Smart mHealth Strategy for Physical Activity and Health Promotion

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTaipei Medical University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

360 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: ControlNo intervention 0 interventions
Group B: Wearable devices onlyActive comparator 7 interventions
Group C: Wearable devices with the 1st behavior change techniqueExperimental treatment 2 interventions
Group D: Wearable devices with the 2nd behavior change techniqueExperimental treatment 2 interventions
Group E: Wearable devices with the 3rd behavior change techniqueExperimental treatment 2 interventions
Group F: Wearable devices with the 4th behavior change techniqueExperimental treatment 2 interventions
Group G: Wearable devices with the 5th behavior change techniqueExperimental treatment 2 interventions
Group H: Wearable devices with all behavior change techniquesExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Subjective physical activity

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

Time frame
up to 12 weeks
2

Objective physical activity

Actigraphy GT9X and GT3X (MET-minute/week)

Time frame
up to 12 weeks
3

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

Higher score higher benefits and barriers

Time frame
up to 12 weeks
4

Exercise self-efficacy scale (EXSE)

Higher score higher self-efficacy

Time frame
up to 12 weeks

Secondary outcomes

1

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)

Time frame
up to 12 weeks
2

blood pressure

Systolic and diastolic blood pressure (mmHg)

Time frame
up to 12 weeks
3

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)

Time frame
up to 12 weeks
4

Depression Anxiety Stress Scale (DASS)

Higher score worse mental health

Time frame
up to 12 weeks

Other outcomes

Sponsors and contacts

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