Sedentary Lifestyle Clinical Trial
Official title:
Smart mHealth Strategy in the Delivery of Behavior Change Techniques for Physical Activity and Health Promotion
NCT number | NCT06423014 |
Other study ID # | N202303041 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2023 |
Est. completion date | December 2026 |
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.
Status | Recruiting |
Enrollment | 360 |
Est. completion date | December 2026 |
Est. primary completion date | July 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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 ? People who have ever had severe allergies to any wearable device ? Professional athletes or student-athletes |
Country | Name | City | State |
---|---|---|---|
Taiwan | Taipei Medical University | Taipei City |
Lead Sponsor | Collaborator |
---|---|
Taipei Medical University |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Subjective physical activity | International Physical Activity Questionnaire (IPAQ-SF, MET-minute/week) | up to 12 weeks | |
Primary | Objective physical activity | Actigraphy GT9X and GT3X (MET-minute/week) | up to 12 weeks | |
Primary | Exercise Benefits/Barriers Scale-Concise (EBBS-C) | Higher score higher benefits and barriers | up to 12 weeks | |
Primary | Exercise self-efficacy scale (EXSE) | Higher score higher self-efficacy | up to 12 weeks | |
Primary | Physical Activity Self-Regulation Scale (PASR) | Higher score higher Self-Regulation | up to 12 weeks | |
Primary | Behavioural Regulation in Exercise Questionnaire (BREQ-3) | Higher score higher Behavioural Regulation | up to 12 weeks | |
Secondary | body composition (Inbody) | Body mass index (BMI, kg/m^2), skeletal muscle index (SMI, kg/m^2), body fat percentage (%), body fat mass (kg), and fat-free mass (kg) | up to 12 weeks | |
Secondary | blood pressure | Systolic and diastolic blood pressure (mmHg) | up to 12 weeks | |
Secondary | heart rate variability | Total power (TP, 0-0.5 Hz), low-frequency power (LF, 0.04-0.15 Hz), high-frequency power (HF, 0.15-0.40 Hz), the ratio of low frequency to high frequency (LF/HF), and the standard deviation of all normal-to-normal intervals (SDNN) | up to 12 weeks | |
Secondary | Depression Anxiety Stress Scale (DASS) | Higher score worse mental health | up to 12 weeks | |
Secondary | World Health Organization Quality of Life Scale (WHOQOL-BREF) | Higher score higher Quality of Life | up to 12 weeks |
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