Swedish Body Project for Prevention of Eating Disorders
NCT ID: NCT02567890
Last Updated: 2019-08-05
Study Results
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Basic Information
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COMPLETED
NA
443 participants
INTERVENTIONAL
2015-09-30
2019-06-28
Brief Summary
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Detailed Description
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Research questions
1. How effective is the Internet-based DBI, immediately after the intervention and 6, 12, 18, and 24 months later, to reduce the onset of eating disorders?
2. What channels in the Internet / social media leads to the best recruitment of the target group?
3. Can further use and implementation of Internet-based DBI be maintained through a collaborative project (e.g., Wikipreventia) where the principles and methods of implementation (from the training of facilitators to recruitment, implementation and evaluation) are described, facilitated, and the experiences are accumulated?
4. Is the adapted DBI cost-effective?
5. Secondary questions concern the new format's potential for engaging the participants in booster sessions, degree of stigma in recruitment, mediators and moderators of outcome, and subgroup analyses.
STUDY DESIGN, MATERIAL AND METHODS Study Design The DBI will be adapted to be widely implemented and delivered via Internet and through a mobile "app", while maintaining its interactivity and underlying principles and theories. An initial evaluation of this model, although in a simpler format than what is proposed here, has shown promising results.
In a randomized trial, a total of at least 400 girls aged 15-18 with self-reported high levels of body dissatisfaction that is an established risk factor for the development of eating disorders will be randomized into three groups:
1. Internet-based DBI, which consists of four interactive occasions, some homework assignments, and monitoring,
2. Expressive Writing (placebo/attention control), and
3. A wait-list control condition.
Those in the wait-list condition will randomized into one of the active interventions as soon as they have done a 6-month follow-up assessment. Direct and long-term effects of the interventions (6, 12, 18, and 24 months post-intervention) will be investigated by systematic measurements.
Study population and sample size Following the ethical guidelines from the Swedish Research Council, informed consent will be obtained, and an initial assessment (telephone interview) will be conducted. Those who meet the diagnostic criteria for any eating disorder, body dysmorphic disorder, or other serious conditions that require psychiatric care will be excluded. A booster session will be available every six months.
With an effect size of d=.32 between the DBI and the active control condition regarding the main outcome variable (eating disorder pathology), with three conditions in total, and at least 3 measurements (pre, post and 6-months follow-up) the investigators need at least 260 participants with p \< .05, an expected drop-out of 15%, and reliability of measures set between .75 and .95 to attain a power of at least .95. Given the recruitment channels, the investigators expect a much larger number than 260 to participate in the study, and to ensure adequate power for analyses using random effects and to take further drop-out over time into consideration the investigators aim for at least 400 participants.
Procedure Participants will be recruited through notes in different social media and the website of the project that will be linked to different fora which are known to engage adolescent girls. After obtaining informed consent, participants will be asked to download the "app" used for the study. Participants will then be asked to respond to the set of questionnaires (pre-intervention assessment) using a secure plattform, and they will be interviewed. They will then be asked to await feedback, and if included allocation to a group. Participants with significantly high scores on measures of depressive symptomatology or potential diagnosis of dysmorphophobia, eating disorders will be advised to seek professional help, and receive guidance on how to do it. The rest of the participants will be randomized to the study arms. They will then receive further information about their participations and use of the app.
The first session will be initiated by the facilitators who introduce basic issues about body image and the thin ideal.
The day before, and an hour before each meeting, the participants would receive a reminder.
The sessions will be each one hour long. The facilitators will guide the participants through the content of each session following a written manual. Participants who miss a session will be asked to listen to the recorded session ahead of the next session, and briefly discuss it with a facilitator.
Those randomized to Expressive Writing condition will be asked to reflect upon issues related to body image and self-concept according to a manual.
Participants will be asked to respond to the post-intervention assessment battery after the end of the fourth session. They will also be invited to participate in the booster sessions provided after the end of the intervention, and to respond to the follow-up assessments.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Internet-based DBI
Internet-based DBI, which consists of four interactive occasions, some homework assignments, and monitoring
Internet-based DBI
Participants will go through a four week interactive program that will improve body acceptance. Includes some homework assignments and monitoring.
Expressive writing
Expressive Writing (placebo/attention control) where participants write texts. This is the active control condition.
Expressive writing
Participants will be asked to reflect upon issues related to body image.
Waiting list
A wait-list control condition.Those in the wait-list condition will not receive any treatment until they have done the 6-month follow-up assessment.
No interventions assigned to this group
Interventions
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Internet-based DBI
Participants will go through a four week interactive program that will improve body acceptance. Includes some homework assignments and monitoring.
Expressive writing
Participants will be asked to reflect upon issues related to body image.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
15 Years
20 Years
FEMALE
Yes
Sponsors
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Linkoeping University
OTHER_GOV
Oregon Research Institute
OTHER
Karolinska Institutet
OTHER
Responsible Party
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Ata Ghaderi
Professor
Principal Investigators
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Ata Ghaderi, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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Karolinska Institutet
Solna, , Sweden
Countries
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References
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Stice E, Shaw H. Eating disorder prevention programs: a meta-analytic review. Psychol Bull. 2004 Mar;130(2):206-27. doi: 10.1037/0033-2909.130.2.206.
Stice E, Rohde P, Durant S, Shaw H. A preliminary trial of a prototype Internet dissonance-based eating disorder prevention program for young women with body image concerns. J Consult Clin Psychol. 2012 Oct;80(5):907-16. doi: 10.1037/a0028016. Epub 2012 Apr 16.
Stice E, Schupak-Neuberg E, Shaw HE, Stein RI. Relation of media exposure to eating disorder symptomatology: an examination of mediating mechanisms. J Abnorm Psychol. 1994 Nov;103(4):836-40. doi: 10.1037//0021-843x.103.4.836.
Stice E, Shaw H, Becker CB, Rohde P. Dissonance-based Interventions for the prevention of eating disorders: using persuasion principles to promote health. Prev Sci. 2008 Jun;9(2):114-28. doi: 10.1007/s11121-008-0093-x. Epub 2008 May 28.
Stice E, Shaw H, Marti CN. A meta-analytic review of eating disorder prevention programs: encouraging findings. Annu Rev Clin Psychol. 2007;3:207-31. doi: 10.1146/annurev.clinpsy.3.022806.091447.
Stice E, Trost A, Chase A. Healthy weight control and dissonance-based eating disorder prevention programs: results from a controlled trial. Int J Eat Disord. 2003 Jan;33(1):10-21. doi: 10.1002/eat.10109.
White JH. Women and eating disorders, Part I: Significance and sociocultural risk factors. Health Care Women Int. 1992 Oct-Dec;13(4):351-62. doi: 10.1080/07399339209516013.
Welch E, Miller JL, Ghaderi A, Vaillancourt T. Does perfectionism mediate or moderate the relation between body dissatisfaction and disordered eating attitudes and behaviors? Eat Behav. 2009 Aug;10(3):168-75. doi: 10.1016/j.eatbeh.2009.05.002. Epub 2009 May 21.
Welch E, Lagerstrom M, Ghaderi A. Body shape questionnaire: psychometric properties of the short version (BSQ-8C) and norms from the general Swedish population. Body Image. 2012 Sep;9(4):547-50. doi: 10.1016/j.bodyim.2012.04.009. Epub 2012 Jun 19.
Welch E, Birgegard A, Parling T, Ghaderi A. Eating disorder examination questionnaire and clinical impairment assessment questionnaire: general population and clinical norms for young adult women in Sweden. Behav Res Ther. 2011 Feb;49(2):85-91. doi: 10.1016/j.brat.2010.10.010. Epub 2010 Nov 2.
Treasure J, Macare C, Mentxaka IO, Harrison A. The use of a vodcast to support eating and reduce anxiety in people with eating disorder: A case series. Eur Eat Disord Rev. 2010 Nov-Dec;18(6):515-21. doi: 10.1002/erv.1034.
Ghaderi A, Stice E, Andersson G, Eno Persson J, Allzen E. A randomized controlled trial of the effectiveness of virtually delivered Body Project (vBP) groups to prevent eating disorders. J Consult Clin Psychol. 2020 Jul;88(7):643-656. doi: 10.1037/ccp0000506.
Other Identifiers
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P14-0838:1
Identifier Type: -
Identifier Source: org_study_id
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