Healthy Aging Resources to Thrive (HART)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sedentary Lifestyle

Intervention / Treatment
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* Behavioral: i-STAND
* Other: Healthy Living control


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: i-STAND<br>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<br>* 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)<br>|
| Active Comparator: Healthy Living control<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from Baseline at 6 months | 
| Change in BMI at 6 Months | BMI was calculated as [weight in kg]/[height in m]2. | 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. | Change from Baseline at 6 months |