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

July 30, 2013 updated by: Kathryn E. Demos, The Miriam Hospital

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Weight Control & Diabetes Research Center
        • Contact:
        • Principal Investigator:
          • Kathryn E Demos, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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).

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • MRI incompatibility
  • left handed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
MINDSETS
overweight/obese

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day (single time point)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day (single time point)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Kathryn E Demos, PhD, Brown University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

March 1, 2014

Study Completion (Anticipated)

March 1, 2014

Study Registration Dates

First Submitted

July 25, 2013

First Submitted That Met QC Criteria

July 30, 2013

First Posted (Estimate)

August 1, 2013

Study Record Updates

Last Update Posted (Estimate)

August 1, 2013

Last Update Submitted That Met QC Criteria

July 30, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • MINDSETS - TOS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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