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| Sponsor: | National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by (Responsible Party): | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00917423 |
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 |
|---|
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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 |
Blood samples
| Estimated Enrollment: | 80 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
Hospital inpatients with anorexia nervosa
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2
Healthy, normal-weight volunteers
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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| Ages Eligible for Study: | 16 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Patients with anorexia nervosa participating in an inpatient treatment program
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Eating Disorders Clinic | 212-543-5739 | edru@pi.cpmc.columbia.edu |
| United States, New York | |
| New York State Psychiatric Institute | Recruiting |
| New York, New York, United States, 10032 | |
| Principal Investigator: Diane Klein, MD | |
More Information
| Responsible Party: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00917423 History of Changes |
| Other Study ID Numbers: | R01 MH083795, DATR A2-AIM |
| Study First Received: | June 8, 2009 |
| Last Updated: | December 14, 2011 |
| Health Authority: | United States: Federal Government |
|
Anorexia Nervosa Exercise Physical Activity |
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Anorexia Anorexia Nervosa Eating Disorders |
Signs and Symptoms, Digestive Signs and Symptoms Mental Disorders |