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i-STAND for Sedentary Lifestyle (HART Trial)

N/A
Waitlist Available
Led By Dori E Rosenberg, PhD, MPH
Research Sponsored by Kaiser Permanente
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Self-reported sitting time of 6+ hours per day
Able to walk one block
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline at 6 months
Awards & highlights

HART Trial Summary

This trial is testing a novel intervention to reduce sitting time in older adults, with the goal of improving health. The study design is a randomized control trial, with participants assigned to either the intervention or a control group. 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.

HART Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You sit for more than 6 hours per day, according to your own report.
Select...
You can walk a short distance (one block).

HART Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Diastolic Blood Pressure at 6 Months
Change in SystolicBlood Pressure at 6 Months
Change in Time Spent Sitting or Lying Down at 6 Months
Secondary outcome measures
Change in BMI at 6 Months
Change in Waist Circumference at 6 Months
Change in Weight at 6 Months
Other outcome measures
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)
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)
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)

HART Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: i-STANDExperimental Treatment1 Intervention
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.
Group II: Healthy Living controlActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
i-STAND
2019
N/A
~290

Find a Location

Who is running the clinical trial?

Kaiser PermanenteLead Sponsor
537 Previous Clinical Trials
24,113,053 Total Patients Enrolled
2 Trials studying Sedentary Lifestyle
70 Patients Enrolled for Sedentary Lifestyle
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,816 Previous Clinical Trials
47,292,786 Total Patients Enrolled
4 Trials studying Sedentary Lifestyle
2,190 Patients Enrolled for Sedentary Lifestyle
Dori E Rosenberg, PhD, MPHPrincipal InvestigatorKaiser Permanente
2 Previous Clinical Trials
70 Total Patients Enrolled
2 Trials studying Sedentary Lifestyle
70 Patients Enrolled for Sedentary Lifestyle

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacant places within this research project for prospective trial participants?

"As per statistics on clinicaltrials.gov, recruitment for this medical trial has been suspended since it was last updated in May 6th 2022; however, there are 18 other trials actively looking for participants at the present moment. This study's first listing occurred on February 5th 2019."

Answered by AI

To whom is this research prospect available?

"This clinical trial aims to enrol 283 patients, aged between sixty and eighty-nine who have a sedentary lifestyle. The protocols demand that the participant should be of any gender or racial background from within the KPWA region with a BMI ranking higher than 30 but lower than 50 kg/m2. Additionally, they must possess the capability to walk one block while also being literate in English without having any vision impediments, utilizing an assistive device or cognitive impairments as judged by study personnel during phone screening stages. Furthermore, participants must agree to wear a specified device (activPAL) for twelve months duration if selected into this research project"

Answered by AI

Is the current research initiative accepting participants over forty years of age?

"The age range for patients eligible to join this trial are 60-89, however there are additional trials specifically recruiting minors and seniors."

Answered by AI
~47 spots leftby Mar 2025