Clinical trial NCT04121598: Project TEACH: The Eating, Affect, and Cognitive Health Study
Official title: Project TEACH: Investigation of Momentary, Prospective Associations Between Working Memory and Eating Behavior in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Obesity
Binge Eating
Keywords: Working Memory
Executive Functioning
Loss of Control Eating
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: The Miriam Hospital
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-10-10
Enrollment: 48
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
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.

Brief summary: Specific aims are to:

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. 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.

Detailed description: Pediatric overweight and obesity continue to represent major threats to public health. One cause is loss of control (LOC) eating, which involves a sense that one cannot control what or how much one is eating, affects up to 30% of youth with overweight/obesity, and may undermine weight control attempts via increased psychiatric distress, including onset of full-syndrome eating disorders. One methodology to explore factors underlying LOC eating is ecological momentary assessment (EMA), which enable examination of "in the moment" processes related to eating behavior. A neurocognitive factor implicated in LOC eating is executive functioning (EF; i.e., the ability to adaptively engage in ongoing, goal-oriented behavior). It is critical to understand the role of EF in the development of LOC eating because EF informs one's ability to understand and respond to emotions, and to engage in healthy weight regulation behaviors. In particular, working memory (WM), conceptualized as the ability to retain goal-relevant information when faced with distracting or irrelevant information, may impact regulation of eating behavior including vulnerability to LOC eating. Although WM is typically conceptualized as a trait-level factor, it is known to vary at the state-level as well, which may increase susceptibility for engaging in goal-incompatible behaviors. The proposed study uses EMA to characterize state-level WM and eating behavior in youth with overweight/obesity and LOC eating to understand how WM variations between- and within-subjects influence acute maladaptive eating. 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.

Eligibility criteria: Inclusion Criteria:

* Are between the ages of 10 and 17

Exclusion Criteria:

* 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

Primary outcomes:
measure: BMI (Body Mass Index)
timeFrame: Visit 1 (pre-EMA)
measure: Eating Behavior
timeFrame: Visit 1 (pre-EMA)
measure: Eating Behavior
timeFrame: Across 2-week EMA period
measure: Working Memory
timeFrame: Visit 1 (pre-EMA)
measure: Working Memory
timeFrame: Across 2-week EMA period
measure: Spatial Reasoning
timeFrame: Across 2-week EMA period
Secondary outcomes:
Other outcomes:
Locations:
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: