Project THINK: Trajectories of Health, Ingestive Behaviors, and Neurocognition in Kids

University of Pittsburgh

Status: Enrolling

Conditions: Binge-Eating Disorder; Pediatric Obesity

Treatments: Behavioral: Observational (not including MRI scanning); Behavioral: Observational (including MRI scanning)

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04701671

R01DK120597 (U.S. NIH Grant/Contract)

STUDY21070033

Details and patient eligibility

About

Overweight/obesity and loss of control eating (characterized by the sense that one cannot control what or how much one is eating) are prevalent among children and adolescents, and both are associated with serious medical and psychosocial health complications. Although our recently published data suggest that youth with these conditions may have relative deficits in neurocognitive functioning, particularly working memory, understanding of how these processes and their neural correlates are related to change and stability in eating and weight-related outcomes over time is limited, thereby impeding development of targeted, optimally timed interventions. The present study aims to assess prospective associations between general and food-specific executive functioning and underlying neural substrates, and eating and weight outcomes among children at varying levels of risk overweight/obesity and eating disorders, which will help guide research efforts towards the development of effective prevention and intervention strategies.

Full description

The current study will examine prospective associations among general and food-specific EF and related neural substrates, and the developmental course of weight gain and LOC eating from middle childhood through early adolescence. Specific aims are to:

1. Investigate prospective associations between general and food-specific EF and z-BMI trajectories. We expect that across risk groups, a) poorer baseline performance on both general and food-specific behavioral EF measures will predict steeper z-BMI gain trajectories; and b) worsening general and food-specific EF will track with the steepest z-BMI gain trajectories.
2. Investigate associations between general and food-specific EF and LOC eating trajectories. We expect that across risk groups, a) poorer baseline performance on general and food-specific behavioral EF measures will predict worsening course of LOC eating; and b) worsening general and food-specific EF will track with worsening course of LOC eating.
3. Investigate prospective associations between EF neural substrates and trajectories of z-BMI and LOC eating. We expect that across risk groups, a) greater activation in prefrontal regions associated with EF (e.g., dorsolateral prefrontal cortex, dorsal cingulate, parietal cortex) during general and food-specific WM tasks, and b) smaller decreases in activation of these regions over 18 months, will predict steeper z-BMI gain trajectories and worsening course of LOC eating.

Enrollment: 180 estimated patients

Sex: All

Ages: 9 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Not currently taking any medications known to affect weight or appetite
• Free of any current or past medical or psychiatric conditions known to significantly affect eating or weight (e.g., diabetes, bulimia nervosa), with the exception of binge eating disorder
• In the low average range or higher on measures of general intellectual functioning
• Free of any conditions affecting executive functioning (e.g., recent concussion, history of traumatic brain injury)
• Fluent in English, and able to read and comprehend study materials
• Not currently pregnant

Trial design

180 participants in 6 patient groups

Normal Weight Control, no MRI-scan (30 participants)

Description:

Adolescents with a BMI percentile under 85% who are not randomly assigned to undergo MRI scans at baseline and 18-months.

Treatment:

Behavioral: Observational (not including MRI scanning)

Normal Weight Control with MRI-scan (30 participants)

Description:

Adolescents with a BMI percentile under 85% who are randomly assigned to undergo MRI scans at baseline and 18-months.

Treatment:

Behavioral: Observational (including MRI scanning)

Overweight Control, no MRI-scan (30 participants)

Description:

Adolescents with a BMI percentile at 85% or higher who are not randomly assigned to undergo MRI scans at baseline and 18-months.

Treatment:

Behavioral: Observational (not including MRI scanning)

Overweight Control with MRI-scan (30 participants)

Description:

Adolescents with a BMI percentile at 85% or higher who are randomly assigned to undergo MRI scans at baseline and 18-months.

Treatment:

Behavioral: Observational (including MRI scanning)

Overweight/Obese Experimental, no MRI-scan (30 participants)

Description:

Adolescents with a BMI percentile at 85% or higher, who report loss of control eating episodes and are not randomly assigned to undergo MRI scans at baseline and 18-months.

Treatment:

Behavioral: Observational (not including MRI scanning)

Overweight/Obese Experimental with MRI-scan (30 participants)

Description:

Adolescents with a BMI percentile at 85% or higher, who report loss of control eating episodes and are randomly assigned to undergo MRI scans at baseline and 18-months.

Treatment:

Behavioral: Observational (including MRI scanning)