Sedentary LifestyleISTANDNCT02670369
Investigating Sedentary Time in Aging: New Directions
A study testing Sitting time prompt in people with Sedentary Lifestyle, run by Kaiser Permanente at 1 site in United States.
Trial summary
The investigators are doing a study to learn how to support patients aged 60+ in taking more breaks from sitting. The goal of the study is to find out if using commercially available devices are helpful in reducing sitting time. Read more about this study
- Who is it for?
- Ages 60 to 89 years
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- Sitting time prompt
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Dec 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 60 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- BMI of 25+
- Ages 60+
- Continuously enrolled at Group Health for previous 12 months
- No record of death
- Not on the No Contact list
Show all 18Show fewer
- Speaks, reads, and writes English
- Able to hold a conversation by phone (no hearing or other limitations)
- Self-reported ability to stand
- Self-reported ability to walk one block unassisted
- No history of an injury from a fall in past 3 months
- Work or retirement situations allows for taking breaks from sitting throughout the day
- Available for the study duration
- No unusual activities planned (e.g. travel, moving) during the study period
- Able to come to Group Health Capitol Hill/Central for measurement visits
- Willing to wear activity monitor (activPAL)
- Self-reports taking less than 4 breaks from sitting during an average hour
- Self-reports sitting more than 7 hours per day
Who cannot join
- Resides in long-term care, hospice care, or skilled nursing facility (previous 12 months)
- Wheelchair bound
- Diagnosis of dementia, serious mental health disorder, or substance use disorder (previous 24 months)
- Use of an assistive device
Trial locations and contacts
1 site in 1 country.
United States1 site
Group Health Research Institute
Seattle, Washington, 98101
About this study
The investigators are doing a study to learn how to support patients aged 60+ in taking more breaks from sitting. The goal of the study is to find out if using commercially available devices are helpful in reducing sitting time.
Read the detailed description
To date, no one has tested whether the prompting features of commercially available wrist-worn devices (e.g., Jawbone Up) improve breaks from sitting. Single case designs are a cost-effective way to conduct a controlled, randomized study that can inform larger intervention trials. Because the investigators are interested in ascertaining the effect of a very specific intervention on a very specific/single outcome, this study is well-suited to this approach.
The investigators will conduct iterative single case experimental studies using randomization tests. This design can help evaluate technologies for behavior change. To increase statistical power, the investigators opted to conduct an ABA study design (also termed a reversal design) where A is baseline and B is an intervention. Using randomization tests, the length of each A and B phase are determined to vary randomly in length prior to the beginning of each participant's experiment. The investigators will constrain the total time of each A and B phase to last a minimum of 5 days to provide adequate exposure to the A (measurement only) and B (intervention) conditions. The maximum total number of days participants will be enrolled is 28.
- Conditions
- Sedentary Lifestyle
- Being tested
- Sitting time prompt
- Keywords
- Sedentary time, Sit-to-stand transitions
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sitting time promptBehavioural
Participants will receive a device that prompts them to take breaks from sitting approximately every 15-20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Sitting time prompt | Experimental | All participants will receive a prompting device (one-arm intervention). Receives: Behavioral: Sitting time prompt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sit-to-stand transitions
Number of activPAL-measured sit-to-stand transitions measured at the day level
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study startJul 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dori E Rosenberg, PhD, MPH, Principal investigator, Group Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02670369
- Sponsor's protocol ID
- 5 K23 HL119352-1
- Other IDs
- 5K23HL119352
- Acronym
- ISTAND
- Status last verified
- Oct 2017
- First submitted
- 21 Jul 2015
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Sedentary Time in Aging: New Directions
- ClinicalTrials.gov ID
- NCT02670369
- Acronym / sponsor ID
- ISTAND / 5 K23 HL119352-1
- Conditions
- Sedentary Lifestyle
- Keywords
- Sedentary time, Sit-to-stand transitions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 Feb 2016 (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.
The investigators are doing a study to learn how to support patients aged 60+ in taking more breaks from sitting. The goal of the study is to find out if using commercially available devices are helpful in reducing sitting time.
Detailed description
To date, no one has tested whether the prompting features of commercially available wrist-worn devices (e.g., Jawbone Up) improve breaks from sitting. Single case designs are a cost-effective way to conduct a controlled, randomized study that can inform larger intervention trials. Because the investigators are interested in ascertaining the effect of a very specific intervention on a very specific/single outcome, this study is well-suited to this approach.
The investigators will conduct iterative single case experimental studies using randomization tests. This design can help evaluate technologies for behavior change. To increase statistical power, the investigators opted to conduct an ABA study design (also termed a reversal design) where A is baseline and B is an intervention. Using randomization tests, the length of each A and B phase are determined to vary randomly in length prior to the beginning of each participant's experiment. The investigators will constrain the total time of each A and B phase to last a minimum of 5 days to provide adequate exposure to the A (measurement only) and B (intervention) conditions. The maximum total number of days participants will be enrolled is 28.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sitting time prompt | Experimental | Behavioral: Sitting time promptAll participants will receive a prompting device (one-arm intervention). |
Who may qualify
- Ages
- 60 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Male or female
- BMI of 25+
- Ages 60+
- Continuously enrolled at Group Health for previous 12 months
- No record of death
Key exclusion criteria (4 listed)
- Resides in long-term care, hospice care, or skilled nursing facility (previous 12 months)
- Wheelchair bound
- Diagnosis of dementia, serious mental health disorder, or substance use disorder (previous 24 months)
- Use of an assistive device
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 |
|---|---|---|
| Sitting time promptParticipants will receive a device that prompts them to take breaks from sitting approximately every 15-20 minutes. | Behavioural | Sitting time prompt |
Primary outcome
Sit-to-stand transitions
Time frame: up to 28 days
Number of activPAL-measured sit-to-stand transitions measured at the day level
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 13 Oct 2017.
- Individual participant dataSharing planned: No
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Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM
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Acute Endocrine Responses to Aerobic and Anaerobic Exercise in Sedentary Women: A Comparative Analysis of Thyroid Hormones and Cortisol
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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.
Dori E Rosenberg, PhD, MPH principal investigator
Group Health Research 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 Sitting time prompt in people with Sedentary Lifestyle, run by Kaiser Permanente 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 18 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 13 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 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?
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?
Sit-to-stand transitions (time frame: up to 28 days). 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 13 Oct 2017.