Effects and Cost-effectiveness of an mHealth Intervention to Improve Diet, Physical Activity and Sedentary Behavior Among Sedentary Workers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Objectively measured dietary behavior
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Objectively measured dietary behavior
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
High-density lipoprotein (HDL) cholesterol
时间窗: Changes from baseline HDL cholesterol at 3-, 12-, and 24-month
HDL cholesterol will be measured by collecting fasting blood sample in the morning
Occupational sitting and physical activity
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Changes from baseline triglycerides at 3-, 12-, and 24-month
Triglycerides will be measured by collecting fasting blood samples in the morning
Fasting insulin
时间窗: 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
时间窗: 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
时间窗: Changes from baseline LDL cholesterol at 3-, 12-, and 24-month
LDL cholesterol will be measured by collecting fasting blood sample in the morning
Blood pressure
时间窗: 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
时间窗: Changes from baseline weight at 3-, 12-, and 24-month
Weight will be measured by ioi 353 body composition analyzer (JAWON MEDICAL)
Abdominal circumference
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
次要结局
- 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)
研究者
Lin, Yun-Ping
Associate Professor
China Medical University Hospital