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
2 other identifiers
observational
180
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2020
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 10, 2020
CompletedFirst Submitted
Initial submission to the registry
January 6, 2021
CompletedFirst Posted
Study publicly available on registry
January 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 9, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 9, 2028
December 10, 2025
December 1, 2025
7.4 years
January 6, 2021
December 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Study Arms (6)
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.
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.
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.
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.
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.
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.
Interventions
Observational data will be obtained through self-report measures, parental report measures, cognitive assessments, and a semi-structured interview.
Observational data will be obtained through self-report measures, parental report measures, cognitive assessments, fMRI imaging, and a semi-structured interview.
Eligibility Criteria
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).
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pittsburghlead
- Brown Universitycollaborator
- The Miriam Hospitalcollaborator
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)collaborator
Study Sites (2)
University of PIttsburgh
Pittsburgh, Pennsylvania, 15213, United States
Weight Control & Diabetes Research Center
Providence, Rhode Island, 02903, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea B. Goldschmidt, Ph.D.
University of Pittsburgh
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 6, 2021
First Posted
January 8, 2021
Study Start
December 10, 2020
Primary Completion (Estimated)
May 9, 2028
Study Completion (Estimated)
May 9, 2028
Last Updated
December 10, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share