Eating DisordersNCT00173160
Epidemiological Studies of Eating Disorders in Gifted Dance Students (2nd Year).
An observational study of Eating Disorders, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This is the second-year part of a two-phase prospective epidemiological study as well as a community case-controled study. The aims of the second year study are firstly, to investigate the clinical course and 1-year outcome of eating disorders in the community, as well as the prospective risk factors of eating… Read more about this study
- Who is it for?
- Ages 17 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating Disorders
- How many people
- 700 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2004to Jul 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
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 17 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- gifted dance high school students.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidemiological Studies of Eating Disorders in Gifted Dance Students: Prevalence Rate, Risk Factors and 1-Year Outcome (2nd Year).
This is the second-year part of a two-phase prospective epidemiological study as well as a community case-controled study. The aims of the second year study are firstly, to investigate the clinical course and 1-year outcome of eating disorders in the community, as well as the prospective risk factors of eating disorders; secondly, a case-control design involving with other psychiatric disorders from the same study population is used for risk factors study.
The study subjects are gifted dance high school students who participated the first-year study and are willing to participate the 2nd-year study (N=675). Screening questionnaires for eating disorders and general psychiatric disorders are EAT, BITE and CHQ-12. Other self-report questionnaires include perfectionism subscale of Eating Disorder Inventor-I (EDI), Rosenberg Self-esteem Scale (RSE), Eyseck Personality Scale, Pubertal Develoment Scale, and body figure test. Subjects who received interviews at the first-year study and those whose scores are above the threshold of the screening questionnaires need to receive interviews at 2nd phase. The criteria of interview threshold included EAT≧20+ BMI<18.5Kg/m2, symptom scale of BITE ≧15 and/or severity scale of BITE≧5, and CHQ ≧4. The content of interview included structured diagnostic interview (SCID-IP 1995) as well as risk factors assessment. Each time a subject with bulimia nervosa was recruited, one matched control subject with no mental illness general psychiatric diagnosis was sought from the same class or school. Potential psychiatric control subjects were identified from their scores on the CHQ. The psychiatric control subjects were required to have no current or past eating disorders. The contents of risk factor assessments include personal vulnerability and family problems.
The relationships between individual risk factors and case status were assessed by univariate analysis. Conditional logistic analysis was used for multivariate analysis of risk factors prediction for eating disorders. To assess the relative importance of different types of exposure, the relationship between case status and exposure in each domain were first assessed by univariate analysis and then in multivariate stepwise regression analyses.
Read the detailed description
This is the second-year part of a two-phase prospective epidemiological study as well as a community case-controled study. The aims of the second year study are firstly, to investigate the clinical course and 1-year outcome of eating disorders in the community, as well as the prospective risk factors of eating disorders; secondly, a case-control design involving with other psychiatric disorders from the same study population is used for risk factors study.
The study subjects are Taiwanese gifted dance high school students.Parental informed consent for nonpartipation was delivered 3 days before study started. Screening questionnaires for eating disorders and general psychiatric disorders included EAT(Eating Attitude Test), BITE(Bulimic Investigatory Test, Ediburgh BITE) and CHQ-12(Chinese Health Questionnaire). Other self-report questionnaires include perfectionism subscale of Eating Disorder Inventor-I (EDI), Rosenberg Self-esteem Scale (RSE), Eyseck Personality Inventory, Pubertal Develoment Scale, and body figure test. Subjects who received interviews at the first-year study and those whose scores are above the threshold of the screening questionnaires need to receive interviews at 2nd phase. The criteria of interview threshold included EAT≧20+ BMI<18.5Kg/m2, symptom scale of BITE ≧15 and/or severity scale of BITE≧5, and CHQ ≧4. The content of interview included structured diagnostic interview (SCID-IP 1995) as well as risk factors assessment. Each time a subject with bulimia nervosa was recruited, one matched control subject with no mental illness general psychiatric diagnosis was sought from the same class or school. Potential psychiatric control subjects were identified from their scores on the CHQ. The psychiatric control subjects were required to have no current or past eating disorders. The contents of risk factor assessments include personal vulnerability and family problems.
The relationships between individual risk factors and case status were assessed by univariate analysis. Conditional logistic analysis was used for multivariate analysis of risk factors prediction for eating disorders. To assess the relative importance of different types of exposure, the relationship between case status and exposure in each domain were first assessed by univariate analysis and then in multivariate stepwise regression analyses.
- Conditions
- Eating Disorders
- Keywords
- Eating disorders, risk factors, prospective study, case-controled study, outcome, gifted dance students
- Medical subject headings
- Feeding and Eating Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startAug 2004
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Defined population
- Time perspective
- Other
- Enrolment
- 700 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Investigators
- Mei-Chih Tseng, MD, Principal investigator, National Taiwan Univetsity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00173160
- Sponsor's protocol ID
- 9461700426
- Other IDs
- NSC-93-2314-B-002-258
- Status last verified
- Aug 2004
- First submitted
- 12 Sep 2005
- Last updated
- 15 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Studies of Eating Disorders in Gifted Dance Students: Prevalence Rate, Risk Factors and 1-Year Outcome (2nd Year).
- ClinicalTrials.gov ID
- NCT00173160
- Acronym / sponsor ID
- 9461700426
- Conditions
- Eating Disorders
- Keywords
- Eating disorders, risk factors, prospective study, case-controled study, outcome, gifted dance students
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Aug 2004
- Study completion
- Jul 2005
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is the second-year part of a two-phase prospective epidemiological study as well as a community case-controled study. The aims of the second year study are firstly, to investigate the clinical course and 1-year outcome of eating disorders in the community, as well as the prospective risk factors of eating disorders; secondly, a case-control design involving with other psychiatric disorders from the same study population is used for risk factors study.
The study subjects are gifted dance high school students who participated the first-year study and are willing to participate the 2nd-year study (N=675). Screening questionnaires for eating disorders and general psychiatric disorders are EAT, BITE and CHQ-12. Other self-report questionnaires include perfectionism subscale of Eating Disorder Inventor-I (EDI), Rosenberg Self-esteem Scale (RSE), Eyseck Personality Scale, Pubertal Develoment Scale, and body figure test. Subjects who received interviews at the first-year study and those whose scores are above the threshold of the screening questionnaires need to receive interviews at 2nd phase. The criteria of interview threshold included EAT≧20+ BMI<18.5Kg/m2, symptom scale of BITE ≧15 and/or severity scale of BITE≧5, and CHQ ≧4. The content of interview included structured diagnostic interview (SCID-IP 1995) as well as risk factors assessment. Each time a subject with bulimia nervosa was recruited, one matched control subject with no mental illness general psychiatric diagnosis was sought from the same class or school. Potential psychiatric control subjects were identified from their scores on the CHQ. The psychiatric control subjects were required to have no current or past eating disorders. The contents of risk factor assessments include personal vulnerability and family problems.
The relationships between individual risk factors and case status were assessed by univariate analysis. Conditional logistic analysis was used for multivariate analysis of risk factors prediction for eating disorders. To assess the relative importance of different types of exposure, the relationship between case status and exposure in each domain were first assessed by univariate analysis and then in multivariate stepwise regression analyses.
Detailed description
This is the second-year part of a two-phase prospective epidemiological study as well as a community case-controled study. The aims of the second year study are firstly, to investigate the clinical course and 1-year outcome of eating disorders in the community, as well as the prospective risk factors of eating disorders; secondly, a case-control design involving with other psychiatric disorders from the same study population is used for risk factors study.
The study subjects are Taiwanese gifted dance high school students.Parental informed consent for nonpartipation was delivered 3 days before study started. Screening questionnaires for eating disorders and general psychiatric disorders included EAT(Eating Attitude Test), BITE(Bulimic Investigatory Test, Ediburgh BITE) and CHQ-12(Chinese Health Questionnaire). Other self-report questionnaires include perfectionism subscale of Eating Disorder Inventor-I (EDI), Rosenberg Self-esteem Scale (RSE), Eyseck Personality Inventory, Pubertal Develoment Scale, and body figure test. Subjects who received interviews at the first-year study and those whose scores are above the threshold of the screening questionnaires need to receive interviews at 2nd phase. The criteria of interview threshold included EAT≧20+ BMI<18.5Kg/m2, symptom scale of BITE ≧15 and/or severity scale of BITE≧5, and CHQ ≧4. The content of interview included structured diagnostic interview (SCID-IP 1995) as well as risk factors assessment. Each time a subject with bulimia nervosa was recruited, one matched control subject with no mental illness general psychiatric diagnosis was sought from the same class or school. Potential psychiatric control subjects were identified from their scores on the CHQ. The psychiatric control subjects were required to have no current or past eating disorders. The contents of risk factor assessments include personal vulnerability and family problems.
The relationships between individual risk factors and case status were assessed by univariate analysis. Conditional logistic analysis was used for multivariate analysis of risk factors prediction for eating disorders. To assess the relative importance of different types of exposure, the relationship between case status and exposure in each domain were first assessed by univariate analysis and then in multivariate stepwise regression analyses.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 17 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- gifted dance high school students.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2005.
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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.
Mei-Chih Tseng, MD principal investigator
National Taiwan Univetsity 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 Eating Disorders, run by National Taiwan University Hospital at 1 site in Taiwan.
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 15 Sep 2005. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
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 15 Sep 2005.