## Protocol Section
### Identification Module
**NCT ID:** NCT06423014

**Brief Title:** Smart mHealth Strategy for Physical Activity and Health Promotion

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

#### Organization Study ID Info
**ID:** N202303041
#### Organization
**Class:** OTHER
**Full Name:** Taipei Medical University
### Status Module
#### Completion Date
**Date:** 2026-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-07

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-05-01

**Type:** ACTUAL

**Status Verified Date:** 2024-03

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Taipei Medical University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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 Module

**Conditions:**

- Health Behavior Change

- Wearable Technology

- Chatbot

- Social Media

- Sedentary Lifestyle

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 360

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Label:** Control

**Type:** NO_INTERVENTION

#### Arm Group 2

**Intervention Names:**

- 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

**Label:** Wearable devices only

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Intervention Names:**

- Behavioral: Wearable devices only

- Behavioral: Wearable devices with all behavior change techniques

**Label:** Wearable devices with the 1st behavior change technique

**Type:** EXPERIMENTAL

#### Arm Group 4

**Intervention Names:**

- Behavioral: Wearable devices only

- Behavioral: Wearable devices with all behavior change techniques

**Label:** Wearable devices with the 2nd behavior change technique

**Type:** EXPERIMENTAL

#### Arm Group 5

**Intervention Names:**

- Behavioral: Wearable devices only

- Behavioral: Wearable devices with all behavior change techniques

**Label:** Wearable devices with the 3rd behavior change technique

**Type:** EXPERIMENTAL

#### Arm Group 6

**Intervention Names:**

- Behavioral: Wearable devices only

- Behavioral: Wearable devices with all behavior change techniques

**Label:** Wearable devices with the 4th behavior change technique

**Type:** EXPERIMENTAL

#### Arm Group 7

**Intervention Names:**

- Behavioral: Wearable devices only

- Behavioral: Wearable devices with all behavior change techniques

**Label:** Wearable devices with the 5th behavior change technique

**Type:** EXPERIMENTAL

#### Arm Group 8

**Intervention Names:**

- Behavioral: Wearable devices only

- Behavioral: Wearable devices with all behavior change techniques

**Label:** Wearable devices with all behavior change techniques

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 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

**Description:** self-monitoring

**Name:** Wearable devices only

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Wearable devices only

**Description:** reminder

**Name:** Wearable devices with the 1st behavior change technique

**Type:** BEHAVIORAL

#### Intervention 3

**Arm Group Labels:**

- Wearable devices only

**Description:** social support

**Name:** Wearable devices with the 2nd behavior change technique

**Type:** BEHAVIORAL

#### Intervention 4

**Arm Group Labels:**

- Wearable devices only

**Description:** Competition

**Name:** Wearable devices with the 3rd behavior change technique

**Type:** BEHAVIORAL

#### Intervention 5

**Arm Group Labels:**

- Wearable devices only

**Description:** Goal-setting

**Name:** Wearable devices with the 4th behavior change technique

**Type:** BEHAVIORAL

#### Intervention 6

**Arm Group Labels:**

- Wearable devices only

**Description:** health coach

**Name:** Wearable devices with the 5th behavior change technique

**Type:** BEHAVIORAL

#### Intervention 7

**Arm Group Labels:**

- 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

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

**Name:** Wearable devices with all behavior change techniques

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Subjective physical activity

**Time Frame:** up to 12 weeks

**Description:** Actigraphy GT9X and GT3X (MET-minute/week)

**Measure:** Objective physical activity

**Time Frame:** up to 12 weeks

**Description:** Higher score higher benefits and barriers

**Measure:** Exercise Benefits/Barriers Scale-Concise (EBBS-C)

**Time Frame:** up to 12 weeks

**Description:** Higher score higher self-efficacy

**Measure:** Exercise self-efficacy scale (EXSE)

**Time Frame:** up to 12 weeks

**Description:** Higher score higher Self-Regulation

**Measure:** Physical Activity Self-Regulation Scale (PASR)

**Time Frame:** up to 12 weeks

**Description:** Higher score higher Behavioural Regulation

**Measure:** Behavioural Regulation in Exercise Questionnaire (BREQ-3)

**Time Frame:** up to 12 weeks

#### Secondary Outcomes

**Description:** 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)

**Measure:** body composition (Inbody)

**Time Frame:** up to 12 weeks

**Description:** Systolic and diastolic blood pressure (mmHg)

**Measure:** blood pressure

**Time Frame:** up to 12 weeks

**Description:** 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)

**Measure:** heart rate variability

**Time Frame:** up to 12 weeks

**Description:** Higher score worse mental health

**Measure:** Depression Anxiety Stress Scale (DASS)

**Time Frame:** up to 12 weeks

**Description:** Higher score higher Quality of Life

**Measure:** World Health Organization Quality of Life Scale (WHOQOL-BREF)

**Time Frame:** up to 12 weeks

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** kenji@tmu.edu.tw

**Name:** Hsin-Yen Yen, PhD

**Phone:** 886-2-2736-1661

**Phone Ext:** 6326

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Taipei City

**Contacts:**

***Contact 1:***

- **Email:** kenji@tmu.edu.tw

- **Name:** Hsin-Yen Yen, PhD

- **Phone:** 886-2-2736-1661

- **Phone Ext:** 6326

- **Role:** CONTACT

**Country:** Taiwan

**Facility:** Taipei Medical University

**Status:** RECRUITING

**Zip:** 110

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
