NCT00934583

Brief Summary

This study will examine the ability of an Internet-based program to prevent college-aged women from developing eating disorders.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
549

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2009

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

July 6, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 8, 2009

Completed
24 days until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

2.7 years

First QC Date

July 6, 2009

Last Update Submit

March 16, 2020

Conditions

Eating Disorders

Keywords

Bulimia NervosaBinge EatingBinge-Eating Disorder

Outcome Measures

Primary Outcomes (1)

  • Eating disorder diagnoses

    Measured after 10 weeks, 1 year, and 1.5 years

Secondary Outcomes (4)

  • Weight Concerns Scale

    Measured after 10 weeks, 1 year, and 1.5 years

  • Eating Disorder Examination Questionnaires (EDE-Q)

    Measured after 10 weeks, 1 year, and 1.5 years

  • Depressive symptoms, as measured by the Beck Depression Inventory and Center for Epidemiologic Studies-Depression Scale

    Measured after 10 weeks, 1 year, and 1.5 years

  • Combined incidence of substance abuse, alcohol abuse, anxiety disorders, and depressive disorders

    Measured after 10 weeks, 1 year, and 1.5 years

Study Arms (2)

Image and Mood (IaM) program

EXPERIMENTAL

Participants will participate in the IaM program.

Behavioral: Image and Mood (IaM) program

Wait-list control

NO INTERVENTION

Participants will be placed on a wait list until after participants in the IaM group have completed all assessments. After that, these participants will be offered the option to complete the IaM program.

Interventions

Image and Mood (IaM) programBEHAVIORAL

A 10-week Internet-based intervention focused on (1) identifying and challenging automatic thoughts in order to improve body image and reduce negative affect, (2) developing adaptive emotion and behavior regulation skills associated with preventing disordered eating and negative affect, and (3) teaching relapse prevention skills. The program includes an online discussion group moderated by a study clinician.

Also known as: Student Bodies+
Image and Mood (IaM) program

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Access to a computer with an Internet connection
  • Weight Concerns Scale score greater than or equal to 47
  • Presence of one additional risk factor, including a history of teasing, a history of depression, or low levels of compensatory behaviors (defined as less than four times per month)
  • Access to a computer with an Internet connection
  • Weight Concerns Scale score greater than or equal to 47

You may not qualify if:

  • Current diagnosis of an eating disorder
  • Treated for an eating disorder within the past 6 months
  • Currently receiving psychological treatment for an eating disorder or depressive disorder
  • Started a new psychiatric medication within the past 2 months
  • Exhibiting a level of psychopathology that would interfere with participation (e.g., acutely suicidal)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stanford University School of Medicine

Stanford, California, 94305-5722, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Related Publications (8)

  • Taylor CB, Bryson S, Luce KH, Cunning D, Doyle AC, Abascal LB, Rockwell R, Dev P, Winzelberg AJ, Wilfley DE. Prevention of eating disorders in at-risk college-age women. Arch Gen Psychiatry. 2006 Aug;63(8):881-8. doi: 10.1001/archpsyc.63.8.881.

    PMID: 16894064BACKGROUND

  • Taylor CB, Sharpe T, Shisslak C, Bryson S, Estes LS, Gray N, McKnight KM, Crago M, Kraemer HC, Killen JD. Factors associated with weight concerns in adolescent girls. Int J Eat Disord. 1998 Jul;24(1):31-42. doi: 10.1002/(sici)1098-108x(199807)24:13.0.co;2-1.

    PMID: 9589309BACKGROUND

  • McKnight Investigators. Risk factors for the onset of eating disorders in adolescent girls: results of the McKnight longitudinal risk factor study. Am J Psychiatry. 2003 Feb;160(2):248-54. doi: 10.1176/ajp.160.2.248.

    PMID: 12562570BACKGROUND

  • Wilfley DE, Welch RR, Stein RI, Spurrell EB, Cohen LR, Saelens BE, Dounchis JZ, Frank MA, Wiseman CV, Matt GE. A randomized comparison of group cognitive-behavioral therapy and group interpersonal psychotherapy for the treatment of overweight individuals with binge-eating disorder. Arch Gen Psychiatry. 2002 Aug;59(8):713-21. doi: 10.1001/archpsyc.59.8.713.

    PMID: 12150647BACKGROUND

  • Wilfley DE, Cohen LR. Psychological treatment of bulimia nervosa and binge eating disorder. Psychopharmacol Bull. 1997;33(3):437-54.

    PMID: 9550890BACKGROUND

  • Manwaring JL, Bryson SW, Goldschmidt AB, Winzelberg AJ, Luce KH, Cunning D, Wilfley DE, Taylor CB. Do adherence variables predict outcome in an online program for the prevention of eating disorders? J Consult Clin Psychol. 2008 Apr;76(2):341-6. doi: 10.1037/0022-006X.76.2.341.

    PMID: 18377129BACKGROUND

  • Tanofsky-Kraff M, Wilfley DE, Young JF, Mufson L, Yanovski SZ, Glasofer DR, Salaita CG. Preventing excessive weight gain in adolescents: interpersonal psychotherapy for binge eating. Obesity (Silver Spring). 2007 Jun;15(6):1345-55. doi: 10.1038/oby.2007.162.

    PMID: 17557971BACKGROUND

  • Taylor CB, Kass AE, Trockel M, Cunning D, Weisman H, Bailey J, Sinton M, Aspen V, Schecthman K, Jacobi C, Wilfley DE. Reducing eating disorder onset in a very high risk sample with significant comorbid depression: A randomized controlled trial. J Consult Clin Psychol. 2016 May;84(5):402-14. doi: 10.1037/ccp0000077. Epub 2016 Jan 21.

    PMID: 26795936DERIVED

MeSH Terms

Conditions

Feeding and Eating DisordersBulimia NervosaBulimiaBinge-Eating Disorder

Condition Hierarchy (Ancestors)

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

Study Officials

  • C. Barr Taylor, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

  • Denise Wilfley, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 6, 2009

First Posted

July 8, 2009

Study Start

August 1, 2009

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

March 17, 2020

Record last verified: 2020-03

Locations

US(2)