Modifiable Predictors of Neural Vulnerabilities for Obesity

Obesity Clinical Trial

Official title:

Modifiable Predictors of Neural Vulnerabilities for Obesity

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04522947
• Other study ID #: 20317
• Secondary ID: R01DK125651
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 30, 2020
• Est. completion date: April 1, 2025

Study information

• Verified date: February 2024
• Source: University of Nebraska Lincoln
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 221
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	University of Nebraska-Lincoln	Lincoln	Nebraska

Sponsors (6)

Lead Sponsor	Collaborator
University of Nebraska Lincoln	Gretchen Swanson Center for Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Stanford University, University of Utah, Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reward region activation	Activation in brain reward regions following taste delivery, as measured by fMRI	5 seconds after taste delivery