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.

Study Overview

• Status: Completed
• Conditions: Nutrition Disorders; Body Weight; Pediatric Obesity; Binge Eating
• Intervention / Treatment: Behavioral: Restricted access task

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 Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14214
      • State University of New York at Buffalo, South Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 11 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Behavioral restriction; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in zBMI	Change in zBMI from baseline to 12 month follow-up	Baseline to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body fat percentage	Change in percent body fat from baseline to 12 month follow-up	Baseline to 12 months
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
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
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

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Katherine Balantekin, PhD, RD, Clinical Associate Professor

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2021
• Primary Completion (Actual): May 22, 2025
• Study Completion (Actual): May 22, 2025

Study Registration Dates

• First Submitted: December 10, 2021
• First Submitted That Met QC Criteria: December 29, 2021
• First Posted (Actual): January 4, 2022

Study Record Updates

• Last Update Posted (Estimated): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 7, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Children; Restriction; Relative Reinforcing Value; Obesity Risk; Loss of Control
• Additional Relevant MeSH Terms: Overnutrition; Hyperphagia; Signs and Symptoms, Digestive; Overweight; Bulimia; Obesity; Body Weight; Pediatric Obesity; Nutrition Disorders
• Other Study ID Numbers: STUDY00002806; K01DK120778 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No