Modifiable Predictors of Neural Vulnerabilities for Obesity

Sponsor
University of Nebraska Lincoln (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04522947
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH), University of Nebraska (Other), The University of Texas at San Antonio (Other), Stanford University (Other)
221
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53
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Milkshake fMRI
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
221 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
All participants complete the same fMRI protocol which includes delivery of appetizing taste stimuli and tasteless stimuli while in the scanner.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)
Primary Purpose:
Other
Official Title:
Modifiable Predictors of Neural Vulnerabilities for Obesity
Actual Study Start Date :
Oct 30, 2020
Anticipated Primary Completion Date :
Apr 1, 2025
Anticipated Study Completion Date :
Apr 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: fMRI

Participants are delivered sips of appetizing tastes (milkshake) and tasteless solution throughout the task while in the MRI scanner.

Other: Milkshake fMRI
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.

Outcome Measures

Primary Outcome Measures

  1. Reward region activation [5 seconds after taste delivery]

    Activation in brain reward regions following taste delivery, as measured by fMRI

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Nebraska-Lincoln Lincoln Nebraska United States 68588

Sponsors and Collaborators

  • University of Nebraska Lincoln
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • University of Nebraska
  • The University of Texas at San Antonio
  • Stanford University

Investigators

  • Principal Investigator: Timothy D Nelson, Ph.D., University of Nebraska Lincoln

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Nebraska Lincoln
ClinicalTrials.gov Identifier:
NCT04522947
Other Study ID Numbers:
  • 20317
  • R01DK125651
First Posted:
Aug 21, 2020
Last Update Posted:
Aug 24, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 24, 2021