Sedentary BehaviorNCT04041869
Residential MapTrek- Increasing Physical Activity Among Older Adults in a Residential-Living
A study testing MapTrek in people with Sedentary Behavior, run by University of Iowa at 1 site in United States.
Trial summary
Older adults are a growing population, with projections to reach 83.7 million by 2050. Furthermore, older adults are the most sedentary and least physically active adult population. It is estimated that nearly 90% of older adults 65 years of age or older do not meet the recommended levels of physical activity. Read more about this study
- Who is it for?
- Ages 25 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior
- What is being tested?
- MapTrek
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2019to 22 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be eligible, participants much be between 25 and 100 years of age, physically able to walk without limitations
Who cannot join
- Patients with cognitive or physical limitations that prohibit walking and visual or cognitive impairments causing inability to read.
Trial locations and contacts
1 site in 1 country.
About this study
Older adults are a growing population, with projections to reach 83.7 million by 2050. Furthermore, older adults are the most sedentary and least physically active adult population. It is estimated that nearly 90% of older adults 65 years of age or older do not meet the recommended levels of physical activity. Evidence suggests great health benefits can be achieved for older adults who are the most sedentary, and that replacing sitting with even light intensity walking can be beneficial.
The overarching goal of the project is to develop an inexpensive and scalable tool to increase volume of physical activity in our target population, older adults living in a residential facility. MapTrek is a web-based application that allows participants to take a virtual walk in interesting locations around the world while tracking their progress against the progress of other older adults living in a retirement community. Steps are counted using a commercially available accelerometer (e.g., Fitbit), and participants see their progress overlaid on Google Maps.
Read the detailed description
All participants will be provided with a Fitbit activity monitor and instructed to wear it 24 hours/day (except for bathing/swimming time) on their wrist for 12 weeks. Participants will participate in four team-based walking races, each two weeks long. Participants will view their team progress on TV monitors placed in various locations at the Oaknoll facility. The Oaknoll leadership has given the research team approval to do this at their facility. The monitors will present aggregated team data and will not report any individual data that could link back to the individual participant.
At the end of the 8 week active intervention, research team members will meet with participants at Oaknoll to administer an exit/process evaluation survey. The exit survey will ask about psychosocial predictors of physical activity as well as participants thoughts and opinions of the MapTrek game. This survey should take approximate 10-15 minutes to complete. The participants will then be asked to wear the Fitbit for four more weeks without playing MapTrek, which will act as a control condition since this is a single-arm study.
The specific aims of the study are:
- To determine the efficacy of MapTrek for improving physical activity levels of older adults living in a residential facility from baseline to 8 weeks.
- To determine the efficacy of MapTrek for improving psychosocial outcomes(e.g., self-efficacy, social support, outcome expectations, social isolation) among older adults living in a residential facility from baseline to 8 weeks.
- Conditions
- Sedentary Behavior
- Being tested
- MapTrek
- Keywords
- Older adults, Walking, Fitbit
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MapTrekBehavioural
Participants will receive a Fitbit activity monitor and access to the MapTrek game which will be visible on monitors set up in the residential facility.
| Study group | Role | What they receive |
|---|---|---|
| MapTrek | Experimental | Not described Receives: Behavioral: MapTrek |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity
Daily steps
Measured: 8 weeks
Secondary outcomes (4)
Self-efficacy
Self-efficacy was measured with the Self-Efficacy for Exercise scale, a 13-item questionnaire designed to assess participants' self-efficacy related to their ability to continue exercising in the face of barriers.
Measured: 8 weeks
Social Support
Social support for physical activity was measured with a modified version of the Social Support and Exercise Survey. The Social Support and Exercise Survey is a 12-item (originally 13 item) questionnaire that assesses the level of support from family and friends that participants have in making health behavior changes (exercise)
Measured: 8 weeks
Outcome Expectations
Outcome expectations were measured with the Outcome Expectations for Exercise Scale. The Outcome Expectations for Exercise is a valid and reliable 9-item scale that assesses the participant's outcome expectations and benefits associated with exercise.
Measured: 8 weeks
Social Isolation
Social isolation was measured with a modified version of the Friendship Scale. The Friendship Scale is a 5-item (originally 6-item) scale that assesses 6 dimensions contributing to social isolation
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start17 Jun 2019
- Primary completion22 Sep 2019
- Study completion22 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sedentary BehaviorStudies of the same condition, open and under way.
- More trials run by University of IowaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Lucas Carr, University of Iowa
- Investigators
- Lucas Carr, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041869
- Sponsor's protocol ID
- 201904816
- Other IDs
- UL1TR002537
- Status last verified
- May 2023
- First submitted
- 30 Jul 2019
- Last updated
- 15 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Residential MapTrek- Increasing Physical Activity Among Older Adults in a Residential-Living
- ClinicalTrials.gov ID
- NCT04041869
- Acronym / sponsor ID
- 201904816
- Conditions
- Sedentary Behavior
- Keywords
- Older adults, Walking, Fitbit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS)
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 22 Sep 2019 (actual)
- Study completion
- 22 Sep 2019 (actual)
- First posted
- 1 Aug 2019 (actual)
- Results
- Posted 11 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Older adults are a growing population, with projections to reach 83.7 million by 2050. Furthermore, older adults are the most sedentary and least physically active adult population. It is estimated that nearly 90% of older adults 65 years of age or older do not meet the recommended levels of physical activity. Evidence suggests great health benefits can be achieved for older adults who are the most sedentary, and that replacing sitting with even light intensity walking can be beneficial.
The overarching goal of the project is to develop an inexpensive and scalable tool to increase volume of physical activity in our target population, older adults living in a residential facility. MapTrek is a web-based application that allows participants to take a virtual walk in interesting locations around the world while tracking their progress against the progress of other older adults living in a retirement community. Steps are counted using a commercially available accelerometer (e.g., Fitbit), and participants see their progress overlaid on Google Maps.
Detailed description
All participants will be provided with a Fitbit activity monitor and instructed to wear it 24 hours/day (except for bathing/swimming time) on their wrist for 12 weeks. Participants will participate in four team-based walking races, each two weeks long. Participants will view their team progress on TV monitors placed in various locations at the Oaknoll facility. The Oaknoll leadership has given the research team approval to do this at their facility. The monitors will present aggregated team data and will not report any individual data that could link back to the individual participant.
At the end of the 8 week active intervention, research team members will meet with participants at Oaknoll to administer an exit/process evaluation survey. The exit survey will ask about psychosocial predictors of physical activity as well as participants thoughts and opinions of the MapTrek game. This survey should take approximate 10-15 minutes to complete. The participants will then be asked to wear the Fitbit for four more weeks without playing MapTrek, which will act as a control condition since this is a single-arm study.
The specific aims of the study are:
- To determine the efficacy of MapTrek for improving physical activity levels of older adults living in a residential facility from baseline to 8 weeks.
- To determine the efficacy of MapTrek for improving psychosocial outcomes(e.g., self-efficacy, social support, outcome expectations, social isolation) among older adults living in a residential facility from baseline to 8 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MapTrek | Experimental | Behavioral: MapTrek |
Who may qualify
- Ages
- 25 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- To be eligible, participants much be between 25 and 100 years of age, physically able to walk without limitations
Key exclusion criteria (1 listed)
- Patients with cognitive or physical limitations that prohibit walking and visual or cognitive impairments causing inability to read.
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 |
|---|---|---|
| MapTrekParticipants will receive a Fitbit activity monitor and access to the MapTrek game which will be visible on monitors set up in the residential facility. | Behavioural | MapTrek |
Primary outcome
Physical Activity
Time frame: 8 weeks
Daily steps
4 secondary outcomes
Self-efficacy
Time frame: 8 weeks
Social Support
Time frame: 8 weeks
Outcome Expectations
Time frame: 8 weeks
Social Isolation
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Lucas Carr, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MapTrek in people with Sedentary Behavior, run by University of Iowa at 1 site in United States.
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 15 May 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 United States. 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?
Yes. Results are posted in the registry (first posted 11 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Physical Activity (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2023.