NCT01913743

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 ('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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

August 1, 2013

Status Verified

July 1, 2013

Enrollment Period

8 months

First QC Date

July 25, 2013

Last Update Submit

July 30, 2013

Conditions

Keywords

fMRIcognitive strategiesobesityweight lossmindsets

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (1)

  • behavioral measures of physical activity and eating behavior assessed via questionnaires

    1 day (single time point)

Study Arms (1)

MINDSETS

overweight/obese

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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).

You may qualify if:

  • MRI compatibility
  • yrs old
  • BMI
  • weight stable
  • right handed

You may not qualify if:

  • MRI incompatibility
  • left handed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weight Control & Diabetes Research Center

Providence, Rhode Island, 02903, United States

RECRUITING

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Kathryn E Demos, PhD

    Brown University Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor (Research)

Study Record Dates

First Submitted

July 25, 2013

First Posted

August 1, 2013

Study Start

July 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

August 1, 2013

Record last verified: 2013-07

Locations