Clinical trial

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

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT04701671

Active, not recruitingNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age9 Years to 12 Years

SexAll

Healthy volunteersAccepted

ConditionPediatric Obesity, Binge-Eating Disorder

Full registry 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

Treatments and study arms

Observational (not including MRI scanning)

Behavioral

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

Observational (including MRI scanning)

Behavioral

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

Primary outcomes

BMI (Body Mass Index)Change in BMI from baseline to 24 months

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

Eating BehaviorChange 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.

General Executive FunctioningChange 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.

Food-Specific Executive FunctioningChange 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.

Study locations

2 locations were listed when this page was built. The first 40 are shown.

University of PIttsburgh🇺🇸 Pittsburgh, Pennsylvania, United States

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Weight Control & Diabetes Research Center🇺🇸 Providence, Rhode Island, United States

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