Swedish Body Project for Prevention of Eating Disorders (sBodyProject)
Primary Purpose
Eating Disorders
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet-based DBI
Expressive writing
Sponsored by
About this trial
This is an interventional prevention trial for Eating Disorders
Eligibility Criteria
Inclusion Criteria:
- Must have self-reported body dissatisfaction that is an established risk factor for the development of eating disorders.
Exclusion Criteria:
- Those who meet the diagnostic criteria for any eating disorder diagnosis, body dysmorphic disorder, or other serious conditions (e.g., bipolar disorders, schizophrenia) that require psychiatric care will be excluded.
Sites / Locations
- Karolinska Institutet
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
No Intervention
Arm Label
Internet-based DBI
Expressive writing
Waiting list
Arm Description
Internet-based DBI, which consists of four interactive occasions, some homework assignments, and monitoring
Expressive Writing (placebo/attention control) where participants write texts. This is the active control condition.
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.
Outcomes
Primary Outcome Measures
Change in the occurrence of Eating disorder diagnosis
Diagnostic interview to establish the diagnoses of eating disorders
Secondary Outcome Measures
Composite EDE score
Standardised and summed scores of the EDE diagnostic items
Self-reported ED symptoms based on the Eating Disorder Diagnostic Scale
Global symptom severity
Positive and Negative Affect
Measured by the Positive and Negative Affect Schedule (PNAS),
Restraint
Restraint subscale of the Eating Disorders Examination Questionnaire
Functional impairment due to eating disorder problems
Measured by the Clinical Impairment Assessment
Satisfaction and dissatisfaction with body parts
Measured by the Body Parts Dissatisfaction Scale
Internalization of the thin beauty ideal
Measured by Ideal Body Stereotype Scale-revised
Body shape dissatisfaction
Measured by the Body Shape Questionnaire
Full Information
NCT ID
NCT02567890
First Posted
September 30, 2015
Last Updated
August 1, 2019
Sponsor
Karolinska Institutet
Collaborators
Linkoeping University, Oregon Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02567890
Brief Title
Swedish Body Project for Prevention of Eating Disorders
Acronym
sBodyProject
Official Title
An Interactive Internet-based Program for Prevention of Eating Disorders on a Broad Basis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
June 28, 2019 (Actual)
Study Completion Date
June 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Linkoeping University, Oregon Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
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?
What channels in the Internet / social media leads to the best recruitment of the target group?
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?
Is the adapted DBI cost-effective?
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:
Internet-based DBI, which consists of four interactive occasions, some homework assignments, and monitoring,
Expressive Writing (placebo/attention control), and
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
443 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Internet-based DBI
Arm Type
Experimental
Arm Description
Internet-based DBI, which consists of four interactive occasions, some homework assignments, and monitoring
Arm Title
Expressive writing
Arm Type
Placebo Comparator
Arm Description
Expressive Writing (placebo/attention control) where participants write texts. This is the active control condition.
Arm Title
Waiting list
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Internet-based DBI
Other Intervention Name(s)
sBody Project
Intervention Description
Participants will go through a four week interactive program that will improve body acceptance. Includes some homework assignments and monitoring.
Intervention Type
Behavioral
Intervention Name(s)
Expressive writing
Intervention Description
Participants will be asked to reflect upon issues related to body image.
Primary Outcome Measure Information:
Title
Change in the occurrence of Eating disorder diagnosis
Description
Diagnostic interview to establish the diagnoses of eating disorders
Time Frame
6 12, 18 and 24 months after the completed intervention that lasts 4 weeks
Secondary Outcome Measure Information:
Title
Composite EDE score
Description
Standardised and summed scores of the EDE diagnostic items
Time Frame
Pre-assessment, and 6, 12, and 24 months post intervention
Title
Self-reported ED symptoms based on the Eating Disorder Diagnostic Scale
Description
Global symptom severity
Time Frame
Pre-assessment, and 6, 12, 18, and 24 months post intervention
Title
Positive and Negative Affect
Description
Measured by the Positive and Negative Affect Schedule (PNAS),
Time Frame
Pre-assessment, and 6, 12, 18, and 24 months post intervention
Title
Restraint
Description
Restraint subscale of the Eating Disorders Examination Questionnaire
Time Frame
Pre-assessment, and 6, 12, 18, and 24 months post intervention
Title
Functional impairment due to eating disorder problems
Description
Measured by the Clinical Impairment Assessment
Time Frame
Pre-assessment, and 6, 12, 18, and 24 months post intervention
Title
Satisfaction and dissatisfaction with body parts
Description
Measured by the Body Parts Dissatisfaction Scale
Time Frame
Pre-assessment, and 6, 12, 18, and 24 months post intervention
Title
Internalization of the thin beauty ideal
Description
Measured by Ideal Body Stereotype Scale-revised
Time Frame
Pre-assessment, and 6, 12, 18, and 24 months post intervention
Title
Body shape dissatisfaction
Description
Measured by the Body Shape Questionnaire
Time Frame
Pre-assessment, and 6, 12, 18, and 24 months post intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Must have self-reported body dissatisfaction that is an established risk factor for the development of eating disorders.
Exclusion Criteria:
Those who meet the diagnostic criteria for any eating disorder diagnosis, body dysmorphic disorder, or other serious conditions (e.g., bipolar disorders, schizophrenia) that require psychiatric care will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ata Ghaderi, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet
City
Solna
ZIP/Postal Code
17177
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
14979770
Citation
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Citation
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PubMed Identifier
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Citation
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Citation
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Results Reference
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Swedish Body Project for Prevention of Eating Disorders
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