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

Executive Functioning, Weight Trajectories, and Loss of Control Eating in Children With Overweight/Obesity: A Prospective Study

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.

Study Overview

• Status: Recruiting
• Conditions: Pediatric Obesity; Binge-Eating Disorder
• Intervention / Treatment: Behavioral: Observational (not including MRI scanning); Behavioral: Observational (including MRI scanning)

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 Type: Observational
• Enrollment (Estimated): 180

Contacts and Locations

• Study Contact: Name: Erin Stalvey, B.S.; Phone Number: 412-586-9066; Email: stalveyer@upmc.edu
• Study Contact Backup: Name: Chloe Hudson, B.S.; Phone Number: 412-586-9082; Email: bitelab@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • University of Pittsburgh
      • Contact: Erin Stalvey, B.S.; Phone Number: 412-586-9066; Email: stalveyer@upmc.edu
      • Principal Investigator: Andrea B Goldschmidt, Ph.D.
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Active, not recruiting
      • Weight Control & Diabetes Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Participants will include 180 children (9-12y) representing a spectrum of risk for eating and weight disorders, including overweight/obese (BMI ≥ 85th age- and sex-adjusted percentile) with LOC eating (n=60), overweight/obese without LOC eating (n=60), and healthy weight without LOC eating (5th percentile ≤ BMI < 85th percentile; n=60).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Other

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normal Weight Control, no MRI-scan (30 participants); Adolescents with a BMI percentile under 85% who are not randomly assigned to undergo MRI scans at baseline and 18-months.	Behavioral: Observational (not including MRI scanning); Observational data will be obtained through self-report measures, parental report measures, cognitive assessments, and a semi-structured interview.
Normal Weight Control with MRI-scan (30 participants); Adolescents with a BMI percentile under 85% who are randomly assigned to undergo MRI scans at baseline and 18-months.	Behavioral: Observational (including MRI scanning); Observational data will be obtained through self-report measures, parental report measures, cognitive assessments, fMRI imaging, and a semi-structured interview.
Overweight Control, no MRI-scan (30 participants); Adolescents with a BMI percentile at 85% or higher who are not randomly assigned to undergo MRI scans at baseline and 18-months.	Behavioral: Observational (not including MRI scanning); Observational data will be obtained through self-report measures, parental report measures, cognitive assessments, and a semi-structured interview.
Overweight Control with MRI-scan (30 participants); Adolescents with a BMI percentile at 85% or higher who are randomly assigned to undergo MRI scans at baseline and 18-months.	Behavioral: Observational (including MRI scanning); Observational data will be obtained through self-report measures, parental report measures, cognitive assessments, fMRI imaging, and a semi-structured interview.
Overweight/Obese Experimental, no MRI-scan (30 participants); 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.	Behavioral: Observational (not including MRI scanning); Observational data will be obtained through self-report measures, parental report measures, cognitive assessments, and a semi-structured interview.
Overweight/Obese Experimental with MRI-scan (30 participants); 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.	Behavioral: Observational (including MRI scanning); Observational data will be obtained through self-report measures, parental report measures, cognitive assessments, fMRI imaging, and a semi-structured interview.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI (Body Mass Index)	BMI will be assessed using height and weight (cm/g)	Change in BMI from baseline to 24 months
Eating Behavior	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.	Change in eating behavior from baseline to 24 months
General Executive Functioning	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.	Change in general executive functioning from baseline to 24 months
Food-Specific Executive Functioning	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.	Change in food-specific executive functioning from baseline to 24 months

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Brown University; The Miriam Hospital
• Investigators: Principal Investigator: Andrea B. Goldschmidt, Ph.D., University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2020
• Primary Completion (Estimated): May 9, 2028
• Study Completion (Estimated): May 9, 2028

Study Registration Dates

• First Submitted: January 6, 2021
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (Actual): January 8, 2021

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Loss of Control Eating; Executive Functioning; Pubertal Development
• Additional Relevant MeSH Terms: Mental Disorders; Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Feeding and Eating Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Pediatric Obesity; Binge-Eating Disorder
• Other Study ID Numbers: STUDY21070033; R01DK120597 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No