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Characteristics and Importance of Physical Activity in Women With Anorexia Nervosa

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00917423
First Posted: June 10, 2009
Last Update Posted: September 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute
  Purpose
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.

Condition
Eating Disorders

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Physical Activity in Anorexia Nervosa: Characteristics and Clinical Significance

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Change in weight [ Time Frame: Measured at baseline and 1 year after hospital discharge ]

Biospecimen Retention:   Samples With DNA
Blood samples

Enrollment: 147
Study Start Date: February 2009
Study Completion Date: June 2016
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Inpatients with anorexia nervosa
Hospital inpatients with anorexia nervosa
Normal weight controls
Healthy, normal-weight volunteers

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with anorexia nervosa participating in an inpatient treatment program
Criteria

Inclusion Criteria:

  • Anorexia nervosa (except amenorrhea), as defined by DSM-IV
  • Medically and psychiatrically stable

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00917423


Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: B. Timothy Walsh, MD New York State Psychiatric Institute
  More Information

Additional Information:
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00917423     History of Changes
Other Study ID Numbers: #5544/#6624R
R01MH083795 ( U.S. NIH Grant/Contract )
DATR A2-AIM ( Other Grant/Funding Number: DATR A2-AIM )
First Submitted: June 8, 2009
First Posted: June 10, 2009
Last Update Posted: September 23, 2016
Last Verified: May 2016

Keywords provided by New York State Psychiatric Institute:
Anorexia Nervosa
Exercise
Physical Activity

Additional relevant MeSH terms:
Feeding and Eating Disorders
Anorexia
Anorexia Nervosa
Mental Disorders
Signs and Symptoms, Digestive
Signs and Symptoms