An Interactive Internet-based Program for Prevention of Eating Disorders on a Broad Basis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 443
- 试验地点
- 1
- 主要终点
- Change in the occurrence of Eating disorder diagnosis
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 20 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Must have self-reported body dissatisfaction that is an established risk factor for the development of eating disorders.
排除标准
- •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.
研究组 & 干预措施
Internet-based DBI
Internet-based DBI, which consists of four interactive occasions, some homework assignments, and monitoring
干预措施: Internet-based DBI (Behavioral)
Expressive writing
Expressive Writing (placebo/attention control) where participants write texts. This is the active control condition.
干预措施: Expressive writing (Behavioral)
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.
结局指标
主要结局
Change in the occurrence of Eating disorder diagnosis
时间窗: 6 12, 18 and 24 months after the completed intervention that lasts 4 weeks
Diagnostic interview to establish the diagnoses of eating disorders
次要结局
- Self-reported ED symptoms based on the Eating Disorder Diagnostic Scale(Pre-assessment, and 6, 12, 18, and 24 months post intervention)
- Positive and Negative Affect(Pre-assessment, and 6, 12, 18, and 24 months post intervention)
- Satisfaction and dissatisfaction with body parts(Pre-assessment, and 6, 12, 18, and 24 months post intervention)
- Composite EDE score(Pre-assessment, and 6, 12, and 24 months post intervention)
- Functional impairment due to eating disorder problems(Pre-assessment, and 6, 12, 18, and 24 months post intervention)
- Internalization of the thin beauty ideal(Pre-assessment, and 6, 12, 18, and 24 months post intervention)
- Body shape dissatisfaction(Pre-assessment, and 6, 12, 18, and 24 months post intervention)
- Restraint(Pre-assessment, and 6, 12, 18, and 24 months post intervention)
研究者
Ata Ghaderi
Professor
Karolinska Institutet