Clinical trial NCT02189187: Keeping Weight Off: Brain Changes Associated With Healthy Behaviors
Official title: Keeping Weight Off: Brain Changes Associated With Healthy Behaviors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: Weight Loss
Body Weight Changes
Body Weight
Magnetic Resonance Imaging
Emotions
Emotion regulation
Health Behavior
Eating behavior
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2014-07-14
Enrollment: 55
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Weight-loss surgery or medications
* Serious Psychiatric or medical conditions
* Substance abuse
* Ineligible for MRI
* Pregnant
* Eating disorder

Primary outcomes:
measure: Functional connectivity on fMRI
timeFrame: 8 weeks
Secondary outcomes:
measure: Association of functional connectivity change with changes in depression symptoms
timeFrame: 6 months
measure: Association of functional connectivity with maintenance of weight loss
timeFrame: 6 months
Other outcomes:
Locations:
city: Worcester
country: United States
facility: Umass Medical School
state: Massachusetts
Study officials:
References:
citation: 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.