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临床试验/NCT04626102
NCT04626102已完成不适用

Healthy Eating Attitudes and Behaviours Group Program: A Randomised Controlled Feasibility Study

Istanbul Arel University2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2018年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
38
试验地点
2
主要终点
The Eating Disorders Examination Questionnaire

研究概览

简要总结

Eating disorders (ED) are serious mental health illnesses interfering psychological, physical and social well-being. Besides the severity of ED, most of the individuals presenting symptoms are either not detected or treated. Among ones undergoing treatment, full recovery and remission are also not very likely. Given many negative consequences of ED and personal, sociocultural and financial barriers for ED treatment and low rates of full recovery, any intervention for preventing the development and/or chronicization of ED would be a useful step for the improvement of public health.

Literature has established that Turkish people represent unhealthy eating attitudes and behaviours as similar to Western societies. Evidence shows that the prevalence of disordered eating attitudes and behaviours in Turkey changed between 2.2% to 12.8%. Prevalence of ED particularly among university students and these problems are also likely to negatively influence students' psychological, social and physical well-being, relationships with pairs, educational attainment and academic success. However, awareness regarding ED, help-seeking and receiving treatment appears to be less likely.

Since there is no ED prevention program available for university students in Turkey, it was aimed to develop a Cognitive Behaviour Therapy oriented 6 session ED prevention program (Healthy Eating Attitudes and Behaviours Group Program) for female university students presenting a high risk for ED. A further aim was to examine feasibility, acceptability and efficacy of this program.

Evidence-based clinical guidelines for ED have indicated that CBT is consistently recommended for all subtypes of ED, and CBT oriented prevention programs have been shown to result in a better outcome for university students. Therefore, it was expected that university students who participated in 6 session Healthy Eating Attitudes and Behaviours Group Program would present significantly greater reductions in ED related psychopathology, body dissatisfaction, emotion regulation difficulties and internalization and pressure of sociocultural attitudes towards appearance compared to participants in active control group condition (single session Eating Disorders and Body Dissatisfaction: A Group Work) and wait-list control condition. Also, it was expected that the level of acceptability and feasibility of 6 session Healthy Eating Attitudes and Behaviours Group Program would be good.

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)

盲法说明

Participants were informed that they are invited to attend a group intervention aiming to improve healthy eating attitudes and behaviours. However, they were not informed that they were invited because they had higher levels of disordered eating attitudes and behaviours than the others who were not invited. Also, they did not know that the real aim was to prevent development of eating disorders.

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • having a score of EDEQ-Total or EAT - 40 higher than the mean average of female participants in a study conducted among university students in Turkey before
  • giving consent during the above-mentioned study for getting an invitation for participating in a study in which a group program for promoting healthy eating attitudes and behaviours.

排除标准

  • current or history of eating disorders diagnosis,
  • current substance abuse problem and/or current or past history of psychotic disorders.

结局指标

主要结局

The Eating Disorders Examination Questionnaire

时间窗: Arm1: Enrollment; Arm2: Baseline(first day of the group intervention), post-treatment (6 weeks after baseline measurement), 1 month follow up (10 weeks after te baseline measurement)

This questionnaire was used for measuring restraint eating, shape concern, weight concern, eating concern and general eating disorders related psychopathology. There are four subscales named Restraint, Eating Concern, Shape Concern and Weight Concern, and a total score. The minimum score for this scale is 0, while the maximum score is 6. Higher scores indicate greater levels of disordered eating attitudes and behaviours. This questionnaire was used to assess the level of change from baseline to post-treatment and from baseline to 1 month follow up.

The Body Shape Questionnaire

时间窗: Arm2: Baseline(first day of the group intervention), post-treatment (6 weeks after baseline measurement), 1 month follow up (10 weeks after te baseline measurement)

This questionnaire was used for measuring preoccupation with body weight and shape. Scores can range from 34 (minimum) to 204 (maximum). Higher scores indicate greater levels of body dissatisfaction. This questionnaire was used to assess the level of change from baseline to post-treatment and from baseline to 1 month follow up.

次要结局

  • The Difficulties in Emotion Regulation Scale -16(Arm2: Baseline(first day of the group intervention), post-treatment (6 weeks after baseline measurement), 1 month follow up (10 weeks after te baseline measurement))
  • The Sociocultural Attitudes towards Appearance Questionnaire-4-Revised(Arm2: Baseline(first day of the group intervention), post-treatment (6 weeks after baseline measurement), 1 month follow up (10 weeks after te baseline measurement))

研究者

发起方
Istanbul Arel University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Başak İnce

Research Assistant

Istanbul Arel University

研究点 (2)

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