N/A N=283 Randomized Supportive Care

Healthy Aging Resources to Thrive (HART)

Sedentary Lifestyle

Bottom Line

View on ClinicalTrials.gov: NCT03739762 ↗

Enrolled (actual)

283

Serious AEs

4.2%

Results posted

Dec 2023

Primary outcome: Primary: Change in Time Spent Sitting or Lying Down at 6 Months — -40.36; -8.51 Minutes — p=0.003

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: i-STAND (Behavioral); Healthy Living control (Other)
Age: Adult, Older Adult · 60+ yrs
Sex: All
Sponsor: Kaiser Permanente
Primary completion: Nov 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Time Spent Sitting or Lying Down at 6 Months	-40.36; -8.51	0.003 sig
PRIMARY Change in SystolicBlood Pressure at 6 Months	-6.67; -3.19	.033 sig
PRIMARY Change in Diastolic Blood Pressure at 6 Months	-1.32; -1.58	.784
SECONDARY Change in Weight at 6 Months	-3.56; -3.45	.927
SECONDARY Change in BMI at 6 Months	-0.51; -0.54	.916
SECONDARY Change in Waist Circumference at 6 Months	-1.0; -0.64	.325

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.

Eligibility 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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03739762). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.