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

NCT ID: NCT05177705

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-11
• Study Completion Date: 2025-05-22

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.

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.

Conditions

Pediatric Obesity; Nutrition Disorders; Binge Eating; Body Weight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Restricted access task

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

State University of New York at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Katherine Balantekin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katherine Balantekin, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

Clinical Associate Professor

Locations

State University of New York at Buffalo, South Campus

Buffalo, New York, United States

Countries

United States

Other Identifiers

K01DK120778

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00002806

Identifier Type: -

Identifier Source: org_study_id