Clinical Trials Directory

Trials / Completed

CompletedNCT03408327

The Application of Wearable Technology to Improve the Physical Activity Level of People With Chronic Mental Illness

The Application of Wearable Technology to Improve the Physical Activity Level of People With Chronic Mental Illness- Accuracy, Acceptability, Feasibility and Effectiveness Analysis

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
50 (actual)
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital · Academic / Other
Sex
All
Age
20 Years – 64 Years
Healthy volunteers
Not accepted

Summary

The object is to develop a physical activity promotion program by applying social cognitive theory and wearable technology and evaluate its feasibility in people with MI Stage I: Accuracy, Acceptability, Feasibility. Stage II: Effectiveness Analysis In stage II, will conduct a single-blinded, randomized controlled study. 90 participants will be randomly assigned to experimental group or control group. The intervention for both groups will last for 12 weeks, with a 12-week of follow-up. The measurements include physical activity level, physical fitness, cognitive function and sleep quality, as well as the moderators of the effectiveness of program.

Detailed description

Background: The health condition of individuals with chronic mental illness (MI) is usually poorer than the general population. This health disparity may be related to their lower physical activity level. One of the critical issues in psychiatric rehabilitation is to develop a health promotion program which utilizes less clinical resources and results in long-term effectiveness. Compared with structure exercise, lifestyle physical activity might be one of the solutions. With the mobile technology and wearable technology becoming popular, mobile health (mHealth) emerges and has showed some preliminary effects on other population. The mHealth may be an innovative health promotion program for people with MI and deserves more research to examine the effectiveness. Purpose: This study is (1) to examine the accuracy and acceptability of wearable technology in persons with MI; (2) to develop a physical activity promotion program by applying social cognitive theory and wearable technology and evaluate its feasibility in people with MI ; (3) to examine the effectiveness of the program on physical activity level and health outcomes ; and (4) to examine the moderators of the program's effectiveness. Methods: Stage I: completed (Accuracy, Acceptability, Feasibility) Stage II: (RCT) The investigators will conduct a single-blinded, randomized controlled study. 90 participants will be randomly assigned to experimental group or control group. The intervention for both groups will last for 12 weeks, with a 12-week of follow-up. The measurements include physical activity level, physical fitness, cognitive function and sleep quality, as well as the moderators of the effectiveness of program. Contributions: The results of study will be one of the evidence-based health promotion programs for individuals with MI. With wearable technology and telecommunication technology, it makes possible to expand the health care services from traditional clinical settings to client's natural milieu, and to serve more people with MI by using less resources. The results of study may also form a much appreciated basis for future studies of mHealth on other heath behavior (e.g., healthy diet) or in other disability groups (e.g., stroke).

Conditions

Interventions

TypeNameDescription
DEVICEWearable technologyFitness wristband \& APP
BEHAVIORALLINE groupPromote social interaction
BEHAVIORALGroup activitiesWhich was developed by applying social cognitive theory
DEVICEHealth promotion manualWhich was about general physical activity promotion content

Timeline

Start date
2018-03-16
Primary completion
2020-07-31
Completion
2020-07-31
First posted
2018-01-24
Last updated
2020-11-06

Locations

1 site across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT03408327. Inclusion in this directory is not an endorsement.