Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Follow-Up Extension to the Family Study of Binge Eating Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00777634
Recruitment Status : Completed
First Posted : October 22, 2008
Results First Posted : May 29, 2012
Last Update Posted : May 29, 2012
Sponsor:
Collaborator:
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
James I. Hudson, MD, Mclean Hospital

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study involves a 2.5 and 5 year follow-up interview for individuals who participated in the initial family study of binge eating disorder. The study includes individuals with and without eating disorder as well as their first degree relatives. As part of the study, participants will be interviewed about their current psychiatric and medical symptoms, their blood pressure will be measured, and laboratory specimens will be obtained.

Condition or disease Intervention/treatment
Binge Eating Disorder Other: No intervention.

Detailed Description:
Previously we completed a family interview study of 150 individuals with binge eating disorder, 150 matched controls, and approximately 888 of their first degree relatives. In follow-up to this, we are interviewing these individuals again at 2.5 and 5 years after their initial interview. During the course of the interview, individuals are asked about their psychiatric and medical history and blood pressure and laboratory specimens are obtained to measure, among other things, fasting lipids and glucose.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 268 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Follow-Up Extension to the Family Study of Binge Eating Disorder
Study Start Date : June 2005
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Binge eating disorder (BED)
Individuals who meet criteria for binge eating disorder.
 Other: No intervention.
There is no intervention used in this study. Cohort members are interviewed and blood pressure, weight, and laboratory specimens are obtained.
Without BED
Individuals who do not meet criteria for binge eating disorder.
 Other: No intervention.
There is no intervention used in this study. Cohort members are interviewed and blood pressure, weight, and laboratory specimens are obtained.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Incidence of Diagnosis of Dyslipidemia [ Time Frame: Baseline to 5 years ]
    The number of participants to acquire a new diagnosis of high cholesterol (dyslipidemia) over the course of the baseline to five-year followup.

  2. Incidence of Diagnosis of Hypertension [ Time Frame: Baseline to 5 years ]
    The number of participants to acquire a new diagnosis of high blood pressure(hypertension) over the course of the baseline to five-year followup.

  3. Incidence of Diagnosis of Type 2 Diabetes [ Time Frame: Baseline to 5 years ]
    The number of participants to acquire a new diagnosis of Type 2 Diabetes over the course of the baseline to five-year followup.

  4. Incidence of Diagnosis of Any Metabolic Syndrome Component [ Time Frame: Baseline to 5 years ]
    The number of participants to acquire a new diagnosis of one component of metabolic syndrome. Metabolic syndrome can include abdominal obesity, high blood pressure, high cholesterol, etc.

  5. Incidence of Diagnosis of Two or More Metabolic Syndrome Components [ Time Frame: Baseline to 5 years ]
    The number of participants to acquire a new diagnosis of two or more components of metabolic syndrome. Metabolic syndrome can include abdominal obesity, high blood pressure, high cholesterol, etc.

  6. Incidence of Diagnosis of Three or More Metabolic Syndrome Components [ Time Frame: Baseline to 5 years ]
    The number of participants to acquire a new diagnosis of three or more components of metabolic syndrome. Metabolic syndrome can include abdominal obesity, high blood pressure, high cholesterol, etc.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This study includes individuals with binge eating disorder, individuals without binge eating disorder, and their relatives.
Criteria

Inclusion Criteria:

  • Individuals with or without binge eating disorder and their family members who participated in the initial family study of binge eating disorder and agree to be followed up at 2.5 and 5 years.

Exclusion Criteria:

  • Unwilling or unable to participate in the follow-up study.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777634


Locations
Layout table for location information
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Mclean Hospital
Ortho-McNeil Janssen Scientific Affairs, LLC
Investigators
Layout table for investigator information
Principal Investigator: James I Hudson, M.D., Sc.D. Mclean Hospital
Principal Investigator: Harrison G Pope, M.D. Mclean Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: James I. Hudson, MD, Professor of Psychiatry, Harvard Medical School, Mclean Hospital
ClinicalTrials.gov Identifier: NCT00777634    
Other Study ID Numbers: 2005-P-000779
First Posted: October 22, 2008    Key Record Dates
Results First Posted: May 29, 2012
Last Update Posted: May 29, 2012
Last Verified: April 2012
Keywords provided by James I. Hudson, MD, Mclean Hospital:
Binge Eating Disorder
Eating Disorder
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Bulimia
Feeding and Eating Disorders
Binge-Eating Disorder
Pathologic Processes
 Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms