Healthy Aging Resources to Thrive (HART) (HART)

November 16, 2023 updated by: Kaiser Permanente

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

283

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98101
        • Kaiser Permanente Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: i-STAND
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
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)
Active Comparator: Healthy Living control
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 from Baseline at 6 months
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 from Baseline at 6 months
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
Change from Baseline at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline at 6 months
Change in BMI at 6 Months
Time Frame: Change from Baseline 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
Time Frame: Change from Baseline 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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory Outcome: Change in time spent sitting or lying down at 12 months for i-STAND Booster Group (As of 3/31/2022 this is no longer an outcome being measured in Y5)
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.
Change from Baseline at 12 months
Exploratory Outcome: Change in Systolic and Diastolic Blood Pressure at 12 months for i-STAND Booster Group (As of 3/31/2022 this is no longer an outcome begin measured in Y5)
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.
Change from Baseline at 12 months
Exploratory Outcome: Change in weight at 12 months for i-STAND booster group (As of 3/31/2022 this is no longer an outcome begin measured in Y5)
Time Frame: Change from Baseline at 12 months
Participants are weighed at each measurement visit. Weight is measured in pounds.
Change from Baseline at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2019

Primary Completion (Actual)

November 7, 2022

Study Completion (Actual)

March 31, 2023

Study Registration Dates

First Submitted

October 31, 2018

First Submitted That Met QC Criteria

November 12, 2018

First Posted (Actual)

November 14, 2018

Study Record Updates

Last Update Posted (Estimated)

December 5, 2023

Last Update Submitted That Met QC Criteria

November 16, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 1315055-1
  • 1R01HL132880-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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