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Eating DisordersNCT00934583

Testing an Internet-Based Intervention for Preventing Eating Disorders

A study testing Image and Mood (IaM) program in people with Eating Disorders, run by Stanford University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 25 years, women only
Conditions the study is for
Eating Disorders
What is being tested?
Image and Mood (IaM) program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
549 participants
Where
2 sitesUnited States
Study dates
Aug 2009to Apr 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 25 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Washington University in St. Louis

    St Louis, Missouri, 63110

  • Stanford University School of Medicine

    Stanford, California, 94305-5722

Other trials in United States

About this study

Official title: Preventing Eating Disorders and Reducing Comorbidity

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

Read the detailed description

Approximately 2% to 4% of college-aged women suffer from eating disorders (EDs), and many more are at risk of developing them. A previous Internet-based intervention called Student Bodies (SB), which focused on body image concerns, was effective in reducing risk factors for EDs among college-aged women. However, the original SB program did not account for certain other risk factors, such as depression and compensatory behaviors like self-induced vomiting, over-exercising, or use of diuretics. Image and Mood (IaM) is an enhanced version of the SB program and takes into account depressive symptoms and the use of compensatory behaviors. This study will examine whether IaM will reduce ED risk factors in a large population of college women who are at high risk of developing EDs.

Participation in this study will last 10 weeks. Participants will be randomly assigned to either receive the IaM program or be placed on a wait list. The IaM program, which will be delivered through the Internet, will provide information about nutrition, exercise, body image, and coping skills-including examples and exercises. It will also include an online message board monitored by a study psychologist. Each week the IaM participants will monitor their behavior, keep a journal about their experiences, and answer self-report questionnaires. Assessments of eating disorder symptoms; weight and shape concerns; depressive symptoms; and incidence of substance abuse, anxiety, or depressive disorders will be completed post-treatment and at 1- and 1.5-month follow-ups. Those assigned to the wait list will complete these assessments and then receive the IaM program after the last follow-up.

Being tested
Image and Mood (IaM) program
Keywords
Bulimia Nervosa, Binge Eating, Binge-Eating Disorder
Medical subject headings
Feeding and Eating Disorders, Bulimia Nervosa, Bulimia, Binge-Eating Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Image and Mood (IaM) programBehavioural

    Also called Student Bodies+

    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.

Study groups in NCT00934583
Study groupRoleWhat they receive
Image and Mood (IaM) programExperimentalParticipants will participate in the IaM program.
Receives: Behavioral: Image and Mood (IaM) program
Wait-list controlNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Eating disorder diagnoses

    Measured: Measured after 10 weeks, 1 year, and 1.5 years

Secondary outcomes (4)

  1. Weight Concerns Scale

    Measured: Measured after 10 weeks, 1 year, and 1.5 years

  2. Eating Disorder Examination Questionnaires (EDE-Q)

    Measured: Measured after 10 weeks, 1 year, and 1.5 years

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

    Measured: Measured after 10 weeks, 1 year, and 1.5 years

  4. Combined incidence of substance abuse, alcohol abuse, anxiety disorders, and depressive disorders

    Measured: Measured after 10 weeks, 1 year, and 1.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2009 (estimated)
  2. Study startAug 2009
  3. Primary completionApr 2012
  4. Study completionApr 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
549 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00934583
Sponsor's protocol ID
R01MH081124
Other IDs
R01MH081124
Status last verified
Mar 2020
First submitted
6 Jul 2009
Last updated
17 Mar 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 16894064

  • 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.

    PubMed 9589309

  • 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.

    PubMed 12562570

  • 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.

    PubMed 12150647

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

    PubMed 9550890

  • 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.

    PubMed 18377129

  • 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.

    PubMed 17557971

  • 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.

    PubMed 26795936

Questions about this trial

What is this clinical trial studying?

A study testing Image and Mood (IaM) program in people with Eating Disorders, run by Stanford University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Eating disorder diagnoses (time frame: Measured after 10 weeks, 1 year, and 1.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00934583, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.

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