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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date March 2024
Source Taipei Medical University
Contact Hsin-Yen Yen, PhD
Phone 886-2-2736-1661
Email kenji@tmu.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Wearable devices only
self-monitoring
Wearable devices with the 1st behavior change technique
reminder
Wearable devices with the 2nd behavior change technique
social support
Wearable devices with the 3rd behavior change technique
Competition
Wearable devices with the 4th behavior change technique
Goal-setting
Wearable devices with the 5th behavior change technique
health coach
Wearable devices with all behavior change techniques
Self-monitoring, health coach, goal-setting, competition, social support, and reminder

Locations

Country Name City State
Taiwan Taipei Medical University Taipei City

Sponsors (1)

Lead Sponsor Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

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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