Pediatric Obesity Clinical Trial
Official title:
The Intersection Between Loss of Control Eating and Obesity: The Role of Restriction and Food Reinforcement
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.
Status | Recruiting |
Enrollment | 110 |
Est. completion date | April 18, 2025 |
Est. primary completion date | April 18, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 8 Years to 11 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | State University of New York at Buffalo, South Campus | Buffalo | New York |
Lead Sponsor | Collaborator |
---|---|
State University of New York at Buffalo | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in zBMI | Change in zBMI from baseline to 12 month follow-up | Baseline to 12 months | |
Secondary | Change in body fat percentage | Change in percent body fat from baseline to 12 month follow-up | Baseline to 12 months | |
Secondary | Impact of parental restriction of a High Energy Dense (HED) food on Loss of Control (LOC) eating. | To examine change in energy intake and macronutrient composition during LOC test meal between parental restriction condition and parental non-restriction condition. | Baseline | |
Secondary | Association between relative reinforcing value of high energy dense foods and LOC | Relationships will be examined between RRV and both self-reported LOC eating and intake (calories, macronutrient distribution) in the LOC test meal. | Baseline | |
Secondary | Relationship between self-reported LOC eating and consumption during LOC test meal | Responses between self-reported feelings of LOC and intake (calories, macronutrient distribution) will be compared. | Baseline |
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