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

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ClinicalTrials.gov Identifier: NCT04121598
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 10, 2019
Sponsor:
Collaborator:
Brown University
Information provided by (Responsible Party):
The Miriam Hospital

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.

Condition or disease Intervention/treatment
Pediatric Obesity Binge Eating Other: Observational

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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Project TEACH: Investigation of Momentary, Prospective Associations Between Working Memory and Eating Behavior in Children
Actual Study Start Date : June 14, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Group/Cohort Intervention/treatment
Normal Weight Control
Adolescents with a BMI percentile under 85%.
Other: Observational
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.
Other: Observational
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.
Other: Observational
Observational data will be obtained through self-report measures, parental report measures, cognitive assessments, and a semi-structured interview.




Primary Outcome Measures :
  1. BMI (Body Mass Index) [ Time Frame: Visit 1 (pre-EMA) ]
    BMI will be assessed using height and weight (cm/g)

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes 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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04121598


Contacts
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Contact: Erin R. Stalvey, B.S. 401-793-8962 estalvey@lifespan.org
Contact: Bailey E. Bradford, B.S. 401-793-8969 bbradford@lifespan.org

Locations
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United States, Rhode Island
Weight Control & Diabetes Research Center Recruiting
Providence, Rhode Island, United States, 02903
Contact: Erin Stalvey, B.S.    401-793-8962    estalvey@lifespan.org   
Contact: Bailey Bradford, B.S.    401-793-8969    bbradford@lifespan.org   
Principal Investigator: Andrea B. Goldschmidt, Ph.D.         
Sponsors and Collaborators
The Miriam Hospital
Brown University
Investigators
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Principal Investigator: Andrea B. Goldschmidt, Ph.D. Brown University
  Study Documents (Full-Text)

Documents provided by The Miriam Hospital:
Informed Consent Form  [PDF] July 10, 2019


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Responsible Party: The Miriam Hospital
ClinicalTrials.gov Identifier: NCT04121598     History of Changes
Other Study ID Numbers: 1288337
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Miriam Hospital:
Working Memory
Executive Functioning
Loss of Control Eating
Additional relevant MeSH terms:
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Pediatric Obesity
Bulimia
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight