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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | The intervention group will target a 120 minute per day reduction in sedentary behavior using an objective activity monitor and mHealth. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sit Less Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
| 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. | 8 weeks |
| Changes of Total Daily Sedentary Time | Total daily sedentary time will be measured from 7 days of activPAL 3 device monitoring. | Baseline and 8 weeks |
| Changes of Prolonged Sedentary Time | Prolonged sitting time (time spent sitting >60mins) will be measured by 7 days of activPAL 3 device monitoring. | Baseline and 8 weeks |
| Changes of Sit-to-stand Transitions | Number of sit-to-stand transitions will be measured by 7 days of activPAL 3 device monitoring. | Baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 8 weeks |
| Changes of Confidence in Reducing Sedentary Behavior Measured by Using 6 Items From the Self-Efficacy Questionnaire for Physical Activity and Sedentary Behavior. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chorong Park, PhD | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University | Nashville | Tennessee | 37240 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42350337 | Derived | Park C, Dietrich M, Larsen B, Mayberry L, Doyle A, Ahn S, Jean J, Maquiling K, Mogos M, Muchira J, Mulvaney S. Feasibility and Preliminary Efficacy of a "Sit Less" Program Leveraging Fitbit Tracking and Tailored Text Messages in Cardiometabolic Disease: Findings from Two Parallel Randomized Controlled Trials in Coronary Artery Disease and Type 2 Diabetes. JMIR Mhealth Uhealth. 2026 Jun 10. doi: 10.2196/56497. Online ahead of print. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 - Control | Control Group (n=8) Participants in this group received standard care and did not participate in the "Sit Less" intervention. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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The baseline characteristics were reported for each of these three analysis populations (Cohort 1 Control, Cohort 1 Intervention, and Cohort 2 Intervention).
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 - Control | Control Group (n=8) Participants in this group received standard care and did not participate in the "Sit Less" intervention. |
| BG001 | Cohort 1 - Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Inter-Quartile Range | score on a scale | 8 weeks |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 - Control | Control Group (n=8) Participants in this group received standard care and did not participate in the "Sit Less" intervention. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain and anxiety | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Participant DM0027 reported increased back pain and anxiety due to the Sit Less program, leading to their withdrawal on 11/6/2023. The PI was informed and agreed with the withdrawal. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Chorong Park | Vanderbilt University School of Nursing | 6153436075 | chorong.park@vanderbilt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2024 | Jan 14, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 10, 2023 | Jul 31, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D057185 | Sedentary Behavior |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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. |
| Baseline and 8 weeks |
| 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. | Baseline and 8 weeks |
| 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. | Baseline and 8 weeks |
| Lost to Follow-up |
|
| Adverse Event |
|
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.
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
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. |
| OG001 | 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. |
|
|
| 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. | Posted | Median | Inter-Quartile Range | days per week | 8 weeks |
|
|
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| Primary | Changes of Total Daily Sedentary Time | Total daily sedentary time will be measured from 7 days of activPAL 3 device monitoring. | Posted | Mean | Standard Deviation | minutes | Baseline and 8 weeks |
|
|
|
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| Primary | Changes of Prolonged Sedentary Time | Prolonged sitting time (time spent sitting >60mins) will be measured by 7 days of activPAL 3 device monitoring. | Posted | Mean | Standard Deviation | minutes | Baseline and 8 weeks |
|
|
|
|
| Primary | Changes of Sit-to-stand Transitions | Number of sit-to-stand transitions will be measured by 7 days of activPAL 3 device monitoring. | Posted | Mean | Standard Deviation | Sit-to-Stand Transitions | Baseline and 8 weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | minutes | Baseline and 8 weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 8 weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 8 weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | mg/dL | Baseline and 8 weeks |
|
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 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. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | 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. | 0 | 15 | 0 | 15 | 1 | 15 |
|
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| D004700 | Endocrine System Diseases |
| D001519 | Behavior |
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