Healthy Aging Resources to Thrive (HART)

Kaiser Permanente283 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

Conditions

Sedentary Lifestyle

Interventions

i-STANDBEHAVIORAL

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 controlOTHER

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.

Eligibility

Sex: ALLMin age: 60 YearsMax age: 89 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Kaiser Permanente Washington

Seattle, Washington, United States

Outcomes

Primary Outcomes

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.