Physical Activity, Sedentary Behavior, Type 2 Diabetes
Conditions
Brief summary
The purpose of this study is to develop and test an 8-week sedentary behavior reduction intervention (Sit Less program) for patients with type 2 diabetes. The program aims to reduce and break sitting times among this population using an objective activity monitor and mHealth. The investigators will test the program to help diabetes patients break up sitting time, reduce daily sitting time, and move more. The investigators will also study preliminary effects of the SB reduction intervention on light physical activity, cardiometabolic markers and patient-centered outcomes, and whether diabetes patients like the program and can follow it.
Detailed description
The investigators propose to develop and conduct a pilot study to test a wearable technology-based sedentary behavior reduction intervention in type 2 diabetes patients. The participants in the first cohort (n=15), 'Sit Less Version 1' will be randomized to either the control group or the sedentary behavior reduction intervention group. The intervention group will target a 120 minute per day reduction in sedentary behavior using an objective activity monitor and mHealth. The study will have an iterative design process with multiple cohorts. After the first cohort completed the study, we will collect their feedback to modify the Sit Less program. With Sit Less Version 2, Cohort 2 (n=20) participants will participate in the intervention as a single group, without randomization. The Sit Less Version 2 will be 8 weeks long. Specifically, the study aims to: determine the feasibility and acceptability of the sedentary behavior reduction intervention in type 2 diabetes patients by evaluating reach, retention, satisfaction, and compliance with the intervention; evaluate the preliminary efficacy of the sedentary behavior reduction intervention on changes in sedentary time; and explore preliminary effects of the sedentary reduction intervention on physical activity, cardiometabolic markers and patient-centered outcomes.
Interventions
BEHAVIORALSit Less Program
The intervention group will target a 120 minute per day reduction in sedentary behavior using an objective activity monitor and mHealth. Outcomes will be measured at baseline and post-intervention.
Sponsors
Vanderbilt University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* ages 18 and above * diagnosed with type 2 diabetes * self-reported HbA1C\<13 * self-report of sitting ≥ 8hr/day * ability to stand and walk * ownership of a smartphone.
Exclusion criteria
* currently using an activity tracker * use of insulin * random blood glucose \>300 * currently participating in exercise or other research programs * non-English speaking * patients who are classified as unstable (e.g. heart failure, uncontrolled arrhythmia) or have kidney disease that limits daily water intake, or any other conditions contradictory to standing or walking * currently pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of Sit-to-stand Transitions | Baseline and 8 weeks | Number of sit-to-stand transitions will be measured by 7 days of activPAL 3 device monitoring. |
| Level of Satisfaction With the Intervention Assessed by Lyons et al and Burner et al.'s Questionnaires | 8 weeks | 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. |
| Level of Compliance With the Intervention Assessed by Number of Days the Fitbit Device Was Worn | 8 weeks | The compliance with the intervention will be assessed by number of days the Fitbit device was worn per week. |
| Changes of Total Daily Sedentary Time | Baseline and 8 weeks | Total daily sedentary time will be measured from 7 days of activPAL 3 device monitoring. |
| Changes of Prolonged Sedentary Time | Baseline and 8 weeks | Prolonged sitting time (time spent sitting \>60mins) will be measured by 7 days of activPAL 3 device monitoring. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of Confidence in Reducing Sedentary Behavior Measured by Using 6 Items From the Self-Efficacy Questionnaire for Physical Activity and Sedentary Behavior. | Baseline and 8 weeks | Confidence 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. |
| Changes of Habit Strength for Sedentary Behavior Assessed by Using the Self-Report Habit Index. | Baseline and 8 weeks | Habit 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. |
| Changes of 24-hour Mean Glucose Levels Assessed by Continuous Glucose Monitors | Baseline and 8 weeks | 24-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. |
| Changes of Physical Activity Measured by 7 Days of activPAL Device Monitoring | Baseline and 8 weeks | Physical activity will be considered stepping time (minutes), measured by 7 days of activPAL monitoring. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 - Control Control Group (n=8) Participants in this group received standard care and did not participate in the Sit Less intervention. | 8 |
| 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. | 5 |
| 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. | 15 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 |
| Overall Study | Physician Decision | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Cohort 1 - Control | Cohort 1 - Intervention | Cohort 2 - Intervention | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 2 Participants | 3 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 3 Participants | 12 Participants | 20 Participants |
| Age, Continuous | 60.54 years STANDARD_DEVIATION 16.67 | 60.54 years STANDARD_DEVIATION 16.67 | 57.4 years STANDARD_DEVIATION 15.1 | 59.8 years STANDARD_DEVIATION 16.19 |
| BMI | 31.58 kg/m2 STANDARD_DEVIATION 3.98 | 37.46 kg/m2 STANDARD_DEVIATION 5.92 | 32.25 kg/m2 STANDARD_DEVIATION 5.65 | 33.11 kg/m2 STANDARD_DEVIATION 5.4 |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 1 Participants | 1 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 6 Participants | 4 Participants | 12 Participants | 22 Participants |
| Sex: Female, Male Female | 5 Participants | 4 Participants | 8 Participants | 17 Participants |
| Sex: Female, Male Male | 3 Participants | 1 Participants | 7 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 6 | 0 / 15 |
| other Total, other adverse events | 0 / 10 | 0 / 6 | 1 / 15 |
| serious Total, serious adverse events | 0 / 10 | 0 / 6 | 0 / 15 |
Outcome results
Primary
Changes of Prolonged Sedentary Time
Prolonged sitting time (time spent sitting \>60mins) will be measured by 7 days of activPAL 3 device monitoring.
Time frame: Baseline and 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 - Intervention | Changes of Prolonged Sedentary Time | Baseline | 262.978375 minutes | Standard Deviation 167.0212359 |
| Cohort 1 - Intervention | Changes of Prolonged Sedentary Time | Post-intervention | 198.121663 minutes | Standard Deviation 140.8557184 |
| Cohort 2 - Intervention | Changes of Prolonged Sedentary Time | Baseline | 226.240200 minutes | Standard Deviation 97.8064178 |
| Cohort 2 - Intervention | Changes of Prolonged Sedentary Time | Post-intervention | 147.582360 minutes | Standard Deviation 140.4909207 |
| Cohort 2 - Intervention | Changes of Prolonged Sedentary Time | Baseline | 187.086785 minutes | Standard Deviation 110.8965832 |
| Cohort 2 - Intervention | Changes of Prolonged Sedentary Time | Post-intervention | 165.056000 minutes | Standard Deviation 126.7480441 |
p-value: 0.6195% CI: [-101.9, 59.5]Regression, Linear
Primary
Changes of Sit-to-stand Transitions
Number of sit-to-stand transitions will be measured by 7 days of activPAL 3 device monitoring.
Time frame: Baseline and 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 - Intervention | Changes of Sit-to-stand Transitions | Baseline | 31.25 Sit-to-Stand Transitions | Standard Deviation 12.51 |
| Cohort 1 - Intervention | Changes of Sit-to-stand Transitions | Post-intervention | 32.75 Sit-to-Stand Transitions | Standard Deviation 11.298 |
| Cohort 2 - Intervention | Changes of Sit-to-stand Transitions | Baseline | 42.80 Sit-to-Stand Transitions | Standard Deviation 9.445 |
| Cohort 2 - Intervention | Changes of Sit-to-stand Transitions | Post-intervention | 43.20 Sit-to-Stand Transitions | Standard Deviation 8.167 |
| Cohort 2 - Intervention | Changes of Sit-to-stand Transitions | Baseline | 46.08 Sit-to-Stand Transitions | Standard Deviation 19.448 |
| Cohort 2 - Intervention | Changes of Sit-to-stand Transitions | Post-intervention | 45.31 Sit-to-Stand Transitions | Standard Deviation 15.25 |
p-value: 0.67495% CI: [-5.68, 8.78]Regression, Linear
Primary
Changes of Total Daily Sedentary Time
Total daily sedentary time will be measured from 7 days of activPAL 3 device monitoring.
Time frame: Baseline and 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 - Intervention | Changes of Total Daily Sedentary Time | Baseline | 622.5488 minutes | Standard Deviation 86.68241 |
| Cohort 1 - Intervention | Changes of Total Daily Sedentary Time | Post-intervention | 554.6351 minutes | Standard Deviation 68.21266 |
| Cohort 2 - Intervention | Changes of Total Daily Sedentary Time | Baseline | 670.8750 minutes | Standard Deviation 99.19531 |
| Cohort 2 - Intervention | Changes of Total Daily Sedentary Time | Post-intervention | 602.8750 minutes | Standard Deviation 122.18354 |
| Cohort 2 - Intervention | Changes of Total Daily Sedentary Time | Baseline | 640.7781 minutes | Standard Deviation 149.77 |
| Cohort 2 - Intervention | Changes of Total Daily Sedentary Time | Post-intervention | 609.5371 minutes | Standard Deviation 155.22499 |
p-value: 0.57895% CI: [-50.68, 90.78]Regression, Linear
Primary
Level of Compliance With the Intervention Assessed by Number of Days the Fitbit Device Was Worn
The compliance with the intervention will be assessed by number of days the Fitbit device was worn per week.
Time frame: 8 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1 - Intervention | Level of Compliance With the Intervention Assessed by Number of Days the Fitbit Device Was Worn | 6.58 days per week |
| Cohort 2 - Intervention | Level of Compliance With the Intervention Assessed by Number of Days the Fitbit Device Was Worn | 6.13 days per week |
Primary
Level of Satisfaction With the Intervention Assessed by Lyons et al and Burner et al.'s Questionnaires
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.
Time frame: 8 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort 1 - Intervention | 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 |
| Cohort 1 - Intervention | 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 |
| Cohort 1 - Intervention | 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 |
| Cohort 1 - Intervention | 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 |
| Cohort 1 - Intervention | 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 |
| Cohort 1 - Intervention | 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 |
| Cohort 1 - Intervention | 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 |
| Cohort 1 - Intervention | Level of Satisfaction With the Intervention Assessed by Lyons et al and Burner et al.'s Questionnaires | Fitbit satisfaction | 5 score on a scale |
| Cohort 1 - Intervention | 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 |
| Cohort 1 - Intervention | 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 |
| Cohort 1 - Intervention | 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 |
| Cohort 1 - Intervention | 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 |
| Cohort 2 - Intervention | Level of Satisfaction With the Intervention Assessed by Lyons et al and Burner et al.'s Questionnaires | Goal setting was useful | 4 score on a scale |
| Cohort 2 - Intervention | 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 |
| Cohort 2 - Intervention | 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 | 5 score on a scale |
| Cohort 2 - Intervention | 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. | 4 score on a scale |
| Cohort 2 - Intervention | Level of Satisfaction With the Intervention Assessed by Lyons et al and Burner et al.'s Questionnaires | Satisfaction on text message satisfaction | 3 score on a scale |
| Cohort 2 - Intervention | Level of Satisfaction With the Intervention Assessed by Lyons et al and Burner et al.'s Questionnaires | I enjoyed the sedentary behavior reduction program | 4 score on a scale |
| Cohort 2 - Intervention | Level of Satisfaction With the Intervention Assessed by Lyons et al and Burner et al.'s Questionnaires | Fitbit satisfaction | 5 score on a scale |
| Cohort 2 - Intervention | 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 |
| Cohort 2 - Intervention | 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 |
| Cohort 2 - Intervention | 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 |
| Cohort 2 - Intervention | 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 |
| Cohort 2 - Intervention | 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 | 5 score on a scale |
Secondary
Changes of 24-hour Mean Glucose Levels Assessed by Continuous Glucose Monitors
24-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.
Time frame: Baseline and 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 - Intervention | Changes of 24-hour Mean Glucose Levels Assessed by Continuous Glucose Monitors | Baseline | 120.7143 mg/dL | Standard Deviation 21.83052 |
| Cohort 1 - Intervention | Changes of 24-hour Mean Glucose Levels Assessed by Continuous Glucose Monitors | Post-intervention | 126.0000 mg/dL | Standard Deviation 56.60094 |
| Cohort 2 - Intervention | Changes of 24-hour Mean Glucose Levels Assessed by Continuous Glucose Monitors | Baseline | 135.2500 mg/dL | Standard Deviation 29.15905 |
| Cohort 2 - Intervention | Changes of 24-hour Mean Glucose Levels Assessed by Continuous Glucose Monitors | Post-intervention | 115.7500 mg/dL | Standard Deviation 20.51625 |
| Cohort 2 - Intervention | Changes of 24-hour Mean Glucose Levels Assessed by Continuous Glucose Monitors | Baseline | 129.3846 mg/dL | Standard Deviation 28.43278 |
| Cohort 2 - Intervention | Changes of 24-hour Mean Glucose Levels Assessed by Continuous Glucose Monitors | Post-intervention | 153.5385 mg/dL | Standard Deviation 35.08945 |
p-value: 0.37695% CI: [-68.99, 26.08]Regression, Linear
Secondary
Changes of Confidence in Reducing Sedentary Behavior Measured by Using 6 Items From the Self-Efficacy Questionnaire for Physical Activity and Sedentary Behavior.
Confidence 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.
Time frame: Baseline and 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 - Intervention | 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 0.68874 |
| Cohort 1 - Intervention | 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 |
| Cohort 2 - Intervention | Changes of Confidence in Reducing Sedentary Behavior Measured by Using 6 Items From the Self-Efficacy Questionnaire for Physical Activity and Sedentary Behavior. | Baseline | 3.7000 score on a scale | Standard Deviation 0.83666 |
| Cohort 2 - Intervention | 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 | 3.8500 score on a scale | Standard Deviation 0.89443 |
| Cohort 2 - Intervention | 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 0.6887 |
| Cohort 2 - Intervention | 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 | 3.3846 score on a scale | Standard Deviation 0.89916 |
p-value: 0.2995% CI: [-0.335, 1.109]Regression, Linear
Secondary
Changes of Habit Strength for Sedentary Behavior Assessed by Using the Self-Report Habit Index.
Habit 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.
Time frame: Baseline and 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 - Intervention | Changes of Habit Strength for Sedentary Behavior Assessed by Using the Self-Report Habit Index. | Baseline | 6.2143 score on a scale | Standard Deviation 0.6343 |
| Cohort 1 - Intervention | 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 |
| Cohort 2 - Intervention | Changes of Habit Strength for Sedentary Behavior Assessed by Using the Self-Report Habit Index. | Baseline | 6.0857 score on a scale | Standard Deviation 1.18924 |
| Cohort 2 - Intervention | Changes of Habit Strength for Sedentary Behavior Assessed by Using the Self-Report Habit Index. | Post-intervention | 5.5143 score on a scale | Standard Deviation 1.24786 |
| Cohort 2 - Intervention | Changes of Habit Strength for Sedentary Behavior Assessed by Using the Self-Report Habit Index. | Baseline | 5.2967 score on a scale | Standard Deviation 1.57517 |
| Cohort 2 - Intervention | Changes of Habit Strength for Sedentary Behavior Assessed by Using the Self-Report Habit Index. | Post-intervention | 5.8462 score on a scale | Standard Deviation 1.0243 |
p-value: 0.70195% CI: [-1.24, 0.833]Regression, Linear
Secondary
Changes of Physical Activity Measured by 7 Days of activPAL Device Monitoring
Physical activity will be considered stepping time (minutes), measured by 7 days of activPAL monitoring.
Time frame: Baseline and 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 - Intervention | Changes of Physical Activity Measured by 7 Days of activPAL Device Monitoring | Baseline | 37.547425 minutes | Standard Deviation 19.0937877 |
| Cohort 1 - Intervention | Changes of Physical Activity Measured by 7 Days of activPAL Device Monitoring | Post-intervention | 54.1757038 minutes | Standard Deviation 29.75937131 |
| Cohort 2 - Intervention | Changes of Physical Activity Measured by 7 Days of activPAL Device Monitoring | Baseline | 63.195200 minutes | Standard Deviation 18.4359097 |
| Cohort 2 - Intervention | Changes of Physical Activity Measured by 7 Days of activPAL Device Monitoring | Post-intervention | 75.4577200 minutes | Standard Deviation 60.05685663 |
| Cohort 2 - Intervention | Changes of Physical Activity Measured by 7 Days of activPAL Device Monitoring | Baseline | 67.806546 minutes | Standard Deviation 18.0175217 |
| Cohort 2 - Intervention | Changes of Physical Activity Measured by 7 Days of activPAL Device Monitoring | Post-intervention | 75.1487769 minutes | Standard Deviation 24.21793627 |
p-value: 0.01395% CI: [-38.5, -4.59]Regression, Linear