Trial Outcomes & Findings for Technology Based Sedentary Reduction Intervention in Patients With Type 2 Diabetes (NCT NCT05691452)
NCT ID: NCT05691452
Last Updated: 2025-03-19
Results Overview
Acceptability of the Sit Less program will be assessed using satisfaction surveys and exit interviews with Sit Less group participants. The surveys combined items from two questionnaires: Lyons et al., which measured overall program satisfaction (e.g., "I would recommend the program"), ease of use, and intention to continue using each program component, and Burner et al., which evaluated the text messaging component, including content relevance, motivational impact, frequency, and timing. Satisfaction with the overall program will be evaluated with six items like "I would recommend the program" and "The program is likely to reduce sedentary behavior." All responses will be made on a Likert-type scale from 1 (strongly disagree) to 5 (strongly agree). Higher scores mean higher levels of satisfaction.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
8 weeks
Results posted on
2025-03-19
Participant Flow
Participant milestones
| Measure |
Cohort 1 - Control
Control Group (n=8) Participants in this group received standard care and did not participate in the "Sit Less" intervention.
|
Cohort 1 - Intervention
Sit Less Intervention Group (n=5) Participants in this group received the 8-week "Sit Less" sedentary behavior reduction intervention, which targeted a 120 minute per day reduction in sedentary time using an activity monitor and mHealth tools.
|
Cohort 2 - Intervention
Sit Less Intervention Group (n=15) All participants in Cohort 2 received the modified "Sit Less Version 2" sedentary behavior reduction intervention, which was an 8-week program using an activity monitor and mHealth tools to target a reduction in daily sedentary time.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
6
|
15
|
|
Overall Study
COMPLETED
|
8
|
5
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
2
|
Reasons for withdrawal
| Measure |
Cohort 1 - Control
Control Group (n=8) Participants in this group received standard care and did not participate in the "Sit Less" intervention.
|
Cohort 1 - Intervention
Sit Less Intervention Group (n=5) Participants in this group received the 8-week "Sit Less" sedentary behavior reduction intervention, which targeted a 120 minute per day reduction in sedentary time using an activity monitor and mHealth tools.
|
Cohort 2 - Intervention
Sit Less Intervention Group (n=15) All participants in Cohort 2 received the modified "Sit Less Version 2" sedentary behavior reduction intervention, which was an 8-week program using an activity monitor and mHealth tools to target a reduction in daily sedentary time.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
Baseline Characteristics
The study included a total of 31 participants across 2 cohorts: Cohort 1 (n=13) Sit Less Intervention Group (n=5) Control Group (n=8) Cohort 2 (n=15) Sit Less Intervention Group (n=15)
Baseline characteristics by cohort
| Measure |
Cohort 1 - Control
n=8 Participants
Control Group (n=8) Participants in this group received standard care and did not participate in the "Sit Less" intervention.
|
Cohort 1 - Intervention
n=5 Participants
Sit Less Intervention Group (n=5) Participants in this group received the 8-week "Sit Less" sedentary behavior reduction intervention, which targeted a 120 minute per day reduction in sedentary time using an activity monitor and mHealth tools.
|
Cohort 2 - Intervention
n=15 Participants
Sit Less Intervention Group (n=15) All participants in Cohort 2 received the modified "Sit Less Version 2" sedentary behavior reduction intervention, which was an 8-week program using an activity monitor and mHealth tools to target a reduction in daily sedentary time.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants • The study included a total of 31 participants across 2 cohorts: Cohort 1 (n=13) Sit Less Intervention Group (n=5) Control Group (n=8) Cohort 2 (n=15) Sit Less Intervention Group (n=15)
|
0 Participants
n=7 Participants • The study included a total of 31 participants across 2 cohorts: Cohort 1 (n=13) Sit Less Intervention Group (n=5) Control Group (n=8) Cohort 2 (n=15) Sit Less Intervention Group (n=15)
|
0 Participants
n=5 Participants • The study included a total of 31 participants across 2 cohorts: Cohort 1 (n=13) Sit Less Intervention Group (n=5) Control Group (n=8) Cohort 2 (n=15) Sit Less Intervention Group (n=15)
|
0 Participants
n=4 Participants • The study included a total of 31 participants across 2 cohorts: Cohort 1 (n=13) Sit Less Intervention Group (n=5) Control Group (n=8) Cohort 2 (n=15) Sit Less Intervention Group (n=15)
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants • The study included a total of 31 participants across 2 cohorts: Cohort 1 (n=13) Sit Less Intervention Group (n=5) Control Group (n=8) Cohort 2 (n=15) Sit Less Intervention Group (n=15)
|
3 Participants
n=7 Participants • The study included a total of 31 participants across 2 cohorts: Cohort 1 (n=13) Sit Less Intervention Group (n=5) Control Group (n=8) Cohort 2 (n=15) Sit Less Intervention Group (n=15)
|
12 Participants
n=5 Participants • The study included a total of 31 participants across 2 cohorts: Cohort 1 (n=13) Sit Less Intervention Group (n=5) Control Group (n=8) Cohort 2 (n=15) Sit Less Intervention Group (n=15)
|
20 Participants
n=4 Participants • The study included a total of 31 participants across 2 cohorts: Cohort 1 (n=13) Sit Less Intervention Group (n=5) Control Group (n=8) Cohort 2 (n=15) Sit Less Intervention Group (n=15)
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants • The study included a total of 31 participants across 2 cohorts: Cohort 1 (n=13) Sit Less Intervention Group (n=5) Control Group (n=8) Cohort 2 (n=15) Sit Less Intervention Group (n=15)
|
2 Participants
n=7 Participants • The study included a total of 31 participants across 2 cohorts: Cohort 1 (n=13) Sit Less Intervention Group (n=5) Control Group (n=8) Cohort 2 (n=15) Sit Less Intervention Group (n=15)
|
3 Participants
n=5 Participants • The study included a total of 31 participants across 2 cohorts: Cohort 1 (n=13) Sit Less Intervention Group (n=5) Control Group (n=8) Cohort 2 (n=15) Sit Less Intervention Group (n=15)
|
8 Participants
n=4 Participants • The study included a total of 31 participants across 2 cohorts: Cohort 1 (n=13) Sit Less Intervention Group (n=5) Control Group (n=8) Cohort 2 (n=15) Sit Less Intervention Group (n=15)
|
|
Age, Continuous
|
60.54 years
STANDARD_DEVIATION 16.67 • n=5 Participants
|
60.54 years
STANDARD_DEVIATION 16.67 • n=7 Participants
|
57.4 years
STANDARD_DEVIATION 15.1 • n=5 Participants
|
59.8 years
STANDARD_DEVIATION 16.19 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
BMI
|
31.58 kg/m2
STANDARD_DEVIATION 3.98 • n=5 Participants
|
37.46 kg/m2
STANDARD_DEVIATION 5.92 • n=7 Participants
|
32.25 kg/m2
STANDARD_DEVIATION 5.65 • n=5 Participants
|
33.11 kg/m2
STANDARD_DEVIATION 5.40 • n=4 Participants
|
PRIMARY outcome
Timeframe: 8 weeksAcceptability of the Sit Less program will be assessed using satisfaction surveys and exit interviews with Sit Less group participants. The surveys combined items from two questionnaires: Lyons et al., which measured overall program satisfaction (e.g., "I would recommend the program"), ease of use, and intention to continue using each program component, and Burner et al., which evaluated the text messaging component, including content relevance, motivational impact, frequency, and timing. Satisfaction with the overall program will be evaluated with six items like "I would recommend the program" and "The program is likely to reduce sedentary behavior." All responses will be made on a Likert-type scale from 1 (strongly disagree) to 5 (strongly agree). Higher scores mean higher levels of satisfaction.
Outcome measures
| Measure |
Cohort 1 - Intervention
n=5 Participants
Sit Less Intervention Group (n=5) Participants in this group received the 8-week "Sit Less" sedentary behavior reduction intervention, which targeted a 120 minute per day reduction in sedentary time using an activity monitor and mHealth tools.
|
Cohort 2 - Intervention
n=13 Participants
Sit Less Intervention Group (n=15) All participants in Cohort 2 received the modified "Sit Less Version 2" sedentary behavior reduction intervention, which was an 8-week program using an activity monitor and mHealth tools to target a reduction in daily sedentary time.
|
Cohort 2 - Intervention
Sit Less Intervention Group (n=15) All participants in Cohort 2 received the modified "Sit Less Version 2" sedentary behavior reduction intervention, which was an 8-week program using an activity monitor and mHealth tools to target a reduction in daily sedentary time.
|
|---|---|---|---|
|
Level of Satisfaction With the Intervention Assessed by Lyons et al and Burner et al.'s Questionnaires
I would recommend the program to family and friends.
|
5 score on a scale
Interval 3.0 to 5.0
|
4 score on a scale
Interval 4.0 to 5.0
|
—
|
|
Level of Satisfaction With the Intervention Assessed by Lyons et al and Burner et al.'s Questionnaires
I enjoyed the sedentary behavior reduction program
|
5 score on a scale
Interval 2.0 to 5.0
|
4 score on a scale
Interval 4.0 to 5.0
|
—
|
|
Level of Satisfaction With the Intervention Assessed by Lyons et al and Burner et al.'s Questionnaires
This program is likely to increase awareness of my sedentary behavior
|
5 score on a scale
Interval 3.5 to 5.0
|
5 score on a scale
Interval 4.5 to 5.0
|
—
|
|
Level of Satisfaction With the Intervention Assessed by Lyons et al and Burner et al.'s Questionnaires
This program is likely to change attitudes toward my sedentary behavior
|
5 score on a scale
Interval 3.5 to 5.0
|
5 score on a scale
Interval 4.0 to 5.0
|
—
|
|
Level of Satisfaction With the Intervention Assessed by Lyons et al and Burner et al.'s Questionnaires
This program is likely to increase intentions/motivation to reduce sedentary behavior
|
4 score on a scale
Interval 3.5 to 5.0
|
5 score on a scale
Interval 4.0 to 5.0
|
—
|
|
Level of Satisfaction With the Intervention Assessed by Lyons et al and Burner et al.'s Questionnaires
Participation in this program is likely to reduce sedentary behavior
|
4 score on a scale
Interval 3.5 to 5.0
|
5 score on a scale
Interval 4.0 to 5.0
|
—
|
|
Level of Satisfaction With the Intervention Assessed by Lyons et al and Burner et al.'s Questionnaires
Fitbit satisfaction
|
5 score on a scale
Interval 4.0 to 5.0
|
5 score on a scale
Interval 3.5 to 5.0
|
—
|
|
Level of Satisfaction With the Intervention Assessed by Lyons et al and Burner et al.'s Questionnaires
Satisfaction on smart water bottle satisfaction
|
4 score on a scale
Interval 2.5 to 5.0
|
4 score on a scale
Interval 3.0 to 4.5
|
—
|
|
Level of Satisfaction With the Intervention Assessed by Lyons et al and Burner et al.'s Questionnaires
Satisfaction on text message satisfaction
|
4 score on a scale
Interval 3.0 to 5.0
|
3 score on a scale
Interval 2.5 to 4.0
|
—
|
|
Level of Satisfaction With the Intervention Assessed by Lyons et al and Burner et al.'s Questionnaires
Goal setting was useful
|
5 score on a scale
Interval 3.0 to 5.0
|
4 score on a scale
Interval 4.0 to 4.0
|
—
|
|
Level of Satisfaction With the Intervention Assessed by Lyons et al and Burner et al.'s Questionnaires
Text message timing
|
4 score on a scale
Interval 3.5 to 5.0
|
4 score on a scale
Interval 3.0 to 4.0
|
—
|
|
Level of Satisfaction With the Intervention Assessed by Lyons et al and Burner et al.'s Questionnaires
Text message frequency
|
4 score on a scale
Interval 3.5 to 5.0
|
4 score on a scale
Interval 3.5 to 4.0
|
—
|
PRIMARY outcome
Timeframe: 8 weeksThe compliance with the intervention will be assessed by number of days the Fitbit device was worn per week.
Outcome measures
| Measure |
Cohort 1 - Intervention
n=5 Participants
Sit Less Intervention Group (n=5) Participants in this group received the 8-week "Sit Less" sedentary behavior reduction intervention, which targeted a 120 minute per day reduction in sedentary time using an activity monitor and mHealth tools.
|
Cohort 2 - Intervention
n=15 Participants
Sit Less Intervention Group (n=15) All participants in Cohort 2 received the modified "Sit Less Version 2" sedentary behavior reduction intervention, which was an 8-week program using an activity monitor and mHealth tools to target a reduction in daily sedentary time.
|
Cohort 2 - Intervention
Sit Less Intervention Group (n=15) All participants in Cohort 2 received the modified "Sit Less Version 2" sedentary behavior reduction intervention, which was an 8-week program using an activity monitor and mHealth tools to target a reduction in daily sedentary time.
|
|---|---|---|---|
|
Level of Compliance With the Intervention Assessed by Number of Days the Fitbit Device Was Worn
|
6.58 days per week
Interval 6.13 to 6.94
|
6.13 days per week
Interval 5.63 to 7.0
|
—
|
PRIMARY outcome
Timeframe: Baseline and 8 weeksTotal daily sedentary time will be measured from 7 days of activPAL 3 device monitoring.
Outcome measures
| Measure |
Cohort 1 - Intervention
n=8 Participants
Sit Less Intervention Group (n=5) Participants in this group received the 8-week "Sit Less" sedentary behavior reduction intervention, which targeted a 120 minute per day reduction in sedentary time using an activity monitor and mHealth tools.
|
Cohort 2 - Intervention
n=5 Participants
Sit Less Intervention Group (n=15) All participants in Cohort 2 received the modified "Sit Less Version 2" sedentary behavior reduction intervention, which was an 8-week program using an activity monitor and mHealth tools to target a reduction in daily sedentary time.
|
Cohort 2 - Intervention
n=13 Participants
Sit Less Intervention Group (n=15) All participants in Cohort 2 received the modified "Sit Less Version 2" sedentary behavior reduction intervention, which was an 8-week program using an activity monitor and mHealth tools to target a reduction in daily sedentary time.
|
|---|---|---|---|
|
Changes of Total Daily Sedentary Time
Baseline
|
622.5488 minutes
Standard Deviation 86.68241
|
670.8750 minutes
Standard Deviation 99.19531
|
640.7781 minutes
Standard Deviation 149.77000
|
|
Changes of Total Daily Sedentary Time
Post-intervention
|
554.6351 minutes
Standard Deviation 68.21266
|
602.8750 minutes
Standard Deviation 122.18354
|
609.5371 minutes
Standard Deviation 155.22499
|
PRIMARY outcome
Timeframe: Baseline and 8 weeksProlonged sitting time (time spent sitting \>60mins) will be measured by 7 days of activPAL 3 device monitoring.
Outcome measures
| Measure |
Cohort 1 - Intervention
n=8 Participants
Sit Less Intervention Group (n=5) Participants in this group received the 8-week "Sit Less" sedentary behavior reduction intervention, which targeted a 120 minute per day reduction in sedentary time using an activity monitor and mHealth tools.
|
Cohort 2 - Intervention
n=5 Participants
Sit Less Intervention Group (n=15) All participants in Cohort 2 received the modified "Sit Less Version 2" sedentary behavior reduction intervention, which was an 8-week program using an activity monitor and mHealth tools to target a reduction in daily sedentary time.
|
Cohort 2 - Intervention
n=13 Participants
Sit Less Intervention Group (n=15) All participants in Cohort 2 received the modified "Sit Less Version 2" sedentary behavior reduction intervention, which was an 8-week program using an activity monitor and mHealth tools to target a reduction in daily sedentary time.
|
|---|---|---|---|
|
Changes of Prolonged Sedentary Time
Baseline
|
262.978375 minutes
Standard Deviation 167.0212359
|
226.240200 minutes
Standard Deviation 97.8064178
|
187.086785 minutes
Standard Deviation 110.8965832
|
|
Changes of Prolonged Sedentary Time
Post-intervention
|
198.121663 minutes
Standard Deviation 140.8557184
|
147.582360 minutes
Standard Deviation 140.4909207
|
165.056000 minutes
Standard Deviation 126.7480441
|
PRIMARY outcome
Timeframe: Baseline and 8 weeksNumber of sit-to-stand transitions will be measured by 7 days of activPAL 3 device monitoring.
Outcome measures
| Measure |
Cohort 1 - Intervention
n=8 Participants
Sit Less Intervention Group (n=5) Participants in this group received the 8-week "Sit Less" sedentary behavior reduction intervention, which targeted a 120 minute per day reduction in sedentary time using an activity monitor and mHealth tools.
|
Cohort 2 - Intervention
n=5 Participants
Sit Less Intervention Group (n=15) All participants in Cohort 2 received the modified "Sit Less Version 2" sedentary behavior reduction intervention, which was an 8-week program using an activity monitor and mHealth tools to target a reduction in daily sedentary time.
|
Cohort 2 - Intervention
n=13 Participants
Sit Less Intervention Group (n=15) All participants in Cohort 2 received the modified "Sit Less Version 2" sedentary behavior reduction intervention, which was an 8-week program using an activity monitor and mHealth tools to target a reduction in daily sedentary time.
|
|---|---|---|---|
|
Changes of Sit-to-stand Transitions
Baseline
|
31.25 Sit-to-Stand Transitions
Standard Deviation 12.510
|
42.80 Sit-to-Stand Transitions
Standard Deviation 9.445
|
46.08 Sit-to-Stand Transitions
Standard Deviation 19.448
|
|
Changes of Sit-to-stand Transitions
Post-intervention
|
32.75 Sit-to-Stand Transitions
Standard Deviation 11.298
|
43.20 Sit-to-Stand Transitions
Standard Deviation 8.167
|
45.31 Sit-to-Stand Transitions
Standard Deviation 15.250
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPhysical activity will be considered stepping time (minutes), measured by 7 days of activPAL monitoring.
Outcome measures
| Measure |
Cohort 1 - Intervention
n=8 Participants
Sit Less Intervention Group (n=5) Participants in this group received the 8-week "Sit Less" sedentary behavior reduction intervention, which targeted a 120 minute per day reduction in sedentary time using an activity monitor and mHealth tools.
|
Cohort 2 - Intervention
n=5 Participants
Sit Less Intervention Group (n=15) All participants in Cohort 2 received the modified "Sit Less Version 2" sedentary behavior reduction intervention, which was an 8-week program using an activity monitor and mHealth tools to target a reduction in daily sedentary time.
|
Cohort 2 - Intervention
n=13 Participants
Sit Less Intervention Group (n=15) All participants in Cohort 2 received the modified "Sit Less Version 2" sedentary behavior reduction intervention, which was an 8-week program using an activity monitor and mHealth tools to target a reduction in daily sedentary time.
|
|---|---|---|---|
|
Changes of Physical Activity Measured by 7 Days of activPAL Device Monitoring
Baseline
|
37.547425 minutes
Standard Deviation 19.0937877
|
63.195200 minutes
Standard Deviation 18.4359097
|
67.806546 minutes
Standard Deviation 18.0175217
|
|
Changes of Physical Activity Measured by 7 Days of activPAL Device Monitoring
Post-intervention
|
54.1757038 minutes
Standard Deviation 29.75937131
|
75.4577200 minutes
Standard Deviation 60.05685663
|
75.1487769 minutes
Standard Deviation 24.21793627
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksConfidence in reducing sedentary behavior will be measured using 6 items from the Self-Efficacy Questionnaire for Physical Activity and Sedentary Behavior. The items assess the level of confidence for specific sitting behaviors and sedentary breaks. Each item is a likert-type scale, ranging from 1 to 5. Higher scores mean a better outcome.
Outcome measures
| Measure |
Cohort 1 - Intervention
n=8 Participants
Sit Less Intervention Group (n=5) Participants in this group received the 8-week "Sit Less" sedentary behavior reduction intervention, which targeted a 120 minute per day reduction in sedentary time using an activity monitor and mHealth tools.
|
Cohort 2 - Intervention
n=5 Participants
Sit Less Intervention Group (n=15) All participants in Cohort 2 received the modified "Sit Less Version 2" sedentary behavior reduction intervention, which was an 8-week program using an activity monitor and mHealth tools to target a reduction in daily sedentary time.
|
Cohort 2 - Intervention
n=13 Participants
Sit Less Intervention Group (n=15) All participants in Cohort 2 received the modified "Sit Less Version 2" sedentary behavior reduction intervention, which was an 8-week program using an activity monitor and mHealth tools to target a reduction in daily sedentary time.
|
|---|---|---|---|
|
Changes of Confidence in Reducing Sedentary Behavior Measured by Using 6 Items From the Self-Efficacy Questionnaire for Physical Activity and Sedentary Behavior.
Baseline
|
3.9038 score on a scale
Standard Deviation .68874
|
3.7000 score on a scale
Standard Deviation .83666
|
3.9038 score on a scale
Standard Deviation .6887
|
|
Changes of Confidence in Reducing Sedentary Behavior Measured by Using 6 Items From the Self-Efficacy Questionnaire for Physical Activity and Sedentary Behavior.
Post-intervention
|
3.3750 score on a scale
Standard Deviation 1.22474
|
3.8500 score on a scale
Standard Deviation 0.89443
|
3.3846 score on a scale
Standard Deviation .89916
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksHabit strength for sedentary behavior will be assessed by 7 items from the Self-Report Sedentary Behavior Habit Index. This measure will evaluate changes in habit strength for sedentary behavior, assessed using the Self-Report Habit Index adapted for sedentary breaks (standing/walking). Habit strength for sedentary behavior will be assessed by using a validated measure, Self-Report Habit Index (Cronbach's alpha = 0.91). This 7- item index was adapted to sedentary breaks (standing/walking) to assess the degree to which sedentary breaks become habitual. Each item is rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). The total score is calculated by taking the mean of the 7 items, which range from 1 to 7, with higher scores indicating a stronger habit strength for taking sedentary breaks.
Outcome measures
| Measure |
Cohort 1 - Intervention
n=8 Participants
Sit Less Intervention Group (n=5) Participants in this group received the 8-week "Sit Less" sedentary behavior reduction intervention, which targeted a 120 minute per day reduction in sedentary time using an activity monitor and mHealth tools.
|
Cohort 2 - Intervention
n=5 Participants
Sit Less Intervention Group (n=15) All participants in Cohort 2 received the modified "Sit Less Version 2" sedentary behavior reduction intervention, which was an 8-week program using an activity monitor and mHealth tools to target a reduction in daily sedentary time.
|
Cohort 2 - Intervention
n=13 Participants
Sit Less Intervention Group (n=15) All participants in Cohort 2 received the modified "Sit Less Version 2" sedentary behavior reduction intervention, which was an 8-week program using an activity monitor and mHealth tools to target a reduction in daily sedentary time.
|
|---|---|---|---|
|
Changes of Habit Strength for Sedentary Behavior Assessed by Using the Self-Report Habit Index.
Baseline
|
6.2143 score on a scale
Standard Deviation .63430
|
6.0857 score on a scale
Standard Deviation 1.18924
|
5.2967 score on a scale
Standard Deviation 1.57517
|
|
Changes of Habit Strength for Sedentary Behavior Assessed by Using the Self-Report Habit Index.
Post-intervention
|
5.8214 score on a scale
Standard Deviation 1.10327
|
5.5143 score on a scale
Standard Deviation 1.24786
|
5.8462 score on a scale
Standard Deviation 1.02430
|
SECONDARY outcome
Timeframe: Baseline and 8 weeks24-hour glucose levels will be measured by the use of a continuous glucose monitor over a 7-day period. The 24-hour glucose control will be evaluated by mean 24-hour glucose levels.
Outcome measures
| Measure |
Cohort 1 - Intervention
n=7 Participants
Sit Less Intervention Group (n=5) Participants in this group received the 8-week "Sit Less" sedentary behavior reduction intervention, which targeted a 120 minute per day reduction in sedentary time using an activity monitor and mHealth tools.
|
Cohort 2 - Intervention
n=4 Participants
Sit Less Intervention Group (n=15) All participants in Cohort 2 received the modified "Sit Less Version 2" sedentary behavior reduction intervention, which was an 8-week program using an activity monitor and mHealth tools to target a reduction in daily sedentary time.
|
Cohort 2 - Intervention
n=13 Participants
Sit Less Intervention Group (n=15) All participants in Cohort 2 received the modified "Sit Less Version 2" sedentary behavior reduction intervention, which was an 8-week program using an activity monitor and mHealth tools to target a reduction in daily sedentary time.
|
|---|---|---|---|
|
Changes of 24-hour Mean Glucose Levels Assessed by Continuous Glucose Monitors
Baseline
|
120.7143 mg/dL
Standard Deviation 21.83052
|
135.2500 mg/dL
Standard Deviation 29.15905
|
129.3846 mg/dL
Standard Deviation 28.43278
|
|
Changes of 24-hour Mean Glucose Levels Assessed by Continuous Glucose Monitors
Post-intervention
|
126.0000 mg/dL
Standard Deviation 56.60094
|
115.7500 mg/dL
Standard Deviation 20.51625
|
153.5385 mg/dL
Standard Deviation 35.08945
|
Adverse Events
Cohort 1 - Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 1 - Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2 - Intervention
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 |
Cohort 1 - Control
n=10 participants at risk
Control Group (n=8) Participants in this group received standard care and did not participate in the "Sit Less" intervention.
|
Cohort 1 - Intervention
n=6 participants at risk
Sit Less Intervention Group (n=5) Participants in this group received the 8-week "Sit Less" sedentary behavior reduction intervention, which targeted a 120 minute per day reduction in sedentary time using an activity monitor and mHealth tools.
|
Cohort 2 - Intervention
n=15 participants at risk
Sit Less Intervention Group (n=15) All participants in Cohort 2 received the modified "Sit Less Version 2" sedentary behavior reduction intervention, which was an 8-week program using an activity monitor and mHealth tools to target a reduction in daily sedentary time.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain and anxiety
|
0.00%
0/10 • 8 weeks
The adverse event data were collected throughout the 8-week study period. The definition of adverse event used in this study is consistent with the clinicaltrials.gov definition - any untoward medical occurrence associated with the use of an intervention, whether or not considered related to the intervention. Serious adverse events, as defined by the FDA, were not observed in this study.
|
0.00%
0/6 • 8 weeks
The adverse event data were collected throughout the 8-week study period. The definition of adverse event used in this study is consistent with the clinicaltrials.gov definition - any untoward medical occurrence associated with the use of an intervention, whether or not considered related to the intervention. Serious adverse events, as defined by the FDA, were not observed in this study.
|
6.7%
1/15 • Number of events 1 • 8 weeks
The adverse event data were collected throughout the 8-week study period. The definition of adverse event used in this study is consistent with the clinicaltrials.gov definition - any untoward medical occurrence associated with the use of an intervention, whether or not considered related to the intervention. Serious adverse events, as defined by the FDA, were not observed in this study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place