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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00777634

Enrollment

268

Registered

2008-10-22

Start date

2005-06-30

Completion date

2009-11-30

Last updated

2012-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Binge Eating Disorder

Keywords

Binge Eating Disorder, Eating Disorder

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.

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.

Interventions

OTHERNo intervention.

There is no intervention used in this study. Cohort members are interviewed and blood pressure, weight, and laboratory specimens are obtained.

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Diagnosis of Dyslipidemia	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	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	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	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	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	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Binge Eating Disorder (BED) Individuals who meet criteria for binge eating disorder.	134
Without BED Individuals who do not meet criteria for binge eating disorder.	134
Total	268

Baseline characteristics

Characteristic	Without BED	Binge Eating Disorder (BED)	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	134 Participants	134 Participants	268 Participants
Age Continuous	47.8 years STANDARD_DEVIATION 12.9	47.0 years STANDARD_DEVIATION 13.2	47.4 years STANDARD_DEVIATION 13.1
Region of Enrollment United States	134 participants	134 participants	268 participants
Sex: Female, Male Female	102 Participants	107 Participants	209 Participants
Sex: Female, Male Male	32 Participants	27 Participants	59 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0

Outcome results

Primary

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.