Clinical trial NCT04701671: Project THINK: Trajectories of Health, Ingestive Behaviors, and Neurocognition in Kids
Official title: Executive Functioning, Weight Trajectories, and Loss of Control Eating in Children With Overweight/Obesity: A Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pediatric Obesity
Binge-Eating Disorder
Keywords: Loss of Control Eating
Executive Functioning
Pubertal Development
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Brown University
name: The Miriam Hospital
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-01-08
Enrollment: 180
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

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.

Detailed description: 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:

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.

Eligibility 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

Primary outcomes:
measure: BMI (Body Mass Index)
timeFrame: Change in BMI from baseline to 24 months
measure: Eating Behavior
timeFrame: Change in eating behavior from baseline to 24 months
measure: General Executive Functioning
timeFrame: Change in general executive functioning from baseline to 24 months
measure: Food-Specific Executive Functioning
timeFrame: Change in food-specific executive functioning from baseline to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of PIttsburgh
state: Pennsylvania
city: Providence
country: United States
facility: Weight Control & Diabetes Research Center
state: Rhode Island
Study officials:
affiliation: University of Pittsburgh
name: Andrea B. Goldschmidt, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: