Translating Neuroscience to Population Health

August 2, 2019 updated by: University of Kansas Medical Center

Changing How the Brain Responds When Making Decisions: Translating Neuroscience to Population Health

The current study will examine the relationship between brain responses and a guided imagery exercise in overweight and obese individuals. Results of this work are highly relevant to public health because they employ neuroimaging methods to understand food decision-making. Findings from this study will inform health decision making and holds great potential for future translation across multiple health behaviors and scalable interventions to impact population health

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Negative health behaviors (e.g. overeating, smoking) are associated with increased negative health outcomes. Engaging in healthy behaviors is not always rewarding (e.g. carrot vs. cake). Neural models of healthy behaviors focus on the balance between reward and regulation brain regions. The current pilot application examines the engagement of these regions during the evaluation of food and nonfood cues before and after a guided imagery exercise targeting positive associations with food and regulation.

The long-term goal is to understand the interaction between positive associations with healthy foods and thinking about future rewards may influence healthy decision-making. The objective of the current study is to empirically test the combined effects of positive affect and positive episodic future thinking on brain activation.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

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

    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

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

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • body mass index 25 to 55 kg/m2
  • right-handed
  • not currently dieting or attempting to lose weight.

Exclusion Criteria:

  • serious medical illness unsuitable for the magnetic resonance imaging scanner based on best clinical judgment
  • any neurologic or current psychiatric diagnosis
  • currently taking anti-seizure medication
  • history of concussion
  • left-handedness
  • risk for hazard due to magnetic fields such as metal in the body surgically or accidentally
  • pregnancy

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

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Guided Imagery
Participants will listen to a guided imagery recording
The guided imagery exercise asks participants to think about positive associations with healthy foods and imagine their future healthy selves.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain Activation in Self-Regulation Brain Regions
Time Frame: 1 hour
Functional Magnetic Resonance Imaging will measure brain activation changes in self-regulation brain regions including the dorsolateral prefrontal cortex, dorsomedial prefrontal cortex and anterior cingulate cortex when participants view healthy compared to unhealthy food images before and after the guided imagery exercise
1 hour
Brain Activation in Reward Brain Regions
Time Frame: 1 hour
Functional Magnetic Resonance Imaging will measure brain activation changes in reward brain regions including the ventromedial prefrontal cortex and striatum when participants view healthy compared to unhealthy food images before and after the guided imagery exercise
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Food Choice
Time Frame: 1 hour
Observational preference for healthy compared to unhealthy food choices measured by the number of healthy and unhealthy foods selected following the guided imagery exercise
1 hour
Food Demand
Time Frame: 1 hour
Behavioral changes in demand for healthy compared to unhealthy foods will be measured by asking participants to indicate how healthy and unhealthy food items they would eat in a day if the items were freely available
1 hour

Collaborators and Investigators

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

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 (Actual)

April 24, 2019

Primary Completion (Actual)

July 11, 2019

Study Completion (Actual)

July 11, 2019

Study Registration Dates

First Submitted

May 29, 2019

First Submitted That Met QC Criteria

June 3, 2019

First Posted (Actual)

June 6, 2019

Study Record Updates

Last Update Posted (Actual)

August 5, 2019

Last Update Submitted That Met QC Criteria

August 2, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00142526

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identified data for primary outcomes will be made available

IPD Sharing Time Frame

Data will be available 1-year after study completion

IPD Sharing Access Criteria

Researchers may contact the Principal Investigator to request the data and will be required to sign research sharing agreements with the institution before gaining access.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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