Effects of an mHealth Intervention to Improve Health Behaviors Among Sedentary Workers
- Conditions
- Health BehaviorIntervention Study
- Interventions
- Behavioral: mHealth InterventionBehavioral: Control Intervention
- Registration Number
- NCT04347096
- Lead Sponsor
- China Medical University Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 103
- 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.
- Part-time employees.
- Has an expected absence from work for more than two weeks or an expected relocation to another workplace within the next 12 months.
- Pregnant or planning to get pregnant within the next 12 months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description mHealth Intervention 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. Control Intervention Control Intervention The control intervention group will only receive educational tools (usual care).
- Primary Outcome Measures
Name Time Method Objectively measured dietary behavior Changes from baseline objectively measured dietary behavior at 3-, 12-, and 24-month Dietary behavior will be objectively measured with 3-day food photography
Self-report dietary behavior Changes from baseline self-report dietary behavior at 3-, 12-, and 24-month Dietary behavior will be assessed by the Healthy Eating Behavior Inventory (HEBI)
Objectively measured physical activity Changes from baseline objectively measured physical activity at 3-, 12-, and 24-month Physical activity will be objectively measured by the wrist-worn Fitbit Charge 3 (3-axis accelerometer)
Self-report physical activity Changes from baseline self-report physical activity at 3-, 12-, and 24-month Physical activity will be assessed by International Physical Activity Questionnaire (IPAQ)-Taiwan short form
Occupational sitting and physical activity Changes from baseline occupational sitting and physical activity at 3-, 12-, and 24-month Occupational sitting and physical activity will be assessed by the Occupational Sitting and Physical Activity Questionnaire (OSPAQ)
Work productivity Changes from baseline work productivity at 3-, 12-, and 24-month Work productivity will be measured by Work Limitation Questionnaire (Taiwan) short-form (WLQ-SF)
Fasting blood glucose Changes from baseline fasting blood glucose at 3-, 12-, and 24-month Fasting blood glucose will be measured by collecting fasting blood samples in the morning
Triglycerides Changes from baseline triglycerides at 3-, 12-, and 24-month Triglycerides will be measured by collecting fasting blood samples in the morning
Fasting insulin Changes from baseline fasting insulin at 3-, 12-, and 24-month Fasting insulin will be measured by collecting fasting blood samples in the morning
Total cholesterol Changes from baseline total cholesterol at 3-, 12-, and 24-month Total cholesterol will be measured by collecting fasting blood sample in the morning
Low-density lipoprotein (LDL) cholesterol Changes from baseline LDL cholesterol at 3-, 12-, and 24-month LDL cholesterol will be measured by collecting fasting blood sample in the morning
High-density lipoprotein (HDL) cholesterol Changes from baseline HDL cholesterol at 3-, 12-, and 24-month HDL cholesterol will be measured by collecting fasting blood sample in the morning
Blood pressure Changes from baseline blood pressure at 3-, 12-, and 24-month 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.
Weight Changes from baseline weight at 3-, 12-, and 24-month Weight will be measured by ioi 353 body composition analyzer (JAWON MEDICAL)
Abdominal circumference Changes from baseline abdominal circumference at 3-, 12-, and 24-month Abdominal circumference will be measured by ioi 353 body composition analyzer (JAWON MEDICAL)
Percent body fat Changes from baseline percent body fat at 3-, 12-, and 24-month Percent body fat will be measured by ioi 353 body composition analyzer (JAWON MEDICAL)
Soft lean mass Changes from baseline soft lean mass at 3-, 12-, and 24-month Soft lean mass will be measured by ioi 353 body composition analyzer (JAWON MEDICAL)
Visceral fat area Changes from baseline visceral fat area at 3-, 12-, and 24-month Visceral fat area will be measured by ioi 353 body composition analyzer (JAWON MEDICAL)
- Secondary Outcome Measures
Name Time Method Self-efficacy for reducing sitting Changes from baseline self-efficacy for reducing sitting at 3-, 12-, and 24-month Self-efficacy for reducing sitting will be assessed by the self-efficacy for reducing sitting scale
Self-efficacy for physical activity Changes from baseline self-efficacy for physical activity at 3-, 12-, and 24-month Self-efficacy for physical activity will be assessed by the self-efficacy for physical activity scale
Self-efficacy for healthy eating Changes from baseline self-efficacy for healthy eating at 3-, 12-, and 24-month Self-efficacy for healthy eating will be assessed by the self-efficacy for healthy eating scale
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 sitting less and moving more will be assessed by the self-regulation for sitting less and moving more scale
Self-regulation of eating behaviour Changes from baseline self-regulation of eating behaviour at 3-, 12-, and 24-month Self-regulation of eating behaviour will be assessed by the Self-Regulation of Eating Behaviour Questionnaire
Trial Locations
- Locations (1)
China Medical University
🇨🇳Taichung, N/A = Not Applicable, Taiwan