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

Recruiting

• Conditions: Binge-Eating Disorder; Pediatric Obesity
• Interventions: Behavioral: Observational (not including MRI scanning); Behavioral: Observational (including MRI scanning)

• Registration Number: NCT04701671
• Lead Sponsor: University of Pittsburgh

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2020-12-10
• Study First Submitted: 2021-01-06
• Study First Submitted QC: 2021-01-06
• Study First Posted: 2021-01-08
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-07
• Primary Completion: 2025-12-09
• Study Completion: 2025-12-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Overweight/Obese Experimental, no MRI-scan (30 participants)	Observational (not including MRI scanning)	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.
Normal Weight Control with MRI-scan (30 participants)	Observational (including MRI scanning)	Adolescents with a BMI percentile under 85% who are randomly assigned to undergo MRI scans at baseline and 18-months.
Overweight/Obese Experimental with MRI-scan (30 participants)	Observational (including MRI scanning)	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.
Normal Weight Control, no MRI-scan (30 participants)	Observational (not including MRI scanning)	Adolescents with a BMI percentile under 85% who are not randomly assigned to undergo MRI scans at baseline and 18-months.
Overweight Control, no MRI-scan (30 participants)	Observational (not including MRI scanning)	Adolescents with a BMI percentile at 85% or higher who are not randomly assigned to undergo MRI scans at baseline and 18-months.
Overweight Control with MRI-scan (30 participants)	Observational (including MRI scanning)	Adolescents with a BMI percentile at 85% or higher who are randomly assigned to undergo MRI scans at baseline and 18-months.

Primary Outcome Measures

Name	Time	Method
BMI (Body Mass Index)	Change in BMI from baseline to 24 months	BMI will be assessed using height and weight (cm/g)
Eating Behavior	Change in eating behavior from baseline to 24 months	Eating behavior will be assessed using the Eating Disorder Examination (EDE), a semi-structured interview. Global scores are calculated, with higher scores indicating higher disordered eating symptomology.
General Executive Functioning	Change in general executive functioning from baseline to 24 months	A general n-back task that will involve continuous presentation of neutral stimuli (letters or numbers). Participants indicate via button press whether the target (current) stimulus was presented n items ago.
Food-Specific Executive Functioning	Change in food-specific executive functioning from baseline to 24 months	A food-specific WM task that involves continuous presentation of stimuli representing food and non-food items. Participants indicate via button press whether the target (current) stimulus was presented n items ago.

Trial Locations

Locations (2)

University of PIttsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Weight Control & Diabetes Research Center; 🇺🇸 Providence, Rhode Island, United States