Clinical trial NCT03739762: Healthy Aging Resources to Thrive (HART)
Official title: Randomized Trial to Reduce Sitting Time and Improve Cardiometabolic Health in Obese Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Lifestyle
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-11-14
Enrollment: 283
Sex: ALL
Minimum age (years): 60
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria: • Self-reported sitting time of 6+ hours per day

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Change in Time Spent Sitting or Lying Down at 6 Months
timeFrame: Change from Baseline at 6 months
measure: Change in SystolicBlood Pressure at 6 Months
timeFrame: Change from Baseline at 6 months
measure: Change in Diastolic Blood Pressure at 6 Months
timeFrame: Change from Baseline at 6 months
Secondary outcomes:
measure: Change in Weight at 6 Months
timeFrame: Change from Baseline at 6 months
measure: Change in BMI at 6 Months
timeFrame: Change from Baseline at 6 months
measure: Change in Waist Circumference at 6 Months
timeFrame: Change from Baseline at 6 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Kaiser Permanente Washington
state: Washington
Study officials:
affiliation: Kaiser Permanente
name: Dori E Rosenberg, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.