- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04347096
Effects of an mHealth Intervention to Improve Health Behaviors Among Sedentary Workers
Effects and Cost-effectiveness of an mHealth Intervention to Improve Diet, Physical Activity and Sedentary Behavior Among Sedentary Workers
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
N/A = Not Applicable
-
Taichung, N/A = Not Applicable, Taiwan, 40402
- China Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
|
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. |
OTHER: Control Intervention
The control intervention group will only receive educational tools (usual care).
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objectively measured physical activity
Time Frame: 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)
|
Changes from baseline objectively measured physical activity at 3-, 12-, and 24-month
|
Self-report physical activity
Time Frame: 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
|
Changes from baseline self-report physical activity at 3-, 12-, and 24-month
|
Objectively measured dietary behavior
Time Frame: Changes from baseline objectively measured dietary behavior at 3-, 12-, and 24-month
|
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
Time Frame: 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)
|
Changes from baseline self-report dietary behavior at 3-, 12-, and 24-month
|
Occupational sitting and physical activity
Time Frame: 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)
|
Changes from baseline occupational sitting and physical activity at 3-, 12-, and 24-month
|
Work productivity
Time Frame: 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)
|
Changes from baseline work productivity at 3-, 12-, and 24-month
|
Fasting blood glucose
Time Frame: 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
|
Changes from baseline fasting blood glucose at 3-, 12-, and 24-month
|
Fasting insulin
Time Frame: Changes from baseline fasting insulin at 3-, 12-, and 24-month
|
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
Time Frame: Changes from baseline total cholesterol at 3-, 12-, and 24-month
|
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
Time Frame: Changes from baseline LDL cholesterol at 3-, 12-, and 24-month
|
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
Time Frame: Changes from baseline HDL cholesterol at 3-, 12-, and 24-month
|
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
Time Frame: Changes from baseline triglycerides at 3-, 12-, and 24-month
|
Triglycerides will be measured by collecting fasting blood samples in the morning
|
Changes from baseline triglycerides at 3-, 12-, and 24-month
|
Blood pressure
Time Frame: 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.
|
Changes from baseline blood pressure at 3-, 12-, and 24-month
|
Weight
Time Frame: Changes from baseline weight at 3-, 12-, and 24-month
|
Weight will be measured by ioi 353 body composition analyzer (JAWON MEDICAL)
|
Changes from baseline weight at 3-, 12-, and 24-month
|
Abdominal circumference
Time Frame: Changes from baseline abdominal circumference at 3-, 12-, and 24-month
|
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
Time Frame: 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)
|
Changes from baseline percent body fat at 3-, 12-, and 24-month
|
Soft lean mass
Time Frame: 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)
|
Changes from baseline soft lean mass at 3-, 12-, and 24-month
|
Visceral fat area
Time Frame: 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)
|
Changes from baseline visceral fat area at 3-, 12-, and 24-month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-efficacy for reducing sitting
Time Frame: 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
|
Changes from baseline self-efficacy for reducing sitting at 3-, 12-, and 24-month
|
Self-efficacy for physical activity
Time Frame: 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
|
Changes from baseline self-efficacy for physical activity at 3-, 12-, and 24-month
|
Self-efficacy for healthy eating
Time Frame: 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
|
Changes from baseline self-efficacy for healthy eating at 3-, 12-, and 24-month
|
Self-regulation of sitting less and moving more
Time Frame: 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
|
Changes from baseline self-regulation of sitting less and moving more at 3-, 12-, and 24-month
|
Self-regulation of eating behaviour
Time Frame: 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
|
Changes from baseline self-regulation of eating behaviour at 3-, 12-, and 24-month
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cost-effectiveness
Time Frame: At 3-, 12-, and 24-month
|
Cost-effectiveness will be assessed by constructing the incremental cost-effectiveness ratio (ICER)
|
At 3-, 12-, and 24-month
|
Collaborators and Investigators
Investigators
- Principal Investigator: Yun-Ping Lin, PhD, China Medical University, Taiwan
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CRREC-109-017
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Health Behavior
-
Holbaek SygehusRecruitingHealth Behavior | Health Knowledge, Attitudes, Practice | Health-Related Behavior | Health LiteracyDenmark
-
Finnish Institute for Health and WelfareCompletedHealth Behavior | Health Care Utilization | Health Care Seeking BehaviorFinland
-
Basque Health ServiceUnknownHealth Promotion | Health Behavior | Health Education | Patient Education | Counseling | Behavior TherapySpain
-
University Hospital, Basel, SwitzerlandSolidarMed LesothoRecruitingRecruitment | Health Behavior | Motivation | Social Behavior | Health Care Utilization | Consumer Behavior | Health Care Seeking Behavior | Researcher-Subject RelationsLesotho
-
Imperial College LondonRecruitingHealth Attitude | Disease | Cancer | Health Behavior | Health Knowledge, Attitudes, Practice | Health-Related BehaviorUnited Kingdom
-
Research on Healthcare Performance Lab U1290RecruitingStress | Health Behavior | Health-Related BehaviorFrance
-
Azienda Sanitaria Locale CN2 Alba-BraUniversity of Turin, Italy; University of Eastern Piedmont; Eclectica Sas di...CompletedEffectiveness of the Updated Version of the School-based Program Diario Della Salute (DDS-2) (DDS-2)Mental Health Wellness 1 | Health Behavior | Adolescent BehaviorItaly
-
Ankara Yildirim Beyazıt UniversityNot yet recruitingHealth Attitude | Health Behavior | Health KnowledgeTurkey
-
Research on Healthcare Performance Lab U1290RecruitingSedentary Behavior | Sedentary Time | Health Behavior | Health-Related Behavior | Physical InactivityFrance
-
World Health OrganizationLondon School of Hygiene and Tropical Medicine; University of Ghana; Biomedical... and other collaboratorsRecruitingHealth-Related Behavior | Adolescent Behavior | Adolescent Development | Health Care Seeking BehaviorGhana, Tanzania, Zimbabwe
Clinical Trials on mHealth Intervention
-
University of ConnecticutNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Recruiting
-
The Hong Kong Polytechnic UniversityThe University of Hong Kong; Kwong Wah Hospital; University of Glasgow; Tsan Yuk...RecruitingQuality of Life | Family Relations | Postnatal DepressionHong Kong
-
Children's National Research InstituteNot yet recruitingSexually Transmitted Diseases
-
Kaiser PermanenteCompletedSmoking | Smoking CessationUnited States
-
KU LeuvenJomo Kenyatta University of Agriculture and TechnologyCompleted
-
University of FloridaCompleted
-
University of OklahomaActive, not recruitingChild Abuse | Parenting | Child Development | Child NeglectUnited States
-
American University of Beirut Medical CenterInternational Development Research Centre, Canada; Ministry of Public Health... and other collaboratorsCompletedHypertension | Diabetes Mellitus
-
Fundació Institut de Recerca de l'Hospital de la...Recruiting
-
New York State Psychiatric InstituteNorthwell Health, Early Treatment Program at Lenox Hill; The Institute for... and other collaboratorsCompletedSchizophrenia | First-Episode PsychosisUnited States