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NCT Number: NCT06423014

Smart mHealth Strategy 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.

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Key information

Conditions

Health Behavior Change Behavior Chatbot Sedentary Behavior Sedentary Lifestyle Social Media Wearable Technology

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wearable devices only

Behavioral

self-monitoring

Wearable devices with the 1st behavior change technique

Behavioral

reminder

Wearable devices with the 2nd behavior change technique

Behavioral

social support

Wearable devices with the 3rd behavior change technique

Behavioral

Competition

Wearable devices with the 4th behavior change technique

Behavioral

Goal-setting

Wearable devices with the 5th behavior change technique

Behavioral

health coach

Wearable devices with all behavior change techniques

Behavioral

Self-monitoring, health coach, goal-setting, competition, social support, and reminder

Primary outcomes

  1. Subjective physical activity

    Time frame: up to 12 weeks

    International Physical Activity Questionnaire (IPAQ-SF, MET-minute/week)

  2. Objective physical activity

    Time frame: up to 12 weeks

    Actigraphy GT9X and GT3X (MET-minute/week)

  3. Exercise Benefits/Barriers Scale-Concise (EBBS-C)

    Time frame: up to 12 weeks

    Higher score higher benefits and barriers

  4. Exercise self-efficacy scale (EXSE)

    Time frame: up to 12 weeks

    Higher score higher self-efficacy

  5. Physical Activity Self-Regulation Scale (PASR)

    Time frame: up to 12 weeks

    Higher score higher Self-Regulation

  6. Behavioural Regulation in Exercise Questionnaire (BREQ-3)

    Time frame: up to 12 weeks

    Higher score higher Behavioural Regulation

Secondary outcomes

  1. body composition (Inbody)

    Time frame: up to 12 weeks

    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)

  2. blood pressure

    Time frame: up to 12 weeks

    Systolic and diastolic blood pressure (mmHg)

  3. heart rate variability

    Time frame: up to 12 weeks

    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)

  4. Depression Anxiety Stress Scale (DASS)

    Time frame: up to 12 weeks

    Higher score worse mental health

  5. World Health Organization Quality of Life Scale (WHOQOL-BREF)

    Time frame: up to 12 weeks

    Higher score higher Quality of Life

Study contacts

Contact information is provided by the study sponsor or research team.

Hsin-Yen Yen, PhD

CONTACT

[email protected]

886-2-2736-1661 ext. 6326

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 21, 2024
Registry last updated
May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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