AzTrials
AzTrials

ObesityNCT02692560

I-STAND R21: Reducing Sedentary Time in Older Adults

A study testing I-STAND and Healthy Living in people with Obesity and Sedentary Lifestyle, run by Kaiser Permanente at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The investigators are doing a study to learn how to support patients aged 60+ in taking more breaks from sitting and reducing total sitting time. The goal of the study is to find out if a sitting time reduction intervention reduces sitting time compared with a control group. Read more about this study

Who is it for?
Ages 60 to 89 years
Conditions the study is for
Obesity, Sedentary Lifestyle
What is being tested?
I-STAND and Healthy Living
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
Feb 2016to Feb 2017
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 60 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Kaiser Permanente Washington enrollees
  • Men and women
  • Age 60 - 89
  • BMI 30 - 50 (calculated based on most recent height ever and most recent weight taken within previous 18 months)
  • Primary care within Integrated Group Practice
  • Continuously enrolled at Kaiser Permanente Washington for previous 12 months
Show all 16Show fewer
  • No record of death
  • Not on the No Contact list
  • Speaks and writes English
  • Able to hold a conversation by phone (no hearing or other limitations)
  • Self-reported sitting time of 6 hours/day or more
  • Self-reported ability to stand with or without an assistive device
  • Self-reported ability to walk one block with or without an assistive device
  • Available for the study duration
  • Able to come to Kaiser Permanente Washington Health Research Institute's research clinic for measurement visits
  • Willing to wear study activity monitors

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

  • Kaiser Permanente Washington Health Research Institute

    Seattle, Washington, 98101

Other trials in United States

About this study

Official title: Take Active Breaks From Sitting (TABS): Reducing Sedentary Time in Older Adults

The investigators are doing a study to learn how to support patients aged 60+ in taking more breaks from sitting and reducing total sitting time. The goal of the study is to find out if a sitting time reduction intervention reduces sitting time compared with a control group.

Read the detailed description

More than one-third of American adults over 60 have a body mass index > 30 kg/m2. These older adults have more sedentary time than any other group -- an average of 10-11 hours per day. Reducing the sedentary behavior of older adults with obesity, rather than only promoting more intensive physical activity, could provide a more feasible approach to health promotion.

This randomized control pilot trial will evaluate a 12-week intervention to decrease sitting time and increase standing time and light physical activity among sedentary older adults a body mass index > 30 kg/m2 as compared to control group. Baseline and 12-week measurements include anthropometric measures, blood draw by finger stick, cardiovascular health assessments, physical function tasks, and a survey. The intervention will consist of two in-person visits with a health coach followed by phone-based coaching.

Being tested
I-STAND, Healthy Living
Keywords
Sedentary time, Sit-to-stand transitions
Medical subject headings
Obesity, Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • I-STANDBehavioural

    Participants receive health coaching, a workbook, an inactivity alert wristband, and feedback charts based on objective measurement of sedentary time.

  • Healthy LivingOther

    Participants receive enhanced usual care based on general healthy living topics that are available to all Kaiser Permanente Washington enrollees.

Study groups in NCT02692560
Study groupRoleWhat they receive
I-STANDExperimentalParticipants randomly assigned to the I-STAND intervention group will receive 2 in-person health coaching sessions and 4 biweekly phone-based health coaching sessions. They will receive a wristband that gives a mild vibration after 20 minutes of inactivity and will be encouraged to stand if possible after each inactivity alert. Participants may also choose to receive biweekly email reminders in the weeks between coaching calls. They will also receive a workbook with content around reducing sitting time.
Receives: Behavioral: I-STAND
Healthy LivingActive comparatorParticipants randomly assigned to the Healthy Living enhanced usual care control group will receive 1 in-person health coaching session and 5 biweekly check-in letters by mail. They will receive a workbook with general healthy living topics that are not expected to impact sitting time. All content is taken from Kaiser Permanente Washington's website and is available to all members. Participants will select topics of interest and review them on their own with no further health coaching.
Receives: Other: Healthy Living

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Hours of Sitting Time

    Average hours of sitting time over the last 7 days measured at baseline and 12 weeks later

    Measured: 12 weeks

Secondary outcomes (7)

  1. Sit-to-stand Transitions

    Change in average daily number of activPAL-measured sit-to-stand transitions, from baseline to 12 weeks

    Measured: 12 weeks

  2. Periods of Sitting for 30+ Minutes

    Change in average daily number of activPAL-measured periods of sitting for 30+ minutes without standing, from baseline to 12 weeks

    Measured: 12 weeks

  3. Physical Function

    Change in Short Physical Performance Battery (SPPB) scale score, from baseline to 12 weeks. The range of scores is 0 to 12, higher values represent better physical function.

    Measured: 12 weeks

  4. Blood Pressure (Systolic Blood Pressure)

    Change in average of second and third blood pressure reading (for systolic blood pressure), from baseline to 12 weeks

    Measured: 12 weeks

  5. Fasting Glucose (mg/dL)

    Change in fasting glucose (mg/dL) from finger stick blood draw, from baseline to 12 weeks

    Measured: 12 weeks

  6. Total Cholesterol (mg/dL)

    Change in total cholesterol (mg/dL) from finger stick blood draw, from baseline to 12 weeks

    Measured: 12 weeks

  7. Depressive Symptoms

    Change in Patient Health Questionnaire (PHQ-8) scale score, from baseline to 12 weeks. The scale range is 0 to 24 with higher scores representing higher depressive symptoms. Scores of 10 or more are considered major depression.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completionFeb 2017
  4. Study completionFeb 2017

Resources

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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02692560
Sponsor's protocol ID
1R21AG043853
Status last verified
May 2018
First submitted
24 Feb 2016
Last updated
29 Jun 2018
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Matson TE, Renz AD, Takemoto ML, McClure JB, Rosenberg DE. Acceptability of a sitting reduction intervention for older adults with obesity. BMC Public Health. 2018 Jun 7;18(1):706. doi: 10.1186/s12889-018-5616-1.

    PubMed 29879948

  • Rosenberg DE, Lee AK, Anderson M, Renz A, Matson TE, Kerr J, Arterburn D, McClure JB. Reducing Sedentary Time for Obese Older Adults: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 Feb 12;7(2):e23. doi: 10.2196/resprot.8883.

    PubMed 29434012

Questions about this trial

What is this clinical trial studying?

A study testing I-STAND and Healthy Living in people with Obesity and 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 16 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 29 Jun 2018. 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 May 2018). 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?

Change in Hours of Sitting Time (time frame: 12 weeks). 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 NCT02692560, 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 29 Jun 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in