Smart mHealth Strategy for Physical Activity and Health Promotion

NCT06423014 — Not applicable, Recruiting, 360 participants, Taipei Medical University

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

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

RegistryNCT06423014
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, prevention
Enrollment360 (Estimated)
SponsorTaipei Medical University (Other)
ConditionsHealth Behavior Change, Wearable Technology, Chatbot, Social Media, Sedentary Lifestyle
InterventionsWearable devices only, 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 all behavior change techniques (Behavioral)
Datesstart 2023-05-01, primary completion 2026-07-01 (estimated), completion 2026-12-01 (estimated), first posted 2024-05-21, last updated 2024-05-21
Locations1 site in Taiwan

Related Papers Related Patents Related Grants Related Experts
All trials for Health Behavior Change All trials for Wearable Technology All trials of Wearable devices only All trials of Wearable devices with the 1st behavior change technique

-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.

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
ControlNo intervention
Wearable devices onlyActive comparatorBehavioral: 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 techniqueExperimentalBehavioral: Wearable devices only; Behavioral: Wearable devices with all behavior change techniques
Wearable devices with the 2nd behavior change techniqueExperimentalBehavioral: Wearable devices only; Behavioral: Wearable devices with all behavior change techniques
Wearable devices with the 3rd behavior change techniqueExperimentalBehavioral: Wearable devices only; Behavioral: Wearable devices with all behavior change techniques
Wearable devices with the 4th behavior change techniqueExperimentalBehavioral: Wearable devices only; Behavioral: Wearable devices with all behavior change techniques
Wearable devices with the 5th behavior change techniqueExperimentalBehavioral: Wearable devices only; Behavioral: Wearable devices with all behavior change techniques
Wearable devices with all behavior change techniquesExperimentalBehavioral: Wearable devices only; Behavioral: Wearable devices with all behavior change techniques
  • 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

+Outcome measures

Primary outcomes

  • Subjective physical activity [up to 12 weeks]: International Physical Activity Questionnaire (IPAQ-SF, MET-minute/week)
  • Objective physical activity [up to 12 weeks]: Actigraphy GT9X and GT3X (MET-minute/week)
  • Exercise Benefits/Barriers Scale-Concise (EBBS-C) [up to 12 weeks]: Higher score higher benefits and barriers
  • Exercise self-efficacy scale (EXSE) [up to 12 weeks]: Higher score higher self-efficacy
  • Physical Activity Self-Regulation Scale (PASR) [up to 12 weeks]: Higher score higher Self-Regulation
  • Behavioural Regulation in Exercise Questionnaire (BREQ-3) [up to 12 weeks]: Higher score higher Behavioural Regulation

Secondary outcomes

  • body composition (Inbody) [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)
  • blood pressure [up to 12 weeks]: Systolic and diastolic blood pressure (mmHg)
  • heart rate variability [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)
  • Depression Anxiety Stress Scale (DASS) [up to 12 weeks]: Higher score worse mental health
  • World Health Organization Quality of Life Scale (WHOQOL-BREF) [up to 12 weeks]: Higher score higher Quality of Life

+Eligibility

Sex: All, ages: 18 Years to 70 Years, accepts healthy volunteers

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

+Locations (1)

FacilityCityCountryStatus
Taipei Medical UniversityTaipeiTaiwanRecruiting