Translating Neuroscience to Population Health
Primary Purpose
Overweight and Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Guided Imagery
Sponsored by
About this trial
This is an interventional basic science trial for Overweight and Obesity
Eligibility Criteria
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
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Guided Imagery
Arm Description
Participants will listen to a guided imagery recording
Outcomes
Primary Outcome Measures
Brain Activation in Self-Regulation Brain Regions
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
Brain Activation in Reward Brain Regions
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
Secondary Outcome Measures
Food Choice
Observational preference for healthy compared to unhealthy food choices measured by the number of healthy and unhealthy foods selected following the guided imagery exercise
Food Demand
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
Full Information
NCT ID
NCT03976427
First Posted
May 29, 2019
Last Updated
August 2, 2019
Sponsor
University of Kansas Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03976427
Brief Title
Translating Neuroscience to Population Health
Official Title
Changing How the Brain Responds When Making Decisions: Translating Neuroscience to Population Health
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 24, 2019 (Actual)
Primary Completion Date
July 11, 2019 (Actual)
Study Completion Date
July 11, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participants will be assigned to a guided imagery exercise
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Guided Imagery
Arm Type
Experimental
Arm Description
Participants will listen to a guided imagery recording
Intervention Type
Behavioral
Intervention Name(s)
Guided Imagery
Intervention Description
The guided imagery exercise asks participants to think about positive associations with healthy foods and imagine their future healthy selves.
Primary Outcome Measure Information:
Title
Brain Activation in Self-Regulation Brain Regions
Description
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
Time Frame
1 hour
Title
Brain Activation in Reward Brain Regions
Description
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
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Food Choice
Description
Observational preference for healthy compared to unhealthy food choices measured by the number of healthy and unhealthy foods selected following the guided imagery exercise
Time Frame
1 hour
Title
Food Demand
Description
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
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Translating Neuroscience to Population Health
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