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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03976427
Other study ID # STUDY00142526
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 24, 2019
Est. completion date July 11, 2019

Study information

Verified date August 2019
Source University of Kansas Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date July 11, 2019
Est. primary completion date July 11, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Guided Imagery
The guided imagery exercise asks participants to think about positive associations with healthy foods and imagine their future healthy selves.

Locations

Country Name City State
United States University of Kansas Medical Center Kansas City Kansas

Sponsors (1)

Lead Sponsor Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 1 hour
Primary 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 1 hour
Secondary 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 1 hour
Secondary 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 1 hour
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