Follow-Up Extension to the Family Study of Binge Eating Disorder
April 23, 2012 updated by: James I. Hudson, MD, Mclean Hospital
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.
Study Overview
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 Type
Observational
Enrollment (Actual)
268
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
-
-
Massachusetts
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Belmont, Massachusetts, United States, 02478
- Mclean Hospital
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-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
This study includes individuals with binge eating disorder, individuals without binge eating disorder, and their relatives.
Description
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.
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 |
|---|---|
|
Binge eating disorder (BED)
Individuals who meet criteria for binge eating disorder.
|
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.
|
There is no intervention used in this study.
Cohort members are interviewed and blood pressure, weight, and laboratory specimens are obtained.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline to 5 years
|
|
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.
|
Baseline to 5 years
|
|
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.
|
Baseline to 5 years
|
|
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.
|
Baseline to 5 years
|
|
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.
|
Baseline to 5 years
|
|
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.
|
Baseline to 5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Harrison G Pope, M.D., Mclean Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
June 1, 2005
Primary Completion (Actual)
November 1, 2009
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
October 20, 2008
First Submitted That Met QC Criteria
October 20, 2008
First Posted (Estimate)
October 22, 2008
Study Record Updates
Last Update Posted (Estimate)
May 29, 2012
Last Update Submitted That Met QC Criteria
April 23, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2005-P-000779
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.