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Completed

NCT Number: NCT03739762

Healthy Aging Resources to Thrive (HART)

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.

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Key information

Age range

60 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Washington

Seattle, Washington, 98101, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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)

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.

Primary outcomes

  1. 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.

  2. 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

  3. 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

Secondary outcomes

  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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Acronym: HART

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Nov 14, 2018
Registry last updated
Jun 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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