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

NCT ID: NCT04121598

Last Updated: 2022-01-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 48 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-14
• Study Completion Date: 2021-11-30

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.

Conditions

Pediatric Obesity; Binge Eating

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Normal Weight Control

Adolescents with a BMI percentile under 85%.

Observational

Intervention Type: OTHER

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

Overweight/Obese Control

Adolescents with a BMI percentile at 85% or higher.

Observational

Intervention Type: OTHER

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

Overweight/Obese Experimental

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

Observational

Intervention Type: OTHER

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

Interventions

Observational

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Miriam Hospital

OTHER

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Andrea Goldschmidt

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea B. Goldschmidt, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Weight Control & Diabetes Research Center

Providence, Rhode Island, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R03DK117198

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY21070036

Identifier Type: -

Identifier Source: org_study_id