Type 2 DiabetesNCT02089477
The Smart-phone as a Physical Fitness Monitor - Validity, Sensitivity and Motivation InterWalk
A study testing Support group in people with Type 2 Diabetes, run by Laura Staun Valentiner at 1 site in Denmark.
Trial summary
Low physical fitness may cause several life style related diseases e.g. cardiovascular disease, cancer and type 2 diabetes. It is important to develop reliable methods for measurement which can be used to follow the development of the physical shape both on an individual level and on at population level. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Support group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2014to Dec 2014
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes, age 30-80 y, BMI >18 but <40 kg/m2 and confirmed T2D diagnose
Who cannot join
- Pregnancy, smoking, contraindication to increased levels of physical activity, insulin dependence, evidence of thyroid, liver, lung, heart or kidney disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Smart-phone as a Physical Fitness Monitor on a Population Level - Validity and Sensitivity and Improtance of Individual Motivation for Doing Interval Walking With the InterWalk Application
Low physical fitness may cause several life style related diseases e.g. cardiovascular disease, cancer and type 2 diabetes. It is important to develop reliable methods for measurement which can be used to follow the development of the physical shape both on an individual level and on at population level.
Associated with the development of new training method known as Interval Walking we developed an application for smartphones. The use of the application InterWalk was meant to increase physical activity in patients with type 2 diabetes. The application should both be able to, 1) be a personal trainer when doing interval walking, and 2) measure the individual physical fitness performed as a walking test. The latter function was developed to make the training more personal and individal adapted, so that the training was neither too hard or too easy.
Read more
It is necessary to test the walking test against a golden standard for measuring physical fitness and that the test in the application is able to measure and register changes in physical fitness.
Our hypothesis is that the individual test, in the InterWalk Application is reliable and able to register changes in physical fitness in patients with type 2 diabetes. The purpose of this project is investigate the reliability of a smartphone-based test of physical fitness, and to investigate whether the test is able to register changes in physical fitness during the project time (3 month). A secondary aim is to investigate whether individual support during the training period, affect the individual effort and time of interval walking per week.
- Conditions
- Type 2 Diabetes
- Being tested
- Support group
- Keywords
- Type 2 diabetes, InterWalk, Individual Support, Motivation
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Support groupOther
The participants in the intervention group receives the intervention and support consisting of:
- Individual Goal Setting: 2-3 functional goals related to everyday life evaluated every 4th week.
- SMS send every Sunday with 5 possible responses. depending on the answer of the participant it will cause a telephone call from a project about motivation and barriers for interval walking.
| Study group | Role | What they receive |
|---|---|---|
| Support | Experimental | The participants in the intervention group receives the intervention and support consisting of:
1. Individual Goal Setting: 2-3 functional goals related to everyday life evaluated every 4th week.
2. SMS send every Sunday with 5 possible responses. depending on the answer of the participant it will cause a telephone call from a project about motivation and barriers for interval walking. Receives: Other: Support group |
| Control group | No intervention | Patient's in the control group receives the intervention with interval Walking and no other support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is amount of time duing interval walking (in minuts) with InterWalk per week after 3 month
Measured: up to 3 months after enrollment
Secondary outcomes (4)
Frequency of Interval walking with InterWalk
Measured: 3 months after enrollment
Quality of data with VO2-peek test in the InterWalk Application
quantity of minuts with high and low intervals after 3 month
Measured: 3 months after enrollment
validation of InterWalk, VO2-peek test
Measured: 3 months after enrollment
VO2-peek test in the InterWalk Application
Measured: 3 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 2 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laura Staun Valentiner
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor-investigator, Laura Staun Valentiner, University of Copenhagen
- Investigators
- Mathias Ried-Larsen, Post Doc, Principal investigator, CIM, University Hospital Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02089477
- Sponsor's protocol ID
- InterWalk - Validation
- Status last verified
- Oct 2017
- First submitted
- 14 Mar 2014
- Last updated
- 5 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Valentiner LS, Thorsen IK, Kongstad MB, Brinklov CF, Larsen RT, Karstoft K, Nielsen JS, Pedersen BK, Langberg H, Ried-Larsen M. Effect of ecological momentary assessment, goal-setting and personalized phone-calls on adherence to interval walking training using the InterWalk application among patients with type 2 diabetes-A pilot randomized controlled trial. PLoS One. 2019 Jan 10;14(1):e0208181. doi: 10.1371/journal.pone.0208181. eCollection 2019.
PubMed 30629601Karstoft K, Brinklov CF, Thorsen IK, Nielsen JS, Ried-Larsen M. Resting Metabolic Rate Does Not Change in Response to Different Types of Training in Subjects with Type 2 Diabetes. Front Endocrinol (Lausanne). 2017 Jun 13;8:132. doi: 10.3389/fendo.2017.00132. eCollection 2017.
PubMed 28659869Brinklov CF, Thorsen IK, Karstoft K, Brons C, Valentiner L, Langberg H, Vaag AA, Nielsen JS, Pedersen BK, Ried-Larsen M. Criterion validity and reliability of a smartphone delivered sub-maximal fitness test for people with type 2 diabetes. BMC Sports Sci Med Rehabil. 2016 Oct 7;8:31. doi: 10.1186/s13102-016-0056-7. eCollection 2016.
PubMed 28174664
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Smart-phone as a Physical Fitness Monitor on a Population Level - Validity and Sensitivity and Improtance of Individual Motivation for Doing Interval Walking With the InterWalk Application
- ClinicalTrials.gov ID
- NCT02089477
- Acronym / sponsor ID
- InterWalk - Validation
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, InterWalk, Individual Support, Motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Laura Staun ValentinerUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- Mar 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 17 Mar 2014 (estimated)
- 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.
Low physical fitness may cause several life style related diseases e.g. cardiovascular disease, cancer and type 2 diabetes. It is important to develop reliable methods for measurement which can be used to follow the development of the physical shape both on an individual level and on at population level.
Associated with the development of new training method known as Interval Walking we developed an application for smartphones. The use of the application InterWalk was meant to increase physical activity in patients with type 2 diabetes. The application should both be able to, 1) be a personal trainer when doing interval walking, and 2) measure the individual physical fitness performed as a walking test. The latter function was developed to make the training more personal and individal adapted, so that the training was neither too hard or too easy.
It is necessary to test the walking test against a golden standard for measuring physical fitness and that the test in the application is able to measure and register changes in physical fitness.
Our hypothesis is that the individual test, in the InterWalk Application is reliable and able to register changes in physical fitness in patients with type 2 diabetes. The purpose of this project is investigate the reliability of a smartphone-based test of physical fitness, and to investigate whether the test is able to register changes in physical fitness during the project time (3 month). A secondary aim is to investigate whether individual support during the training period, affect the individual effort and time of interval walking per week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Support | Experimental | Other: Support groupThe participants in the intervention group receives the intervention and support consisting of: 1. Individual Goal Setting: 2-3 functional goals related to everyday life evaluated every 4th week. 2. SMS send every Sunday with 5 possible responses. depending on the answer of the participant it will cause a telephone call from a project about motivation and barriers for interval walking. |
| Control group | No intervention | –Patient's in the control group receives the intervention with interval Walking and no other support. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type 2 diabetes, age 30-80 y, BMI >18 but <40 kg/m2 and confirmed T2D diagnose
Key exclusion criteria (1 listed)
- Pregnancy, smoking, contraindication to increased levels of physical activity, insulin dependence, evidence of thyroid, liver, lung, heart or kidney disease
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 |
|---|---|---|
| Support groupThe participants in the intervention group receives the intervention and support consisting of: 1. Individual Goal Setting: 2-3 functional goals related to everyday life evaluated every 4th week. 2. SMS send every Sunday with 5 possible responses. depending on the answer of the participant it will cause a telephone call from a project about motivation and barriers for interval walking. | Other | Support |
Primary outcome
The primary outcome is amount of time duing interval walking (in minuts) with InterWalk per week after 3 month
Time frame: up to 3 months after enrollment
4 secondary outcomes
Frequency of Interval walking with InterWalk
Time frame: 3 months after enrollment
Quality of data with VO2-peek test in the InterWalk Application
Time frame: 3 months after enrollment
validation of InterWalk, VO2-peek test
Time frame: 3 months after enrollment
VO2-peek test in the InterWalk Application
Time frame: 3 months after enrollment
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 5 Oct 2017.
- Derived from this study: PubMed 30629601Valentiner LS, Thorsen IK, Kongstad MB, Brinklov CF, Larsen RT, Karstoft K, Nielsen JS, Pedersen BK, Langberg H, Ried-Larsen M. Effect of ecological momentary assessment, goal-setting and personalized phone-calls on adherence to interval walking training using the InterWalk application among patients with type 2 diabetes-A pilot randomized controlled trial. PLoS One. 2019 Jan 10;14(1):e0208181. doi: 10.1371/journal.pone.0208181. eCollection 2019.
- Derived from this study: PubMed 28659869Karstoft K, Brinklov CF, Thorsen IK, Nielsen JS, Ried-Larsen M. Resting Metabolic Rate Does Not Change in Response to Different Types of Training in Subjects with Type 2 Diabetes. Front Endocrinol (Lausanne). 2017 Jun 13;8:132. doi: 10.3389/fendo.2017.00132. eCollection 2017.
- Derived from this study: PubMed 28174664Brinklov CF, Thorsen IK, Karstoft K, Brons C, Valentiner L, Langberg H, Vaag AA, Nielsen JS, Pedersen BK, Ried-Larsen M. Criterion validity and reliability of a smartphone delivered sub-maximal fitness test for people with type 2 diabetes. BMC Sports Sci Med Rehabil. 2016 Oct 7;8:31. doi: 10.1186/s13102-016-0056-7. eCollection 2016.
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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.
Mathias Ried-Larsen, Post Doc principal investigator
CIM, University Hospital Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Support group in people with Type 2 Diabetes, run by Laura Staun Valentiner at 1 site in Denmark.
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 1 inclusion and 1 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 5 Oct 2017. 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 Denmark. 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?
The primary outcome is amount of time duing interval walking (in minuts) with InterWalk per week after 3 month (time frame: up to 3 months after enrollment). 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 NCT02089477, which also lists 3 linked publications.
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 5 Oct 2017.