Binge Eating DisorderNCT00777634
Follow-Up Extension to the Family Study of Binge Eating Disorder
An observational study of Binge Eating Disorder, run by Mclean Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Binge Eating Disorder
- How many people
- 268 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Nov 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study includes individuals with binge eating disorder, individuals without binge eating disorder, and their relatives.
Who may be able to join
- 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.
Who cannot join
- Unwilling or unable to participate in the follow-up study.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Binge Eating Disorder
- Being tested
- No intervention.
- Keywords
- Binge Eating Disorder, Eating Disorder
- Medical subject headings
- Binge-Eating Disorder, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention.Other
There is no intervention used in this study. Cohort members are interviewed and blood pressure, weight, and laboratory specimens are obtained.
| Study group | Role | What they receive |
|---|---|---|
| Binge eating disorder (BED) | Individuals who meet criteria for binge eating disorder. Receives: Other: No intervention. | |
| Without BED | Individuals who do not meet criteria for binge eating disorder. Receives: Other: No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Diagnosis of Dyslipidemia
The number of participants to acquire a new diagnosis of high cholesterol (dyslipidemia) over the course of the baseline to five-year followup.
Measured: Baseline to 5 years
Incidence of Diagnosis of Hypertension
The number of participants to acquire a new diagnosis of high blood pressure(hypertension) over the course of the baseline to five-year followup.
Measured: Baseline to 5 years
Incidence of Diagnosis of Type 2 Diabetes
The number of participants to acquire a new diagnosis of Type 2 Diabetes over the course of the baseline to five-year followup.
Measured: Baseline to 5 years
Incidence of Diagnosis of Any Metabolic Syndrome Component
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.
Measured: Baseline to 5 years
Incidence of Diagnosis of Two or More Metabolic Syndrome Components
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.
Measured: Baseline to 5 years
Incidence of Diagnosis of Three or More Metabolic Syndrome Components
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.
Measured: Baseline to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2008 (estimated)
- Study startJun 2005
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Binge Eating DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ortho-McNeil Janssen Scientific Affairs, LLC
- Responsible party
- Principal investigator, James I. Hudson, MD, Mclean Hospital
- Investigators
- James I Hudson, M.D., Sc.D., Principal investigator, Mclean HospitalHarrison G Pope, M.D., Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00777634
- Sponsor's protocol ID
- 2005-P-000779
- Status last verified
- Apr 2012
- First submitted
- 20 Oct 2008
- Last updated
- 29 May 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hudson JI, Lalonde JK, Coit CE, Tsuang MT, McElroy SL, Crow SJ, Bulik CM, Hudson MS, Yanovski JA, Rosenthal NR, Pope HG Jr. Longitudinal study of the diagnosis of components of the metabolic syndrome in individuals with binge-eating disorder. Am J Clin Nutr. 2010 Jun;91(6):1568-73. doi: 10.3945/ajcn.2010.29203. Epub 2010 Apr 28.
PubMed 20427731
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-Up Extension to the Family Study of Binge Eating Disorder
- ClinicalTrials.gov ID
- NCT00777634
- Acronym / sponsor ID
- 2005-P-000779
- Conditions
- Binge Eating Disorder
- Keywords
- Binge Eating Disorder, Eating Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- Ortho-McNeil Janssen Scientific Affairs, LLC
- Study start
- Jun 2005
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 22 Oct 2008 (estimated)
- Results
- Posted 29 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Binge eating disorder (BED) | – | Other: No intervention.Individuals who meet criteria for binge eating disorder. |
| Without BED | – | Other: No intervention.Individuals who do not meet criteria for binge eating disorder. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study includes individuals with binge eating disorder, individuals without binge eating disorder, and their relatives.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Unwilling or unable to participate in the follow-up study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention.There is no intervention used in this study. Cohort members are interviewed and blood pressure, weight, and laboratory specimens are obtained. | Other | Binge eating disorder (BED), Without BED |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20427731Hudson JI, Lalonde JK, Coit CE, Tsuang MT, McElroy SL, Crow SJ, Bulik CM, Hudson MS, Yanovski JA, Rosenthal NR, Pope HG Jr. Longitudinal study of the diagnosis of components of the metabolic syndrome in individuals with binge-eating disorder. Am J Clin Nutr. 2010 Jun;91(6):1568-73. doi: 10.3945/ajcn.2010.29203. Epub 2010 Apr 28.
Related trials for Binge Eating Disorder
Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
Enrolling by invitationPhase 3
A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge Eating Disorder
Binge-Eating Disorder
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Enrolling by invitation
Sleep and Activity For Eating Disorders
Eating Disorders, Anorexia Nervosa
Active, not recruiting
Project VIBE: Virtual Intervention for Binge Eating in Adolescents
Obesity, Binge-Eating Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James I Hudson, M.D., Sc.D. principal investigator
Mclean Hospital
Harrison G Pope, M.D. principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Binge Eating Disorder, run by Mclean Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Diagnosis of Dyslipidemia (time frame: Baseline to 5 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00777634, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2012.