Active — Not RecruitingNot Applicable

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

United States180 participantsStarted 2020-12-10

Plain-language 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.

Who can participate

Age range

9 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

BMI (Body Mass Index)

Timeframe: Change in BMI from baseline to 24 months

Eating Behavior

Timeframe: Change in eating behavior from baseline to 24 months

General Executive Functioning

Timeframe: Change in general executive functioning from baseline to 24 months

Food-Specific Executive Functioning

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

Trial details

NCT IDNCT04701671

SponsorUniversity of Pittsburgh

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-05-09

View on ClinicalTrials.gov More Pediatric Obesity trials