Smart mHealth Strategy for Physical Activity and Health Promotion

NCT06423014 | Recruiting

• 1 other identifier: N202303041
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• body composition (Inbody)

  up to 12 weeks

• blood pressure

  up to 12 weeks

• heart rate variability

  up to 12 weeks

• Depression Anxiety Stress Scale (DASS)

  up to 12 weeks

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

  up to 12 weeks

Study Arms (8)

Control

NO INTERVENTION

Wearable devices only

ACTIVE COMPARATOR

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

Wearable devices with the 1st behavior change technique

EXPERIMENTAL

Behavioral: Wearable devices only; Behavioral: Wearable devices with all behavior change techniques

Wearable devices with the 2nd behavior change technique

EXPERIMENTAL

Behavioral: Wearable devices only; Behavioral: Wearable devices with all behavior change techniques

Wearable devices with the 3rd behavior change technique

EXPERIMENTAL

Behavioral: Wearable devices only; Behavioral: Wearable devices with all behavior change techniques

Wearable devices with the 4th behavior change technique

EXPERIMENTAL

Behavioral: Wearable devices only; Behavioral: Wearable devices with all behavior change techniques

Wearable devices with the 5th behavior change technique

EXPERIMENTAL

Behavioral: Wearable devices only; Behavioral: Wearable devices with all behavior change techniques

Wearable devices with all behavior change techniques

EXPERIMENTAL

Behavioral: Wearable devices only; Behavioral: Wearable devices with all behavior change techniques

Interventions

Wearable devices only BEHAVIORAL

self-monitoring

Wearable devices only; Wearable devices with all behavior change techniques; Wearable devices with the 1st behavior change technique; Wearable devices with the 2nd behavior change technique; Wearable devices with the 3rd behavior change technique; Wearable devices with the 4th behavior change technique; Wearable devices with the 5th behavior change technique

Wearable devices with the 1st behavior change technique BEHAVIORAL

reminder

Wearable devices only

Wearable devices with the 2nd behavior change technique BEHAVIORAL

social support

Wearable devices only

Wearable devices with the 3rd behavior change technique BEHAVIORAL

Competition

Wearable devices only

Wearable devices with the 4th behavior change technique BEHAVIORAL

Goal-setting

Wearable devices only

Wearable devices with the 5th behavior change technique BEHAVIORAL

health coach

Wearable devices only

Wearable devices with all behavior change techniques BEHAVIORAL

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

Wearable devices only; Wearable devices with all behavior change techniques; Wearable devices with the 1st behavior change technique; Wearable devices with the 2nd behavior change technique; Wearable devices with the 3rd behavior change technique; Wearable devices with the 4th behavior change technique; Wearable devices with the 5th behavior change technique

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults who is the age of majority, with insufficient physical activity, and a sedentary lifestyle who have smartphones

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University

Taipei, 110, Taiwan

RECRUITING

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Wearable Electronic Devices

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Central Study Contacts

Hsin-Yen Yen, PhD

CONTACT

886-2-2736-1661; kenji@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 21, 2024
• Study Start: May 1, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 21, 2024

Record last verified: 2024-03

Locations

TW (1)