Trial record 13 of 17 for:    Thoracic Outlet Syndrome

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

This study is currently recruiting participants.
Verified July 2013 by The Miriam Hospital
Sponsor:
Collaborator:
The Obesity Society
Information provided by (Responsible Party):
Kathryn E. Demos, The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT01913743
First received: July 25, 2013
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

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
Obesity

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: The Effects of Mindsets on the Brain's Response to Food Cues

Resource links provided by NLM:


Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:
  • Blood oxygen level dependent (BOLD) signal differences between 4 different mindset conditions in response to food cues [ Time Frame: 1 day (single time point) ] [ Designated as safety issue: No ]
    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:
  • behavioral measures of physical activity and eating behavior assessed via questionnaires [ Time Frame: 1 day (single time point) ] [ Designated as safety issue: No ]
    behavioral measures of physical activity and eating behavior will be assessed via questionnaires in order to describe the sample


Estimated Enrollment: 35
Study Start Date: July 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
MINDSETS
overweight/obese

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Both
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).

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • MRI incompatibility
  • left handed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01913743

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

No publications provided

Responsible Party: Kathryn E. Demos, Assistant Professor (Research), The Miriam Hospital
ClinicalTrials.gov Identifier: NCT01913743     History of Changes
Other Study ID Numbers: MINDSETS - TOS
Study First Received: July 25, 2013
Last Updated: July 30, 2013
Health Authority: United States: Institutional Review Board, The Miriam Hospital
United States: Institutional Review Board, Brown University

Keywords provided by The Miriam Hospital:
fMRI
cognitive strategies
obesity
weight loss
mindsets

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 14, 2014