Eating DisordersNCT00050570
Reducing Eating Disorder Risk Factors
A study testing Web-based intervention to reduce eating disorder risk factors in people with Eating Disorders, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a web-based program is effective in reducing the incidence of eating disorders in college women who are at high risk for developing an eating disorder. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Eating Disorders
- What is being tested?
- Web-based intervention to reduce eating disorder risk factors
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2001to 30 Apr 2012
- Phase
- Interventional
- 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 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- College students at risk for developing an eating disorder
Who cannot join
- Suicidal or other severe psychopathology
- Alcohol or drug abuse
- Body mass index (BMI) < 18 or > 32
- Current diagnosis of anorexia nervosa, binge eating disorder, or bulimia nervosa and have been in treatment within the past 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University, Dept. of Psychiatry and Behavioral Sciences
Stanford, California, 94305
About this study
Official title: Interventions to Reduce Eating Disorder Risk Factors
The purpose of this study is to determine whether a web-based program is effective in reducing the incidence of eating disorders in college women who are at high risk for developing an eating disorder.
Read the detailed description
Female college students who use unhealthy weight control methods and have body image concerns may be at risk for developing an eating disorder. Developing and evaluating interventions to reduce eating disorders in high-risk populations is of great public health importance.
Participants are randomly assigned to either join a web-based risk-reduction program or receive no intervention. The 9-week risk-reduction program focuses on reducing body image and weight/shape concerns, identifying the risks of eating disorders, and increasing healthy weight regulation practices. The program includes weekly readings, writing assignments, and participation in a moderated electronic discussion group. Changes in body mass index (BMI) and the occurrence of major stressors and psychiatric events are assessed to determine their impact on the incidence of eating disorders. One-year incidence of eating disorders is determined by a diagnostic interview, and follow up may continue for up to 2.5 years.
- Conditions
- Eating Disorders
- Being tested
- Web-based intervention to reduce eating disorder risk factors
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based intervention to reduce eating disorder risk factorsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | An 8-week, Internet- based, structured cognitive- behavioral program combined with an online, asynchronous, moderated discussion group. Receives: Behavioral: Web-based intervention to reduce eating disorder risk factors |
| Control | No intervention | The waitlist control group was only contacted at the time of assessments and was offered the intervention at the end of the study, after the 2-year follow-up assessment was completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of an eating disorder
The main outcome is the onset of an eating disorder, as defined by DSM-IV
Measured: 2 years
Secondary outcomes (1)
Change in eating disorder behaviors
Eating disorder behaviors as measured by the Eating Disorder Examination. We will also measure attitudes related to eating disorder onset risk
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2002 (estimated)
- Study startFeb 2001
- Primary completion30 Apr 2012
- Study completion30 Apr 2012
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 Stanford UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Craig Barr Taylor, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00050570
- Sponsor's protocol ID
- R01MH060453
- Other IDs
- R01MH060453, DSIR CT-P
- Status last verified
- Mar 2020
- First submitted
- 16 Dec 2002
- Last updated
- 18 Mar 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions to Reduce Eating Disorder Risk Factors
- ClinicalTrials.gov ID
- NCT00050570
- Acronym / sponsor ID
- R01MH060453
- Conditions
- Eating Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Feb 2001
- Primary completion
- 30 Apr 2012 (actual)
- Study completion
- 30 Apr 2012 (actual)
- First posted
- 17 Dec 2002 (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.
The purpose of this study is to determine whether a web-based program is effective in reducing the incidence of eating disorders in college women who are at high risk for developing an eating disorder.
Detailed description
Female college students who use unhealthy weight control methods and have body image concerns may be at risk for developing an eating disorder. Developing and evaluating interventions to reduce eating disorders in high-risk populations is of great public health importance.
Participants are randomly assigned to either join a web-based risk-reduction program or receive no intervention. The 9-week risk-reduction program focuses on reducing body image and weight/shape concerns, identifying the risks of eating disorders, and increasing healthy weight regulation practices. The program includes weekly readings, writing assignments, and participation in a moderated electronic discussion group. Changes in body mass index (BMI) and the occurrence of major stressors and psychiatric events are assessed to determine their impact on the incidence of eating disorders. One-year incidence of eating disorders is determined by a diagnostic interview, and follow up may continue for up to 2.5 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Web-based intervention to reduce eating disorder risk factorsAn 8-week, Internet- based, structured cognitive- behavioral program combined with an online, asynchronous, moderated discussion group. |
| Control | No intervention | –The waitlist control group was only contacted at the time of assessments and was offered the intervention at the end of the study, after the 2-year follow-up assessment was completed. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- College students at risk for developing an eating disorder
Key exclusion criteria (4 listed)
- Suicidal or other severe psychopathology
- Alcohol or drug abuse
- Body mass index (BMI) < 18 or > 32
- Current diagnosis of anorexia nervosa, binge eating disorder, or bulimia nervosa and have been in treatment within the past 6 months
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 |
|---|---|---|
| Web-based intervention to reduce eating disorder risk factors | Behavioural | Intervention |
Primary outcome
Onset of an eating disorder
Time frame: 2 years
The main outcome is the onset of an eating disorder, as defined by DSM-IV
1 secondary outcome
Change in eating disorder behaviors
Time frame: 2 years
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 18 Mar 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based intervention to reduce eating disorder risk factors in people with Eating Disorders, run by Stanford University 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 4 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 18 Mar 2020. 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?
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.
What does the primary outcome measure?
Onset of an eating disorder (time frame: 2 years). It is what the study was designed to measure, not a finding.
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 18 Mar 2020.