Swedish Body Project for Prevention of Eating Disorders
Condition: Eating Disorders
MeSH terms: Feeding and Eating Disorders
Study type: Interventional

Summary: 
      Women in general and young girls in particular are constantly exposed to unhealthy body and
      appearance ideals through media that contribute to body dissatisfaction and unhealthy
      behaviors such as rigid dieting, which in interaction with genes and other factors increase
      the risk of developing eating disorders such as anorexia nervosa and bulimia nervosa. The
      investigators aim is to investigate the extent to which an interactive prevention program,
      delivered through Internet, called the Swedish Body Project (sBody Project) can decrease the
      emergence of eating disorders among young females. The sBody Project is based on a
      "Dissonance-Based Intervention: (DBI)" that has shown very promising results. The adaptations
      and changes in the format of delivery accomplished in this study might help to disseminate
      the program on a broad basis, and consequently affect the health of young females on a much
      larger scale the ever before.
    

Detailed description: 
      OVERALL AIM AND RESEARCH QUESTIONS The overall aim of this project is to adapt the DBI to be
      implementable on a large scale by means of interactive groups working online, and new methods
      for easily and effectively training program facilitators), with recruitment using the model
      of social media (e.g., through various websites, collaborative projects, and blogs that are
      popular among the youth), and to evaluate the effect of the adapted version of the DBI. The
      program will remain interactive, and its effect can most probably be maintained over time to
      a higher degree than when implemented in its original format, as booster sessions can easily
      be included with no major problems in terms of logistics, meetings, allocation of
      participants, etc. The new format will also provide a framework for recruitment which reduces
      the risk of stigmatization.

      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.
    

Intervention name(s): Internet-based DBI; Expressive writing
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will go through a four week interactive program that will improve body acceptance. Includes some homework assignments and monitoring.; Participants will be asked to reflect upon issues related to body image.
Other intervention name(s): sBody Project
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention