Type2 DiabetesMySteps-CoVNCT04587414
eHealth Intervention on Physical Activity for Type 2 Diabetics - Frustrated by COVID-19
A study testing eHealth +counselling contacts and eHealth in people with Type2 Diabetes, run by UKK Institute at 1 site in Finland.
Trial summary
This pragmatic 3-arm randomized controlled trial is conducted within the primary health care setting. The trial evaluates the effectiveness of a personalized eHealth intervention based on a hip-worn accelerometer, smartphone application and cloud service (www.exced.com) with or without face-to-face and telephone… Read more about this study
- Who is it for?
- Ages 20 to 69 years
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- eHealth +counselling contacts and eHealth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteFinland
- Study dates
- 6 Mar 2019to 31 Oct 2020
- 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 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a diagnosed type 2 diabetes
- a prescheduled appointment with a health care professional regarding PA counselling in primary care settings of North Karelia Hospital District, Finland
- body mass index <40
- does not meet the current PA recommendation for health
- is able to conduct six minute walk test.
Who cannot join
- any problem that limits ability to walk without an aid
- any health problem that hinders participation in light to moderate intensity PA,
- not able or willing to use smartphone
- not willing to wear the research accelerometer at the baseline
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Personalized eHealth Intervention in Patients With Type 2 Diabetes to Promote Daily Physical Activity Utilizing 24h Self-monitoring - Implementation Frustrated by COVID-19 Epidemic
This pragmatic 3-arm randomized controlled trial is conducted within the primary health care setting. The trial evaluates the effectiveness of a personalized eHealth intervention based on a hip-worn accelerometer, smartphone application and cloud service (www.exced.com) with or without face-to-face and telephone counselling contacts on physical activity (PA) compared to usual care in increasing daily PA and reducing sedentary behavior (SB) among type 2 diabetes (T2D) patients.The duration of the intervention period is 6 months, after which there is a 6 month follow-up for evaluating the maintenance of anticipated intervention effects. The primary goal of the intervention is that the T2D patients increase their daily number of steps by replacing SB with low intensity PA. The secondary goal is to increase short bouts of moderate-to-vigorous PA according to personal goals. It is expected that the eHealth intervention complemented by individual counselling is the most effective in reaching the goals, and the eHealth intervention is more effective than usual care.
Measurements are done at baseline, after the 6-month intervention, and after the 6-month follow-up. Participants' one-week PA and SB are measured with a hip-worn triaxial accelerometer and analyzed with validated algorithms. Cardiorespiratory fitness is assessed with a validated 6-minute walk test. Diabetes-related metabolic biomarkers (HbA1C, LDL-c, HDL-c, oxidized LDL and HDL lipids) and cardiovascular risk factors (blood pressure, BMI, waist circumference) are measured with standard laboratory methods. Quality of life is assessed by RAND-36 method. The interventions are evaluated with RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) method. Besides effectiveness, RE-AIM methods evaluates the target group reach and adherence; provider adoption; intervention fidelity; maintenance of the changes in PA and SB behavior, biomarkers and CVD risk factors; intervention transferability to clinical practice; adverse events; and patient and provider satisfaction.
Unexpectedly, the COVID-19 pandemic in spring 2020 led to substantial restrictions in outdoors mobility of T2D patients and their access access to health care in Finland, facts that frustrated the planned implementation of the original intervention, related measurements and their scheduling. This means that not all planned measurements could be done at all or at the scheduled time point. Irrespective of the time of recruitment, all follow-up measurements are done from June to September 2020. Notwithstanding the COVID-19 pandemic annulled the original intervention, the collected data yet provides unique insights into measured physical activity, fitness and metabolic biomarkers of T2D patients before and during the COVID-19 pandemic and consequent restrictions.In addition, the data allows to evaluate the implementation of eHealth approach and face-to-face and telephone PA counselling contacts within the primary health care setting.
- Conditions
- Type2 Diabetes
- Being tested
- eHealth +counselling contacts, eHealth, Usual care
- Keywords
- physical activity, sedentary behavior, accelerometer, eHealth, COVID-19
- Medical subject headings
- Motor Activity, Sedentary Behavior, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eHealth +counselling contactsBehavioural
The 6 month eHealth intervention comprises continuous self-monitoring of PA and SB using hip-worn accelerometer and ExSed application, which gives cloud-computed personal feedback about accelerometer-measured PA and SB on smartphone and provides a platform for a health care professional to set and monitor patient's personal activity goals as well as give personalized feedback to the patient. In addition, instructions and video-demonstrations on how to reach the goals are provided via Internet. The eHealth intervention is complemented by face-to-face and telephone counselling on physical activity which comprises 4 to 6 contacts between a health care professional and the patient as well as at least 3 telephone contacts during 6 months.
eHealthBehavioural
The 6 month eHealth intervention comprises continuous self-monitoring of PA and SB using hip-worn accelerometer and ExSed application, which gives cloud-computed personal feedback about accelerometer-measured PA and SB on smartphone and provides a platform for a health care professional to set and monitor patient's personal activity goals as well as give personalized feedback to the patient. In addition, instructions and video-demonstrations on how to reach the goals are provided via Internet. No telephone calls nor face-to-face counselling contacts on physical activity are taken.
Usual careBehavioural
Usual care and councelling given to type 2 diabetics within the primary health care setting.
| Study group | Role | What they receive |
|---|---|---|
| eHealth + counselling contacts | Experimental | 6-month eHealth physical activity intervention complemented by face-to-face and telephone counselling contacts on physical activity.. Receives: Behavioral: eHealth +counselling contacts; Behavioral: Usual care |
| eHealth | Experimental | 6-month eHealth physical activity intervention Receives: Behavioral: eHealth; Behavioral: Usual care |
| Usual care | Other | Usual care of type 2 diabetics within the primary health care setting. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total mean daily step count
Step count during one week is measured with a hip-worn accelerometer at baseline, 6 months, and 12 months
Measured: At 6 and 12 months compared to baseline (0 months). N.B. Because of COVID-19, the schedule and contents of measurements may change individually depending on the time of recruitment.
Secondary outcomes (2)
Changes in total mean daily time of sedentary, low intensity PA and moderate-to-vigorous PA
Sedentary time and PA time at different intensity ranges are measured with a hip-worn accelerometer at baseline, 6 months and 12 months
Measured: at 6 and 12 months compared to baseline (0 months). N.B. Because of COVID-19, the schedule and contents of measurements may change individually depending on the time of recruitment.
Changes in the mean daily number of moderate-to-vigorous PA bouts lasting at least 1, 5 and 10 minutes.
Durations of moderate-to-vigorous PA bouts measured with a hip-worn accelerometer at baseline, 6 months and 12 months
Measured: at 6 and 12 months compared to baseline (0 months). N.B. Because of COVID-19, the schedule and contents of measurements may change individually depending on the time of recruitment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start6 Mar 2019
- Primary completion31 Oct 2020 (estimated)
- Study completion31 Oct 2020 (estimated)
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 Type2 DiabetesStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a pragmatic three-arm randomized controlled trial carried out within the primary health care setting. Besides the usual care given to type 2 diabetics, the patients may be assigned either into a 6-month eHealth intervention complemented by face-to-face and telephone counselling contacts on physical activity or into a 6-month eHealth intervention without counselling contacts. After the 6-month intervention, there is a 6-month follow-up period.
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- UKK Institute
- Sponsor type
- University, hospital or other
- Collaborators
- North Karelia Hospital District, University of Eastern Finland
- Responsible party
- Principal investigator, Harri Sievanen, UKK Institute
- Investigators
- Tommi Vasankari, MD, PhD, Principal investigator, UKK Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587414
- Sponsor's protocol ID
- MySteps ETL 303/2017
- Acronym
- MySteps-CoV
- Status last verified
- Oct 2020
- First submitted
- 8 Sep 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aittasalo M, Tokola K, Vaha-Ypya H, Husu P, Manttari A, Martiskainen T, Laatikainen T, Sievanen H. mHealth Intervention to Promote Nonexercise Physical Activity in Patients With Type 2 Diabetes: Secondary Analysis and Implementation Study. JMIR Form Res. 2026 Mar 19;10:e80304. doi: 10.2196/80304.
PubMed 41855496
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized eHealth Intervention in Patients With Type 2 Diabetes to Promote Daily Physical Activity Utilizing 24h Self-monitoring - Implementation Frustrated by COVID-19 Epidemic
- ClinicalTrials.gov ID
- NCT04587414
- Acronym / sponsor ID
- MySteps-CoV / MySteps ETL 303/2017
- Conditions
- Type2 Diabetes
- Keywords
- physical activity, sedentary behavior, accelerometer, eHealth, COVID-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (actual)
- Lead sponsor
- UKK InstituteUniversity, hospital or other
- Collaborators
- North Karelia Hospital District, University of Eastern Finland
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 31 Oct 2020 (estimated)
- First posted
- 14 Oct 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.
This pragmatic 3-arm randomized controlled trial is conducted within the primary health care setting. The trial evaluates the effectiveness of a personalized eHealth intervention based on a hip-worn accelerometer, smartphone application and cloud service (www.exced.com) with or without face-to-face and telephone counselling contacts on physical activity (PA) compared to usual care in increasing daily PA and reducing sedentary behavior (SB) among type 2 diabetes (T2D) patients.The duration of the intervention period is 6 months, after which there is a 6 month follow-up for evaluating the maintenance of anticipated intervention effects. The primary goal of the intervention is that the T2D patients increase their daily number of steps by replacing SB with low intensity PA. The secondary goal is to increase short bouts of moderate-to-vigorous PA according to personal goals. It is expected that the eHealth intervention complemented by individual counselling is the most effective in reaching the goals, and the eHealth intervention is more effective than usual care.
Measurements are done at baseline, after the 6-month intervention, and after the 6-month follow-up. Participants' one-week PA and SB are measured with a hip-worn triaxial accelerometer and analyzed with validated algorithms. Cardiorespiratory fitness is assessed with a validated 6-minute walk test. Diabetes-related metabolic biomarkers (HbA1C, LDL-c, HDL-c, oxidized LDL and HDL lipids) and cardiovascular risk factors (blood pressure, BMI, waist circumference) are measured with standard laboratory methods. Quality of life is assessed by RAND-36 method. The interventions are evaluated with RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) method. Besides effectiveness, RE-AIM methods evaluates the target group reach and adherence; provider adoption; intervention fidelity; maintenance of the changes in PA and SB behavior, biomarkers and CVD risk factors; intervention transferability to clinical practice; adverse events; and patient and provider satisfaction.
Unexpectedly, the COVID-19 pandemic in spring 2020 led to substantial restrictions in outdoors mobility of T2D patients and their access access to health care in Finland, facts that frustrated the planned implementation of the original intervention, related measurements and their scheduling. This means that not all planned measurements could be done at all or at the scheduled time point. Irrespective of the time of recruitment, all follow-up measurements are done from June to September 2020. Notwithstanding the COVID-19 pandemic annulled the original intervention, the collected data yet provides unique insights into measured physical activity, fitness and metabolic biomarkers of T2D patients before and during the COVID-19 pandemic and consequent restrictions.In addition, the data allows to evaluate the implementation of eHealth approach and face-to-face and telephone PA counselling contacts within the primary health care setting.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study is a pragmatic three-arm randomized controlled trial carried out within the primary health care setting. Besides the usual care given to type 2 diabetics, the patients may be assigned either into a 6-month eHealth intervention complemented by face-to-face and telephone counselling contacts on physical activity or into a 6-month eHealth intervention without counselling contacts. After the 6-month intervention, there is a 6-month follow-up period.
| Arm | Type | Receives |
|---|---|---|
| eHealth + counselling contacts | Experimental | Behavioral: eHealth +counselling contacts, Behavioral: Usual care6-month eHealth physical activity intervention complemented by face-to-face and telephone counselling contacts on physical activity.. |
| eHealth | Experimental | Behavioral: eHealth, Behavioral: Usual care6-month eHealth physical activity intervention |
| Usual care | Other | Behavioral: Usual careUsual care of type 2 diabetics within the primary health care setting. |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- a diagnosed type 2 diabetes
- a prescheduled appointment with a health care professional regarding PA counselling in primary care settings of North Karelia Hospital District, Finland
- body mass index <40
- does not meet the current PA recommendation for health
- is able to conduct six minute walk test.
Key exclusion criteria (4 listed)
- any problem that limits ability to walk without an aid
- any health problem that hinders participation in light to moderate intensity PA,
- not able or willing to use smartphone
- not willing to wear the research accelerometer at the baseline
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 |
|---|---|---|
| eHealth +counselling contactsThe 6 month eHealth intervention comprises continuous self-monitoring of PA and SB using hip-worn accelerometer and ExSed application, which gives cloud-computed personal feedback about accelerometer-measured PA and SB on smartphone and provides a platform for a health care professional to set and monitor patient's personal activity goals as well as give personalized feedback to the patient. In addition, instructions and video-demonstrations on how to reach the goals are provided via Internet. The eHealth intervention is complemented by face-to-face and telephone counselling on physical activity which comprises 4 to 6 contacts between a health care professional and the patient as well as at least 3 telephone contacts during 6 months. | Behavioural | eHealth + counselling contacts |
| eHealthThe 6 month eHealth intervention comprises continuous self-monitoring of PA and SB using hip-worn accelerometer and ExSed application, which gives cloud-computed personal feedback about accelerometer-measured PA and SB on smartphone and provides a platform for a health care professional to set and monitor patient's personal activity goals as well as give personalized feedback to the patient. In addition, instructions and video-demonstrations on how to reach the goals are provided via Internet. No telephone calls nor face-to-face counselling contacts on physical activity are taken. | Behavioural | eHealth |
| Usual careUsual care and councelling given to type 2 diabetics within the primary health care setting. | Behavioural | Usual care, eHealth, eHealth + counselling contacts |
Primary outcome
Change in total mean daily step count
Time frame: At 6 and 12 months compared to baseline (0 months). N.B. Because of COVID-19, the schedule and contents of measurements may change individually depending on the time of recruitment.
Step count during one week is measured with a hip-worn accelerometer at baseline, 6 months, and 12 months
2 secondary outcomes
Changes in total mean daily time of sedentary, low intensity PA and moderate-to-vigorous PA
Time frame: at 6 and 12 months compared to baseline (0 months). N.B. Because of COVID-19, the schedule and contents of measurements may change individually depending on the time of recruitment.
Changes in the mean daily number of moderate-to-vigorous PA bouts lasting at least 1, 5 and 10 minutes.
Time frame: at 6 and 12 months compared to baseline (0 months). N.B. Because of COVID-19, the schedule and contents of measurements may change individually depending on the time of recruitment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Derived from this study: PubMed 41855496Aittasalo M, Tokola K, Vaha-Ypya H, Husu P, Manttari A, Martiskainen T, Laatikainen T, Sievanen H. mHealth Intervention to Promote Nonexercise Physical Activity in Patients With Type 2 Diabetes: Secondary Analysis and Implementation Study. JMIR Form Res. 2026 Mar 19;10:e80304. doi: 10.2196/80304.
- Individual participant dataSharing planned: No
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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.
Tommi Vasankari, MD, PhD principal investigator
UKK Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eHealth +counselling contacts and eHealth in people with Type2 Diabetes, run by UKK Institute at 1 site in Finland.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Oct 2020. 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 Finland. 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?
Results are not available in the source record.
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?
Change in total mean daily step count (time frame: At 6 and 12 months compared to baseline (0 months). N.B. Because of COVID-19, the schedule and contents of measurements may change individually depending on the time of recruitment.). 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 NCT04587414, 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 14 Oct 2020; AzTrials last refreshed its copy on 6 Nov 2026.