Anorexia NervosaNCT00961428
Motivation to Exercise in People With Anorexia Nervosa
An observational study of Anorexia Nervosa, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
The purpose of this research study is to determine the importance and level of physical activity in people with Anorexia Nervosa. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Anorexia Nervosa
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Jul 2011
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Participants will be patients with anorexia nervosa on the inpatient unit at New York State Psychiatric Institute
Who may be able to join
- DSM-IV diagnosis of Anorexia Nervosa (except amenorrhea)
- Female
- Age 18-45
- Medically Stable for exercise participation
- At a minimum of 75% Ideal Body Weight
Who cannot join
- Significant or current past medical illness including diabetes mellitis and heart disease
- Current or lifetime history or schizophrenia, bipolar disorder, or other psychotic disorder as defined by DSM-IV-TR
- Current suicidal ideation or recent suicidal behavior (within past 3 months)
- Drug or alcohol abuse in last 6 months
- Taking psychotropic medication
- Pregnancy
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: Behavioral Assessment of the Reinforcing Effects of Exercise in Patients With Anorexia Nervosa
The purpose of this research study is to determine the importance and level of physical activity in people with Anorexia Nervosa.
Read the detailed description
A laboratory paradigm that uses a progressive ratio computerized work task will be used to determine the reinforcing value of exercise in hospitalized patients with AN, both before and after weight gain. In addition, we will examine the relationship between the reinforcing value of exercise and free-living physical activity in this population. We will also examine the relationship between the reinforcing value of exercise and measures of depression, anxiety, and cortisol, which we have found in previous studies to be associated with other measures of physical activity and exercise motivation. In order to determine whether physical activity in women with AN differs from that of non-eating disordered women, we will extend studies of physical activity to free-living control participants. All adult patients and controls will undergo body composition assessment once to measure the association between physical activity and percent body fat. Finally, to determine the impact of exercise reinforcement and physical activity on outcome in women with AN, we will conduct follow-up assessments in all patient participants for one year after discharge from the inpatient treatment unit."
- Conditions
- Anorexia Nervosa
- Keywords
- Anorexia Nervosa, Eating Disorders, Exercise, Physical Activity
- Medical subject headings
- Anorexia Nervosa, Feeding and Eating Disorders, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
physical activity
Measured: Physical activity before and after weight restoration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2009 (estimated)
- Study startDec 2007
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies 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
- Time perspective
- Prospective
- Enrolment
- 60 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, Study director, NYSPIEvelyn Attia, MD, Principal investigator, NYSPI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00961428
- Sponsor's protocol ID
- #5544
- Other IDs
- K23MH071285-02, NIMH K23 071285, DATR AK-TNAI1
- Status last verified
- Dec 2012
- First submitted
- 18 Aug 2009
- Last updated
- 5 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Assessment of the Reinforcing Effects of Exercise in Patients With Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT00961428
- Acronym / sponsor ID
- #5544
- Conditions
- Anorexia Nervosa
- Keywords
- Anorexia Nervosa, Eating Disorders, Exercise, Physical Activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Dec 2007
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 19 Aug 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.
The purpose of this research study is to determine the importance and level of physical activity in people with Anorexia Nervosa.
Detailed description
A laboratory paradigm that uses a progressive ratio computerized work task will be used to determine the reinforcing value of exercise in hospitalized patients with AN, both before and after weight gain. In addition, we will examine the relationship between the reinforcing value of exercise and free-living physical activity in this population. We will also examine the relationship between the reinforcing value of exercise and measures of depression, anxiety, and cortisol, which we have found in previous studies to be associated with other measures of physical activity and exercise motivation. In order to determine whether physical activity in women with AN differs from that of non-eating disordered women, we will extend studies of physical activity to free-living control participants. All adult patients and controls will undergo body composition assessment once to measure the association between physical activity and percent body fat. Finally, to determine the impact of exercise reinforcement and physical activity on outcome in women with AN, we will conduct follow-up assessments in all patient participants for one year after discharge from the inpatient treatment unit."
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants will be patients with anorexia nervosa on the inpatient unit at New York State Psychiatric Institute
Key inclusion criteria (5 listed)
- DSM-IV diagnosis of Anorexia Nervosa (except amenorrhea)
- Female
- Age 18-45
- Medically Stable for exercise participation
- At a minimum of 75% Ideal Body Weight
Key exclusion criteria (6 listed)
- Significant or current past medical illness including diabetes mellitis and heart disease
- Current or lifetime history or schizophrenia, bipolar disorder, or other psychotic disorder as defined by DSM-IV-TR
- Current suicidal ideation or recent suicidal behavior (within 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
physical activity
Time frame: Physical activity before and after weight restoration
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 5 Dec 2012.
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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 study director
NYSPI
Evelyn Attia, MD principal investigator
NYSPI
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 Anorexia Nervosa, 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 5 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 5 Dec 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?
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?
physical activity (time frame: Physical activity before and after weight restoration). 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 5 Dec 2012.