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

NCT ID: NCT01913743

Last Updated: 2013-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

fMRI cognitive strategies obesity weight loss mindsets

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MINDSETS

overweight/obese

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* MRI incompatibility
* left handed
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Obesity Society

OTHER

Sponsor Role collaborator

The Miriam Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kathryn E. Demos

Assistant Professor (Research)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kathryn E Demos, PhD

Role: PRINCIPAL_INVESTIGATOR

Brown University Medical School

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Weight Control & Diabetes Research Center

Providence, Rhode Island, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Kathryn E Demos, PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MINDSETS - TOS

Identifier Type: -

Identifier Source: org_study_id