Clinical trial NCT05177705: The Intersection Between Loss of Control Eating and Obesity: The Role of Restriction and Food Reinforcement
Official title: The Intersection Between Loss of Control Eating and Obesity: The Role of Restriction and Food Reinforcement
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pediatric Obesity
Nutrition Disorders
Binge Eating
Body Weight
Keywords: Relative Reinforcing Value
Obesity Risk
Children
Loss of Control
Restriction
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-01-04
Enrollment: 110
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in zBMI
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Change in body fat percentage
timeFrame: Baseline to 12 months
measure: Impact of parental restriction of a High Energy Dense (HED) food on Loss of Control (LOC) eating.
timeFrame: Baseline
measure: Association between relative reinforcing value of high energy dense foods and LOC
timeFrame: Baseline
measure: Relationship between self-reported LOC eating and consumption during LOC test meal
timeFrame: Baseline
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: State University of New York at Buffalo, South Campus
state: New York
Study officials:
affiliation: Clinical Associate Professor
name: Katherine Balantekin, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: