NCT04347096

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 15, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

April 27, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 2, 2025

Status Verified

July 1, 2020

Enrollment Period

2.3 years

First QC Date

April 13, 2020

Last Update Submit

August 25, 2025

Conditions

Keywords

Sedentary workersHealthy dietPhysical activityMobile HealthWeb appCardiometabolic risk biomarkersWork productivityCost-effectiveness

Outcome Measures

Primary Outcomes (18)

  • Objectively measured physical activity

    Physical activity will be objectively measured by the wrist-worn Fitbit Charge 3 (3-axis accelerometer)

    Changes from baseline objectively measured physical activity at 3-, 12-, and 24-month

  • Self-report physical activity

    Physical activity will be assessed by International Physical Activity Questionnaire (IPAQ)-Taiwan short form

    Changes from baseline self-report physical activity at 3-, 12-, and 24-month

  • Objectively measured dietary behavior

    Dietary behavior will be objectively measured with 3-day food photography

    Changes from baseline objectively measured dietary behavior at 3-, 12-, and 24-month

  • Self-report dietary behavior

    Dietary behavior will be assessed by the Healthy Eating Behavior Inventory (HEBI)

    Changes from baseline self-report dietary behavior at 3-, 12-, and 24-month

  • Occupational sitting and physical activity

    Occupational sitting and physical activity will be assessed by the Occupational Sitting and Physical Activity Questionnaire (OSPAQ)

    Changes from baseline occupational sitting and physical activity at 3-, 12-, and 24-month

  • Work productivity

    Work productivity will be measured by Work Limitation Questionnaire (Taiwan) short-form (WLQ-SF)

    Changes from baseline work productivity at 3-, 12-, and 24-month

  • Fasting blood glucose

    Fasting blood glucose will be measured by collecting fasting blood samples in the morning

    Changes from baseline fasting blood glucose at 3-, 12-, and 24-month

  • Fasting insulin

    Fasting insulin will be measured by collecting fasting blood samples in the morning

    Changes from baseline fasting insulin at 3-, 12-, and 24-month

  • Total cholesterol

    Total cholesterol will be measured by collecting fasting blood sample in the morning

    Changes from baseline total cholesterol at 3-, 12-, and 24-month

  • Low-density lipoprotein (LDL) cholesterol

    LDL cholesterol will be measured by collecting fasting blood sample in the morning

    Changes from baseline LDL cholesterol at 3-, 12-, and 24-month

  • High-density lipoprotein (HDL) cholesterol

    HDL cholesterol will be measured by collecting fasting blood sample in the morning

    Changes from baseline HDL cholesterol at 3-, 12-, and 24-month

  • Triglycerides

    Triglycerides will be measured by collecting fasting blood samples in the morning

    Changes from baseline triglycerides at 3-, 12-, and 24-month

  • Blood pressure

    Blood pressure will be measured twice per person via an automated sphygmomanometer using the right arm and an appropriately sized cuff. A third measurement will be taken if the systolic BP differs by \>10 mmHg or the diastolic BP by \>6 mmHg.

    Changes from baseline blood pressure at 3-, 12-, and 24-month

  • Weight

    Weight will be measured by ioi 353 body composition analyzer (JAWON MEDICAL)

    Changes from baseline weight at 3-, 12-, and 24-month

  • Abdominal circumference

    Abdominal circumference will be measured by ioi 353 body composition analyzer (JAWON MEDICAL)

    Changes from baseline abdominal circumference at 3-, 12-, and 24-month

  • Percent body fat

    Percent body fat will be measured by ioi 353 body composition analyzer (JAWON MEDICAL)

    Changes from baseline percent body fat at 3-, 12-, and 24-month

  • Soft lean mass

    Soft lean mass will be measured by ioi 353 body composition analyzer (JAWON MEDICAL)

    Changes from baseline soft lean mass at 3-, 12-, and 24-month

  • Visceral fat area

    Visceral fat area will be measured by ioi 353 body composition analyzer (JAWON MEDICAL)

    Changes from baseline visceral fat area at 3-, 12-, and 24-month

Secondary Outcomes (5)

  • Self-efficacy for reducing sitting

    Changes from baseline self-efficacy for reducing sitting at 3-, 12-, and 24-month

  • Self-efficacy for physical activity

    Changes from baseline self-efficacy for physical activity at 3-, 12-, and 24-month

  • Self-efficacy for healthy eating

    Changes from baseline self-efficacy for healthy eating at 3-, 12-, and 24-month

  • Self-regulation of sitting less and moving more

    Changes from baseline self-regulation of sitting less and moving more at 3-, 12-, and 24-month

  • Self-regulation of eating behaviour

    Changes from baseline self-regulation of eating behaviour at 3-, 12-, and 24-month

Other Outcomes (1)

  • Cost-effectiveness

    At 3-, 12-, and 24-month

Study Arms (2)

mHealth Intervention

EXPERIMENTAL

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.

Behavioral: mHealth Intervention

Control Intervention

OTHER

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

Behavioral: Control Intervention

Interventions

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.

mHealth 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.

Control Intervention

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Full-time employees with sedentary occupations that involve sitting most of the time.
  • Age 20 years and older.
  • No physical limitations that would prevent them from performing physical activity.
  • Has access to the Internet.

You may not qualify if:

  • Part-time employees.
  • Has an expected absence from work for more than two weeks or an expected relocation to another workplace within the next 3 months.
  • Pregnant or planning to get pregnant within the next 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University

Taichung, N/A = Not Applicable, 40402, Taiwan

Location

Related Publications (1)

  • Lin YP, Lu SH, Lee KC, Ma WF, Ho YF, Liao WC, Yang HT, Hong O. Short-Term Effects of a Mobile Health Intervention on Healthy Behaviors and Cardiometabolic Health in Sedentary Employees: A Quasi-Experimental Study. JMIR Mhealth Uhealth. 2026 Jan 22. doi: 10.2196/70074. Online ahead of print.

MeSH Terms

Conditions

Health BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Yun-Ping Lin, PhD

    China Medical University, Taiwan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 13, 2020

First Posted

April 15, 2020

Study Start

April 27, 2020

Primary Completion

July 31, 2022

Study Completion

December 31, 2022

Last Updated

September 2, 2025

Record last verified: 2020-07

Locations