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NCT Number: NCT04701671

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

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.

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Key information

Conditions

Pediatric Obesity Binge-Eating Disorder Body Weight Feeding and Eating Disorders Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

9 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of PIttsburgh, Pittsburgh, Pennsylvania, United States

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About this study

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:

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. BMI (Body Mass Index)

    Time frame: Change in BMI from baseline to 24 months

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

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Brown University
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • The Miriam Hospital

Registry information

Official study title

Executive Functioning, Weight Trajectories, and Loss of Control Eating in Children With Overweight/Obesity: A Prospective Study

Important dates

Study start
2020
Primary completion
2028
Study completion
2028
First posted
Jan 8, 2021
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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