Smart mHealth Strategy for Physical Activity and Health Promotion

May 15, 2024 updated by: Taipei Medical University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
360

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Subjective physical activity
Time Frame: up to 12 weeks
International Physical Activity Questionnaire (IPAQ-SF, MET-minute/week)
up to 12 weeks
Objective physical activity
Time Frame: up to 12 weeks
Actigraphy GT9X and GT3X (MET-minute/week)
up to 12 weeks
Exercise Benefits/Barriers Scale-Concise (EBBS-C)
Time Frame: up to 12 weeks
Higher score higher benefits and barriers
up to 12 weeks
Exercise self-efficacy scale (EXSE)
Time Frame: up to 12 weeks
Higher score higher self-efficacy
up to 12 weeks
Physical Activity Self-Regulation Scale (PASR)
Time Frame: up to 12 weeks
Higher score higher Self-Regulation
up to 12 weeks
Behavioural Regulation in Exercise Questionnaire (BREQ-3)
Time Frame: up to 12 weeks
Higher score higher Behavioural Regulation
up to 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
up to 12 weeks
blood pressure
Time Frame: up to 12 weeks
Systolic and diastolic blood pressure (mmHg)
up to 12 weeks
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)
up to 12 weeks
Depression Anxiety Stress Scale (DASS)
Time Frame: up to 12 weeks
Higher score worse mental health
up to 12 weeks
World Health Organization Quality of Life Scale (WHOQOL-BREF)
Time Frame: up to 12 weeks
Higher score higher Quality of Life
up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taipei Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 21, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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