Trial Outcomes & Findings for Sit Less Program for Patients With Type 2 Diabetes (NCT NCT06457802)
NCT ID: NCT06457802
Last Updated: 2025-03-13
Results Overview
The primary outcome measure will assess the change in total sedentary behavior (SB) time from baseline to post-intervention. Sedentary behavior will be objectively measured using the activPAL device, which participants will wear on their thigh for 7 days at both baseline and post-intervention. The activPAL device will record the amount of time participants spend sitting or lying down during waking hours each day.
TERMINATED
NA
4 participants
Baseline and 8 weeks post-intervention
2025-03-13
Participant Flow
Participant milestones
| Measure |
Sit Less Group - mHealth Intervention
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.
Sit 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.
|
Control Group - Standard Care
Participants in the control group will receive standard care, including educational materials from the American Heart Association's Healthy Living booklet and a Fitbit. They will not receive the smart water bottle or the tailored text messages aimed at reducing sedentary behavior. The Fitbit move alert setting will be disabled for the control group.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Sit Less Group - mHealth Intervention
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.
Sit 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.
|
Control Group - Standard Care
Participants in the control group will receive standard care, including educational materials from the American Heart Association's Healthy Living booklet and a Fitbit. They will not receive the smart water bottle or the tailored text messages aimed at reducing sedentary behavior. The Fitbit move alert setting will be disabled for the control group.
|
|---|---|---|
|
Overall Study
Early termination of study prior to participant completion
|
2
|
2
|
Baseline Characteristics
Sit Less Program for Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Sit Less Group - mHealth Intervention
n=2 Participants
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.
Sit 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.
|
Control Group - Standard Care
n=2 Participants
Participants in the control group will receive standard care, including educational materials from the American Heart Association's Healthy Living booklet and a Fitbit. They will not receive the smart water bottle or the tailored text messages aimed at reducing sedentary behavior. The Fitbit move alert setting will be disabled for the control group.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age (Mean and Range)
|
62.0 years
n=5 Participants
|
57.5 years
n=7 Participants
|
59.75 years
n=5 Participants
|
|
Sex/Gender, Customized
Sex/Gender (Count) · Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Sex/Gender (Count) · Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity (Count) · White (Not Hispanic or Latino)
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity (Count) · Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Baseline Total Sedentary Behavior Time
|
616.39 minutes/day
STANDARD_DEVIATION 61.96 • n=5 Participants
|
616.39 minutes/day
STANDARD_DEVIATION 61.96 • n=7 Participants
|
616.39 minutes/day
STANDARD_DEVIATION 61.96 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 8 weeks post-interventionPopulation: Zero participants completed the study. Change was not assessed as no data was collected for this outcome measure at 8-weeks post intervention.
The primary outcome measure will assess the change in total sedentary behavior (SB) time from baseline to post-intervention. Sedentary behavior will be objectively measured using the activPAL device, which participants will wear on their thigh for 7 days at both baseline and post-intervention. The activPAL device will record the amount of time participants spend sitting or lying down during waking hours each day.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 8 weeks post-interventionPopulation: Zero participants completed the study. Data was not collected for this outcome measure as no questionnaires were completed 8-weeks post intervention.
Satisfaction will be assessed using a 23-item questionnaire. This questionnaire includes items on the perceived helpfulness, ease of use, and overall experience with the wearable devices, text messages, and goal-setting sessions. The questionnaire uses a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate greater satisfaction with the intervention.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 8 weeks post-interventionPopulation: Zero participants completed the study. Data was not collected for this outcome measure as no questionnaires were completed 8-weeks post intervention.
Usability will be assessed using a 10-item System Usability Scale. The System Usability Scale provides a global measure of usability and uses a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). It has a minimum score of 0 and a maximum score of 100, where higher scores indicate better usability.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 8 weeks post-interventionPopulation: Zero participants completed the study. Data was not collected for this outcome measure as no questionnaires were completed 8-weeks post intervention.
Compliance with the intervention will be evaluated by tracking the usage data from the Fitbit devices, specifically the number of days the device was worn for at least 10 hours per day.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 8 weeks post-interventionPopulation: Zero participants completed the study. Data was not collected for this outcome measure as no questionnaires were completed 8-weeks post intervention.
Adherence will be evaluated by tracking the percentage of set sedentary behavior reduction goals met by participants.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 8 weeks post-interventionPopulation: Zero participants completed the study. Data was not collected for this outcome measure as no questionnaires were completed 8-weeks post intervention.
Compliance will be evaluated by tracking the response rates (percentage) to the tailored text messages sent as part of the intervention.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 8 weeks post-interventionPopulation: Zero participants completed the study. Change was not assessed as no data was collected for this outcome measure at 8-weeks post intervention.
This measure will assess the change in the number of prolonged sedentary bouts, defined as periods of uninterrupted sitting or lying down lasting 30 minutes or more. Data will be collected using the activPAL device worn by participants for 7 days at both baseline and post-intervention.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 8 weeks post-interventionPopulation: Zero participants completed the study. Change was not assessed as no data was collected for this outcome measure at 8-weeks post intervention.
This measure will evaluate changes in light physical activity, including total standing and stepping times. Participants will wear the activPAL device for 7 days at both baseline and post-intervention to capture these activity levels.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 8 weeks post-interventionPopulation: Zero participants completed the study. Change was not assessed as no data was collected for this outcome measure at 8-weeks post intervention.
24-hour glucose levels will be measured by continuous glucose monitoring over a 7-day period. The 24-hour glucose control will be evaluated using the Glucose Management Indicator (GMI), which provides an estimated average glucose (eAG) based on the mean 24-hour glucose levels. The GMI will be calculated from the mean glucose values and reported as a single aggregated value. Additionally, the numbers of events and time in hypoglycemia (glucose \< 3.9 mmol/L), euglycemia (glucose 3.9-7.8 mmol/L), hyperglycemia (glucose \> 7.8 mmol/L), and above target (glucose \> 9 mmol/L) will be monitored to provide context to the GMI value, but these will not be separately reported as primary outcome measures. Unit of Measure: GMI (Glucose Management Indicator, as a percentage)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 8 weeks post-interventionPopulation: Zero participants completed the study. Change was not assessed as no data was collected for this outcome measure at 8-weeks post intervention.
This measure will evaluate changes in BMI, calculated using participants' height and weight measurements taken at baseline and post-intervention.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 8 weeks post-interventionPopulation: Zero participants completed the study. Change was not assessed as no data was collected for this outcome measure at 8-weeks post intervention.
This measure will assess changes in waist circumference, measured at the narrowest point between the rib cage and the iliac crest using a flexible tape measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 8 weeks post-interventionPopulation: Zero participants completed the study. Change was not assessed as no data was collected for this outcome measure at 8-weeks post intervention.
This measure will evaluate changes in systolic and diastolic blood pressure, measured using an automated and validated blood pressure monitor at baseline and post-intervention.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 8 weeks post-interventionPopulation: Zero participants completed the study. Change was not assessed as no data was collected for this outcome measure at 8-weeks post intervention.
This measure will assess changes in participants' confidence in their ability to reduce sedentary behavior, evaluated using a validated self-efficacy questionnaire for physical activity and sedentary behavior. Confidence in reducing SB and increasing physical activity will be measured using 12 items from the Self-Efficacy Questionnaire for Physical Activity and Sedentary Behavior (Cronbach's alpha = 0.79). Each item is rated on a 5-point Likert scale ranging from 1 (not at all confident) to 5 (extremely confident). The total score ranges from 12 to 60, with higher scores indicating greater confidence in reducing sedentary behavior and increasing physical activity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 8 weeks post-interventionPopulation: Zero participants completed the study. Change was not assessed as no data was collected for this outcome measure at 8-weeks post intervention.
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 SB 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 5 (strongly agree). The total score ranges from 7 to 35, with higher scores indicating stronger habit strength for taking sedentary breaks.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 8 weeks post-interventionPopulation: Zero participants completed the study. Change was not assessed as no data was collected for this outcome measure at 8-weeks post intervention.
Quality of life will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS)-Global Health, a 10-item measure developed by the NIH as an indicator for Healthy People. Each item is rated on a 5-point Likert scale, and the total score is calculated to range from 10 to 50. Higher scores indicate better quality of life.
Outcome measures
Outcome data not reported
Adverse Events
Sit Less Group - mHealth Intervention
Control Group - Standard Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Shelagh Mulvaney, PhD
Vanderbilt University School of Nursing
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place