Pediatric ObesityNCT04121598
Project TEACH: The Eating, Affect, and Cognitive Health Study
An observational study of Pediatric Obesity and Binge Eating, run by University of Pittsburgh at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Pediatric Obesity, Binge Eating
- What is being tested?
- Observational
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2019to 30 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- Child
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.
Who may be able to join
- Are between the ages of 10 and 17
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Weight Control & Diabetes Research Center
Providence, Rhode Island, 02903
About this study
Official title: 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.
Read the 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
- Being tested
- Observational
- Keywords
- Working Memory, Executive Functioning, Loss of Control Eating
- Medical subject headings
- Pediatric Obesity, Bulimia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Observational data will be obtained through self-report measures, parental report measures, cognitive assessments, and a semi-structured interview.
| Study group | Role | What they receive |
|---|---|---|
| Normal Weight Control | Adolescents with a BMI percentile under 85%. Receives: Other: Observational | |
| Overweight/Obese Control | Adolescents with a BMI percentile at 85% or higher. Receives: Other: Observational | |
| Overweight/Obese Experimental | Adolescents with a BMI percentile at 85% or higher, who report loss of control eating episodes. Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI (Body Mass Index)
BMI will be assessed using height and weight (cm/g)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Across 2-week EMA period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start14 Jun 2019
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- The Miriam Hospital, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Andrea Goldschmidt, University of Pittsburgh
- Investigators
- Andrea B. Goldschmidt, Ph.D., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121598
- Sponsor's protocol ID
- STUDY21070036
- Other IDs
- R03DK117198
- Status last verified
- Jan 2022
- First submitted
- 3 Oct 2019
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project TEACH: Investigation of Momentary, Prospective Associations Between Working Memory and Eating Behavior in Children
- ClinicalTrials.gov ID
- NCT04121598
- Acronym / sponsor ID
- STUDY21070036
- Conditions
- Pediatric Obesity, Binge Eating
- Keywords
- Working Memory, Executive Functioning, Loss of Control Eating
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- The Miriam Hospital, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 14 Jun 2019 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 10 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal Weight Control | – | Other: ObservationalAdolescents with a BMI percentile under 85%. |
| Overweight/Obese Control | – | Other: ObservationalAdolescents with a BMI percentile at 85% or higher. |
| Overweight/Obese Experimental | – | Other: ObservationalAdolescents with a BMI percentile at 85% or higher, who report loss of control eating episodes. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Are between the ages of 10 and 17
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalObservational data will be obtained through self-report measures, parental report measures, cognitive assessments, and a semi-structured interview. | Other | Normal Weight Control, Overweight/Obese Control, Overweight/Obese Experimental |
Primary outcome
BMI (Body Mass Index)
Time frame: Visit 1 (pre-EMA)
BMI will be assessed using height and weight (cm/g)
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea B. Goldschmidt, Ph.D. principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Obesity and Binge Eating, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI (Body Mass Index) (time frame: Visit 1 (pre-EMA)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2022.