Modifiable Predictors of Neural Vulnerabilities for Obesity
Primary Purpose
Obesity
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Milkshake fMRI
Sponsored by

About this trial
This is an interventional other trial for Obesity
Eligibility Criteria
Inclusion Criteria:
- Age 19 years or older
- Previous participation in the Preschool Problem Solving Study OR lived in Lancaster County, NE for at least part of high school
Exclusion Criteria:
- Contraindications for functional magnetic resonance imaging (fMRI):
- metal in body
- pregnancy
- braces
- non-removal piercings
- hair extensions
- As of 8/13/21, for individuals who were not in the Preschool Problem Solving Study but are invited to participate in the current study because they lived in Lancaster County for at least part of high school, the maximum age for eligibility is 20 years of age.
Sites / Locations
- University of Nebraska-Lincoln
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
fMRI
Arm Description
Participants are delivered sips of appetizing tastes (milkshake) and tasteless solution throughout the task while in the MRI scanner.
Outcomes
Primary Outcome Measures
Reward region activation
Activation in brain reward regions following taste delivery, as measured by fMRI
Secondary Outcome Measures
Full Information
NCT ID
NCT04522947
First Posted
August 13, 2020
Last Updated
October 6, 2023
Sponsor
University of Nebraska Lincoln
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), The University of Texas at San Antonio, Stanford University, University of Utah, Gretchen Swanson Center for Nutrition
1. Study Identification
Unique Protocol Identification Number
NCT04522947
Brief Title
Modifiable Predictors of Neural Vulnerabilities for Obesity
Official Title
Modifiable Predictors of Neural Vulnerabilities for Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 30, 2020 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska Lincoln
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), The University of Texas at San Antonio, Stanford University, University of Utah, Gretchen Swanson Center for Nutrition
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 purpose of this study is to examine how certain factors in childhood and adolescence relate to neural vulnerabilities for obesity in young adulthood. It is hypothesized that specific individual and environmental factors will significantly predict neural vulnerabilities for obesity.
Detailed Description
Studies aimed at elucidating neural vulnerability factors for obesity - including high food reward sensitivity and poor food regulation - hold particular promise. However, relatively little is known about the modifiable factors that contribute to these neural vulnerabilities, thus precluding the development of potentially powerful interventions to promote healthy long-term weight trajectories. Further, the limited research in this area lacks critical developmental and environmental context. The current proposal addresses these gaps by examining the roles of selected modifiable cognitive (executive control), behavioral (diet, sleep), affective (negative affect), and environmental (obesogenic environment) factors throughout childhood and adolescence in predicting emerging neural vulnerabilities for obesity during the pivotal transition to young adulthood. The specific aims are to: 1) Determine the impact of executive control development across childhood and adolescence on food reward sensitivity and regulation in young adulthood; 2) Determine the impact of a set of behavioral and affective factors in adolescence (i.e., diet, sleep, negative affect) on food reward sensitivity and regulation in young adulthood; and 3) Explore the impact of the obesogenic environment encountered in adolescence on food reward sensitivity and regulation in young adulthood.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants complete the same fMRI protocol which includes delivery of appetizing taste stimuli and tasteless stimuli while in the scanner.
Masking
None (Open Label)
Allocation
N/A
Enrollment
221 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
fMRI
Arm Type
Experimental
Arm Description
Participants are delivered sips of appetizing tastes (milkshake) and tasteless solution throughout the task while in the MRI scanner.
Intervention Type
Other
Intervention Name(s)
Milkshake fMRI
Intervention Description
While in the MRI scanner, the participant is shown a cue indicating the impending delivery of either milkshake or tasteless solution, followed by a brief blank screen, then delivery of the sip, and then a swallow cue. This procedure is repeated throughout the task.
Primary Outcome Measure Information:
Title
Reward region activation
Description
Activation in brain reward regions following taste delivery, as measured by fMRI
Time Frame
5 seconds after taste delivery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 19 years or older
Previous participation in the Preschool Problem Solving Study OR lived in Lancaster County, NE for at least part of high school
Exclusion Criteria:
Contraindications for functional magnetic resonance imaging (fMRI):
metal in body
pregnancy
braces
non-removal piercings
hair extensions
As of 8/13/21, for individuals who were not in the Preschool Problem Solving Study but are invited to participate in the current study because they lived in Lancaster County for at least part of high school, the maximum age for eligibility is 20 years of age.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy D Nelson, Ph.D.
Organizational Affiliation
University of Nebraska Lincoln
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska-Lincoln
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68588
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available
Learn more about this trial
Modifiable Predictors of Neural Vulnerabilities for Obesity
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