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

Pediatric Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04701671
• Other study ID #: STUDY21070033
• Secondary ID: R01DK120597
• Status: Recruiting
• Start date: December 10, 2020
• Est. completion date: December 9, 2025

Study information

• Verified date: February 2024
• Source: University of Pittsburgh
• Contact: Erin Stalvey, B.S.
• Phone: 412-586-9066
• Email: stalveyer[@]upmc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 9, 2025
• Est. primary completion date: December 9, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Binge-Eating Disorder
• Bulimia
• Feeding and Eating Disorders
• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Observational (not including MRI scanning)
Observational data will be obtained through self-report measures, parental report measures, cognitive assessments, and a semi-structured interview.
• Observational (including MRI scanning)
Observational data will be obtained through self-report measures, parental report measures, cognitive assessments, fMRI imaging, and a semi-structured interview.

Locations

Country	Name	City	State
United States	University of PIttsburgh	Pittsburgh	Pennsylvania
United States	Weight Control & Diabetes Research Center	Providence	Rhode Island

Sponsors (4)

Lead Sponsor	Collaborator
University of Pittsburgh	Brown University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), The Miriam Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI (Body Mass Index)	BMI will be assessed using height and weight (cm/g)	Change in BMI from baseline to 24 months
Primary	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
Primary	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
Primary	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