Project THINK: Trajectories of Health, Ingestive Behaviors, and Neurocognition in Kids
NCT ID: NCT04701671
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
180 participants
OBSERVATIONAL
2020-12-10
2028-05-09
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
OTHER
Study Groups
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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.
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.
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.
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.
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.
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.
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.
Interventions
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Observational (not including MRI scanning)
Observational data will be obtained through self-report measures, parental report measures, cognitive assessments, and a semi-structured interview.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
9 Years
12 Years
ALL
Yes
Sponsors
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Brown University
OTHER
The Miriam Hospital
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Pittsburgh
OTHER
Responsible Party
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Andrea Goldschmidt
Associate Professor
Principal Investigators
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Andrea B. Goldschmidt, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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University of PIttsburgh
Pittsburgh, Pennsylvania, United States
Weight Control & Diabetes Research Center
Providence, Rhode Island, United States
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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STUDY21070033
Identifier Type: -
Identifier Source: org_study_id
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