Smart mHealth Strategy for Physical Activity and Health Promotion

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sedentary Lifestyle; Social Media; Wearable Technology; Health Behavior Change; Chatbot
• Intervention / Treatment: Behavioral: Wearable devices only; Behavioral: Wearable devices with the 1st behavior change technique; Behavioral: Wearable devices with the 2nd behavior change technique; Behavioral: Wearable devices with the 3rd behavior change technique; Behavioral: Wearable devices with the 4th behavior change technique; Behavioral: Wearable devices with the 5th behavior change technique; Behavioral: Wearable devices with all behavior change techniques

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hsin-Yen Yen, PhD; Phone Number: 6326 886-2-2736-1661; Email: kenji@tmu.edu.tw

Study Locations

• Taiwan
  • Taipei City, Taiwan, 110
    • Recruiting
    • Taipei Medical University
    • Contact: Hsin-Yen Yen, PhD; Phone Number: 6326 886-2-2736-1661; Email: kenji@tmu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Active Comparator: Wearable devices only	Behavioral: Wearable devices only; self-monitoring; Behavioral: Wearable devices with the 1st behavior change technique; reminder; Behavioral: Wearable devices with the 2nd behavior change technique; social support; Behavioral: Wearable devices with the 3rd behavior change technique; Competition; Behavioral: Wearable devices with the 4th behavior change technique; Goal-setting; Behavioral: Wearable devices with the 5th behavior change technique; health coach; Behavioral: Wearable devices with all behavior change techniques; Self-monitoring, health coach, goal-setting, competition, social support, and reminder
Experimental: Wearable devices with the 1st behavior change technique	Behavioral: Wearable devices only; self-monitoring; Behavioral: Wearable devices with all behavior change techniques; Self-monitoring, health coach, goal-setting, competition, social support, and reminder
Experimental: Wearable devices with the 2nd behavior change technique	Behavioral: Wearable devices only; self-monitoring; Behavioral: Wearable devices with all behavior change techniques; Self-monitoring, health coach, goal-setting, competition, social support, and reminder
Experimental: Wearable devices with the 3rd behavior change technique	Behavioral: Wearable devices only; self-monitoring; Behavioral: Wearable devices with all behavior change techniques; Self-monitoring, health coach, goal-setting, competition, social support, and reminder
Experimental: Wearable devices with the 4th behavior change technique	Behavioral: Wearable devices only; self-monitoring; Behavioral: Wearable devices with all behavior change techniques; Self-monitoring, health coach, goal-setting, competition, social support, and reminder
Experimental: Wearable devices with the 5th behavior change technique	Behavioral: Wearable devices only; self-monitoring; Behavioral: Wearable devices with all behavior change techniques; Self-monitoring, health coach, goal-setting, competition, social support, and reminder
Experimental: Wearable devices with all behavior change techniques	Behavioral: Wearable devices only; self-monitoring; Behavioral: Wearable devices with all behavior change techniques; Self-monitoring, health coach, goal-setting, competition, social support, and reminder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective physical activity	International Physical Activity Questionnaire (IPAQ-SF, MET-minute/week)	up to 12 weeks
Objective physical activity	Actigraphy GT9X and GT3X (MET-minute/week)	up to 12 weeks
Exercise Benefits/Barriers Scale-Concise (EBBS-C)	Higher score higher benefits and barriers	up to 12 weeks
Exercise self-efficacy scale (EXSE)	Higher score higher self-efficacy	up to 12 weeks
Physical Activity Self-Regulation Scale (PASR)	Higher score higher Self-Regulation	up to 12 weeks
Behavioural Regulation in Exercise Questionnaire (BREQ-3)	Higher score higher Behavioural Regulation	up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
blood pressure	Systolic and diastolic blood pressure (mmHg)	up to 12 weeks
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
Depression Anxiety Stress Scale (DASS)	Higher score worse mental health	up to 12 weeks
World Health Organization Quality of Life Scale (WHOQOL-BREF)	Higher score higher Quality of Life	up to 12 weeks

Collaborators and Investigators

• Sponsor: Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 8, 2024
• First Submitted That Met QC Criteria: May 15, 2024
• First Posted (Actual): May 21, 2024

Study Record Updates

• Last Update Posted (Actual): May 21, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: N202303041

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No