Eating DisordersNCT00917423
Characteristics and Importance of Physical Activity in Women With Anorexia Nervosa
An observational study of Eating Disorders, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
This study will determine the importance and the level of physical activity among women with anorexia nervosa, both during inpatient treatment and 1 year after hospital discharge. Read more about this study
- Who is it for?
- Ages 16 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Eating Disorders
- How many people
- 147 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jun 2016
- 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 16 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Patients with anorexia nervosa participating in an inpatient treatment program
Who may be able to join
- Anorexia nervosa (except amenorrhea), as defined by DSM-IV
- Medically and psychiatrically stable
Who cannot join
- Significant current or past medical illness, including diabetes mellitus and heart disease
- Current or lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder, as defined by DSM-IV-TR
- Suicidal ideation or suicidal behavior within the past 3 months
- Drug or alcohol abuse in last 6 months
- Taking psychotropic medication
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Physical Activity in Anorexia Nervosa: Characteristics and Clinical Significance
This study will determine the importance and the level of physical activity among women with anorexia nervosa, both during inpatient treatment and 1 year after hospital discharge.
Read the detailed description
Anorexia nervosa is a disorder that causes people to maintain an unhealthily low body weight, often through eating too little or exercising too much. Treatment for anorexia nervosa often begins with a supervised program for raising a person's weight to a healthy level. This study will monitor activity levels during inpatient treatment and for 1 year after hospital discharge in order to determine the impact of physical activity on weight gain during anorexia treatment.
Participation in this study will last until 1 year after participants are discharged from inpatient treatment for anorexia nervosa. Discharge is based on each person's progression in treatment and may vary among participants. During the study, participants will have their activity monitored two or three times-at low weight, at 90% of ideal body weight (IBW), and, if the participant is living near the study clinic, within 6 weeks after discharge from the hospital. Two monitoring devices will be attached to participants continuously for 48 hours for the first two assessments and for 72 hours for the third. The first device is a SenseWear armband, which is a wireless monitor strapped to the back of the upper arm that measures body movement and body temperature. The second is an Intelligent Device for Energy Expenditure and Activity (IDEEA) monitor, which consists of five sensors that will be taped to each participant's feet, thighs, and chest. The device measures activity levels and energy expenditure. Participants will complete a blood draw within 1 week of completing activity monitoring assessments. Participants will also complete a computer "work" task at two time points-at 75% of IBW and at 90% of IBW. This task will last 40 minutes and will involve tapping a keyboard in order to earn rewards. Adult participants will also complete a dual X-ray absorptiometry (DXA) test to assess body composition when 90% IBW is reached.
Follow-up assessments will occur 1, 2, 4, and 8 months after discharge. These will involve a phone call or in-person visit in which health, body weight, and eating disorder symptoms are discussed. One year after discharge, participants will attend an in-person assessment that will involve completing questionnaires and an interview. Healthy participants will be recruited as a control group, and these participants will complete one session of activity monitoring, one blood draw, and self-rating forms without follow-up measurements.
- Conditions
- Eating Disorders
- Keywords
- Anorexia Nervosa, Exercise, Physical Activity
- Medical subject headings
- Feeding and Eating Disorders, Anorexia Nervosa, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Inpatients with anorexia nervosa | Hospital inpatients with anorexia nervosa | |
| Normal weight controls | Healthy, normal-weight volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight
Measured: Measured at baseline and 1 year after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startFeb 2009
- Primary completionFeb 2015
- Study completionJun 2016
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.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- B. Timothy Walsh, MD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917423
- Sponsor's protocol ID
- #5544/#6624R
- Other IDs
- R01MH083795, DATR A2-AIM
- Status last verified
- May 2016
- First submitted
- 8 Jun 2009
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity in Anorexia Nervosa: Characteristics and Clinical Significance
- ClinicalTrials.gov ID
- NCT00917423
- Acronym / sponsor ID
- #5544/#6624R
- Conditions
- Eating Disorders
- Keywords
- Anorexia Nervosa, Exercise, Physical Activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Feb 2009
- Primary completion
- Feb 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 10 Jun 2009 (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 study will determine the importance and the level of physical activity among women with anorexia nervosa, both during inpatient treatment and 1 year after hospital discharge.
Detailed description
Anorexia nervosa is a disorder that causes people to maintain an unhealthily low body weight, often through eating too little or exercising too much. Treatment for anorexia nervosa often begins with a supervised program for raising a person's weight to a healthy level. This study will monitor activity levels during inpatient treatment and for 1 year after hospital discharge in order to determine the impact of physical activity on weight gain during anorexia treatment.
Participation in this study will last until 1 year after participants are discharged from inpatient treatment for anorexia nervosa. Discharge is based on each person's progression in treatment and may vary among participants. During the study, participants will have their activity monitored two or three times-at low weight, at 90% of ideal body weight (IBW), and, if the participant is living near the study clinic, within 6 weeks after discharge from the hospital. Two monitoring devices will be attached to participants continuously for 48 hours for the first two assessments and for 72 hours for the third. The first device is a SenseWear armband, which is a wireless monitor strapped to the back of the upper arm that measures body movement and body temperature. The second is an Intelligent Device for Energy Expenditure and Activity (IDEEA) monitor, which consists of five sensors that will be taped to each participant's feet, thighs, and chest. The device measures activity levels and energy expenditure. Participants will complete a blood draw within 1 week of completing activity monitoring assessments. Participants will also complete a computer "work" task at two time points-at 75% of IBW and at 90% of IBW. This task will last 40 minutes and will involve tapping a keyboard in order to earn rewards. Adult participants will also complete a dual X-ray absorptiometry (DXA) test to assess body composition when 90% IBW is reached.
Follow-up assessments will occur 1, 2, 4, and 8 months after discharge. These will involve a phone call or in-person visit in which health, body weight, and eating disorder symptoms are discussed. One year after discharge, participants will attend an in-person assessment that will involve completing questionnaires and an interview. Healthy participants will be recruited as a control group, and these participants will complete one session of activity monitoring, one blood draw, and self-rating forms without follow-up measurements.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inpatients with anorexia nervosa | – | –Hospital inpatients with anorexia nervosa |
| Normal weight controls | – | –Healthy, normal-weight volunteers |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients with anorexia nervosa participating in an inpatient treatment program
Key inclusion criteria (2 listed)
- Anorexia nervosa (except amenorrhea), as defined by DSM-IV
- Medically and psychiatrically stable
Key exclusion criteria (6 listed)
- Significant current or past medical illness, including diabetes mellitus and heart disease
- Current or lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder, as defined by DSM-IV-TR
- Suicidal ideation or suicidal behavior within the past 3 months
- Drug or alcohol abuse in last 6 months
- Taking psychotropic medication
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
Change in weight
Time frame: Measured at baseline and 1 year after hospital discharge
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 23 Sep 2016.
- Click here for more information on the Columbia Center for Eating DisordersLink provided by the sponsor.
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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.
B. Timothy Walsh, MD principal investigator
New York State Psychiatric Institute
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 New York State Psychiatric Institute 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 2 inclusion and 6 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 23 Sep 2016. 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?
Change in weight (time frame: Measured at baseline and 1 year after hospital discharge). 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 23 Sep 2016.