Project TEACH: The Eating, Affect, and Cognitive Health Study

NCT04121598 | Completed

• 2 other identifiers: STUDY21070036R03DK117198
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Specific aims are to:

1. 1.Assess variability in performance on state-level measures of working memory (WM) delivered via Ecological Momentary Assessment (EMA). The investigators expect WM performance to vary over the course of a day across participants, and to be poorer and more variable among youth with overweight/obesity and loss of control (LOC) eating relative to overweight/obese and non-overweight controls.
2. 2.Investigate the relationship between state WM and eating behavior. The investigators expect that poorer momentary WM will predict an increased likelihood of LOC eating as assessed via EMA, and greater energy intake and poorer dietary quality as assessed via dietary recall, across participants. The investigators expect these effects to be strongest among youth with concomitant overweight/obesity and LOC eating.

Conditions

Pediatric Obesity; Binge Eating

Keywords

Working Memory; Executive Functioning; Loss of Control Eating

Outcome Measures

Primary Outcomes (6)

• BMI (Body Mass Index)

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

  Visit 1 (pre-EMA)

• 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.

  Visit 1 (pre-EMA)

• Eating Behavior

  Eating behavior will be assessed through Nutritional Data System for Research (NDSR) software, which calculates daily macro-nutrient numbers based on self-report food recalls.

  Across 2-week EMA period

• Working Memory

  Working memory will be assessed using 3 NIH Toolbox measures: the list sort task, the Flanker task, and the dimensional card task.

  Visit 1 (pre-EMA)

• Working Memory

  Working memory will be assessed using a number changing task created for the purpose of this study. Sum correct responses will be scored with higher scores indicating a higher number of correct responses.

  Across 2-week EMA period

• Spatial Reasoning

  Spatial reasoning will be assessed using a moving grid task created for the purpose of this study. Sum correct responses will be scored with higher scores indicating a higher number of correct responses.

  Across 2-week EMA period

Study Arms (3)

Normal Weight Control

Adolescents with a BMI percentile under 85%.

Other: Observational

Overweight/Obese Control

Adolescents with a BMI percentile at 85% or higher.

Other: Observational

Overweight/Obese Experimental

Adolescents with a BMI percentile at 85% or higher, who report loss of control eating episodes.

Other: Observational

Interventions

Observational OTHER

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

Normal Weight Control; Overweight/Obese Control; Overweight/Obese Experimental

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be 50 children, ages 10-17, 20 of whom are overweight/obese and report LOC eating (i.e., at least 3 objectively or subjectively large LOC episodes in the past 3 months), 20 of whom who will serve as overweight/obese controls with no LOC eating, and 10 of whom are normal-weight controls with no LOC eating.

You may qualify if:

• Are between the ages of 10 and 17

You may not qualify if:

• Are currently taking any medications known to affect weight or appetite
• Report 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
• Have an Intelligence Quotient (IQ) in the borderline range or lower, or any condition affecting executive functioning (e.g., recent concussion, history of traumatic brain injury);
• Are unable to read or comprehend study materials
• Are receiving concurrent treatment for overweight/obesity

Sponsors & Collaborators

• University of Pittsburgh: lead
• The Miriam Hospital: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Weight Control & Diabetes Research Center

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Pediatric Obesity; Bulimia

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperphagia; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Andrea B. Goldschmidt, Ph.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 10, 2019
• Study Start: June 14, 2019
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: January 10, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)