NCT00917423

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 10, 2009

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 23, 2016

Status Verified

May 1, 2016

Enrollment Period

6 years

First QC Date

June 8, 2009

Last Update Submit

September 22, 2016

Conditions

Eating Disorders

Keywords

Anorexia NervosaExercisePhysical Activity

Outcome Measures

Primary Outcomes (1)

  • Change in weight

    Measured at baseline and 1 year after hospital discharge

Study Arms (2)

Inpatients with anorexia nervosa

Hospital inpatients with anorexia nervosa

Normal weight controls

Healthy, normal-weight volunteers

Eligibility Criteria

Age16 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with anorexia nervosa participating in an inpatient treatment program

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Feeding and Eating DisordersAnorexia NervosaMotor Activity

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersBehavior

Study Officials

  • B. Timothy Walsh, MD

    New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2009

First Posted

June 10, 2009

Study Start

February 1, 2009

Primary Completion

February 1, 2015

Study Completion

June 1, 2016

Last Updated

September 23, 2016

Record last verified: 2016-05

Locations

US(1)