Intervention StudyNCT04347096
Effects of an mHealth Intervention to Improve Health Behaviors Among Sedentary Workers
A study testing mHealth Intervention in people with Intervention Study and Health Behavior, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intervention Study, Health Behavior
- What is being tested?
- mHealth Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Apr 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read more
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.
Read the 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.
- Conditions
- Intervention Study, Health Behavior
- Being tested
- mHealth Intervention, Control Intervention
- Keywords
- Sedentary workers, Healthy diet, Physical activity, Mobile Health, Web app, Cardiometabolic risk biomarkers, Work productivity, Cost-effectiveness
- Medical subject headings
- Health Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth InterventionBehavioural
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.
Control InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| mHealth Intervention | Experimental | 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. Receives: Behavioral: mHealth Intervention |
| Control Intervention | Other | The control intervention group will only receive educational tools (usual care). Receives: Behavioral: Control Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objectively measured physical activity
Physical activity will be objectively measured by the wrist-worn Fitbit Charge 3 (3-axis accelerometer)
Measured: Changes from baseline objectively measured physical activity at 3-, 12-, and 24-month
Self-report physical activity
Physical activity will be assessed by International Physical Activity Questionnaire (IPAQ)-Taiwan short form
Measured: Changes from baseline self-report physical activity at 3-, 12-, and 24-month
Objectively measured dietary behavior
Dietary behavior will be objectively measured with 3-day food photography
Measured: Changes from baseline objectively measured dietary behavior at 3-, 12-, and 24-month
Self-report dietary behavior
Dietary behavior will be assessed by the Healthy Eating Behavior Inventory (HEBI)
Measured: Changes from baseline self-report dietary behavior at 3-, 12-, and 24-month
Occupational sitting and physical activity
Occupational sitting and physical activity will be assessed by the Occupational Sitting and Physical Activity Questionnaire (OSPAQ)
Measured: Changes from baseline occupational sitting and physical activity at 3-, 12-, and 24-month
Work productivity
Work productivity will be measured by Work Limitation Questionnaire (Taiwan) short-form (WLQ-SF)
Measured: Changes from baseline work productivity at 3-, 12-, and 24-month
Fasting blood glucose
Fasting blood glucose will be measured by collecting fasting blood samples in the morning
Measured: Changes from baseline fasting blood glucose at 3-, 12-, and 24-month
Fasting insulin
Fasting insulin will be measured by collecting fasting blood samples in the morning
Measured: Changes from baseline fasting insulin at 3-, 12-, and 24-month
Total cholesterol
Total cholesterol will be measured by collecting fasting blood sample in the morning
Measured: Changes from baseline total cholesterol at 3-, 12-, and 24-month
Low-density lipoprotein (LDL) cholesterol
LDL cholesterol will be measured by collecting fasting blood sample in the morning
Measured: Changes from baseline LDL cholesterol at 3-, 12-, and 24-month
High-density lipoprotein (HDL) cholesterol
HDL cholesterol will be measured by collecting fasting blood sample in the morning
Measured: Changes from baseline HDL cholesterol at 3-, 12-, and 24-month
Triglycerides
Triglycerides will be measured by collecting fasting blood samples in the morning
Measured: Changes from baseline triglycerides at 3-, 12-, and 24-month
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.
Measured: Changes from baseline blood pressure at 3-, 12-, and 24-month
Weight
Weight will be measured by ioi 353 body composition analyzer (JAWON MEDICAL)
Measured: Changes from baseline weight at 3-, 12-, and 24-month
Abdominal circumference
Abdominal circumference will be measured by ioi 353 body composition analyzer (JAWON MEDICAL)
Measured: Changes from baseline abdominal circumference at 3-, 12-, and 24-month
Percent body fat
Percent body fat will be measured by ioi 353 body composition analyzer (JAWON MEDICAL)
Measured: Changes from baseline percent body fat at 3-, 12-, and 24-month
Soft lean mass
Soft lean mass will be measured by ioi 353 body composition analyzer (JAWON MEDICAL)
Measured: Changes from baseline soft lean mass at 3-, 12-, and 24-month
Visceral fat area
Visceral fat area will be measured by ioi 353 body composition analyzer (JAWON MEDICAL)
Measured: Changes from baseline visceral fat area at 3-, 12-, and 24-month
Secondary outcomes (5)
Self-efficacy for reducing sitting
Self-efficacy for reducing sitting will be assessed by the self-efficacy for reducing sitting scale
Measured: Changes from baseline self-efficacy for reducing sitting at 3-, 12-, and 24-month
Self-efficacy for physical activity
Self-efficacy for physical activity will be assessed by the self-efficacy for physical activity scale
Measured: Changes from baseline self-efficacy for physical activity at 3-, 12-, and 24-month
Self-efficacy for healthy eating
Self-efficacy for healthy eating will be assessed by the self-efficacy for healthy eating scale
Measured: Changes from baseline self-efficacy for healthy eating at 3-, 12-, and 24-month
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
Measured: Changes from baseline self-regulation of sitting less and moving more at 3-, 12-, and 24-month
Self-regulation of eating behaviour
Self-regulation of eating behaviour will be assessed by the Self-Regulation of Eating Behaviour Questionnaire
Measured: Changes from baseline self-regulation of eating behaviour at 3-, 12-, and 24-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start27 Apr 2020
- Primary completion31 Jul 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intervention StudyStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan, China Medical University, Taiwan
- Responsible party
- Principal investigator, Lin, Yun-Ping, China Medical University Hospital
- Investigators
- Yun-Ping Lin, PhD, Principal investigator, China Medical University, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04347096
- Sponsor's protocol ID
- CRREC-109-017
- Status last verified
- Jul 2020
- First submitted
- 13 Apr 2020
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lin YP, Lu SH, Lee KC, Ma WF, Ho YF, Liao WC, Yang HT, Hong O. Short-Term Effects of an mHealth Intervention on Healthy Behaviors and Cardiometabolic Health in Sedentary Employees: Quasi-Experimental Study. JMIR Mhealth Uhealth. 2026 Apr 27;14:e70074. doi: 10.2196/70074.
PubMed 42044372
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects and Cost-effectiveness of an mHealth Intervention to Improve Diet, Physical Activity and Sedentary Behavior Among Sedentary Workers
- ClinicalTrials.gov ID
- NCT04347096
- Acronym / sponsor ID
- CRREC-109-017
- Conditions
- Intervention Study, Health Behavior
- Keywords
- Sedentary workers, Healthy diet, Physical activity, Mobile Health, Web app, Cardiometabolic risk biomarkers, Work productivity, Cost-effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan, China Medical University, Taiwan
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 15 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mHealth Intervention | Experimental | Behavioral: mHealth InterventionThe 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 | Other | Behavioral: Control InterventionThe control intervention group will only receive educational tools (usual care). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealth InterventionThe 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. | Behavioural | mHealth Intervention |
| Control InterventionThe 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. | Behavioural | Control Intervention |
Primary outcome
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)
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
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
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)
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)
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)
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
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
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
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
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
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
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.
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)
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)
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)
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)
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)
5 secondary outcomes
Self-efficacy for reducing sitting
Time frame: 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 healthy eating
Time frame: 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 eating behaviour
Time frame: Changes from baseline self-regulation of eating behaviour at 3-, 12-, and 24-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Derived from this study: PubMed 42044372Lin YP, Lu SH, Lee KC, Ma WF, Ho YF, Liao WC, Yang HT, Hong O. Short-Term Effects of an mHealth Intervention on Healthy Behaviors and Cardiometabolic Health in Sedentary Employees: Quasi-Experimental Study. JMIR Mhealth Uhealth. 2026 Apr 27;14:e70074. doi: 10.2196/70074.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yun-Ping Lin, PhD principal investigator
China Medical University, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth Intervention in people with Intervention Study and Health Behavior, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objectively measured physical activity (time frame: Changes from baseline objectively measured physical activity at 3-, 12-, and 24-month). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04347096, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.