The Intersection Between Loss of Control Eating and Obesity: The Role of Restriction and Food Reinforcement

NCT05177705 | Completed

• 2 other identifiers: STUDY00002806K01DK120778
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pediatric Obesity; Nutrition Disorders; Binge Eating; Body Weight

Keywords

Relative Reinforcing Value; Obesity Risk; Children; Loss of Control; Restriction

Outcome Measures

Primary Outcomes (1)

• Change in zBMI

  Change in zBMI from baseline to 12 month follow-up

  Baseline to 12 months

Secondary Outcomes (4)

• Change in body fat percentage

  Baseline to 12 months

• Impact of parental restriction of a High Energy Dense (HED) food on Loss of Control (LOC) eating.

  Baseline

• Association between relative reinforcing value of high energy dense foods and LOC

  Baseline

• Relationship between self-reported LOC eating and consumption during LOC test meal

  Baseline

Study Arms (1)

Behavioral restriction

EXPERIMENTAL

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.

Behavioral: Restricted access task

Interventions

Restricted access task BEHAVIORAL

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 no restricted period, participants and their parents will be given several portions of the preferred food and will consume it throughout the two-week period.

Behavioral restriction

Eligibility Criteria

• Age: 8 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

State University of New York at Buffalo, South Campus

Buffalo, New York, 14214, United States

Location

MeSH Terms

Conditions

Pediatric Obesity; Nutrition Disorders; Bulimia; Body Weight

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperphagia; Signs and Symptoms, Digestive

Study Officials

• Katherine Balantekin, PhD, RD

  Clinical Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: January 4, 2022
• Study Start: November 11, 2021
• Primary Completion: May 22, 2025
• Study Completion: May 22, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-07

Locations

US (1)