Behavioral Intervention to Promote Healthy Lifestyle Behaviors: A Feasibility Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- session duration - descriptive
研究概览
简要总结
in this study to "the investigators aim to improve lifestyle behaviors through behavioral interventions. Participants will be assigned to one of two groups. both groups will be asked to complete online survey before and after a 6 virtual session (twice weekly)
详细描述
Participants were randomly assigned into two groups (motivational interviewing intervention or attention group), using a (1:1) computer-generated randomization program (www.graphpad.com).
motivational interviewing intervention: Each session contained a different component and topic that included substance abuse, physical activity, healthy sleep, stress management, nutrition and social support. The components in order were randomized for each participant. Interviews were conducted using a video meeting platform (Zoom Video Communications Inc., 2016); with both video and audio function enabled while, participants were giving the choice to refuse video calls should they desire. Alternative session delivery method, such as phone calls were used and documented based on participant request.
attention group: received the same amount of virtual session equivalent to MI form. However, the structure of the sessions consisted of brief advice to promote healthy lifestyle delivered by different therapists. The therapist firmly and clearly discussed general lifestyle health topics and provided educational materials during each session
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •living in Saudi Arabia with stay home advisory
- •speak Arabic
排除标准
- •confirmed or suspected COVID-19 diagnosis
结局指标
主要结局
session duration - descriptive
时间窗: immediately after the intervention
reported as the average session time for intervention group or attention group
retention rates - descriptive
时间窗: immediately after the intervention
reported as the number of participants completing all study sessions
recruitment rate - descriptive
时间窗: immediately after the intervention
reported as the number of participants' consented divide by the number of people that were invited to participate
次要结局
- physical activity and sedentary behavior - questionnaire(outcome measure was assessed at baseline and within 7 days from the last study session)
- dietary habits - questionnaire(outcome measure was assessed at baseline and within 7 days from the last study session)
- social support - questionnaire(outcome measure was assessed at baseline and within 7 days from the last study session)
- psychosocial distress - questionnaire(outcome measure was assessed at baseline and within 7 days from the last study session)
- sleep - questionnaire(outcome measure was assessed at baseline and within 7 days from the last study session)
- fear of COVID-19 - questionnaire(outcome measure was assessed at baseline and within 7 days from the last study session)
研究者
Shaima Alothman
Associate Researcher, Clinical Assistant Professor
Princess Nourah Bint Abdulrahman University