- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03976427
Translating Neuroscience to Population Health
Changing How the Brain Responds When Making Decisions: Translating Neuroscience to Population Health
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
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
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Overweight and Obesity
-
University Hospital, LilleNational Research Agency, France; European Union; University of Lille Nord de... and other collaboratorsNot yet recruitingOverweight and Obesity | Overweight, Childhood | Overweight, Infant
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Institut Investigacio Sanitaria Pere VirgiliCompletedObesity, Childhood | Overweight and Obesity | Overweight, ChildhoodSpain
-
Memorial Sloan Kettering Cancer CenterRecruitingObesity | Overweight | Overweight and Obesity | Obese | Overweight or ObesityUnited States
-
Holbaek SygehusUniversity of Copenhagen; University of Florida; University of Minnesota; Hebrew... and other collaboratorsRecruitingChildhood Overweight and ObesityDenmark
-
Universidade do Extremo Sul Catarinense - Unidade...RecruitingObesity | Overweight and Obesity | Obesity; Endocrine | Overweight, Obesity and Other HyperalimentationBrazil
-
Mexican National Institute of Public HealthUNICEFCompleted
-
Universidade do PortoFundação para a Ciência e a Tecnologia; Administração Regional de Saúde do... and other collaboratorsCompletedOverweight and ObesityPortugal
-
University of British ColumbiaTerminatedOverweight and ObesityCanada
-
National Taiwan University HospitalCompleted
Clinical Trials on Guided Imagery
-
University of MinhoFoundation for Science and Technology, PortugalActive, not recruitingDiabetes Mellitus | Diabetic Foot UlcerPortugal
-
William Beaumont HospitalsWithdrawnChronic Pain | Pelvic PainUnited States
-
Universiti Sains MalaysiaCompletedFunctional Gastrointestinal DisordersMalaysia
-
University of MinhoFoundation for Science and Technology, PortugalCompletedDiabetes Mellitus | Diabetic Foot UlcerPortugal
-
Dicle UniversityCompleted
-
University of TorontoDalhousie University; AWHONN Canada, with Canadian Nurses Foundation Nursing... and other collaboratorsCompletedHypertension | Pre-Eclampsia | Hypertension, Pregnancy-InducedCanada
-
Kenneth M Peters, MDTerminatedPelvic Pain | Cystitis, InterstitialUnited States
-
University of Wisconsin, MadisonCompletedStress, Psychological
-
University of California, Los AngelesChildren's Hospital Los AngelesCompletedSickle Cell DiseaseUnited States
-
Virginia Commonwealth UniversityNational Institute of Nursing Research (NINR)CompletedPreterm Birth | Maternal StressUnited States