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

NCT05177705 | Completed Results

• 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

Body Weight; Pediatric Obesity; Nutrition Disorders; Binge Eating

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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)

  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)

  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

  Session 2 (day 7)

• Relationship Between Self-reported Loss of Control (LOC) Eating and Macronutrient Intake During the Session 2 (Control) Test Meal

  Session 2 (day 7)

Study Arms (2)

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.

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.

Behavioral: Restricted access task; Behavioral: Structured Intake

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.

Behavioral restriction first then structured intake; Structured intake first then behavioral restriction

Structured Intake BEHAVIORAL

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.

Behavioral restriction first then structured intake; Structured intake first then 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

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

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

Results Point of Contact

• Title: Dr. Katherine Balantekin
• Organization: University at Buffalo

knbalant@buffalo.edu

(716) 829 - 5578

Study Officials

• Katherine Balantekin, PhD, RD

  Clinical Associate Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: October 1, 2026
• Results First Posted: October 1, 2026

Record last verified: 2026-09

Locations

US (1)