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

Pediatric Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05177705
• Other study ID #: STUDY00002806
• Secondary ID: K01DK120778
• Status: Recruiting
• Phase: Early Phase 1
• Start date: November 11, 2021
• Est. completion date: April 18, 2025

Study information

• Verified date: February 2024
• Source: State University of New York at Buffalo
• Contact: Katherine Balantekin, PhD, RD
• Phone: (716) 829-5578
• Email: knbalant[@]buffalo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Binge Eating
• Body Weight
• Bulimia
• Nutrition Disorders
• Obesity
• Pediatric Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	State University of New York at Buffalo, South Campus	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
State University of New York at Buffalo	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

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