Modifiable Predictors of Neural Vulnerabilities for Obesity

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Obesity
• Intervention / Treatment: Other: Milkshake fMRI

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 Type: Interventional
• Enrollment (Estimated): 221
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68588
      • University of Nebraska-Lincoln

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reward region activation	Activation in brain reward regions following taste delivery, as measured by fMRI	5 seconds after taste delivery

Collaborators and Investigators

• Sponsor: University of Nebraska Lincoln
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Wayne State University; Stanford University; University of Utah; Gretchen Swanson Center for Nutrition
• Investigators: Principal Investigator: Timothy D Nelson, Ph.D., University of Nebraska Lincoln

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2020
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: August 13, 2020
• First Submitted That Met QC Criteria: August 18, 2020
• First Posted (Actual): August 21, 2020

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 20317; R01DK125651 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No