Clinical trial NCT06423014: Smart mHealth Strategy for Physical Activity and Health Promotion
Official title: Smart mHealth Strategy in the Delivery of Behavior Change Techniques for Physical Activity and Health Promotion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Health Behavior Change
Wearable Technology
Chatbot
Social Media
Sedentary Lifestyle
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Subjective physical activity
timeFrame: up to 12 weeks
measure: Objective physical activity
timeFrame: up to 12 weeks
measure: Exercise Benefits/Barriers Scale-Concise (EBBS-C)
timeFrame: up to 12 weeks
measure: Exercise self-efficacy scale (EXSE)
timeFrame: up to 12 weeks
measure: Physical Activity Self-Regulation Scale (PASR)
timeFrame: up to 12 weeks
measure: Behavioural Regulation in Exercise Questionnaire (BREQ-3)
timeFrame: up to 12 weeks
Secondary outcomes:
measure: body composition (Inbody)
timeFrame: up to 12 weeks
measure: blood pressure
timeFrame: up to 12 weeks
measure: heart rate variability
timeFrame: up to 12 weeks
measure: Depression Anxiety Stress Scale (DASS)
timeFrame: up to 12 weeks
measure: World Health Organization Quality of Life Scale (WHOQOL-BREF)
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Taipei Medical University
Study officials:
References: