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

Sponsor

State University of New York at Buffalo (Other)

Overall Status

Recruiting

CT.gov ID

NCT05177705

Collaborator

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

110

Enrollment

Location

33.6

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pediatric Obesity Nutrition Disorders Binge Eating Body Weight	Behavioral: Restricted access task	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Nov 11, 2021

Anticipated Primary Completion Date :

Oct 14, 2023

Anticipated Study Completion Date :

Aug 31, 2024

Outcome Measures

Primary Outcome Measures

Change in zBMI [Baseline to 12 months]
Change in zBMI from baseline to 12 month follow-up

Secondary Outcome Measures

Change in body fat percentage [Baseline to 12 months]
Change in percent body fat from baseline to 12 month follow-up
Impact of parental restriction of a High Energy Dense (HED) food on Loss of Control (LOC) eating. [Baseline]
To examine change in energy intake and macronutrient composition during LOC test meal between parental restriction condition and parental non-restriction condition.
Association between relative reinforcing value of high energy dense foods and LOC [Baseline]
Relationships will be examined between RRV and both self-reported LOC eating and intake (calories, macronutrient distribution) in the LOC test meal.
Relationship between self-reported LOC eating and consumption during LOC test meal [Baseline]
Responses between self-reported feelings of LOC and intake (calories, macronutrient distribution) will be compared.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 11 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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