The Intersection Between Loss of Control Eating and Obesity: The Role of Restriction and Food Reinforcement
Primary Purpose
Pediatric Obesity, Nutrition Disorders, Binge Eating
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Restricted access task
Sponsored by
About this trial
This is an interventional prevention trial for Pediatric Obesity focused on measuring Relative Reinforcing Value, Obesity Risk, Children, Loss of Control, Restriction
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
Sites / Locations
- State University of New York at Buffalo, South CampusRecruiting
Outcomes
Primary Outcome Measures
Change in zBMI
Change in zBMI from baseline to 12 month follow-up
Secondary Outcome Measures
Change in body fat percentage
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.
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
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
Responses between self-reported feelings of LOC and intake (calories, macronutrient distribution) will be compared.
Full Information
NCT ID
NCT05177705
First Posted
December 10, 2021
Last Updated
February 13, 2023
Sponsor
State University of New York at Buffalo
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT05177705
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 11, 2021 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity, Nutrition Disorders, Binge Eating, Body Weight
Keywords
Relative Reinforcing Value, Obesity Risk, Children, Loss of Control, Restriction
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Restricted access task
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in zBMI
Description
Change in zBMI from baseline to 12 month follow-up
Time Frame
Baseline to 12 months
Secondary Outcome Measure Information:
Title
Change in body fat percentage
Description
Change in percent body fat from baseline to 12 month follow-up
Time Frame
Baseline to 12 months
Title
Impact of parental restriction of a High Energy Dense (HED) food on Loss of Control (LOC) eating.
Description
To examine change in energy intake and macronutrient composition during LOC test meal between parental restriction condition and parental non-restriction condition.
Time Frame
Baseline
Title
Association between relative reinforcing value of high energy dense foods and LOC
Description
Relationships will be examined between RRV and both self-reported LOC eating and intake (calories, macronutrient distribution) in the LOC test meal.
Time Frame
Baseline
Title
Relationship between self-reported LOC eating and consumption during LOC test meal
Description
Responses between self-reported feelings of LOC and intake (calories, macronutrient distribution) will be compared.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine Balantekin, PhD, RD
Phone
(716) 829-5578
Email
knbalant@buffalo.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Hannah Kolpack, BS
Phone
7168295820
Email
hkolpack@buffalo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Balantekin, PhD, RD
Organizational Affiliation
Clinical Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
State University of New York at Buffalo, South Campus
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Balantekin, PhD, RD
Phone
716-829-5578
Email
knbalant@buffalo.edu
12. IPD Sharing Statement
Learn more about this trial
The Intersection Between Loss of Control Eating and Obesity: The Role of Restriction and Food Reinforcement
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