Cardiovascular Risk FactorWALKNCT04524572
The Role of a Motion Sensor With Accompanying Web Application on Step Counts, Energy Balance, and Metabolic Markers in Nurses
A study testing Motion sensor in people with Cardiovascular Risk Factor and Cardiovascular Diseases, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial summary
The purpose of this prospective randomized controlled trial is to explore the role of a motion sensor with accompany web application on step counts, energy balance, and metabolic markers in nurses. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor, Cardiovascular Diseases
- What is being tested?
- Motion sensor
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteCanada
- Study dates
- 26 Nov 2013to 1 Aug 2015
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Participant must be a registered nurse with the University of Ottawa Heart Institute;
- 2. Participant must be 18 years of age or older;
- 3. Participant must be able to walk unassisted;
- 4. Participant is able and willing to provide informed consent.
Who cannot join
- Participant is pregnant, lactating or planning to become pregnant during the study period;
- Participant is unable to read and understand English;
- Medical contraindications to exercise;
- Already using a motion sensor device to track physical activity. -
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this prospective randomized controlled trial is to explore the role of a motion sensor with accompany web application on step counts, energy balance, and metabolic markers in nurses. Additionally, eating behaviours, behavioural regulation in exercise, and mood states that may impact these parameters will also be examined.
- Being tested
- Motion sensor
- Keywords
- cardiovascular disease, motor activity, woman, workplace, Delivery of health care
- Medical subject headings
- Cardiovascular Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motion sensorBehavioural
To explore the role of a motion sensor with accompanying web application on step counts, energy balance, and metabolic markers in nurses
| Study group | Role | What they receive |
|---|---|---|
| Individual Challenge | Experimental | Participants will be able to log onto their Tractivity® Online web account at any time during the 4-week intervention phase to track their daily step counts and physical activity expenditure Receives: Behavioral: Motion sensor |
| friend challenge | Experimental | Participants will be able to log onto their Tractivity® Online web account at any time during the 4-week intervention phase to track their daily step counts and physical activity expenditure in comparison to the group average of all participants randomized to the friend challenge. Receives: Behavioral: Motion sensor |
| Team challenge | Experimental | participants will be able to log onto their Tractivity® Online web account at any time during the 4-week intervention phase to track their teams' daily step counts and physical activity expenditure in comparison to the group average of other teams. Receives: Behavioral: Motion sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step counts
All participants will be asked to wear a Tractivity® motion sensor device on their ankle for to assess their daily step count and physical activity energy expenditure
Measured: 6 weeks during observation and 6 weeks during intervention
Secondary outcomes (3)
Body Mass (kg)
Body weight will be measured using a digital scale to the nearest 0.1 kilogram
Measured: Screening (week 1), Observation (weeks 2-5), during the intervention (weeks 6-9), post study at week 26 and week 52
Waist Circumference
Waist circumference will be measured using a tape measure
Measured: Screening (week 1), Observation (weeks 2-5), during the intervention (weeks 6-9), post study at week 26 and week 52
Fat mass
Fat mass will be measured using bioelectrical impedance analysis
Measured: Screening (week 1), Observation (weeks 2-5), during the intervention (weeks 6-9), post study at week 26 and week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start26 Nov 2013
- Primary completion25 Apr 2014
- Study completion1 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Reed, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524572
- Sponsor's protocol ID
- 20130429
- Acronym
- WALK
- Status last verified
- Sep 2023
- First submitted
- 19 Aug 2020
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Brunet J, Black M, Tulloch HE, Pipe AL, Reid RD, Reed JL. Work-related factors predict changes in physical activity among nurses participating in a web-based worksite intervention: A randomized controlled trial. BMC Nurs. 2021 Nov 9;20(1):224. doi: 10.1186/s12912-021-00739-4.
PubMed 34749710Brunet J, Tulloch HE, Wolfe Phillips E, Reid RD, Pipe AL, Reed JL. Motivation Predicts Change in Nurses' Physical Activity Levels During a Web-Based Worksite Intervention: Results From a Randomized Trial. J Med Internet Res. 2020 Sep 11;22(9):e11543. doi: 10.2196/11543.
PubMed 32915158
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of a Motion Sensor With Accompanying Web Application on Step Counts, Energy Balance, and Metabolic Markers in Nurses
- ClinicalTrials.gov ID
- NCT04524572
- Acronym / sponsor ID
- WALK / 20130429
- Keywords
- cardiovascular disease, motor activity, woman, workplace, Delivery of health care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- 26 Nov 2013 (actual)
- Primary completion
- 25 Apr 2014 (actual)
- Study completion
- 1 Aug 2015 (actual)
- First posted
- 24 Aug 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.
The purpose of this prospective randomized controlled trial is to explore the role of a motion sensor with accompany web application on step counts, energy balance, and metabolic markers in nurses. Additionally, eating behaviours, behavioural regulation in exercise, and mood states that may impact these parameters will also be examined.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Individual Challenge | Experimental | Behavioral: Motion sensorParticipants will be able to log onto their Tractivity® Online web account at any time during the 4-week intervention phase to track their daily step counts and physical activity expenditure |
| friend challenge | Experimental | Behavioral: Motion sensorParticipants will be able to log onto their Tractivity® Online web account at any time during the 4-week intervention phase to track their daily step counts and physical activity expenditure in comparison to the group average of all participants randomized to the friend challenge. |
| Team challenge | Experimental | Behavioral: Motion sensorparticipants will be able to log onto their Tractivity® Online web account at any time during the 4-week intervention phase to track their teams' daily step counts and physical activity expenditure in comparison to the group average of other teams. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Participant must be a registered nurse with the University of Ottawa Heart Institute;
- 2. Participant must be 18 years of age or older;
- 3. Participant must be able to walk unassisted;
- 4. Participant is able and willing to provide informed consent.
Key exclusion criteria (4 listed)
- Participant is pregnant, lactating or planning to become pregnant during the study period;
- Participant is unable to read and understand English;
- Medical contraindications to exercise;
- Already using a motion sensor device to track physical activity. -
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 |
|---|---|---|
| Motion sensorTo explore the role of a motion sensor with accompanying web application on step counts, energy balance, and metabolic markers in nurses | Behavioural | Individual Challenge, Team challenge, friend challenge |
Primary outcome
Step counts
Time frame: 6 weeks during observation and 6 weeks during intervention
All participants will be asked to wear a Tractivity® motion sensor device on their ankle for to assess their daily step count and physical activity energy expenditure
3 secondary outcomes
Body Mass (kg)
Time frame: Screening (week 1), Observation (weeks 2-5), during the intervention (weeks 6-9), post study at week 26 and week 52
Waist Circumference
Time frame: Screening (week 1), Observation (weeks 2-5), during the intervention (weeks 6-9), post study at week 26 and week 52
Fat mass
Time frame: Screening (week 1), Observation (weeks 2-5), during the intervention (weeks 6-9), post study at week 26 and week 52
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 6 Sep 2023.
- Derived from this study: PubMed 34749710Brunet J, Black M, Tulloch HE, Pipe AL, Reid RD, Reed JL. Work-related factors predict changes in physical activity among nurses participating in a web-based worksite intervention: A randomized controlled trial. BMC Nurs. 2021 Nov 9;20(1):224. doi: 10.1186/s12912-021-00739-4.
- Derived from this study: PubMed 32915158Brunet J, Tulloch HE, Wolfe Phillips E, Reid RD, Pipe AL, Reed JL. Motivation Predicts Change in Nurses' Physical Activity Levels During a Web-Based Worksite Intervention: Results From a Randomized Trial. J Med Internet Res. 2020 Sep 11;22(9):e11543. doi: 10.2196/11543.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motion sensor in people with Cardiovascular Risk Factor and Cardiovascular Diseases, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
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 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: finished, as of the sponsor's last update on 6 Sep 2023. 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 Canada. 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?
Step counts (time frame: 6 weeks during observation and 6 weeks during intervention). 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 NCT04524572, which also lists 2 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 6 Sep 2023.