Clinical trial NCT01913743: The Effects of Mindsets on the Brain's Response to Food Cues
Official title: The Effects of Mindsets on the Brain's Response to Food Cues
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Keywords: fMRI
cognitive strategies
obesity
weight loss
mindsets
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: The Obesity Society
First posted: 2013-08-01
Enrollment: 35
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The recruited sample will include both males and females between the ages of 25-55 years with BMIs between 25-40. This age range reflects the modal ages for obese participants presenting for behavioral weight loss, and individuals with BMIs greater than 40 typically do not fit comfortably within the scanner bore. As with previous studies at the WCDRC, all participants will be weight stable (defined as within +/- 5 lbs. for the past two months).

Brief summary: Previous studies have shown that obese individuals exhibit greater reward-related brain activity in response to food cues than lean individuals and our group has shown that successful weight loss maintainers who were previously obese and now maintain a healthy weight have increased control-related activity when viewing food cues. These findings suggest key roles for both reward-related brain areas and inhibitory control regions in eating behavior. However, no studies to date have examined (a) whether the response to food cues (i.e., cue-reactivity) can be changed in obese individuals, (b) which strategies are most effective at altering brain response to food cues, or (c) the neural mechanisms that support such change.

Given the omnipresent environmental cues to eat and the association between heightened reward-responsivity and obesity, it is critical to investigate ways to potentially alter food cue-reactivity in the obese. The most widely employed approach for behavioral weight loss treatment is Cognitive Behavioral Therapy (CBT), which incorporates strategies to control and change cognitions (e.g., avoid desire to eat tempting foods by focusing on something else). This approach is sometimes described as "change- focused" because modifying negative thoughts is assumed to thereby change associated maladaptive emotions and behaviors. Alternatively, emerging evidence suggests Acceptance and Commitment Therapy (ACT), which teaches participants to recognize and accept their cravings as feelings that need not be acted upon, may also be effective in treating obesity. A third strategy often employed in smoking cessation and substance abuse treatment is to focus on the long-term consequences of behaviors, however this form of treatment is not typically used in behavioral weight loss therapy. Thus although each approach is potentially effective, these treatment approaches differ greatly in the cognitive strategies they employ.

The primary aim of the proposed research is to compare a cognitive strategy used in CBT ('CHANGE'), a cognitive strategy emphasized in ACT ('ACCEPT'), and a cognitive strategy used in smoking cessation ('LATER') relative to a control condition ('NOW'), in their effectiveness in altering reward and inhibitory control responses to food cues among obese individuals.


Eligibility criteria: Inclusion Criteria:

* MRI compatibility
* 25-55 yrs old
* 25-40 BMI
* weight stable
* right handed

Exclusion Criteria:

* MRI incompatibility
* left handed

Primary outcomes:
measure: Blood oxygen level dependent (BOLD) signal differences between 4 different mindset conditions in response to food cues
timeFrame: 1 day (single time point)
Secondary outcomes:
measure: behavioral measures of physical activity and eating behavior assessed via questionnaires
timeFrame: 1 day (single time point)
Other outcomes:
Locations:
city: Providence
country: United States
facility: Weight Control & Diabetes Research Center
state: Rhode Island
Study officials:
affiliation: Brown University Medical School
name: Kathryn E Demos, PhD
role: PRINCIPAL_INVESTIGATOR
References: