Healthy Aging Resources to Thrive (HART) (HART)

• ClinicalTrials.gov Identifier: NCT03739762
• Recruitment Status: Recruiting
• First Posted: November 14, 2018
• Last Update Posted: October 5, 2021
• Sponsor: Kaiser Permanente
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Kaiser Permanente

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Sedentary Lifestyle	Behavioral: i-STAND; Other: Healthy Living control	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 284 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Randomized Trial to Reduce Sitting Time and Improve Cardiometabolic Health in Obese Older Adults
• Actual Study Start Date: February 5, 2019
• Estimated Primary Completion Date: March 31, 2022
• Estimated Study Completion Date: March 31, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: i-STAND; i-STAND participants have a Baseline visit followed by their first Coaching visit. They are offered wristbands that vibrate every 15 minutes to prompt a standing break, standing desks, a workbook and 10 phone-based coaching sessions focused on sitting less and standing more. At 3 months they will participate in a measurement visit. The program ends at 6 months where they wear an activPAL and participate in a measurement. Their coach will provide feedback on their sitting time from the activPAL after all activPAL wears (Baseline, 3, 6 and 12 month). They may also opt in to wear an activPAL at 6 weeks and receive feedback. They will be re-randomized at 6 months, where half will be assigned to intervention boosters (5 more phone coaching sessions / one 9-month optional activPAL wear) before the 12 month time point for a final activPAL wear and final measurement visit. Those not randomized to receive boosters will have no further contact with the study team until the 12 month time point.	Behavioral: i-STAND; 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.
Active Comparator: Healthy Living control; In this arm, participants have a phone-based Baseline visit followed by their first phone-based Coaching visit. They are not offered any prompting devices or desks, and their coaching sessions focus on a variety of topics related to healthy living, but without a focus on sitting less/standing more. They have 10 phone calls with a health coach. Participants are given a workbook. All content is from Kaiser Permanente Washington and is available to all members. Participants will select topics of interest and review them with their health coach. At 3 months, participants will participate in a measurement visit. The program ends at 6 months where participants will wear an activPAL and participate in a measurement visit. After that, they will not have contact with the study team until 12 months when they will again wear an activPAL and participate in their final measurement visit.	Other: Healthy Living control; 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.

Outcome Measures

Primary Outcome Measures :

1. Change in time spent sitting or lying down at 6 months [ Time Frame: Change from Baseline at 6 months ]
   Time spent sitting/lying during waking hours will be measured objectively by the activPAL worn for one week following each measurement visit.
2. Change in Systolic and Diastolic Blood Pressure at 6 months [ Time Frame: Change from Baseline at 6 months ]
   Another primary outcome is systolic and diastolic blood pressure. This will be measured at the measurement visits using blood pressure monitors mailed to the participant.

Secondary Outcome Measures :

1. Change in Weight at 6 months [ Time Frame: Change from Baseline at 6 months ]
   Participants provide their weight at each measurement visit. Weight is measured in pounds using a scale mailed to the participant.

Other Outcome Measures:

1. Exploratory Outcome: Change in time spent sitting or lying down at 12 months for i-STAND Booster Group [ Time Frame: Change from Baseline at 12 months ]
   Time spent sitting/lying during waking hours will be measured objectively by the activPAL worn for one week following each measurement visit and an additional wear at 9 months by only the i-STAND Booster group.
2. Exploratory Outcome: Change in Systolic and Diastolic Blood Pressure at 12 months for i-STAND Booster Group [ Time Frame: Change from Baseline at 12 months ]
   Another primary outcome is systolic and diastolic blood pressure. This will be measured at the measurement visits.
3. Exploratory Outcome: Change in weight at 12 months for i-STAND booster group [ Time Frame: Change from Baseline at 12 months ]
   Participants are weighed at each measurement visit. Weight is measured in pounds.

Eligibility Criteria

• Ages Eligible for Study: 60 Years to 89 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Contacts

Contact: Julie B Cooper, MPA; 206-287-2802; julie.b.cooper@kp.org

Locations

United States, Washington

Kaiser Permanente Washington; Recruiting

Seattle, Washington, United States, 98101

Contact: Julie B Cooper, MPA 206-287-2802 julie.b.cooper@kp.org

Principal Investigator: Dori E Rosenberg, PhD, MPH

Sponsors and Collaborators

Kaiser Permanente

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Dori E Rosenberg, PhD, MPH; Kaiser Permanente

More Information

• Responsible Party: Kaiser Permanente
• ClinicalTrials.gov Identifier: NCT03739762
• Other Study ID Numbers: 1315055-1; 1R01HL132880-01A1 ( U.S. NIH Grant/Contract )
• First Posted: November 14, 2018
• Last Update Posted: October 5, 2021
• Last Verified: October 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No