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出境医 / 临床实验 / Translating Neuroscience to Population Health

Translating Neuroscience to Population Health

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

Condition or disease Intervention/treatment Phase
Overweight and Obesity Behavioral: Guided Imagery Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Participants will be assigned to a guided imagery exercise
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Changing How the Brain Responds When Making Decisions: Translating Neuroscience to Population Health
Actual Study Start Date : April 24, 2019
Actual Primary Completion Date : July 11, 2019
Actual Study Completion Date : July 11, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: Guided Imagery
Participants will listen to a guided imagery recording
 Behavioral: Guided Imagery
The guided imagery exercise asks participants to think about positive associations with healthy foods and imagine their future healthy selves.
Outcome Measures
Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Locations
Layout table for location information
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
Tracking Information
First Submitted Date  ICMJE May 29, 2019
First Posted Date  ICMJE June 6, 2019
Last Update Posted Date August 5, 2019
Actual Study Start Date  ICMJE April 24, 2019
Actual Primary Completion Date July 11, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2019)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2019)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Translating Neuroscience to Population Health
Official Title  ICMJE Changing How the Brain Responds When Making Decisions: Translating Neuroscience to Population Health
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Participants will be assigned to a guided imagery exercise
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Overweight and Obesity
Intervention  ICMJE Behavioral: Guided Imagery
The guided imagery exercise asks participants to think about positive associations with healthy foods and imagine their future healthy selves.
Study Arms  ICMJE Experimental: Guided Imagery
Participants will listen to a guided imagery recording
Intervention: Behavioral: Guided Imagery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 3, 2019) 		20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 11, 2019
Actual Primary Completion Date July 11, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03976427
Other Study ID Numbers  ICMJE STUDY00142526
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified data for primary outcomes will be made available
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Data will be available 1-year after study completion
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.
Responsible Party University of Kansas Medical Center
Study Sponsor  ICMJE University of Kansas Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Kansas Medical Center
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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