Motivating Factors That Play a Role in Bulimia Nervosa

May 23, 2016 updated by: New York State Psychiatric Institute

Translational Research on Eating Disorders: Behavioral Assessment of Motivation to Eat

This study will evaluate whether people with bulimia nervosa will binge eat in a structured laboratory setting and display behavioral patterns similar to those of individuals who are dependent on drugs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Bulimia nervosa (BN) is a serious eating disorder that is characterized by frequent uncontrolled eating binges. These binges are often followed by compensatory behavior, including the following: self-induced vomiting; misuse of laxatives, diuretics, enemas, or other medications to induce purging; fasting; or excessive exercise. If left untreated, BN can lead to many serious health issues: tooth decay; irregular menstruation; bowel damage; constipation; heart and kidney disease; intestinal damage; puffiness, especially in the face and fingers; increased hair growth on the face and body; and mineral imbalances in the body. Similar to drug abuse disorders, food-related thinking and disordered eating behavior can interfere with other occupational and social activities, as well. This study will evaluate whether people with bulimia nervosa will binge eat in a structured laboratory setting and display behavioral patterns similar to those of individuals who are dependent on drugs.

Interested participants will first report to the study site for a screening visit, during which they will be assessed for eligibility using blood tests and an interview. Eligible participants will return to the study site on 3 additional days. Participants will be asked to refrain from eating or drinking between 10 P.M. each night before reporting to the study site and 10 A.M. the next day. Each day, participants will receive breakfast, after which they will not be allowed to eat or drink until the end of the day. Participants will then use a computer program to earn food (a yogurt shake) by tapping on the keyboard. More taps on the keyboard will result in a larger amount of food earned by the end of the day. Once experimentation is complete on Day 1, participants will be instructed to eat as much as they can. On Days 2 and 3, participants will be given a small serving of the yogurt shake prior to beginning the computer task. Following the computer task, they will be instructed to either eat until they are comfortable (without restricting or binging), or eat as much as they can. A private bathroom will be available if needed. All participants, including those who did not meet criteria for participation, will be offered treatment at the study clinic once the study is complete.

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Eating Disorders Clinic, New York State Psychiatric Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants who meet DSM-IV criteria for bulimia nervosa and control participants who weigh between 80 and 120% of ideal weight

Description

Inclusion Criteria:

Participants with Bulimia Nervosa:

  • Meets DSM-IV criteria for bulimia nervosa
  • Duration of illness is greater than 1 year
  • Self-induces vomiting
  • Weighs between 80% and 120% of ideal weight
  • Female

Control Group:

  • Weighs between 80% and 120% of ideal weight
  • Female
  • Ages 18-45
  • No current or past psychiatric illness
  • No history of eating disorder

Exclusion Criteria:

Participants with Bulimia Nervosa:

  • Significant medical illness
  • Current Axis I illness other than major depression
  • Severe or very severe depression
  • At risk for suicide
  • Currently taking medication
  • History of drug or alcohol abuse within the 6 months prior to study entry
  • Pregnant
  • Male

Control Group:

  • Significant medical illness
  • Currently taking medication
  • History of drug or alcohol abuse within the 6 months prior to study entry
  • Pregnant
  • Male
  • History of any eating disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects with bulimia nervosa
Participants with bulimia nervosa
Behavioral: Motivation to eat
Participants will use a computer program to earn food (a yogurt shake) by tapping on the keyboard. More taps on the keyboard will result in a larger amount of food earned by the end of the day. Once experimentation is complete on Day 1, participants will be instructed to eat as much as they can. On Days 2 and 3, participants will be given a small serving of the yogurt shake prior to beginning the computer task. Following the computer task, they will be instructed to either eat until they are comfortable (without restricting or binging), or eat as much as they can.
Controls between 80-120% of ideal weight
Controls without bulimia nervosa
Behavioral: Motivation to eat
Participants will use a computer program to earn food (a yogurt shake) by tapping on the keyboard. More taps on the keyboard will result in a larger amount of food earned by the end of the day. Once experimentation is complete on Day 1, participants will be instructed to eat as much as they can. On Days 2 and 3, participants will be given a small serving of the yogurt shake prior to beginning the computer task. Following the computer task, they will be instructed to either eat until they are comfortable (without restricting or binging), or eat as much as they can.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Breakpoint
Time Frame: Measured at Day 3
Measured at Day 3
Total work performed on progressive task
Time Frame: Measured at Day 3
Measured at Day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Collaborators

National Institute of Mental Health (NIMH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ACTUAL)

May 1, 2016

Study Registration Dates

First Submitted

March 15, 2006

First Submitted That Met QC Criteria

March 15, 2006

First Posted (ESTIMATE)

March 17, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

May 24, 2016

Last Update Submitted That Met QC Criteria

May 23, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #5049/#6178R
  • R21MH065024-05 (NIH)
  • DNBBS 72-NBR (DNBBS 72-NBR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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