NCT03976427

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 24, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 29, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 6, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2019

Completed
Last Updated

August 5, 2019

Status Verified

August 1, 2019

Enrollment Period

3 months

First QC Date

May 29, 2019

Last Update Submit

August 2, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Food Choice

    1 hour

  • Food Demand

    1 hour

Study Arms (1)

Guided Imagery

EXPERIMENTAL

Participants will listen to a guided imagery recording

Behavioral: Guided Imagery

Interventions

Guided ImageryBEHAVIORAL

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

Guided Imagery

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

OverweightObesity

Interventions

Imagery, Psychotherapy

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Participants will be assigned to a guided imagery exercise
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2019

First Posted

June 6, 2019

Study Start

April 24, 2019

Primary Completion

July 11, 2019

Study Completion

July 11, 2019

Last Updated

August 5, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will share

De-identified data for primary outcomes will be made available

Shared Documents
STUDY PROTOCOL, SAP, 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.

Locations