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Active, not recruitingNCT04701671Updated Jun 4, 2026

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

An observational study in Pediatric Obesity and Binge-Eating Disorder, sponsored by University of Pittsburgh. Active, not recruiting at 2 sites in United States. Open to participants aged 9 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-04.

Sponsored by University of Pittsburgh · Observational

Study type
Observational
Model
Case-control
Time perspective
Other
Enrollment
180
Ages
9 Years to 12 Years
Sex
All
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Study 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.

Read the 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.
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Conditions studied

  • Pediatric Obesity
  • Binge-Eating Disorder

Keywords

  • Loss of Control Eating
  • Executive Functioning
  • Pubertal Development
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In context

Pediatric Obesity

1,117 studies on the registry are indexed under Pediatric Obesity; 189 are open to participants now.

This study's planned enrollment of 180 is close to the median of 200 across 231 observational studies indexed under Pediatric Obesity.

Browse Pediatric Obesity studies →

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
9 Years to 12 Years
Sexes eligible
All
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).

Eligibility 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
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Study design

Observational model
Case-control
Time perspective
Other
Enrollment
180 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

Interventions

  • BehavioralObservational (not including MRI scanning)

    Observational data will be obtained through self-report measures, parental report measures, cognitive assessments, and a semi-structured interview.

  • BehavioralObservational (including MRI scanning)

    Observational data will be obtained through self-report measures, parental report measures, cognitive assessments, fMRI imaging, and a semi-structured interview.

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What researchers measure

Primary outcomes

  1. BMI (Body Mass Index)

    BMI will be assessed using height and weight (cm/g)

    Time frame: Change in BMI from baseline to 24 months

  2. 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.

    Time frame: Change in eating behavior from baseline to 24 months

  3. 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.

    Time frame: Change in general executive functioning from baseline to 24 months

  4. 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.

    Time frame: Change in food-specific executive functioning from baseline to 24 months

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Study locations

2 sites
  • University of PIttsburgh
    Pittsburgh, Pennsylvania 15213, United States
  • Weight Control & Diabetes Research Center
    Providence, Rhode Island 02903, United States
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References and documents

Study documents

  • Informed consent form · Nov 4, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04701671
Lead sponsor
University of Pittsburgh
Collaborators
Brown University, The Miriam Hospital, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Andrea Goldschmidt (Associate Professor, University of Pittsburgh) — Principal investigator
First posted
Jan 8, 2021
Start date
Dec 10, 2020
Primary completion
May 9, 2028 (estimated)
Completion
May 9, 2028 (estimated)
Last update
Jun 4, 2026

Study contacts

Andrea B. Goldschmidt, Ph.D.
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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