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临床试验/NCT05046938
NCT05046938已完成不适用

The Effect of Online Group Motivational Interviewing on Eating Behaviour, Healthy Lifestyle Behaviours and Quality of Life in Nursing Students With Food Addiction: Randomized Controlled Study

Merve Işık2 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2021年9月7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
59
试验地点
2
主要终点
Evolution of eating behaviour

研究概览

简要总结

The aim of this study is to determine the effect of online group motivational interviewing (MI) on eating behavior, healthy lifestyle behaviors and quality of life in nursing participants with food addiction at three state universities in Ankara. The population of the research will be those who meet the diagnostic criteria for food addiction according to the Yale Food Addiction Scale. The research sample size was calculated with the G* Power package program. As a result of the power analysis, a total of 52 participants, 26 for the intervention group and 26 for the control group, were found sufficient for the sample with 90% power, 5% margin of error and 0.2065 effect size. Considering that the number of participants would decrease during the research process, the number of samples was increased by 10% to a total of 58 university participants, 29 of which were interventions and 29 were controls. Among the participants who meet the food addiction criteria, the participants who meet the inclusion criteria and agree to participate in the research will be randomly assigned to the intervention and control groups (n1=29; n2=29). After these participants are stratified according to the change (pre-contemplation and contemplation stage) phase, a simple random assignment process within the strata will be done by an independent researcher to avoid selection bias. Random assignment will be done through a simple random numbers table. The independent researcher who does not know which group is the intervention group and which group is the control group will collect the data. Data collection tools will be applied to the participants in the intervention and control groups in the pre-MI session, the post-MI session, and 2 months later in the follow-up session. It was planned to apply 5 sessions of MI to the intervention group, and to follow-up 2 months after the interviews were completed. No application will be made to the participants in the control group, and at the end of the study, a seminar on food addiction and quality of life will be given to the participants.

详细描述

The research will be conducted as a randomized controlled experimental design to determine the effect of online group motivational interviewing on eating behavior, healthy lifestyle behaviors and quality of life in nursing participants with food addiction.

Research hypotheses:

H0-1: Motivational interview has no effect on the level of healthy lifestyle behaviors of nursing participants.

H1-1: Motivational interview has an effect on the level of healthy lifestyle behaviors of nursing participants.

H0-2: Motivational interview has no effect on the quality of life of nursing students.

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 (Investigator)

盲法说明

Among the students who meet the food addiction criteria, the students who meet the inclusion criteria and agree to participate in the research will be randomly assigned to the intervention and control groups (n1=29; n2=29). After these students are stratified according to the change (pre-contemplation and contemplation stage) phase, a simple random assignment process within the strata will be done by an independent researcher to avoid selection bias. Random assignment will be done through a simple random numbers table. The independent researcher who does not know which group is the intervention group and which group is the control group will collect the data.

入排标准

性别
All
接受健康志愿者

入选标准

  • Meeting at least 3 diagnostic criteria according to the Yale Food Addiction Scale (YFAS) and having clinical significance
  • Not having a written or verbal communication problem
  • Volunteer to participate in research
  • Among the motivational interview change stages, those who do not intend to change their eating behavior and those who intend to do so

排除标准

  • Having a neurological or psychiatric illness that interferes with reading and understanding data collection tools
  • Have previously received treatment/psychotherapy for food addiction/eating disorder
  • Receiving ongoing treatment/psychotherapy/psychological counseling regarding food addiction/eating disorder
  • Having trouble speaking/understanding Turkish
  • Being at the stage of preparation, action and maintenance in making changes in nutritional behavior, which is one of the motivational interview change stages

结局指标

主要结局

Evolution of eating behaviour

时间窗: 5 weeks after randomization

Yale Food Addiction Scale (Measured by the Yale Food Addiction Scale Minimum score = 0 symptoms, Maximum score = 11 symptoms. Greater symptoms mean worse outcome.

次要结局

  • Evolution of health lifestyle behaviour(From baseline, up to 3 months)
  • Evolution of SF-36 quality of life(From baseline, up to 3 months)

研究者

发起方
Merve Işık
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Merve Işık

research assistant

Gazi University

研究点 (2)

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