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临床试验/NCT06423014
NCT06423014招募中不适用

Smart mHealth Strategy in the Delivery of Behavior Change Techniques for Physical Activity and Health Promotion

Taipei Medical University1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2023年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
360
试验地点
1
主要终点
Objective physical activity

研究概览

简要总结

The purpose of this study is to develop a Smart mHealth Strategy that delivers behavior change techniques through wearable physical activity trackers and social media chatbots, including self-monitoring, real-time feedback and reminders, goal-setting, competition and rewards, social support, and health coaching. This study also aims to explore the effect of the Smart mHealth Strategy on the behavioral outcomes and psychological factors of physical activity, and physical and mental health. The study design is a three-stage randomized controlled trial. In each stage, 120 are recruited and randomly assigned to control and experimental groups. Participants are adults with insufficient physical activity and a sedentary lifestyle. The Smart mHealth Strategy uses smartwatches and self-developed chatbots. The constrained dialogue content is designed to finally deliver the six behavior change techniques. Data are collected in the pre-, mid-, and post-tests. The measurement includes self-administered questionnaires, Actigraphy GT9X, Inbody 270S, OMRON HEM-7130, and heart rate variability monitors.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Adults who is the age of majority, with insufficient physical activity, and a sedentary lifestyle who have smartphones

排除标准

  • •Individuals' health conditions may affect physical activity in daily living and the experiment, such as disability, serious health problems
  • •There are unconventional life plans during the experiment, such as going abroad for vacation, pregnancy, and surgery.
  • •Individuals have using experiences in any wearable physical activity trackers in the past six months ④ People who have ever had severe allergies to any wearable device ⑤ Professional athletes or student-athletes

研究组 & 干预措施

Wearable devices with the 3rd behavior change technique

Experimental

干预措施: Wearable devices only (Behavioral)

Wearable devices with the 4th behavior change technique

Experimental

干预措施: Wearable devices only (Behavioral)

Wearable devices with the 4th behavior change technique

Experimental

干预措施: Wearable devices with all behavior change techniques (Behavioral)

Wearable devices with the 5th behavior change technique

Experimental

干预措施: Wearable devices only (Behavioral)

Wearable devices with the 5th behavior change technique

Experimental

干预措施: Wearable devices with all behavior change techniques (Behavioral)

Wearable devices with all behavior change techniques

Experimental

干预措施: Wearable devices only (Behavioral)

Wearable devices with all behavior change techniques

Experimental

干预措施: Wearable devices with all behavior change techniques (Behavioral)

Wearable devices with the 2nd behavior change technique

Experimental

干预措施: Wearable devices only (Behavioral)

Wearable devices with the 2nd behavior change technique

Experimental

干预措施: Wearable devices with all behavior change techniques (Behavioral)

Wearable devices with the 3rd behavior change technique

Experimental

干预措施: Wearable devices with all behavior change techniques (Behavioral)

Control

No Intervention

Wearable devices only

Active Comparator

干预措施: Wearable devices with the 2nd behavior change technique (Behavioral)

Wearable devices only

Active Comparator

干预措施: Wearable devices only (Behavioral)

Wearable devices only

Active Comparator

干预措施: Wearable devices with the 1st behavior change technique (Behavioral)

Wearable devices only

Active Comparator

干预措施: Wearable devices with the 3rd behavior change technique (Behavioral)

Wearable devices only

Active Comparator

干预措施: Wearable devices with the 4th behavior change technique (Behavioral)

Wearable devices only

Active Comparator

干预措施: Wearable devices with the 5th behavior change technique (Behavioral)

Wearable devices only

Active Comparator

干预措施: Wearable devices with all behavior change techniques (Behavioral)

Wearable devices with the 1st behavior change technique

Experimental

干预措施: Wearable devices only (Behavioral)

Wearable devices with the 1st behavior change technique

Experimental

干预措施: Wearable devices with all behavior change techniques (Behavioral)

结局指标

主要结局

Objective physical activity

时间窗: up to 12 weeks

Actigraphy GT9X and GT3X (MET-minute/week)

Subjective physical activity

时间窗: up to 12 weeks

International Physical Activity Questionnaire (IPAQ-SF, MET-minute/week)

Exercise Benefits/Barriers Scale-Concise (EBBS-C)

时间窗: up to 12 weeks

Higher score higher benefits and barriers

Behavioural Regulation in Exercise Questionnaire (BREQ-3)

时间窗: up to 12 weeks

Higher score higher Behavioural Regulation

Exercise self-efficacy scale (EXSE)

时间窗: up to 12 weeks

Higher score higher self-efficacy

Physical Activity Self-Regulation Scale (PASR)

时间窗: up to 12 weeks

Higher score higher Self-Regulation

次要结局

  • Depression Anxiety Stress Scale (DASS)(up to 12 weeks)
  • World Health Organization Quality of Life Scale (WHOQOL-BREF)(up to 12 weeks)
  • heart rate variability(up to 12 weeks)
  • body composition (Inbody)(up to 12 weeks)
  • blood pressure(up to 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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