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

June 2, 2026 updated by: Andrea Goldschmidt, University of Pittsburgh

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Weight Control & Diabetes Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
BMI (Body Mass Index)
Time Frame: Change in BMI from baseline to 24 months
BMI will be assessed using height and weight (cm/g)
Change in BMI from baseline to 24 months
Eating Behavior
Time Frame: 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.
Change in eating behavior from baseline to 24 months
General Executive Functioning
Time Frame: 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.
Change in general executive functioning from baseline to 24 months
Food-Specific Executive Functioning
Time Frame: 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.
Change in food-specific executive functioning from baseline to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pittsburgh

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Brown University
The Miriam Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrea B. Goldschmidt, Ph.D., University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 10, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 9, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 9, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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