- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04121598
Project TEACH: The Eating, Affect, and Cognitive Health Study
January 5, 2022 updated by: Andrea Goldschmidt, University of Pittsburgh
Project TEACH: Investigation of Momentary, Prospective Associations Between Working Memory and Eating Behavior in Children
Specific aims are to:
- 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.
- 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
48
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02903
- Weight Control & Diabetes Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 17 years (Child)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Normal Weight Control
Adolescents with a BMI percentile under 85%.
|
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 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 data will be obtained through self-report measures, parental report measures, cognitive assessments, and a semi-structured interview.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BMI (Body Mass Index)
Time Frame: Visit 1 (pre-EMA)
|
BMI will be assessed using height and weight (cm/g)
|
Visit 1 (pre-EMA)
|
Eating Behavior
Time Frame: Visit 1 (pre-EMA)
|
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
Time Frame: Across 2-week EMA period
|
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
Time Frame: Visit 1 (pre-EMA)
|
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
Time Frame: Across 2-week EMA period
|
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
Time Frame: Across 2-week EMA period
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 14, 2019
Primary Completion (Actual)
November 30, 2021
Study Completion (Actual)
November 30, 2021
Study Registration Dates
First Submitted
October 3, 2019
First Submitted That Met QC Criteria
October 7, 2019
First Posted (Actual)
October 10, 2019
Study Record Updates
Last Update Posted (Actual)
January 10, 2022
Last Update Submitted That Met QC Criteria
January 5, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY21070036
- R03DK117198 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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