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

Obesity Clinical Trial

— MINDSETS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01913743
• Other study ID #: MINDSETS - TOS
• Status: Recruiting
• Phase: N/A
• First received: July 25, 2013
• Last updated: July 30, 2013
• Start date: July 2013
• Est. completion date: March 2014

Study information

• Verified date: July 2013
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board, The Miriam HospitalUnited States: Institutional Review Board, Brown University
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 55 Years

Eligibility

Inclusion Criteria:

• MRI compatibility

• 25-55 yrs old

• 25-40 BMI

• weight stable

• right handed

Exclusion Criteria:

• MRI incompatibility

• left handed

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Obesity

Locations

Country	Name	City	State
United States	Weight Control & Diabetes Research Center	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
The Miriam Hospital	The Obesity Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood oxygen level dependent (BOLD) signal differences between 4 different mindset conditions in response to food cues	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)	No
Secondary	behavioral measures of physical activity and eating behavior assessed via questionnaires	behavioral measures of physical activity and eating behavior will be assessed via questionnaires in order to describe the sample	1 day (single time point)	No