Pediatric ObesityNCT04701671
Project THINK: Trajectories of Health, Ingestive Behaviors, and Neurocognition in Kids
An observational study of Pediatric Obesity and Binge-Eating Disorder, run by University of Pittsburgh at 2 sites in United States.
Trial summary
Overweight/obesity and loss of control eating (characterized by the sense that one cannot control what or how much one is eating) are prevalent among children and adolescents, and both are associated with serious medical and psychosocial health complications. Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity, Binge-Eating Disorder
- What is being tested?
- Observational (not including MRI scanning) and Observational (including MRI scanning)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 180 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Dec 2020to 9 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Participants will include 180 children (9-12y) representing a spectrum of risk for eating and weight disorders, including overweight/obese (BMI ≥ 85th age- and sex-adjusted percentile) with LOC eating (n=60), overweight/obese without LOC eating (n=60), and healthy weight without LOC eating (5th percentile ≤ BMI < 85th percentile; n=60).
Who may be able to join
- Not currently taking any medications known to affect weight or appetite
- Free of any 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
- In the low average range or higher on measures of general intellectual functioning
- Free of any conditions affecting executive functioning (e.g., recent concussion, history of traumatic brain injury)
- Fluent in English, and able to read and comprehend study materials
- Not currently pregnant
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of PIttsburgh
Pittsburgh, Pennsylvania, 15213
Weight Control & Diabetes Research Center
Providence, Rhode Island, 02903
About this study
Official title: Executive Functioning, Weight Trajectories, and Loss of Control Eating in Children With Overweight/Obesity: A Prospective Study
Overweight/obesity and loss of control eating (characterized by the sense that one cannot control what or how much one is eating) are prevalent among children and adolescents, and both are associated with serious medical and psychosocial health complications. Although our recently published data suggest that youth with these conditions may have relative deficits in neurocognitive functioning, particularly working memory, understanding of how these processes and their neural correlates are related to change and stability in eating and weight-related outcomes over time is limited, thereby impeding development of targeted, optimally timed interventions. The present study aims to assess prospective associations between general and food-specific executive functioning and underlying neural substrates, and eating and weight outcomes among children at varying levels of risk overweight/obesity and eating disorders, which will help guide research efforts towards the development of effective prevention and intervention strategies.
Read the detailed description
The current study will examine prospective associations among general and food-specific EF and related neural substrates, and the developmental course of weight gain and LOC eating from middle childhood through early adolescence. Specific aims are to:
- Investigate prospective associations between general and food-specific EF and z-BMI trajectories. We expect that across risk groups, a) poorer baseline performance on both general and food-specific behavioral EF measures will predict steeper z-BMI gain trajectories; and b) worsening general and food-specific EF will track with the steepest z-BMI gain trajectories.
- Investigate associations between general and food-specific EF and LOC eating trajectories. We expect that across risk groups, a) poorer baseline performance on general and food-specific behavioral EF measures will predict worsening course of LOC eating; and b) worsening general and food-specific EF will track with worsening course of LOC eating.
- Investigate prospective associations between EF neural substrates and trajectories of z-BMI and LOC eating. We expect that across risk groups, a) greater activation in prefrontal regions associated with EF (e.g., dorsolateral prefrontal cortex, dorsal cingulate, parietal cortex) during general and food-specific WM tasks, and b) smaller decreases in activation of these regions over 18 months, will predict steeper z-BMI gain trajectories and worsening course of LOC eating.
- Conditions
- Pediatric Obesity, Binge-Eating Disorder
- Being tested
- Observational (not including MRI scanning), Observational (including MRI scanning)
- Keywords
- Loss of Control Eating, Executive Functioning, Pubertal Development
- Medical subject headings
- Pediatric Obesity, Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational (not including MRI scanning)Behavioural
Observational data will be obtained through self-report measures, parental report measures, cognitive assessments, and a semi-structured interview.
Observational (including MRI scanning)Behavioural
Observational data will be obtained through self-report measures, parental report measures, cognitive assessments, fMRI imaging, and a semi-structured interview.
| Study group | Role | What they receive |
|---|---|---|
| Normal Weight Control, no MRI-scan (30 participants) | Adolescents with a BMI percentile under 85% who are not randomly assigned to undergo MRI scans at baseline and 18-months. Receives: Behavioral: Observational (not including MRI scanning) | |
| Normal Weight Control with MRI-scan (30 participants) | Adolescents with a BMI percentile under 85% who are randomly assigned to undergo MRI scans at baseline and 18-months. Receives: Behavioral: Observational (including MRI scanning) | |
| Overweight Control, no MRI-scan (30 participants) | Adolescents with a BMI percentile at 85% or higher who are not randomly assigned to undergo MRI scans at baseline and 18-months. Receives: Behavioral: Observational (not including MRI scanning) | |
| Overweight Control with MRI-scan (30 participants) | Adolescents with a BMI percentile at 85% or higher who are randomly assigned to undergo MRI scans at baseline and 18-months. Receives: Behavioral: Observational (including MRI scanning) | |
| Overweight/Obese Experimental, no MRI-scan (30 participants) | Adolescents with a BMI percentile at 85% or higher, who report loss of control eating episodes and are not randomly assigned to undergo MRI scans at baseline and 18-months. Receives: Behavioral: Observational (not including MRI scanning) | |
| Overweight/Obese Experimental with MRI-scan (30 participants) | Adolescents with a BMI percentile at 85% or higher, who report loss of control eating episodes and are randomly assigned to undergo MRI scans at baseline and 18-months. Receives: Behavioral: Observational (including MRI scanning) |
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: Change in BMI from baseline to 24 months
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: Change in eating behavior from baseline to 24 months
General Executive Functioning
A general n-back task that will involve continuous presentation of neutral stimuli (letters or numbers). Participants indicate via button press whether the target (current) stimulus was presented n items ago.
Measured: Change in general executive functioning from baseline to 24 months
Food-Specific Executive Functioning
A food-specific WM task that involves continuous presentation of stimuli representing food and non-food items. Participants indicate via button press whether the target (current) stimulus was presented n items ago.
Measured: Change in food-specific executive functioning from baseline to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start10 Dec 2020
- Primary completion9 May 2028 (estimated)
- Study completion9 May 2028 (estimated)
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
- Case-control
- Time perspective
- Other
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University, 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
- NCT04701671
- Sponsor's protocol ID
- STUDY21070033
- Other IDs
- R01DK120597
- Status last verified
- Jun 2026
- First submitted
- 6 Jan 2021
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Executive Functioning, Weight Trajectories, and Loss of Control Eating in Children With Overweight/Obesity: A Prospective Study
- ClinicalTrials.gov ID
- NCT04701671
- Acronym / sponsor ID
- STUDY21070033
- Conditions
- Pediatric Obesity, Binge-Eating Disorder
- Keywords
- Loss of Control Eating, Executive Functioning, Pubertal Development
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Brown University, The Miriam Hospital, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 9 May 2028 (estimated)
- Study completion
- 9 May 2028 (estimated)
- First posted
- 8 Jan 2021 (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.
Overweight/obesity and loss of control eating (characterized by the sense that one cannot control what or how much one is eating) are prevalent among children and adolescents, and both are associated with serious medical and psychosocial health complications. Although our recently published data suggest that youth with these conditions may have relative deficits in neurocognitive functioning, particularly working memory, understanding of how these processes and their neural correlates are related to change and stability in eating and weight-related outcomes over time is limited, thereby impeding development of targeted, optimally timed interventions. The present study aims to assess prospective associations between general and food-specific executive functioning and underlying neural substrates, and eating and weight outcomes among children at varying levels of risk overweight/obesity and eating disorders, which will help guide research efforts towards the development of effective prevention and intervention strategies.
Detailed description
The current study will examine prospective associations among general and food-specific EF and related neural substrates, and the developmental course of weight gain and LOC eating from middle childhood through early adolescence. Specific aims are to:
- Investigate prospective associations between general and food-specific EF and z-BMI trajectories. We expect that across risk groups, a) poorer baseline performance on both general and food-specific behavioral EF measures will predict steeper z-BMI gain trajectories; and b) worsening general and food-specific EF will track with the steepest z-BMI gain trajectories.
- Investigate associations between general and food-specific EF and LOC eating trajectories. We expect that across risk groups, a) poorer baseline performance on general and food-specific behavioral EF measures will predict worsening course of LOC eating; and b) worsening general and food-specific EF will track with worsening course of LOC eating.
- Investigate prospective associations between EF neural substrates and trajectories of z-BMI and LOC eating. We expect that across risk groups, a) greater activation in prefrontal regions associated with EF (e.g., dorsolateral prefrontal cortex, dorsal cingulate, parietal cortex) during general and food-specific WM tasks, and b) smaller decreases in activation of these regions over 18 months, will predict steeper z-BMI gain trajectories and worsening course of LOC eating.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Normal Weight Control, no MRI-scan (30 participants) | – | Behavioral: Observational (not including MRI scanning)Adolescents with a BMI percentile under 85% who are not randomly assigned to undergo MRI scans at baseline and 18-months. |
| Normal Weight Control with MRI-scan (30 participants) | – | Behavioral: Observational (including MRI scanning)Adolescents with a BMI percentile under 85% who are randomly assigned to undergo MRI scans at baseline and 18-months. |
| Overweight Control, no MRI-scan (30 participants) | – | Behavioral: Observational (not including MRI scanning)Adolescents with a BMI percentile at 85% or higher who are not randomly assigned to undergo MRI scans at baseline and 18-months. |
| Overweight Control with MRI-scan (30 participants) | – | Behavioral: Observational (including MRI scanning)Adolescents with a BMI percentile at 85% or higher who are randomly assigned to undergo MRI scans at baseline and 18-months. |
| Overweight/Obese Experimental, no MRI-scan (30 participants) | – | Behavioral: Observational (not including MRI scanning)Adolescents with a BMI percentile at 85% or higher, who report loss of control eating episodes and are not randomly assigned to undergo MRI scans at baseline and 18-months. |
| Overweight/Obese Experimental with MRI-scan (30 participants) | – | Behavioral: Observational (including MRI scanning)Adolescents with a BMI percentile at 85% or higher, who report loss of control eating episodes and are randomly assigned to undergo MRI scans at baseline and 18-months. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Participants will include 180 children (9-12y) representing a spectrum of risk for eating and weight disorders, including overweight/obese (BMI ≥ 85th age- and sex-adjusted percentile) with LOC eating (n=60), overweight/obese without LOC eating (n=60), and healthy weight without LOC eating (5th percentile ≤ BMI < 85th percentile; n=60).
Key inclusion criteria (6 listed)
- Not currently taking any medications known to affect weight or appetite
- Free of any 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
- In the low average range or higher on measures of general intellectual functioning
- Free of any conditions affecting executive functioning (e.g., recent concussion, history of traumatic brain injury)
- Fluent in English, and able to read and comprehend study materials
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Observational (not including MRI scanning)Observational data will be obtained through self-report measures, parental report measures, cognitive assessments, and a semi-structured interview. | Behavioural | Normal Weight Control, no MRI-scan (30 participants), Overweight Control, no MRI-scan (30 participants), Overweight/Obese Experimental, no MRI-scan (30 participants) |
| Observational (including MRI scanning)Observational data will be obtained through self-report measures, parental report measures, cognitive assessments, fMRI imaging, and a semi-structured interview. | Behavioural | Normal Weight Control with MRI-scan (30 participants), Overweight Control with MRI-scan (30 participants), Overweight/Obese Experimental with MRI-scan (30 participants) |
Primary outcome
BMI (Body Mass Index)
Time frame: Change in BMI from baseline to 24 months
BMI will be assessed using height and weight (cm/g)
Eating Behavior
Time frame: Change in eating behavior from baseline to 24 months
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.
General Executive Functioning
Time frame: Change in general executive functioning from baseline to 24 months
A general n-back task that will involve continuous presentation of neutral stimuli (letters or numbers). Participants indicate via button press whether the target (current) stimulus was presented n items ago.
Food-Specific Executive Functioning
Time frame: Change in food-specific executive functioning from baseline to 24 months
A food-specific WM task that involves continuous presentation of stimuli representing food and non-food items. Participants indicate via button press whether the target (current) stimulus was presented n items ago.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- 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
2 sites 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 Disorder, run by University of Pittsburgh at 2 sites 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 6 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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: Change in BMI from baseline to 24 months). The study lists 4 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 4 Jun 2026.