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The Effects of Mindsets on the Brain's Response to Food Cues (MINDSETS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01913743
Recruitment Status : Unknown
Verified July 2013 by Kathryn E. Demos, The Miriam Hospital.
Recruitment status was:  Recruiting
First Posted : August 1, 2013
Last Update Posted : August 1, 2013
The Obesity Society
Information provided by (Responsible Party):
Kathryn E. Demos, The Miriam Hospital

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 (ʻCHANGEʼ), a cognitive strategy emphasized in ACT (ʻACCEPTʼ), and a cognitive strategy used in smoking cessation (ʻLATERʼ) relative to a control condition (ʻNOWʼ), in their effectiveness in altering reward and inhibitory control responses to food cues among obese individuals.

Condition or disease

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Study Type : Observational
Estimated Enrollment : 35 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: The Effects of Mindsets on the Brain's Response to Food Cues
Study Start Date : July 2013
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : March 2014


Primary Outcome Measures :
  1. Blood oxygen level dependent (BOLD) signal differences between 4 different mindset conditions in response to food cues [ Time Frame: 1 day (single time point) ]
    brain response to food cues measured via functional magnetic resonance imaging (fMRI) BOLD signal change will be assessed across all participants while using the 4 different mindsets potential differences in the BOLD response to food cues will be assessed between the 4 mindsets

Secondary Outcome Measures :
  1. behavioral measures of physical activity and eating behavior assessed via questionnaires [ Time Frame: 1 day (single time point) ]
    behavioral measures of physical activity and eating behavior will be assessed via questionnaires in order to describe the sample

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Inclusion Criteria:

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

Exclusion Criteria:

  • MRI incompatibility
  • left handed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01913743

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United States, Rhode Island
Weight Control & Diabetes Research Center Recruiting
Providence, Rhode Island, United States, 02903
Contact: Kathryn E Demos, PhD    401-793-8939   
Principal Investigator: Kathryn E Demos, PhD         
Sponsors and Collaborators
The Miriam Hospital
The Obesity Society
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Principal Investigator: Kathryn E Demos, PhD Brown University Medical School

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Responsible Party: Kathryn E. Demos, Assistant Professor (Research), The Miriam Hospital Identifier: NCT01913743     History of Changes
Other Study ID Numbers: MINDSETS - TOS
First Posted: August 1, 2013    Key Record Dates
Last Update Posted: August 1, 2013
Last Verified: July 2013
Keywords provided by Kathryn E. Demos, The Miriam Hospital:
cognitive strategies
weight loss
Additional relevant MeSH terms:
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Nutrition Disorders
Body Weight
Signs and Symptoms