Clinical trial NCT04347096: Effects of an mHealth Intervention to Improve Health Behaviors Among Sedentary Workers
Official title: Effects and Cost-effectiveness of an mHealth Intervention to Improve Diet, Physical Activity and Sedentary Behavior Among Sedentary Workers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intervention Study
Health Behavior
Keywords: Sedentary workers
Healthy diet
Physical activity
Mobile Health
Web app
Cardiometabolic risk biomarkers
Work productivity
Cost-effectiveness
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
name: China Medical University, Taiwan
First posted: 2020-04-15
Enrollment: 103
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 12 months.
3. Pregnant or planning to get pregnant within the next 12 months.

Primary outcomes:
measure: Objectively measured physical activity
timeFrame: Changes from baseline objectively measured physical activity at 3-, 12-, and 24-month
measure: Self-report physical activity
timeFrame: Changes from baseline self-report physical activity at 3-, 12-, and 24-month
measure: Objectively measured dietary behavior
timeFrame: Changes from baseline objectively measured dietary behavior at 3-, 12-, and 24-month
measure: Self-report dietary behavior
timeFrame: Changes from baseline self-report dietary behavior at 3-, 12-, and 24-month
measure: Occupational sitting and physical activity
timeFrame: Changes from baseline occupational sitting and physical activity at 3-, 12-, and 24-month
measure: Work productivity
timeFrame: Changes from baseline work productivity at 3-, 12-, and 24-month
measure: Fasting blood glucose
timeFrame: Changes from baseline fasting blood glucose at 3-, 12-, and 24-month
measure: Fasting insulin
timeFrame: Changes from baseline fasting insulin at 3-, 12-, and 24-month
measure: Total cholesterol
timeFrame: Changes from baseline total cholesterol at 3-, 12-, and 24-month
measure: Low-density lipoprotein (LDL) cholesterol
timeFrame: Changes from baseline LDL cholesterol at 3-, 12-, and 24-month
measure: High-density lipoprotein (HDL) cholesterol
timeFrame: Changes from baseline HDL cholesterol at 3-, 12-, and 24-month
measure: Triglycerides
timeFrame: Changes from baseline triglycerides at 3-, 12-, and 24-month
measure: Blood pressure
timeFrame: Changes from baseline blood pressure at 3-, 12-, and 24-month
measure: Weight
timeFrame: Changes from baseline weight at 3-, 12-, and 24-month
measure: Abdominal circumference
timeFrame: Changes from baseline abdominal circumference at 3-, 12-, and 24-month
measure: Percent body fat
timeFrame: Changes from baseline percent body fat at 3-, 12-, and 24-month
measure: Soft lean mass
timeFrame: Changes from baseline soft lean mass at 3-, 12-, and 24-month
measure: Visceral fat area
timeFrame: Changes from baseline visceral fat area at 3-, 12-, and 24-month
Secondary outcomes:
measure: Self-efficacy for reducing sitting
timeFrame: Changes from baseline self-efficacy for reducing sitting at 3-, 12-, and 24-month
measure: Self-efficacy for physical activity
timeFrame: Changes from baseline self-efficacy for physical activity at 3-, 12-, and 24-month
measure: Self-efficacy for healthy eating
timeFrame: Changes from baseline self-efficacy for healthy eating at 3-, 12-, and 24-month
measure: Self-regulation of sitting less and moving more
timeFrame: Changes from baseline self-regulation of sitting less and moving more at 3-, 12-, and 24-month
measure: Self-regulation of eating behaviour
timeFrame: Changes from baseline self-regulation of eating behaviour at 3-, 12-, and 24-month
Other outcomes:
measure: Cost-effectiveness
timeFrame: At 3-, 12-, and 24-month
Locations:
city: Taichung
country: Taiwan
facility: China Medical University
state: N/A = Not Applicable
Study officials:
affiliation: China Medical University, Taiwan
name: Yun-Ping Lin, PhD
role: PRINCIPAL_INVESTIGATOR
References: