Trial Outcomes & Findings for Intervention to Reduce Sedentary Time (NCT NCT02878486)
NCT ID: NCT02878486
Last Updated: 2019-07-29
Results Overview
Average daily sitting time (minus sleep) at 6 weeks minus average daily sitting time (minus sleep) at baseline measured using the activPAL monitor
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
Change from Baseline to Week 6
Results posted on
2019-07-29
Participant Flow
Participant milestones
| Measure |
Intervention Group (Jawbone Up Wrist Monitor)
Subjects will have clinic visits, home visits, and telephone visits. Subjects will be asked to wear a wrist monitor (Jawbone Up) for duration of the study, will meet with the study team to review Physical Activity Education and also be asked to wear the ActivPAL device to assess sitting time.
Jawbone Up: Jawbone Up is a wrist wore water resistant activity monitor.
Physical Activity Education: A study team member will discuss benefits of changing sitting habits and ways to make changes to personal habits.
ActivPAL: Devices measures postural changes over time. Participants will wear device for 7 days. The device measures time sitting, standing, and posture changes (i.e. sit-to-stand).
|
Control Group (No Wrist Monitor)
Subjects will make clinic visits. At home visits, subjects will meet with the study team to review Physical Activity Education and also be asked to wear the ActivPAL device to assess sitting time.
Physical Activity Education: A study team member will discuss benefits of changing sitting habits and ways to make changes to personal habits.
ActivPAL: Devices measures postural changes over time. Participants will wear device for 7 days. The device measures time sitting, standing, and posture changes (i.e. sit-to-stand).
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intervention to Reduce Sedentary Time
Baseline characteristics by cohort
| Measure |
Intervention Group (Jawbone Up Wrist Monitor)
n=3 Participants
Intervention group will have vibrotactile reminders from a wrist worn device, education about changing sitting habits, and coaching to change habits
|
Control Group (No Wrist Monitor)
n=3 Participants
Control group will have education about changing sitting habits, no coaching or vibrotactile reminders
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
81.33 years
STANDARD_DEVIATION 8.62 • n=5 Participants
|
80.83 years
STANDARD_DEVIATION 5.35 • n=7 Participants
|
81.08 years
STANDARD_DEVIATION 6.42 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline to Week 6Average daily sitting time (minus sleep) at 6 weeks minus average daily sitting time (minus sleep) at baseline measured using the activPAL monitor
Outcome measures
| Measure |
Intervention Group (Jawbone Up Wrist Monitor)
n=3 Participants
Subjects will have clinic visits, home visits, and telephone visits. Subjects will be asked to wear a wrist monitor (Jawbone Up) for duration of the study, will meet with the study team to review Physical Activity Education and also be asked to wear the ActivPAL device to assess sitting time.
Jawbone Up: Jawbone Up is a wrist wore water resistant activity monitor.
Physical Activity Education: A study team member will discuss benefits of changing sitting habits and ways to make changes to personal habits.
ActivPAL: Devices measures postural changes over time. Participants will wear device for 7 days. The device measures time sitting, standing, and posture changes (i.e. sit-to-stand).
|
Control Group (No Wrist Monitor)
n=3 Participants
Subjects will make clinic visits. At home visits, subjects will meet with the study team to review Physical Activity Education and also be asked to wear the ActivPAL device to assess sitting time.
Physical Activity Education: A study team member will discuss benefits of changing sitting habits and ways to make changes to personal habits.
ActivPAL: Devices measures postural changes over time. Participants will wear device for 7 days. The device measures time sitting, standing, and posture changes (i.e. sit-to-stand).
|
|---|---|---|
|
Change in Average Daily Sitting Time
|
0.43 minutes per day
Standard Deviation 0.53
|
0.98 minutes per day
Standard Deviation 1.82
|
SECONDARY outcome
Timeframe: Change from Baseline to Week 12Average daily sitting time (minus sleep) at 12 weeks minus average daily sitting time (minus sleep) at baseline measured using the ActivPAL monitor
Outcome measures
| Measure |
Intervention Group (Jawbone Up Wrist Monitor)
n=3 Participants
Subjects will have clinic visits, home visits, and telephone visits. Subjects will be asked to wear a wrist monitor (Jawbone Up) for duration of the study, will meet with the study team to review Physical Activity Education and also be asked to wear the ActivPAL device to assess sitting time.
Jawbone Up: Jawbone Up is a wrist wore water resistant activity monitor.
Physical Activity Education: A study team member will discuss benefits of changing sitting habits and ways to make changes to personal habits.
ActivPAL: Devices measures postural changes over time. Participants will wear device for 7 days. The device measures time sitting, standing, and posture changes (i.e. sit-to-stand).
|
Control Group (No Wrist Monitor)
n=3 Participants
Subjects will make clinic visits. At home visits, subjects will meet with the study team to review Physical Activity Education and also be asked to wear the ActivPAL device to assess sitting time.
Physical Activity Education: A study team member will discuss benefits of changing sitting habits and ways to make changes to personal habits.
ActivPAL: Devices measures postural changes over time. Participants will wear device for 7 days. The device measures time sitting, standing, and posture changes (i.e. sit-to-stand).
|
|---|---|---|
|
Change in Average Daily Sitting Time
|
-0.17 minutes per day
Standard Deviation 0.41
|
-0.24 minutes per day
Standard Deviation 0.56
|
SECONDARY outcome
Timeframe: Week 12Change in the number of sitting bouts greater than 30 min measured using the ActivPAL monitor
Outcome measures
| Measure |
Intervention Group (Jawbone Up Wrist Monitor)
n=3 Participants
Subjects will have clinic visits, home visits, and telephone visits. Subjects will be asked to wear a wrist monitor (Jawbone Up) for duration of the study, will meet with the study team to review Physical Activity Education and also be asked to wear the ActivPAL device to assess sitting time.
Jawbone Up: Jawbone Up is a wrist wore water resistant activity monitor.
Physical Activity Education: A study team member will discuss benefits of changing sitting habits and ways to make changes to personal habits.
ActivPAL: Devices measures postural changes over time. Participants will wear device for 7 days. The device measures time sitting, standing, and posture changes (i.e. sit-to-stand).
|
Control Group (No Wrist Monitor)
n=3 Participants
Subjects will make clinic visits. At home visits, subjects will meet with the study team to review Physical Activity Education and also be asked to wear the ActivPAL device to assess sitting time.
Physical Activity Education: A study team member will discuss benefits of changing sitting habits and ways to make changes to personal habits.
ActivPAL: Devices measures postural changes over time. Participants will wear device for 7 days. The device measures time sitting, standing, and posture changes (i.e. sit-to-stand).
|
|---|---|---|
|
Number of Sitting Bouts Greater Than 30 Min
|
1 sitting bouts
Standard Deviation 1.41
|
.167 sitting bouts
Standard Deviation .764
|
SECONDARY outcome
Timeframe: Change from Baseline to Week 12Population: Only three participants had data available for the mixed meal tolerance test
The average area under the curve at week 12 minus the average area under the curve at baseline. Blood was collected at baseline (pre-mixed meal). Post-mixed meal it was collected at 15, 30, 45, 60, 90, 120 minutes. The Area Under the Curve (AUC) was computed using the trapezoidal rule as we have previously described (Burns et. al. 2012, Morris et al 2014). This results in a single AUC pre-intervention value, and a single AUC post-intervention value for each metabolic outcome measure (glucose, insulin, etc). The Area Under the Curve (AUC) for each individual is calculated as a single unitless value that results from calculating the definite integral under a timecourse curve. This method has been widely used and cited in metabolic studies for more than two decades https://doi.org/10.2337/diacare.17.2.152. This results in a single unitless AUC pre-intervention value, and a single AUC post-intervention value for each metabolic outcome response measure (glucose, insulin, etc).
Outcome measures
| Measure |
Intervention Group (Jawbone Up Wrist Monitor)
n=2 Participants
Subjects will have clinic visits, home visits, and telephone visits. Subjects will be asked to wear a wrist monitor (Jawbone Up) for duration of the study, will meet with the study team to review Physical Activity Education and also be asked to wear the ActivPAL device to assess sitting time.
Jawbone Up: Jawbone Up is a wrist wore water resistant activity monitor.
Physical Activity Education: A study team member will discuss benefits of changing sitting habits and ways to make changes to personal habits.
ActivPAL: Devices measures postural changes over time. Participants will wear device for 7 days. The device measures time sitting, standing, and posture changes (i.e. sit-to-stand).
|
Control Group (No Wrist Monitor)
n=1 Participants
Subjects will make clinic visits. At home visits, subjects will meet with the study team to review Physical Activity Education and also be asked to wear the ActivPAL device to assess sitting time.
Physical Activity Education: A study team member will discuss benefits of changing sitting habits and ways to make changes to personal habits.
ActivPAL: Devices measures postural changes over time. Participants will wear device for 7 days. The device measures time sitting, standing, and posture changes (i.e. sit-to-stand).
|
|---|---|---|
|
Change in Glucose Levels Area Under the Curve in Response to Mixed Meal Tolerance Test
|
178.88 unitless
Standard Deviation 2144.12
|
1008.38 unitless
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Change from Baseline to Week 12Population: Only three participants had data available for the mixed meal tolerance test
The average area under the curve at week 12 minus the average area under the curve at baseline. Blood was collected at baseline (pre-mixed meal). Post-mixed meal it was collected at 15, 30, 45, 60, 90, 120 minutes. The Area Under the Curve (AUC) was computed using the trapezoidal rule as we have previously described (Burns et. al. 2012, Morris et al 2014). This results in a single AUC pre-intervention value, and a single AUC post-intervention value for each metabolic outcome measure (glucose, insulin, etc). The Area Under the Curve (AUC) for each individual is calculated as a single unitless value that results from calculating the definite integral under a timecourse curve. This method has been widely used and cited in metabolic studies for more than two decades https://doi.org/10.2337/diacare.17.2.152. This results in a single unitless AUC pre-intervention value, and a single AUC post-intervention value for each metabolic outcome response measure (glucose, insulin, etc).
Outcome measures
| Measure |
Intervention Group (Jawbone Up Wrist Monitor)
n=2 Participants
Subjects will have clinic visits, home visits, and telephone visits. Subjects will be asked to wear a wrist monitor (Jawbone Up) for duration of the study, will meet with the study team to review Physical Activity Education and also be asked to wear the ActivPAL device to assess sitting time.
Jawbone Up: Jawbone Up is a wrist wore water resistant activity monitor.
Physical Activity Education: A study team member will discuss benefits of changing sitting habits and ways to make changes to personal habits.
ActivPAL: Devices measures postural changes over time. Participants will wear device for 7 days. The device measures time sitting, standing, and posture changes (i.e. sit-to-stand).
|
Control Group (No Wrist Monitor)
n=1 Participants
Subjects will make clinic visits. At home visits, subjects will meet with the study team to review Physical Activity Education and also be asked to wear the ActivPAL device to assess sitting time.
Physical Activity Education: A study team member will discuss benefits of changing sitting habits and ways to make changes to personal habits.
ActivPAL: Devices measures postural changes over time. Participants will wear device for 7 days. The device measures time sitting, standing, and posture changes (i.e. sit-to-stand).
|
|---|---|---|
|
Change in Insulin Levels Area Under the Curve Based on a Mixed Meal Tolerance Test
|
2623.43 unitless
Standard Deviation 1929.77
|
1776.38 unitless
Standard Deviation 0
|
POST_HOC outcome
Timeframe: Change from baseline to week 12Population: Only three participants had data available for the mixed meal tolerance test
HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) is calculated as fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5. The average HOMA-IR at week 12 minus the average HOMA-IR at baseline. A lower score means a person is more sensitive to insulin, whereas a higher score indicates greater resistance to insulin. The HOMA-IR is a tool for calculating degree of insulin resistance. Given that this is a product of insulin and glucose values divided by a constant, there is no maximum score for this measure. The minimum score would be zero as neither insulin or glucose would drop below zero.
Outcome measures
| Measure |
Intervention Group (Jawbone Up Wrist Monitor)
n=2 Participants
Subjects will have clinic visits, home visits, and telephone visits. Subjects will be asked to wear a wrist monitor (Jawbone Up) for duration of the study, will meet with the study team to review Physical Activity Education and also be asked to wear the ActivPAL device to assess sitting time.
Jawbone Up: Jawbone Up is a wrist wore water resistant activity monitor.
Physical Activity Education: A study team member will discuss benefits of changing sitting habits and ways to make changes to personal habits.
ActivPAL: Devices measures postural changes over time. Participants will wear device for 7 days. The device measures time sitting, standing, and posture changes (i.e. sit-to-stand).
|
Control Group (No Wrist Monitor)
n=1 Participants
Subjects will make clinic visits. At home visits, subjects will meet with the study team to review Physical Activity Education and also be asked to wear the ActivPAL device to assess sitting time.
Physical Activity Education: A study team member will discuss benefits of changing sitting habits and ways to make changes to personal habits.
ActivPAL: Devices measures postural changes over time. Participants will wear device for 7 days. The device measures time sitting, standing, and posture changes (i.e. sit-to-stand).
|
|---|---|---|
|
Change in HOMA-IR (Homeostatic Model Assessment of Insulin Resistance)
|
96438.33 units on a scale
Standard Deviation 25698.46
|
63383.80 units on a scale
Standard Deviation 0
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1
n=3 participants at risk
Subjects will have clinic visits, home visits, and telephone visits. Subjects will be asked to wear a wrist monitor (Jawbone Up) for duration of the study, will meet with the study team to review Physical Activity Education and also be asked to wear the ActivPAL device to assess sitting time.
Jawbone Up: Jawbone Up is a wrist wore water resistant activity monitor.
Physical Activity Education: A study team member will discuss benefits of changing sitting habits and ways to make changes to personal habits.
ActivPAL: Devices measures postural changes over time. Participants will wear device for 7 days. The device measures time sitting, standing, and posture changes (i.e. sit-to-stand).
|
Group 2
n=3 participants at risk
Subjects will make clinic visits. At home visits, subjects will meet with the study team to review Physical Activity Education and also be asked to wear the ActivPAL device to assess sitting time.
Physical Activity Education: A study team member will discuss benefits of changing sitting habits and ways to make changes to personal habits.
ActivPAL: Devices measures postural changes over time. Participants will wear device for 7 days. The device measures time sitting, standing, and posture changes (i.e. sit-to-stand).
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/3 • 12 weeks
Note that only 3 of the 6 participants were tested with the mixed meal tolerance test and blood draws. Thus, only 3 were exposed to potential risks associated with these procedures.
|
33.3%
1/3 • Number of events 1 • 12 weeks
Note that only 3 of the 6 participants were tested with the mixed meal tolerance test and blood draws. Thus, only 3 were exposed to potential risks associated with these procedures.
|
|
Skin and subcutaneous tissue disorders
IV site irritation
|
50.0%
1/2 • Number of events 1 • 12 weeks
Note that only 3 of the 6 participants were tested with the mixed meal tolerance test and blood draws. Thus, only 3 were exposed to potential risks associated with these procedures.
|
0.00%
0/1 • 12 weeks
Note that only 3 of the 6 participants were tested with the mixed meal tolerance test and blood draws. Thus, only 3 were exposed to potential risks associated with these procedures.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place