Keeping Weight Off: Brain Changes Associated With Healthy Behaviors
1 other identifier
interventional
55
1 country
1
Brief Summary
The goal of this project is to characterize changes in emotion regulation pathways associated with healthy behaviors in people who have recently lost weight and are seeking to maintain weight loss over a 1-year period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2014
CompletedFirst Posted
Study publicly available on registry
July 14, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedJuly 31, 2017
July 1, 2017
1.5 years
June 24, 2014
July 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Functional connectivity on fMRI
Functional Magnetic Resonance Imaging (fMRI)
8 weeks
Secondary Outcomes (2)
Association of functional connectivity change with changes in depression symptoms
6 months
Association of functional connectivity with maintenance of weight loss
6 months
Study Arms (2)
Mindfulness Based Stress Reduction (MBSR) program
EXPERIMENTALMindfulness Based Stress Reduction (MBSR) is an 8-week program that consists of training in mindfulness practices, the application of mindfulness to daily life, and information about healthy living and the role played by thoughts and emotions in health.
Healthy Living Course (HLC)
ACTIVE COMPARATORHealthy Living Course (HLC) an 8-week psycho-educational program that consists of lectures and discussion on healthy living, stress management, time management, and unhealthy behaviors (e.g. smoking, drinking).
Interventions
Eligibility Criteria
You may qualify if:
- to 60 years old
- Healthy individuals who have intentionally lost at least 5% of their body weight over the past year
- BMI \>20.5 kg/m2 at study entry and \>25 in past 2 years
You may not qualify if:
- Weight-loss surgery or medications
- Serious Psychiatric or medical conditions
- Substance abuse
- Ineligible for MRI
- Pregnant
- Eating disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Umass Medical School
Worcester, Massachusetts, 01655, United States
Related Publications (1)
Fulwiler C, Siegel JA, Allison J, Rosal MC, Brewer J, King JA. Keeping Weight Off: study protocol of an RCT to investigate brain changes associated with mindfulness-based stress reduction. BMJ Open. 2016 Nov 30;6(11):e012573. doi: 10.1136/bmjopen-2016-012573.
PMID: 27903561DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Psychiatry
Study Record Dates
First Submitted
June 24, 2014
First Posted
July 14, 2014
Study Start
December 1, 2014
Primary Completion
June 1, 2016
Study Completion
July 1, 2017
Last Updated
July 31, 2017
Record last verified: 2017-07