likely to transition to a healthy weight by the end of the trial as compared with control students.The intervention was not successful in achieving BMI differences between treatment groups. However, an 8% reduction in the prevalence of overweight and obesity over time may have population-level significance.This study is registered at www.clinicaltrials.gov NCT01134783.

Dataset Information

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

Publications

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

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