Health Behavior Clinical Trial
Official title:
Effects and Cost-effectiveness of an mHealth Intervention to Improve Diet, Physical Activity and Sedentary Behavior Among Sedentary Workers
Verified date | July 2020 |
Source | China Medical University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 103 |
Est. completion date | December 31, 2022 |
Est. primary completion date | May 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years and older |
Eligibility |
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 12 months. 3. Pregnant or planning to get pregnant within the next 12 months. |
Country | Name | City | State |
---|---|---|---|
Taiwan | China Medical University | Taichung | N/A = Not Applicable |
Lead Sponsor | Collaborator |
---|---|
China Medical University Hospital | China Medical University, Taiwan, Ministry of Science and Technology, Taiwan |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Cost-effectiveness | Cost-effectiveness will be assessed by constructing the incremental cost-effectiveness ratio (ICER) | At 3-, 12-, and 24-month | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Triglycerides | Triglycerides will be measured by collecting fasting blood samples in the morning | Changes from baseline triglycerides at 3-, 12-, and 24-month | |
Primary | 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 | |
Primary | Weight | Weight will be measured by ioi 353 body composition analyzer (JAWON MEDICAL) | Changes from baseline weight at 3-, 12-, and 24-month | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Self-efficacy for reducing sitting | Self-efficacy for reducing sitting will be assessed by the self-efficacy for reducing sitting scale | Changes from baseline self-efficacy for reducing sitting at 3-, 12-, and 24-month | |
Secondary | Self-efficacy for physical activity | Self-efficacy for physical activity will be assessed by the self-efficacy for physical activity scale | Changes from baseline self-efficacy for physical activity at 3-, 12-, and 24-month | |
Secondary | Self-efficacy for healthy eating | Self-efficacy for healthy eating will be assessed by the self-efficacy for healthy eating scale | Changes from baseline self-efficacy for healthy eating at 3-, 12-, and 24-month | |
Secondary | Self-regulation of sitting less and moving more | Self-regulation of sitting less and moving more will be assessed by the self-regulation for sitting less and moving more scale | Changes from baseline self-regulation of sitting less and moving more at 3-, 12-, and 24-month | |
Secondary | Self-regulation of eating behaviour | Self-regulation of eating behaviour will be assessed by the Self-Regulation of Eating Behaviour Questionnaire | Changes from baseline self-regulation of eating behaviour at 3-, 12-, and 24-month |
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