Trial Outcomes & Findings for Healthy Aging Resources to Thrive (HART) (NCT NCT03739762)
NCT ID: NCT03739762
Last Updated: 2024-06-25
Results Overview
Time (minutes) spent sitting/lying during waking hours will be measured objectively by the activPAL worn for one week following each measurement visit.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
283 participants
Primary outcome timeframe
Change from Baseline at 6 months
Results posted on
2024-06-25
Participant Flow
Goal was 284 randomized participants. A total of 357 potential participants were recruited, with 283 consenting and completing baseline measurements and randomization.
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.
Participant milestones
| Measure |
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)
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
140
|
143
|
|
Overall Study
COMPLETED
|
137
|
136
|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
Reasons for withdrawal
| Measure |
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)
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
6
|
Baseline Characteristics
We had missing data for baseline sitting time: 2 in the intervention group and 4 in the control group.
Baseline characteristics by cohort
| Measure |
i-STAND
n=140 Participants
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)
|
Healthy Living Control
n=143 Participants
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.
|
Total
n=283 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=140 Participants
|
0 Participants
n=143 Participants
|
0 Participants
n=283 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
43 Participants
n=140 Participants
|
46 Participants
n=143 Participants
|
89 Participants
n=283 Participants
|
|
Age, Categorical
>=65 years
|
97 Participants
n=140 Participants
|
97 Participants
n=143 Participants
|
194 Participants
n=283 Participants
|
|
Age, Continuous
|
68.57 years
n=140 Participants
|
69.03 years
n=143 Participants
|
68.8 years
n=283 Participants
|
|
Sex/Gender, Customized
Non-Binary
|
1 Participants
n=140 Participants
|
0 Participants
n=143 Participants
|
1 Participants
n=283 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=140 Participants
|
99 Participants
n=143 Participants
|
187 Participants
n=283 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=140 Participants
|
44 Participants
n=143 Participants
|
96 Participants
n=283 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=140 Participants
|
2 Participants
n=143 Participants
|
3 Participants
n=283 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=140 Participants
|
6 Participants
n=143 Participants
|
10 Participants
n=283 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=140 Participants
|
2 Participants
n=143 Participants
|
6 Participants
n=283 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=140 Participants
|
17 Participants
n=143 Participants
|
42 Participants
n=283 Participants
|
|
Race (NIH/OMB)
White
|
97 Participants
n=140 Participants
|
107 Participants
n=143 Participants
|
204 Participants
n=283 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=140 Participants
|
7 Participants
n=143 Participants
|
14 Participants
n=283 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=140 Participants
|
2 Participants
n=143 Participants
|
4 Participants
n=283 Participants
|
|
Region of Enrollment
United States
|
140 Participants
n=140 Participants
|
143 Participants
n=143 Participants
|
283 Participants
n=283 Participants
|
|
Baseline Measure of Time Spent Sitting or Lying Down
|
650.4 Minutes
STANDARD_DEVIATION 117.9 • n=138 Participants • We had missing data for baseline sitting time: 2 in the intervention group and 4 in the control group.
|
654.5 Minutes
STANDARD_DEVIATION 115.5 • n=139 Participants • We had missing data for baseline sitting time: 2 in the intervention group and 4 in the control group.
|
652.4 Minutes
STANDARD_DEVIATION 116.5 • n=277 Participants • We had missing data for baseline sitting time: 2 in the intervention group and 4 in the control group.
|
|
Baseline Measure of Systolic Blood Pressure mmHg
|
135.4 mmHg
STANDARD_DEVIATION 18.8 • n=140 Participants • We had missing SBP for 1 participant in the baseline control group
|
136.7 mmHg
STANDARD_DEVIATION 18.3 • n=142 Participants • We had missing SBP for 1 participant in the baseline control group
|
136.1 mmHg
STANDARD_DEVIATION 18.5 • n=282 Participants • We had missing SBP for 1 participant in the baseline control group
|
|
Baseline measure of Diastolic Blood Pressure mmHg
|
79.6 mmHg
STANDARD_DEVIATION 11.1 • n=140 Participants • We had missing DBP for 1 participant in the baseline control group
|
79.8 mmHg
STANDARD_DEVIATION 10.2 • n=142 Participants • We had missing DBP for 1 participant in the baseline control group
|
79.7 mmHg
STANDARD_DEVIATION 10.7 • n=282 Participants • We had missing DBP for 1 participant in the baseline control group
|
PRIMARY outcome
Timeframe: Change from Baseline at 6 monthsPopulation: Number of participants who had a 6-month measure for change in sitting time
Time (minutes) spent sitting/lying during waking hours will be measured objectively by the activPAL worn for one week following each measurement visit.
Outcome measures
| Measure |
i-STAND
n=124 Participants
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)
|
Healthy Living Control
n=122 Participants
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.
|
|---|---|---|
|
Change in Time Spent Sitting or Lying Down at 6 Months
|
-40.36 Minutes
Interval -54.86 to -25.85
|
-8.51 Minutes
Interval -23.97 to 6.95
|
PRIMARY outcome
Timeframe: Change from Baseline at 6 monthsPopulation: Number of participants who had a 6-month measure for SBP
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
Outcome measures
| Measure |
i-STAND
n=127 Participants
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)
|
Healthy Living Control
n=127 Participants
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.
|
|---|---|---|
|
Change in SystolicBlood Pressure at 6 Months
|
-6.67 mmHg
Interval -8.82 to -4.52
|
-3.19 mmHg
Interval -5.44 to -0.94
|
PRIMARY outcome
Timeframe: Change from Baseline at 6 monthsPopulation: Number of participants who had a 6-month measure for Diastolic BP
Another primary outcome is change in diastolic blood pressure
Outcome measures
| Measure |
i-STAND
n=127 Participants
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)
|
Healthy Living Control
n=127 Participants
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.
|
|---|---|---|
|
Change in Diastolic Blood Pressure at 6 Months
|
-1.32 mmHg
Interval -2.66 to 0.02
|
-1.58 mmHg
Interval -2.93 to -0.23
|
SECONDARY outcome
Timeframe: Change from Baseline at 6 monthsParticipants provide their weight at each measurement visit. Weight is measured in pounds using a scale mailed to the participant.
Outcome measures
| Measure |
i-STAND
n=99 Participants
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)
|
Healthy Living Control
n=111 Participants
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.
|
|---|---|---|
|
Change in Weight at 6 Months
|
-3.56 pounds
Interval -5.5 to -1.63
|
-3.45 pounds
Interval -4.95 to -1.94
|
SECONDARY outcome
Timeframe: Change from Baseline at 6 monthsBMI was calculated as \[weight in kg\]/\[height in m\]2.
Outcome measures
| Measure |
i-STAND
n=99 Participants
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)
|
Healthy Living Control
n=111 Participants
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.
|
|---|---|---|
|
Change in BMI at 6 Months
|
-0.51 kg/m^2
Interval -0.85 to -0.17
|
-0.54 kg/m^2
Interval -0.81 to -0.26
|
SECONDARY outcome
Timeframe: Change from Baseline at 6 monthsParticipants provided their waist circumference at each measurement visit. Waist circumference was measured at the superior border of the iliac crest.
Outcome measures
| Measure |
i-STAND
n=124 Participants
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)
|
Healthy Living Control
n=124 Participants
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.
|
|---|---|---|
|
Change in Waist Circumference at 6 Months
|
-1.0 inches
Interval -1.55 to -0.45
|
-0.64 inches
Interval -1.09 to -0.19
|
Adverse Events
i-STAND
Serious events: 6 serious events
Other events: 72 other events
Deaths: 0 deaths
Healthy Living Control
Serious events: 6 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
i-STAND
n=140 participants at risk
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)
|
Healthy Living Control
n=143 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Unrelated SAE
|
0.71%
1/140 • Number of events 1 • 6 months
AE data was collected at coaching calls and measurement calls no matter the relation to the study. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
|
0.70%
1/143 • Number of events 1 • 6 months
AE data was collected at coaching calls and measurement calls no matter the relation to the study. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
|
|
Cardiac disorders
Unrelated SAE
|
0.00%
0/140 • 6 months
AE data was collected at coaching calls and measurement calls no matter the relation to the study. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
|
0.70%
1/143 • Number of events 1 • 6 months
AE data was collected at coaching calls and measurement calls no matter the relation to the study. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
|
|
Eye disorders
Unrelated SAE
|
0.71%
1/140 • Number of events 1 • 6 months
AE data was collected at coaching calls and measurement calls no matter the relation to the study. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
|
0.00%
0/143 • 6 months
AE data was collected at coaching calls and measurement calls no matter the relation to the study. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
|
|
Gastrointestinal disorders
Unrelated SAE
|
0.71%
1/140 • Number of events 1 • 6 months
AE data was collected at coaching calls and measurement calls no matter the relation to the study. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
|
0.00%
0/143 • 6 months
AE data was collected at coaching calls and measurement calls no matter the relation to the study. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
|
|
General disorders
Unrelated SAE
|
0.00%
0/140 • 6 months
AE data was collected at coaching calls and measurement calls no matter the relation to the study. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
|
0.70%
1/143 • Number of events 1 • 6 months
AE data was collected at coaching calls and measurement calls no matter the relation to the study. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
|
|
Musculoskeletal and connective tissue disorders
Unrelated SAE
|
0.71%
1/140 • Number of events 1 • 6 months
AE data was collected at coaching calls and measurement calls no matter the relation to the study. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
|
0.70%
1/143 • Number of events 1 • 6 months
AE data was collected at coaching calls and measurement calls no matter the relation to the study. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
|
|
Renal and urinary disorders
Unrelated SAE
|
1.4%
2/140 • Number of events 2 • 6 months
AE data was collected at coaching calls and measurement calls no matter the relation to the study. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
|
0.00%
0/143 • 6 months
AE data was collected at coaching calls and measurement calls no matter the relation to the study. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
|
|
Surgical and medical procedures
Unrelated SAE
|
0.00%
0/140 • 6 months
AE data was collected at coaching calls and measurement calls no matter the relation to the study. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
|
0.70%
1/143 • Number of events 1 • 6 months
AE data was collected at coaching calls and measurement calls no matter the relation to the study. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Unrelated SAE
|
0.00%
0/140 • 6 months
AE data was collected at coaching calls and measurement calls no matter the relation to the study. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
|
0.70%
1/143 • Number of events 1 • 6 months
AE data was collected at coaching calls and measurement calls no matter the relation to the study. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
|
Other adverse events
| Measure |
i-STAND
n=140 participants at risk
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)
|
Healthy Living Control
n=143 participants at risk
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.
|
|---|---|---|
|
General disorders
Unrelated Other AE
|
10.0%
14/140 • Number of events 14 • 6 months
AE data was collected at coaching calls and measurement calls no matter the relation to the study. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
|
8.4%
12/143 • Number of events 12 • 6 months
AE data was collected at coaching calls and measurement calls no matter the relation to the study. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
|
|
Musculoskeletal and connective tissue disorders
Unrelated Other AE
|
25.0%
35/140 • Number of events 35 • 6 months
AE data was collected at coaching calls and measurement calls no matter the relation to the study. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
|
13.3%
19/143 • Number of events 19 • 6 months
AE data was collected at coaching calls and measurement calls no matter the relation to the study. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
|
|
Skin and subcutaneous tissue disorders
Anticipated Related AE
|
6.4%
9/140 • Number of events 9 • 6 months
AE data was collected at coaching calls and measurement calls no matter the relation to the study. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
|
0.70%
1/143 • Number of events 1 • 6 months
AE data was collected at coaching calls and measurement calls no matter the relation to the study. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
|
|
Vascular disorders
Unrelated Other AE
|
10.0%
14/140 • Number of events 14 • 6 months
AE data was collected at coaching calls and measurement calls no matter the relation to the study. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
|
10.5%
15/143 • Number of events 15 • 6 months
AE data was collected at coaching calls and measurement calls no matter the relation to the study. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
|
Additional Information
Dori Rosenberg, Principal Investigator
Kaiser Permanente
Phone: 206-287-2532
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place