Pediatric ObesityNCT05177705
The Intersection Between Loss of Control Eating and Obesity: The Role of Restriction and Food Reinforcement
A study testing Restricted access task and Structured Intake in people with Pediatric Obesity and Nutrition Disorders, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
This study aims to determine the relationships among loss of control eating, restriction, relative reinforcing value of high energy-dense food, and obesity risk. In order to achieve this aim, the investigators will follow children over the course of a year, obtaining behavioral and observational measurements, in… Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity, Nutrition Disorders, Binge Eating
- What is being tested?
- Restricted access task and Structured Intake
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2021to 22 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 8 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children (male and female) ages 8-11
- At risk for obesity or with obesity (defined as either having a BMI percentile that classifies the child as having overweight-BMI >85th percentile but <99th OR one + biological parent with overweight/obesity-BMI >25)
- Rating of neutral or higher for 50% of the study foods
- Consumption of one of the study foods at least twice/week
Who cannot join
- Children below age 8 or above age 11
- Not at risk for obesity (defined as having a BMI percentile that classifies the child as having normal weight-BMI <85th percentile without having a parent with overweight or obesity)
- Allergic to study foods
- Dislike of study foods (Less than 50% of the study foods rated neutral or higher)
- Does not consume at least one study food at least twice/week
- Current diagnosis of a clinical eating disorder (ED)
- Use of medications known to affect appetite (Ritalin, Adderall, Concerta, Wellbutrin, Prednisone, etc)
- Unwillingness to complete study visits
Trial locations and contacts
1 site in 1 country.
United States1 site
State University of New York at Buffalo, South Campus
Buffalo, New York, 14214
About this study
This study aims to determine the relationships among loss of control eating, restriction, relative reinforcing value of high energy-dense food, and obesity risk. In order to achieve this aim, the investigators will follow children over the course of a year, obtaining behavioral and observational measurements, in addition to a two-week restricted access and two week non-restricted access period.
Read the detailed description
The study will be mostly observational but will also include a randomized, cross-over design (the restricted access paradigm). The investigators will recruit children at risk for obesity in Erie County, New York (N=100, 50 boys, 50 girls). The study will include 4 visits at baseline and follow-up visits at 6 and 12 months. At the first visit, the participants will complete consent, height/weight/body fat, questionnaires, and complete a delayed discount task and the relative reinforcing value task. The participants will be randomized to have two weeks of restricted access first or two weeks of non-restricted access first, and then will come into the laboratory to do the loss of control test meal. Then they will have a one-week washout period, and will then complete the other two weeks of restricted/not restricted access. Following this, they will complete the loss of control test meal again. At the follow-up visits, participants will come into the laboratory to have their height/weight/body fat measured, complete questionnaires, and complete the delayed discounting task, food reinforcement and loss of control test meals. Participants will be compensated for their time after each visit. The details of the measures and procedures are outlined below.
- Conditions
- Pediatric Obesity, Nutrition Disorders, Binge Eating, Body Weight
- Being tested
- Restricted access task, Structured Intake
- Keywords
- Relative Reinforcing Value, Obesity Risk, Children, Loss of Control, Restriction
- Medical subject headings
- Pediatric Obesity, Nutrition Disorders, Bulimia, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restricted access taskBehavioural
In the restriction period participants will have their preferred (chosen after doing a preference task, including liking) food and similar alternatives restricted by their parent for 2 weeks.
Structured IntakeBehavioural
In the structured intake period, participants and their parents will be given several portions of the preferred food (chosen after doing a preference task, including liking) and will consume it throughout the two-week period.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral restriction first then structured intake | Experimental | This arm reflects participants assigned to the restriction - first condition order. In the restriction period participants will have their preferred (chosen after doing a preference task, including liking) food and similar alternatives restricted by their parent for 2 weeks. In the structured intake period period, participants and their parents will be given several portions of the preferred food (chosen after doing a preference task, including liking) and will consume it throughout the two-week period. Receives: Behavioral: Restricted access task; Behavioral: Structured Intake |
| Structured intake first then behavioral restriction | Experimental | This arm reflects participants assigned to the structured intake - first condition order. In the structured intake period, participants and their parents will be given several portions of the preferred food (chosen after doing a preference task, including liking) and will consume it throughout the two-week period. In the restriction period participants will have their preferred (chosen after doing a preference task, including liking) food and similar alternatives restricted by their parent for 2 weeks. Receives: Behavioral: Restricted access task; Behavioral: Structured Intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall kcal and STUDY Food kcal Consumed After the Intervention Conditions (Behavioral Restriction and Structured Intake)
This measure examines the energy intake during test meal after BOTH paradigm conditions: behavioral restriction (2 weeks of restricted access to the STUDY food and similar items followed by a test meal) and structured intake (2 weeks to consume 8 provided portions of the STUDY food followed by a test meal). Conditions occurred between session 2 and session 3, and session 3 and session 4. All participants were exposed to both conditions, these conditions were randomized and there was a one week wash out period week between the two conditions.
Measured: Visit 3 (day 21) and visit 4 (day 42)
Overall Macronutrients Consumed After the Intervention Conditions (Behavioral Restriction and Structured Intake)
This measure examines the macronutrient intake during test meal after BOTH paradigm conditions: behavioral restriction (2 weeks of restricted access to the STUDY food and similar items followed by a test meal) and structured intake (2 weeks to consume 8 provided portions of the STUDY food followed by a test meal). Conditions occurred between session 2 and session 3, and session 3 and session 4. All participants were exposed to both conditions, these conditions were randomized and there was a one week wash out period week between the two conditions.
Measured: Visit 3 (day 21) and visit 4 (day 42)
Secondary outcomes (4)
Association Between the Logged Relative Reinforcing Value (RRV Log) of a High Energy Dense Food (Referred to as the STUDY Food) and Loss of Control (LOC)
Relationships will be examined between the relative reinforcing value (RRV) of the STUDY food (which was measured at SESSION 1) and self-reported loss of control (LOC) eating (which was measured at the session 2 test meal; control test meal; no intervention occurred leading up to this test meal). RRV refers to how hard an individual is willing to work for a food and it is measured via the logged value of total responses (the logged value adjusts for skews). Scores range from 0 to 9.232. Higher values (worse outcome) indicate that an individual is willing to work harder (click longer) for their STUDY food. LOC eating was self - reported through a yes (value: 1; worse outcome) or no (value: 0; better outcome) question completed after the participant finished eating at the session 2 (control) test meal.
This outcome measure is focused on the survey data (thus, scores on a scale).
Measured: Session 1 (day 1) and Session 2 (day 7)
Association Between the Logged Relative Reinforcing Value (RRV Log) of a High Energy Dense Food (Referred to as the STUDY Food) and Loss of Control (LOC)
Relationships will be examined between the relative reinforcing value (RRV) of the STUDY food (which was measured at SESSION 1) and self-reported loss of control (LOC) eating (which was measured at the SESSION 2 test meal; control test meal; no intervention occurred leading up to this test meal). RRV refers to how hard an individual is willing to work for a food and it is measured via the logged value of total responses (the logged value adjusts for skews). Scores range from 0 to 9.232. Higher values (worse outcome) indicate that an individual is willing to work harder (click longer) for their STUDY food. LOC eating was self - reported through a yes (value: 1; worse outcome) or no (value: 0; better outcome) question completed after the participant finished eating at the session 2 (control) test meal.
This outcome measure is focused on the RRV measure, with the unit of Log(Response), as it is measured using the logged value of total responses to adjust for skew.
Measured: Session 1 (day 1) and Session 2 (day 7)
Relationship Between Self-reported Loss of Control (LOC) Eating and Energy Intake During Session 2 (Control) Test Meal
Relationships between self-reported feelings of LOC after the session 2 test meal and energy intake during the session 2 test meal (control test meal; no intervention occurred leading up to this test meal) will be assessed. LOC eating was self - reported through a yes (value: 1; worse outcome) or no (value: 0; better outcome) question completed after the participant finished eating at the session 2 (control) test meal. .
Measured: Session 2 (day 7)
Relationship Between Self-reported Loss of Control (LOC) Eating and Macronutrient Intake During the Session 2 (Control) Test Meal
Relationships between self-reported feelings of LOC after the session 2 test meal and macronutrient intake during the session 2 test meal (control test meal; no intervention occurred leading up to this test meal) will be assessed. LOC eating was self - reported through a yes (value: 1; worse outcome) or no (value: 0; better outcome) question completed after the participant finished eating at the session 2 (control) test meal. These analyses will look at how self-reported feelings of LOC during the session 2 test meal predict macronutrient intake during that same test meal.
Measured: Session 2 (day 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start11 Nov 2021
- Primary completion22 May 2025
- Study completion22 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Balantekin, State University of New York at Buffalo
- Investigators
- Katherine Balantekin, PhD, RD, Principal investigator, Clinical Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05177705
- Sponsor's protocol ID
- STUDY00002806
- Other IDs
- K01DK120778
- Status last verified
- Sep 2026
- First submitted
- 10 Dec 2021
- Last updated
- 1 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Intersection Between Loss of Control Eating and Obesity: The Role of Restriction and Food Reinforcement
- ClinicalTrials.gov ID
- NCT05177705
- Acronym / sponsor ID
- STUDY00002806
- Conditions
- Pediatric Obesity, Nutrition Disorders, Binge Eating, Body Weight
- Keywords
- Relative Reinforcing Value, Obesity Risk, Children, Loss of Control, Restriction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 22 May 2025 (actual)
- Study completion
- 22 May 2025 (actual)
- First posted
- 4 Jan 2022 (actual)
- Results
- Posted 1 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine the relationships among loss of control eating, restriction, relative reinforcing value of high energy-dense food, and obesity risk. In order to achieve this aim, the investigators will follow children over the course of a year, obtaining behavioral and observational measurements, in addition to a two-week restricted access and two week non-restricted access period.
Detailed description
The study will be mostly observational but will also include a randomized, cross-over design (the restricted access paradigm). The investigators will recruit children at risk for obesity in Erie County, New York (N=100, 50 boys, 50 girls). The study will include 4 visits at baseline and follow-up visits at 6 and 12 months. At the first visit, the participants will complete consent, height/weight/body fat, questionnaires, and complete a delayed discount task and the relative reinforcing value task. The participants will be randomized to have two weeks of restricted access first or two weeks of non-restricted access first, and then will come into the laboratory to do the loss of control test meal. Then they will have a one-week washout period, and will then complete the other two weeks of restricted/not restricted access. Following this, they will complete the loss of control test meal again. At the follow-up visits, participants will come into the laboratory to have their height/weight/body fat measured, complete questionnaires, and complete the delayed discounting task, food reinforcement and loss of control test meals. Participants will be compensated for their time after each visit. The details of the measures and procedures are outlined below.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral restriction first then structured intake | Experimental | Behavioral: Restricted access task, Behavioral: Structured IntakeThis arm reflects participants assigned to the restriction - first condition order. In the restriction period participants will have their preferred (chosen after doing a preference task, including liking) food and similar alternatives restricted by their parent for 2 weeks. In the structured intake period period, participants and their parents will be given several portions of the preferred food (chosen after doing a preference task, including liking) and will consume it throughout the two-week period. |
| Structured intake first then behavioral restriction | Experimental | Behavioral: Restricted access task, Behavioral: Structured IntakeThis arm reflects participants assigned to the structured intake - first condition order. In the structured intake period, participants and their parents will be given several portions of the preferred food (chosen after doing a preference task, including liking) and will consume it throughout the two-week period. In the restriction period participants will have their preferred (chosen after doing a preference task, including liking) food and similar alternatives restricted by their parent for 2 weeks. |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children (male and female) ages 8-11
- At risk for obesity or with obesity (defined as either having a BMI percentile that classifies the child as having overweight-BMI >85th percentile but <99th OR one + biological parent with overweight/obesity-BMI >25)
- Rating of neutral or higher for 50% of the study foods
- Consumption of one of the study foods at least twice/week
Key exclusion criteria (8 listed)
- Children below age 8 or above age 11
- Not at risk for obesity (defined as having a BMI percentile that classifies the child as having normal weight-BMI <85th percentile without having a parent with overweight or obesity)
- Allergic to study foods
- Dislike of study foods (Less than 50% of the study foods rated neutral or higher)
- Does not consume at least one study food at least twice/week
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 |
|---|---|---|
| Restricted access taskIn the restriction period participants will have their preferred (chosen after doing a preference task, including liking) food and similar alternatives restricted by their parent for 2 weeks. | Behavioural | Behavioral restriction first then structured intake, Structured intake first then behavioral restriction |
| Structured IntakeIn the structured intake period, participants and their parents will be given several portions of the preferred food (chosen after doing a preference task, including liking) and will consume it throughout the two-week period. | Behavioural | Behavioral restriction first then structured intake, Structured intake first then behavioral restriction |
Primary outcome
Overall kcal and STUDY Food kcal Consumed After the Intervention Conditions (Behavioral Restriction and Structured Intake)
Time frame: Visit 3 (day 21) and visit 4 (day 42)
This measure examines the energy intake during test meal after BOTH paradigm conditions: behavioral restriction (2 weeks of restricted access to the STUDY food and similar items followed by a test meal) and structured intake (2 weeks to consume 8 provided portions of the STUDY food followed by a test meal). Conditions occurred between session 2 and session 3, and session 3 and session 4. All participants were exposed to both conditions, these conditions were randomized and there was a one week wash out period week between the two conditions.
Overall Macronutrients Consumed After the Intervention Conditions (Behavioral Restriction and Structured Intake)
Time frame: Visit 3 (day 21) and visit 4 (day 42)
This measure examines the macronutrient intake during test meal after BOTH paradigm conditions: behavioral restriction (2 weeks of restricted access to the STUDY food and similar items followed by a test meal) and structured intake (2 weeks to consume 8 provided portions of the STUDY food followed by a test meal). Conditions occurred between session 2 and session 3, and session 3 and session 4. All participants were exposed to both conditions, these conditions were randomized and there was a one week wash out period week between the two conditions.
4 secondary outcomes
Association Between the Logged Relative Reinforcing Value (RRV Log) of a High Energy Dense Food (Referred to as the STUDY Food) and Loss of Control (LOC)
Time frame: Session 1 (day 1) and Session 2 (day 7)
Association Between the Logged Relative Reinforcing Value (RRV Log) of a High Energy Dense Food (Referred to as the STUDY Food) and Loss of Control (LOC)
Time frame: Session 1 (day 1) and Session 2 (day 7)
Relationship Between Self-reported Loss of Control (LOC) Eating and Energy Intake During Session 2 (Control) Test Meal
Time frame: Session 2 (day 7)
Relationship Between Self-reported Loss of Control (LOC) Eating and Macronutrient Intake During the Session 2 (Control) Test Meal
Time frame: Session 2 (day 7)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Pediatric Obesity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
RecruitingPhase 3
Efficacy, Safety, and Pharmacokinetics of Tirzepatide (LY3298176) Once Weekly Versus Placebo in Pediatric Participants 6 to Less Than 12 Years of Age Who Have Obesity (ADVANCE-SURMOUNT-KIDS)
Obesity
Recruiting
National Childhood Obesity Prevention Programme BE FIT 24
Childhood Obesity
RecruitingPhase 2
Oxytocin for Weight Loss in Adolescents
Obesity, Adolescent, Oxytocin
RecruitingPhase 3
A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)
Obesity, Overweight
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.
Katherine Balantekin, PhD, RD principal investigator
Clinical Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restricted access task and Structured Intake in people with Pediatric Obesity and Nutrition Disorders, run by State University of New York at Buffalo 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 4 inclusion and 8 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 1 Oct 2026. 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?
Yes. Results are posted in the registry (first posted 1 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall kcal and STUDY Food kcal Consumed After the Intervention Conditions (Behavioral Restriction and Structured Intake) (time frame: Visit 3 (day 21) and visit 4 (day 42)). The study lists 2 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 1 Oct 2026.