OverweightNCT02189187
Keeping Weight Off: Brain Changes Associated With Healthy Behaviors
A study testing Mindfulness and Psychoeducation in people with Overweight and Obesity, run by University of Massachusetts, Worcester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Mindfulness and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 25 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
Who cannot join
- Weight-loss surgery or medications
- Serious Psychiatric or medical conditions
- Substance abuse
- Ineligible for MRI
- Pregnant
- Eating disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Umass Medical School
Worcester, Massachusetts, 01655
About this study
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.
Read the detailed description
Unhealthy behaviors such as overeating and a sedentary lifestyle are largely responsible for overweight and obesity which substantially increase risk for chronic conditions such as heart disease, high blood pressure, stroke, diabetes, arthritis and certain cancers. The rapid rise in obesity threatens to reverse recent gains in life expectancy and account for a large percentage of premature deaths in the U.S. Although there is evidence for the short-term efficacy of a number of methods for initiating health behavior change to lose weight, these interventions have shown only limited ability to affect significant, long-term behavioral changes in the majority of adults. In part this may be because they fail to adequately address how psychological factors that lead to relapse to unhealthy behaviors and failure to maintain long-term behavior change.
The purpose of the study is to understand brain changes that accompany participation in programs that foster healthy behaviors in people seeking to maintain weight loss. We will use MRI scans to study brain function in men and women 25-60 years old who have lost weight in the last year without surgery. Participants will be assigned to one of two programs to help them maintain weight loss and will be compensated for their time. Our goal is to gain a better understanding of the brain changes that lead to long-term success in keeping weight off, in the hope that this knowledge will assist in the development of improved treatments.
- Conditions
- Overweight, Obesity
- Being tested
- Mindfulness, Psychoeducation
- Keywords
- Weight Loss, Body Weight Changes, Body Weight, Magnetic Resonance Imaging, Emotions, Emotion regulation, Health Behavior, Eating behavior
- Medical subject headings
- Overweight, Obesity, Weight Loss, Body Weight Changes, Body Weight, Emotional Regulation, Health Behavior, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulnessBehavioural
PsychoeducationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Based Stress Reduction (MBSR) program | Experimental | Mindfulness 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. Receives: Behavioral: Mindfulness |
| Healthy Living Course (HLC) | Active comparator | Healthy 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). Receives: Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional connectivity on fMRI
Functional Magnetic Resonance Imaging (fMRI)
Measured: 8 weeks
Secondary outcomes (2)
Association of functional connectivity change with changes in depression symptoms
Center for Epidemiological Studies-Depression Scale (CES-D)
Measured: 6 months
Association of functional connectivity with maintenance of weight loss
BMI
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2014 (estimated)
- Study startDec 2014
- Primary completionJun 2016
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Carl Fulwiler, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02189187
- Sponsor's protocol ID
- 5R34AT006963
- Status last verified
- Jul 2017
- First submitted
- 24 Jun 2014
- Last updated
- 31 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27903561
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Keeping Weight Off: Brain Changes Associated With Healthy Behaviors
- ClinicalTrials.gov ID
- NCT02189187
- Acronym / sponsor ID
- 5R34AT006963
- Conditions
- Overweight, Obesity
- Keywords
- Weight Loss, Body Weight Changes, Body Weight, Magnetic Resonance Imaging, Emotions, Emotion regulation, Health Behavior, Eating behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Dec 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 14 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Unhealthy behaviors such as overeating and a sedentary lifestyle are largely responsible for overweight and obesity which substantially increase risk for chronic conditions such as heart disease, high blood pressure, stroke, diabetes, arthritis and certain cancers. The rapid rise in obesity threatens to reverse recent gains in life expectancy and account for a large percentage of premature deaths in the U.S. Although there is evidence for the short-term efficacy of a number of methods for initiating health behavior change to lose weight, these interventions have shown only limited ability to affect significant, long-term behavioral changes in the majority of adults. In part this may be because they fail to adequately address how psychological factors that lead to relapse to unhealthy behaviors and failure to maintain long-term behavior change.
The purpose of the study is to understand brain changes that accompany participation in programs that foster healthy behaviors in people seeking to maintain weight loss. We will use MRI scans to study brain function in men and women 25-60 years old who have lost weight in the last year without surgery. Participants will be assigned to one of two programs to help them maintain weight loss and will be compensated for their time. Our goal is to gain a better understanding of the brain changes that lead to long-term success in keeping weight off, in the hope that this knowledge will assist in the development of improved treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Based Stress Reduction (MBSR) program | Experimental | Behavioral: MindfulnessMindfulness 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 comparator | Behavioral: PsychoeducationHealthy 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). |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 25 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
Key exclusion criteria (6 listed)
- Weight-loss surgery or medications
- Serious Psychiatric or medical conditions
- Substance abuse
- Ineligible for MRI
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness | Behavioural | Mindfulness Based Stress Reduction (MBSR) program |
| Psychoeducation | Behavioural | Healthy Living Course (HLC) |
Primary outcome
Functional connectivity on fMRI
Time frame: 8 weeks
Functional Magnetic Resonance Imaging (fMRI)
2 secondary outcomes
Association of functional connectivity change with changes in depression symptoms
Time frame: 6 months
Association of functional connectivity with maintenance of weight loss
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2017.
- Derived from this study: PubMed 27903561Fulwiler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness and Psychoeducation in people with Overweight and Obesity, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional connectivity on fMRI (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02189187, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2017.