Sedentary Lifestyle
Conditions
Brief 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.
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.
Interventions
BEHAVIORALi-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)
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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Participants will be randomized into one of two cohorts/arms: one called i-STAND with coaching sessions focused directly on sitting less and standing more; the other called Healthy Living with coaching sessions focused on various topics related to a healthy lifestyle, but without a focus on standing more. Those randomized to the i-STAND intervention will also be re-randomized half-way through the study, with half of that cohort moving on to phase 2, which involves booster sessions on sitting less and standing more. All participants regardless of cohort will be mailed a blood pressure monitor and a scale to keep. UPDATE: As of March 31, 2022, beginning in our final year (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 and will end all activities after the 6-month timepoint.
Eligibility
Sex/Gender
ALL
Age
60 Years to 89 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Time Spent Sitting or Lying Down at 6 Months | 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 in SystolicBlood Pressure at 6 Months | 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 in Diastolic Blood Pressure at 6 Months | Change from Baseline at 6 months | Another primary outcome is change in diastolic blood pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Weight at 6 Months | 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 in BMI at 6 Months | Change from Baseline at 6 months | BMI was calculated as \[weight in kg\]/\[height in m\]2. |
| Change in Waist Circumference at 6 Months | 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. |
Countries
United States
Participant flow
Recruitment details
Goal was 284 randomized participants. A total of 357 potential participants were recruited, with 283 consenting and completing baseline measurements and randomization.
Pre-assignment details
We had 11 participants consent\* to the study but who were never randomized thus \*not enrolled\*. Of these, 3 completed a baseline visit but before randomization, 2 never responded to our attempts to reach them (5 calls and one letter) and 1 said they were too busy to continue. The remaining 8 were non responsive to our attempts to reach them after initial consent. All of these participants were remote and thus their randomization took place up to 2 weeks after the baseline visit.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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) | 140 |
| 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.
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. | 143 |
| Total | 283 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 6 |
Baseline characteristics
| Characteristic | i-STAND | Healthy Living Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 97 Participants | 97 Participants | 194 Participants |
| Age, Categorical Between 18 and 65 years | 43 Participants | 46 Participants | 89 Participants |
| Age, Continuous | 68.57 years | 69.03 years | 68.8 years |
| Baseline measure of Diastolic Blood Pressure mmHg | 79.6 mmHg STANDARD_DEVIATION 11.1 | 79.8 mmHg STANDARD_DEVIATION 10.2 | 79.7 mmHg STANDARD_DEVIATION 10.7 |
| Baseline Measure of Systolic Blood Pressure mmHg | 135.4 mmHg STANDARD_DEVIATION 18.8 | 136.7 mmHg STANDARD_DEVIATION 18.3 | 136.1 mmHg STANDARD_DEVIATION 18.5 |
| Baseline Measure of Time Spent Sitting or Lying Down | 650.4 Minutes STANDARD_DEVIATION 117.9 | 654.5 Minutes STANDARD_DEVIATION 115.5 | 652.4 Minutes STANDARD_DEVIATION 116.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 6 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 25 Participants | 17 Participants | 42 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 7 Participants | 14 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) White | 97 Participants | 107 Participants | 204 Participants |
| Region of Enrollment United States | 140 Participants | 143 Participants | 283 Participants |
| Sex: Female, Male Female | 88 Participants | 99 Participants | 187 Participants |
| Sex: Female, Male Male | 52 Participants | 44 Participants | 96 Participants |
| Sex/Gender, Customized Non-Binary | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 140 | 0 / 143 |
| other Total, other adverse events | 72 / 140 | 47 / 143 |
| serious Total, serious adverse events | 6 / 140 | 6 / 143 |
Outcome results
Primary
Change in Diastolic Blood Pressure at 6 Months
Another primary outcome is change in diastolic blood pressure
Time frame: Change from Baseline at 6 months
Population: Number of participants who had a 6-month measure for Diastolic BP
| Arm | Measure | Value (MEAN) |
|---|---|---|
| i-STAND | Change in Diastolic Blood Pressure at 6 Months | -1.32 mmHg |
| Healthy Living Control | Change in Diastolic Blood Pressure at 6 Months | -1.58 mmHg |
p-value: 0.78495% CI: [-1.63, 2.16]Regression, Linear
Primary
Change in SystolicBlood Pressure 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
Time frame: Change from Baseline at 6 months
Population: Number of participants who had a 6-month measure for SBP
| Arm | Measure | Value (MEAN) |
|---|---|---|
| i-STAND | Change in SystolicBlood Pressure at 6 Months | -6.67 mmHg |
| Healthy Living Control | Change in SystolicBlood Pressure at 6 Months | -3.19 mmHg |
p-value: 0.03395% CI: [-6.68, -0.28]Regression, Linear
Primary
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.
Time frame: Change from Baseline at 6 months
Population: Number of participants who had a 6-month measure for change in sitting time
| Arm | Measure | Value (MEAN) |
|---|---|---|
| i-STAND | Change in Time Spent Sitting or Lying Down at 6 Months | -40.36 Minutes |
| Healthy Living Control | Change in Time Spent Sitting or Lying Down at 6 Months | -8.51 Minutes |
Comparison: The sample size of 284 ensured 90% power to detect a 41-minute difference in sitting time between I-STAND and the attention control from baseline to 6 months, assuming a standard deviation (SD) of 97 minutes/day for change in sitting time (based on our pilot data), and 15% loss to follow-up. Sample and power calculations were performed using R software version 3.5 \[39\] via simulation, assuming specified SDs and differences between means.p-value: 0.00395% CI: [-52.91, -10.79]Regression, Linear
Secondary
Change in BMI at 6 Months
BMI was calculated as \[weight in kg\]/\[height in m\]2.
Time frame: Change from Baseline at 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| i-STAND | Change in BMI at 6 Months | -0.51 kg/m^2 |
| Healthy Living Control | Change in BMI at 6 Months | -0.54 kg/m^2 |
p-value: 0.91695% CI: [-0.42, 0.47]Regression, Linear
Secondary
Change in Waist Circumference at 6 Months
Participants provided their waist circumference at each measurement visit. Waist circumference was measured at the superior border of the iliac crest.
Time frame: Change from Baseline at 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| i-STAND | Change in Waist Circumference at 6 Months | -1.0 inches |
| Healthy Living Control | Change in Waist Circumference at 6 Months | -0.64 inches |
p-value: 0.32595% CI: [-1.09, 0.36]Regression, Linear
Secondary
Change in Weight at 6 Months
Participants provide their weight at each measurement visit. Weight is measured in pounds using a scale mailed to the participant.
Time frame: Change from Baseline at 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| i-STAND | Change in Weight at 6 Months | -3.56 pounds |
| Healthy Living Control | Change in Weight at 6 Months | -3.45 pounds |
p-value: 0.92795% CI: [-2.61, 2.38]Regression, Linear