Effects of an mHealth Intervention to Improve Health Behaviors Among Sedentary Workers

NCT ID: NCT04347096

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-27
• Study Completion Date: 2022-12-31

Brief Summary

Background: Studies have shown the negative impact of physical inactivity, sedentary and unhealthy eating behavior on worker health and productivity. Sedentary workers are at greater risk of developing chronic diseases due to these behavioral risk factors. The literature moderately supports mHealth interventions for promoting physical activity and healthy diets. However, there is a dearth of research on mHealth interventions targeting the clustering of physical activity, sedentary and dietary behavior among sedentary workers in the occupational setting. Furthermore, there is a lack of evidence on its long-term sustainability and cost-effectiveness on health behaviors as well as health-related and work- related outcomes.

Purpose: To evaluate a 12-week theory-driven, tailored mHealth intervention for improving diet, physical activity and sedentary behavior among sedentary workers. Three specific aims are to: (1) determine intervention participants' perceptions of and engagement with the mHealth program components to understand intervention effects by surveys and focus groups; (2) determine the effectiveness of the mHealth intervention compared to usual care; and (3) determine the cost-effectiveness of the mHealth intervention compared to usual care, using incremental cost-effectiveness ratios (ICERs).

Methods: This is a three-year research project. Year 1 is mHealth intervention delivery and evaluation using a quasi-experimental design. Concepts of social cognitive theory of self-regulation and self-efficacy and an ecological model provide the theoretical foundation for the intervention. Year 2 will be primarily to evaluate the intervention. Year 3 will be primarily an international comparison of cost-effectiveness of mHealth interventions to improve diet, physical activity and sedentary behavior for employees.

A total of 100 sedentary workers (50 per condition) will be recruited from two workplaces. The intervention group will have access to the Internet for using a newly developed Simple health web app and receive an activity tracker. A sample of 100 is required to detect differences in primary outcomes: cardiometabolic risk biomarkers, productivity loss, body composition, physical activity, sedentary behavior, and dietary behavior; and secondary outcomes: self-report self-efficacy and self-regulation, at baseline, 3-, 12-, and 24-month follow up. Generalized estimating equations (GEE) will be used to examine intervention effects over time.

Detailed Description

The Simple health web app will consist of six major components: (1) daily healthy eating goals and records; (2) daily physical activity goals and records; (3) daily stand-up goals and records; (4) advice and reminder; (5) educational and motivational tools; and (6) personal and team health ranking.

Conditions

Intervention Study; Health Behavior

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

mHealth Intervention

The mHealth intervention group will have access to the Internet for using a newly developed Simple health web app and receive an activity tracker. The web app users are required to: (1) wear an activity tracker every day; (2) set goals of daily stand-up, physical activity, and healthy eating bi-weekly; (3) record stand-up, physical activity, and healthy eating behaviors daily; (4) set reminders to stand-up and record health behaviors; and (5) read educational and motivational tools. After completing the behavioral record, the personal advice will automatically provide to encourage, motivate and support the user. Moreover, the user will be able to look at his/her personal and team health ranking.

Group Type: EXPERIMENTAL

mHealth Intervention

Intervention Type: BEHAVIORAL

The mHealth Intervention will provide sedentary workers with evidence-based information on diet, physical activity and sedentary behavior, and tailored feedback on their responses to daily records. Key features of this intervention will include individualized feedback and multimedia presentation in the form of web app. The intervention group will also receive a reliable device for wireless physical activity tracking for monitoring step counts.

The web app will consist of seven major components: (1) daily healthy eating goals and records; (2) daily physical activity goals and records; (3) daily stand-up goals and records; (4) advice and reminder; (5) educational and motivational tools; (6) personal and team health ranking; and (7) online social network. In addition, the intervention will be enhanced with follow-up booster coaching calls bi-monthly at 2, 4, 6, 8 months after the 12-week intervention.

Control Intervention

The control intervention group will only receive educational tools (usual care).

Group Type: OTHER

Control Intervention

Intervention Type: BEHAVIORAL

The control intervention group will receive educational tools, which will provide knowledge on benefits of physical activity and healthy eating, health risks of sitting and unhealthy diets, and recommendations on physical activity and a balanced healthy diet for good health.

Interventions

mHealth Intervention

The mHealth Intervention will provide sedentary workers with evidence-based information on diet, physical activity and sedentary behavior, and tailored feedback on their responses to daily records. Key features of this intervention will include individualized feedback and multimedia presentation in the form of web app. The intervention group will also receive a reliable device for wireless physical activity tracking for monitoring step counts.

The web app will consist of seven major components: (1) daily healthy eating goals and records; (2) daily physical activity goals and records; (3) daily stand-up goals and records; (4) advice and reminder; (5) educational and motivational tools; (6) personal and team health ranking; and (7) online social network. In addition, the intervention will be enhanced with follow-up booster coaching calls bi-monthly at 2, 4, 6, 8 months after the 12-week intervention.

Intervention Type: BEHAVIORAL

Control Intervention

The control intervention group will receive educational tools, which will provide knowledge on benefits of physical activity and healthy eating, health risks of sitting and unhealthy diets, and recommendations on physical activity and a balanced healthy diet for good health.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Full-time employees with sedentary occupations that involve sitting most of the time.

2. Age 20 years and older.

3. No physical limitations that would prevent them from performing physical activity.

4. Has access to the Internet.

Exclusion Criteria

1. Part-time employees.

2. Has an expected absence from work for more than two weeks or an expected relocation to another workplace within the next 3 months.

3. Pregnant or planning to get pregnant within the next 3 months.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Science and Technology, Taiwan

OTHER_GOV

Sponsor Role: collaborator

China Medical University, Taiwan

OTHER

Sponsor Role: collaborator

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lin, Yun-Ping

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yun-Ping Lin, PhD

Role: PRINCIPAL_INVESTIGATOR

China Medical University, Taiwan

Locations

China Medical University

Taichung, N/A = Not Applicable, Taiwan

Countries

Taiwan

Other Identifiers

CRREC-109-017

Identifier Type: -

Identifier Source: org_study_id