Healthy Aging Resources to Thrive (HART)

NCT03739762 | Completed Results DMC

• 2 other identifiers: 1315055-11R01HL132880-01A1
• Study Type: interventional
• Target: 283
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sedentary Lifestyle

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  Change from Baseline at 6 months

• Change in Diastolic Blood Pressure at 6 Months

  Another primary outcome is change in diastolic blood pressure

  Change from Baseline at 6 months

Secondary Outcomes (3)

• Change in Weight at 6 Months

  Change from Baseline at 6 months

• Change in BMI at 6 Months

  Change from Baseline at 6 months

• Change in Waist Circumference at 6 Months

  Change from Baseline at 6 months

Study Arms (2)

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.

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.

Other: Healthy Living control

Interventions

i-STAND BEHAVIORAL

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)

i-STAND

Healthy Living control OTHER

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.

Healthy Living control

Eligibility Criteria

• Age: 60 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI ≥30 and \<50 kg/m2
• men and women of all races and ethnicities from anywhere in the KPWA region (state-wide)
• We will oversample people of color statewide
• Able to walk one block
• Able to speak and read English,
• no self-reported vision limitations, sedentary time, use of an assistive device, able to stand.
• no cognitive impairment that is perceived by the study staff during phone screening
• Willingness to wear device (activPAL)
• Willingness to participate in study for a full year
• Continuously enrolled at KP for previous 12 months
• Not on the No Contact list
• Not previously enrolled in ISTAND or TABS
• Not currently enrolled in ACT, STOP-FALLS or SMARRT studies

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Kaiser Permanente Washington

Seattle, Washington, 98101, United States

Location

Related Publications (5)

• 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.

  PMID: 34666182 BACKGROUND

• 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.

  PMID: 34095079 BACKGROUND

• 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.

  PMID: 35506125 RESULT

• 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.

  PMID: 38536177 RESULT

• 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 12:1-12. doi: 10.1123/japa.2024-0387. Online ahead of print.

  PMID: 41223847 DERIVED

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

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.

Results Point of Contact

• Title: Dori Rosenberg, Principal Investigator
• Organization: Kaiser Permanente

dori.e.rosenberg@kp.org

206-287-2532

Study Officials

• Dori E Rosenberg, PhD, MPH

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 14, 2018
• Study Start: February 5, 2019
• Primary Completion: November 7, 2022
• Study Completion: March 31, 2023
• Last Updated: June 25, 2024
• Results First Posted: December 5, 2023

Record last verified: 2024-05

Locations

US (1)