The Intersection Between Loss of Control Eating and Obesity: The Role of Restriction and Food Rei… (NCT05177705) | Clinical Trial Compass
CompletedNot Applicable
The Intersection Between Loss of Control Eating and Obesity: The Role of Restriction and Food Reinforcement
United States126 participantsStarted 2021-11-11
Plain-language 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 addition to a two-week restricted access and two week non-restricted access period.
Who can participate
Age range
8 Years – 11 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.