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Completed

NCT Number: NCT05177705

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

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.

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Key information

Conditions

Pediatric Obesity Binge Eating Body Weight Bulimia Hyperphagia Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

8 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

State University of New York at Buffalo, South Campus

Buffalo, New York, 14214, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Restricted access task

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.

Primary outcomes

  1. Change in zBMI

    Time frame: Baseline to 12 months

    Change in zBMI from baseline to 12 month follow-up

Secondary outcomes

  1. Change in body fat percentage

    Time frame: Baseline to 12 months

    Change in percent body fat from baseline to 12 month follow-up

  2. Impact of parental restriction of a High Energy Dense (HED) food on Loss of Control (LOC) eating.

    Time frame: Baseline

    To examine change in energy intake and macronutrient composition during LOC test meal between parental restriction condition and parental non-restriction condition.

  3. Association between relative reinforcing value of high energy dense foods and LOC

    Time frame: Baseline

    Relationships will be examined between RRV and both self-reported LOC eating and intake (calories, macronutrient distribution) in the LOC test meal.

  4. Relationship between self-reported LOC eating and consumption during LOC test meal

    Time frame: Baseline

    Responses between self-reported feelings of LOC and intake (calories, macronutrient distribution) will be compared.

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Collaborators

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

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jan 4, 2022
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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