Sedentary LifestyleHARTNCT03739762

Healthy Aging Resources to Thrive (HART)

A study testing i-STAND in people with 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

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Trial summary

Who is it for?: Ages 60 to 89 yearsHealthy volunteers can take part
Conditions the study is for: Sedentary Lifestyle
What is being tested?: i-STAND
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 283 participants
Where: 1 siteUnited States
Study dates: 5 Feb 2019to 31 Mar 2023
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

unable to speak and read English (phone screen)
unable to walk 1 block (with or without assistive devices) (phone screen)
self-reported sitting time less than 6 hours per day (phone screen)
diagnosis codes indicating hearing loss, dementia or serious mental illness (e.g., schizophrenia, bipolar disorder), or a terminal or serious illness (e.g., cancer) in the past 2 years (from the EMR)

Trial locations and contacts

1 site in 1 country.

United States1 site

Kaiser Permanente Washington
Seattle, Washington, 98101

Other trials in United States

About this study

Official title: Randomized Trial to Reduce Sitting Time and Improve Cardiometabolic Health in Obese Older Adults

Healthy Aging Resources to Thrive (HART) uses a rigorous two-stage randomized control design, adapted and refined based on pilot studies, to test a novel intervention to reduce sitting time in older adults. Half the participants will be randomized to the intervention aimed at decreasing sitting time, and the other half will be randomized to a healthy living control that does not focus on reduced sitting time. After 6 months, the intervention group will be further randomized so that half continue with the intervention and the other half receive no further intervention. All participants will be followed for 12 months.

Read the detailed description

Healthy Aging Resources to Thrive (HART) is a two-stage randomized controlled trial (RCT) of adults over age 60 with obesity to determine the efficacy of a novel sitting-reduction intervention and its impact on cardiometabolic risk markers. Participants will be randomized to a 6-month sitting reduction intervention (termed I-STAND) or healthy-living attention control (Stage 1). All participants will be mailed a scale and a blood pressure monitor (to keep) which will be used during the phone-based measurement visits at Baseline, 3, 6 and 12 months. All participants will have phone-based Coaching sessions.

After 6 months, I-STAND participants will be re-randomized to receive either booster sessions or no further intervention (Stage 2). Attention control participants will receive no further intervention. All participants will be followed for 12 months total with phone-based assessments at baseline, 3, 6, and 12 months. Primary outcomes are reduction in sitting time at 6 months, objectively measured using the activPAL device, and blood pressure. The design will answer novel questions about the impact of sitting reduction on cardiometabolic risk markers as well as maintenance of sitting reduction.

UPDATE: As of 3/31/31, (final year 5) of the study, participants randomized to the i-STAND intervention will no longer be re-randomized at 6 months. We will no longer follow participants to the 12-month timepoint \& will end all activities after 6-months.

Conditions: Sedentary Lifestyle
Being tested: i-STAND, Healthy Living control
Medical subject headings: Sedentary Behavior

What participants receive

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

i-STANDBehavioural
Via in-person and phone coaching sessions, participants randomized to this arm will be coached to find ways to sit less and stand more, and look for ways to change their home environment to encourage this, as well as look at how their lifestyle may contribute to their sitting time. Participants in this arm may be re-randomized at the half-way point to continue with additional phone coaching sessions. (As of 3/31/2022 Re-randomizations are no longer taking place)
Healthy Living controlOther
In this arm, participants will have phone coaching sessions focused on a variety of topics aimed at improving healthy habits. There is no focus on standing more or sitting less.

Study groups in NCT03739762
Study group	Role	What they receive
i-STAND	Experimental	i-STAND participants have a Baseline visit followed by the 1st Coaching visit. They receive wristbands that vibrate every 15 minutes to prompt a standing break, standing desks, workbook \& 10 phone-based coaching calls focused on sitting less/standing more. There is a 3 month measurement visit. Program ends at 6 months when they wear an activPAL \& have a measurement visit. Coach provides feedback on activPAL sitting time after all activPAL wears (Bsln, 3, 6 \& 12 month). They may opt to wear activPAL at 6 weeks \& get feedback. They are re-randomized at 6 months; half to be assigned to intervention boosters (5 more phone sessions/a 9-month optional activPAL) before the 12 month final activPAL \& final measurement visit. Those not randomized to boosters will have no contact until the 12 month visit. UPDATE: As of 3/31/2022, (final year 5), i-STAND ppts will no longer be re-randomized at 6 months. We will no longer follow to the 12-month timepoint \& will end all activities after 6-months. Receives: Behavioral: i-STAND
Healthy Living control	Active comparator	In this arm, participants have a phone-based Baseline visit followed by the 1st phone-based Coaching visit. No prompting devices/desks are offered; coaching focuses on topics related to healthy living, but with no focus on sitting less/standing more. They have 10 phone calls with a health coach. Participants receive a workbook. All content is from KaiserPermanente WA and is available to all members. Participants select topics \& review them with their health coach. At 3 months, participants have a measurement visit. The program ends at 6 months where participants will wear an activPAL and have a measurement visit. After that, there is no contact with the study team until 12 months when they will again wear an activPAL \& have a final measurement visit. UPDATE: As of 3/31/2022, our final year (year 5) of the study, participants randomized to the control arm will no longer be followed to the 12-month timepoint and will end all activities after the 6-month timepoint. Receives: Other: Healthy Living control

What is being measured

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

Change in Time Spent Sitting or Lying Down at 6 Months
Time (minutes) spent sitting/lying during waking hours will be measured objectively by the activPAL worn for one week following each measurement visit.
Measured: Change from Baseline at 6 months
Change in SystolicBlood Pressure at 6 Months
Another primary outcome is change in systolic blood pressure. This will be measured at the measurement visits using blood pressure monitors mailed to the participant
Measured: Change from Baseline at 6 months
Change in Diastolic Blood Pressure at 6 Months
Another primary outcome is change in diastolic blood pressure
Measured: Change from Baseline at 6 months

Secondary outcomes (3)

Change in Weight at 6 Months
Participants provide their weight at each measurement visit. Weight is measured in pounds using a scale mailed to the participant.
Measured: Change from Baseline at 6 months
Change in BMI at 6 Months
BMI was calculated as [weight in kg]/[height in m]2.
Measured: Change from Baseline at 6 months
Change in Waist Circumference at 6 Months
Participants provided their waist circumference at each measurement visit. Waist circumference was measured at the superior border of the iliac crest.
Measured: Change from Baseline at 6 months

Timeline

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

5 Feb 201931 Mar 2023

First posted14 Nov 2018
Study start5 Feb 2019
Primary completion7 Nov 2022
Study completion31 Mar 2023

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.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Sedentary LifestyleStudies 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants will be randomized into one of two cohorts/arms: one called "i-STAND" with coaching sessions focused directly on sitting less and standing more; the other called "Healthy Living" with coaching sessions focused on various topics related to a healthy lifestyle, but without a focus on standing more. Those randomized to the i-STAND intervention will also be re-randomized half-way through the study, with half of that cohort moving on to phase 2, which involves booster sessions on sitting less and standing more. All participants regardless of cohort will be mailed a blood pressure monitor and a scale to keep. UPDATE: As of March 31, 2022, beginning in our final year (year 5) of the study, participants randomized to the i-STAND intervention will no longer be re-randomized at 6 months. We will no longer follow participants to the 12-month timepoint and will end all activities after the 6-month timepoint.
Masking: None (open label)
Enrolment: 283 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03739762
Sponsor's protocol ID: 1315055-1
Other IDs: 1R01HL132880-01A1
Acronym: HART
Status last verified: May 2024
First submitted: 31 Oct 2018
Last updated: 25 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Rosenberg DE, Greenwood-Hickman MA, Zhou J, Cook AJ, Mettert KD, Cooper J, Arterburn D, Green BB, Walsh-Bailey C, Kerr J, Owen N, Dunstan D, McClure JB. Protocol for a randomized controlled trial of sitting reduction to improve cardiometabolic health in older adults. Contemp Clin Trials. 2021 Dec;111:106593. doi: 10.1016/j.cct.2021.106593. Epub 2021 Oct 16.
PubMed 34666182
Greenwood-Hickman MA, Dahlquist J, Cooper J, Holden E, McClure JB, Mettert KD, Perry SR, Rosenberg DE. "They're Going to Zoom It": A Qualitative Investigation of Impacts and Coping Strategies During the COVID-19 Pandemic Among Older Adults. Front Public Health. 2021 May 19;9:679976. doi: 10.3389/fpubh.2021.679976. eCollection 2021.
PubMed 34095079
Greenwood-Hickman MA, Zhou J, Cook A, Mettert KD, Green B, McClure J, Arterburn D, Florez-Acevedo S, Rosenberg DE. Exploring Differences in Older Adult Accelerometer-Measured Sedentary Behavior and Resting Blood Pressure Before and During the COVID-19 Pandemic. Gerontol Geriatr Med. 2022 Apr 27;8:23337214221096007. doi: 10.1177/23337214221096007. eCollection 2022 Jan-Dec.
PubMed 35506125
Rosenberg DE, Zhu W, Greenwood-Hickman MA, Cook AJ, Florez Acevedo S, McClure JB, Arterburn DE, Cooper J, Owen N, Dunstan D, Perry SR, Yarborough L, Mettert KD, Green BB. Sitting Time Reduction and Blood Pressure in Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2024 Mar 4;7(3):e243234. doi: 10.1001/jamanetworkopen.2024.3234.
PubMed 38536177
Florez-Acevedo S, Greenwood-Hickman MA, Zhu W, Cook AJ, Delaney K, Green BB, Arterburn DE, McClure JB, Rosenberg DE. Exploratory Analysis of Mental Health and Quality of Life Outcomes in a Randomized Controlled Trial to Reduce Sitting Time in Older Adults With Obesity. J Aging Phys Act. 2025 Nov 12;34(4):496-507. doi: 10.1123/japa.2024-0387. Print 2026 Aug 1.
PubMed 41223847

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Sedentary Lifestyle trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Trial to Reduce Sitting Time and Improve Cardiometabolic Health in Obese Older Adults
ClinicalTrials.gov ID: NCT03739762
Acronym / sponsor ID: HART / 1315055-1
Conditions: Sedentary Lifestyle
Study type: Interventional
Recruitment status: Completed
Enrolment: 283 participants (actual)
Lead sponsor: Kaiser PermanenteUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: 5 Feb 2019 (actual)
Primary completion: 7 Nov 2022 (actual)
Study completion: 31 Mar 2023 (actual)
First posted: 14 Nov 2018 (actual)
Results: Posted 5 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Participants will be randomized into one of two cohorts/arms: one called "i-STAND" with coaching sessions focused directly on sitting less and standing more; the other called "Healthy Living" with coaching sessions focused on various topics related to a healthy lifestyle, but without a focus on standing more. Those randomized to the i-STAND intervention will also be re-randomized half-way through the study, with half of that cohort moving on to phase 2, which involves booster sessions on sitting less and standing more. All participants regardless of cohort will be mailed a blood pressure monitor and a scale to keep. UPDATE: As of March 31, 2022, beginning in our final year (year 5) of the study, participants randomized to the i-STAND intervention will no longer be re-randomized at 6 months. We will no longer follow participants to the 12-month timepoint and will end all activities after the 6-month timepoint.

Arm	Type	Receives
i-STAND	Experimental	Behavioral: i-STANDi-STAND participants have a Baseline visit followed by the 1st Coaching visit. They receive wristbands that vibrate every 15 minutes to prompt a standing break, standing desks, workbook \& 10 phone-based coaching calls focused on sitting less/standing more. There is a 3 month measurement visit. Program ends at 6 months when they wear an activPAL \& have a measurement visit. Coach provides feedback on activPAL sitting time after all activPAL wears (Bsln, 3, 6 \& 12 month). They may opt to wear activPAL at 6 weeks \& get feedback. They are re-randomized at 6 months; half to be assigned to intervention boosters (5 more phone sessions/a 9-month optional activPAL) before the 12 month final activPAL \& final measurement visit. Those not randomized to boosters will have no contact until the 12 month visit. UPDATE: As of 3/31/2022, (final year 5), i-STAND ppts will no longer be re-randomized at 6 months. We will no longer follow to the 12-month timepoint \& will end all activities after 6-months.
Healthy Living control	Active comparator	Other: Healthy Living controlIn this arm, participants have a phone-based Baseline visit followed by the 1st phone-based Coaching visit. No prompting devices/desks are offered; coaching focuses on topics related to healthy living, but with no focus on sitting less/standing more. They have 10 phone calls with a health coach. Participants receive a workbook. All content is from KaiserPermanente WA and is available to all members. Participants select topics \& review them with their health coach. At 3 months, participants have a measurement visit. The program ends at 6 months where participants will wear an activPAL and have a measurement visit. After that, there is no contact with the study team until 12 months when they will again wear an activPAL \& have a final measurement visit. UPDATE: As of 3/31/2022, our final year (year 5) of the study, participants randomized to the control arm will no longer be followed to the 12-month timepoint and will end all activities after the 6-month timepoint.

Who may qualify

Ages: 60 to 89 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (4 listed)

unable to speak and read English (phone screen)
unable to walk 1 block (with or without assistive devices) (phone screen)
self-reported sitting time less than 6 hours per day (phone screen)
diagnosis codes indicating hearing loss, dementia or serious mental illness (e.g., schizophrenia, bipolar disorder), or a terminal or serious illness (e.g., cancer) in the past 2 years (from the EMR)

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
i-STANDVia in-person and phone coaching sessions, participants randomized to this arm will be coached to find ways to sit less and stand more, and look for ways to change their home environment to encourage this, as well as look at how their lifestyle may contribute to their sitting time. Participants in this arm may be re-randomized at the half-way point to continue with additional phone coaching sessions. (As of 3/31/2022 Re-randomizations are no longer taking place)	Behavioural	i-STAND
Healthy Living controlIn this arm, participants will have phone coaching sessions focused on a variety of topics aimed at improving healthy habits. There is no focus on standing more or sitting less.	Other	Healthy Living control

Primary outcome

Change in Time Spent Sitting or Lying Down at 6 Months
Time frame: Change from Baseline at 6 months
Time (minutes) spent sitting/lying during waking hours will be measured objectively by the activPAL worn for one week following each measurement visit.
Change in SystolicBlood Pressure at 6 Months
Time frame: Change from Baseline at 6 months
Another primary outcome is change in systolic blood pressure. This will be measured at the measurement visits using blood pressure monitors mailed to the participant
Change in Diastolic Blood Pressure at 6 Months
Time frame: Change from Baseline at 6 months
Another primary outcome is change in diastolic blood pressure

3 secondary outcomes

Change in Weight at 6 Months
Time frame: Change from Baseline at 6 months
Change in BMI at 6 Months
Time frame: Change from Baseline at 6 months
Change in Waist Circumference at 6 Months
Time frame: Change from Baseline at 6 months

Results and safety

Results posted to the registry on 5 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
i-STAND	140	137
Healthy Living Control	143	136

Primary outcome: Change in Time Spent Sitting or Lying Down at 6 Months

Time frame: Change from Baseline at 6 months. Mean (95% Confidence Interval). Unit: Minutes

Measure	i-STAND n = 124	Healthy Living Control n = 122
Value	-40.36 (-54.86 to -25.85)	-8.51 (-23.97 to 6.95)

i-STAND vs Healthy Living Control: Mean Difference (Final Values): -31.85 (95% CI -52.91 to -10.79), p = 0.003, Regression, Linear

Population analysed: Number of participants who had a 6-month measure for change in sitting time

Primary outcome: Change in SystolicBlood Pressure at 6 Months

Time frame: Change from Baseline at 6 months. Mean (95% Confidence Interval). Unit: mmHg

Measure	i-STAND n = 127	Healthy Living Control n = 127
Value	-6.67 (-8.82 to -4.52)	-3.19 (-5.44 to -0.94)

i-STAND vs Healthy Living Control: Mean Difference (Final Values): -3.48 (95% CI -6.68 to -0.28), p = .033, Regression, Linear

Population analysed: Number of participants who had a 6-month measure for SBP

Primary outcome: Change in Diastolic Blood Pressure at 6 Months

Time frame: Change from Baseline at 6 months. Mean (95% Confidence Interval). Unit: mmHg

Measure	i-STAND n = 127	Healthy Living Control n = 127
Value	-1.32 (-2.66 to 0.02)	-1.58 (-2.93 to -0.23)

i-STAND vs Healthy Living Control: Mean Difference (Final Values): 0.27 (95% CI -1.63 to 2.16), p = .784, Regression, Linear

Population analysed: Number of participants who had a 6-month measure for Diastolic BP

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
i-STAND	6 of 140 (4.3%)	72 of 140 (51.4%)	0 of 140
Healthy Living Control	6 of 143 (4.2%)	47 of 143 (32.9%)	0 of 143

Limitations and caveats (from the sponsor): Limitations of our study include the interruption caused by the COVID-19 pandemic, which occurred after 100 of the 283 participants were enrolled. We had to rely on participant-measured outcomes post-pandemic.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 34666182Rosenberg DE, Greenwood-Hickman MA, Zhou J, Cook AJ, Mettert KD, Cooper J, Arterburn D, Green BB, Walsh-Bailey C, Kerr J, Owen N, Dunstan D, McClure JB. Protocol for a randomized controlled trial of sitting reduction to improve cardiometabolic health in older adults. Contemp Clin Trials. 2021 Dec;111:106593. doi: 10.1016/j.cct.2021.106593. Epub 2021 Oct 16.
Background: PubMed 34095079Greenwood-Hickman MA, Dahlquist J, Cooper J, Holden E, McClure JB, Mettert KD, Perry SR, Rosenberg DE. "They're Going to Zoom It": A Qualitative Investigation of Impacts and Coping Strategies During the COVID-19 Pandemic Among Older Adults. Front Public Health. 2021 May 19;9:679976. doi: 10.3389/fpubh.2021.679976. eCollection 2021.
Results publication: PubMed 35506125Greenwood-Hickman MA, Zhou J, Cook A, Mettert KD, Green B, McClure J, Arterburn D, Florez-Acevedo S, Rosenberg DE. Exploring Differences in Older Adult Accelerometer-Measured Sedentary Behavior and Resting Blood Pressure Before and During the COVID-19 Pandemic. Gerontol Geriatr Med. 2022 Apr 27;8:23337214221096007. doi: 10.1177/23337214221096007. eCollection 2022 Jan-Dec.
Results publication: PubMed 38536177Rosenberg DE, Zhu W, Greenwood-Hickman MA, Cook AJ, Florez Acevedo S, McClure JB, Arterburn DE, Cooper J, Owen N, Dunstan D, Perry SR, Yarborough L, Mettert KD, Green BB. Sitting Time Reduction and Blood Pressure in Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2024 Mar 4;7(3):e243234. doi: 10.1001/jamanetworkopen.2024.3234.
Derived from this study: PubMed 41223847Florez-Acevedo S, Greenwood-Hickman MA, Zhu W, Cook AJ, Delaney K, Green BB, Arterburn DE, McClure JB, Rosenberg DE. Exploratory Analysis of Mental Health and Quality of Life Outcomes in a Randomized Controlled Trial to Reduce Sitting Time in Older Adults With Obesity. J Aging Phys Act. 2025 Nov 12;34(4):496-507. doi: 10.1123/japa.2024-0387. Print 2026 Aug 1.

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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

Kaiser Permanente

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing i-STAND 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 0 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 25 Jun 2024. 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 5 Dec 2023). 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 Time Spent Sitting or Lying Down at 6 Months (time frame: Change from Baseline at 6 months). The study lists 3 primary outcomes in all. 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 NCT03739762, which also lists 5 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 25 Jun 2024.