Smart mHealth Strategy for Physical Activity and Health Promotion

Sedentary Lifestyle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06423014
• Other study ID #: N202303041
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Sedentary Lifestyle
• Social Media

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