Characteristics and Importance of Physical Activity in Women With Anorexia Nervosa - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	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
Eating Disorders

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

Resource links provided by NLM:

MedlinePlus related topics: Eating Disorders

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Change in weight [ Time Frame: Measured at baseline and 1 year after hospital discharge ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

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
2 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

Ages Eligible for Study:	16 Years to 40 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00917423

Contacts

Contact: Eating Disorders Clinic

212-543-5739

edru@pi.cpmc.columbia.edu

Locations

United States, New York
New York State Psychiatric Institute	Recruiting
New York, New York, United States, 10032
Principal Investigator: Diane Klein, MD

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

More Information

Additional Information:

Click here for more information on the Columbia Center for Eating Disorders This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Columbia University Medical Center ( Diane Klein, MD )
Study ID Numbers:	R01 MH083795, DATR A2-AIM
Study First Received:	June 8, 2009
Last Updated:	September 18, 2009
ClinicalTrials.gov Identifier:	NCT00917423 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Anorexia Nervosa
Exercise
Physical Activity

Additional relevant MeSH terms:

Signs and Symptoms
Signs and Symptoms, Digestive
Mental Disorders

Anorexia
Anorexia Nervosa
Eating Disorders

ClinicalTrials.gov processed this record on November 27, 2009