Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT06457802
Status:
TERMINATED
Last Update Posted:
2025-03-13
First Post:
2024-05-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Sit Less Program for Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D057185', 'term': 'Sedentary Behavior'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'shelagh.mulvaney@vanderbilt.edu', 'phone': '6153221198', 'title': 'Dr. Shelagh Mulvaney, PhD', 'organization': 'Vanderbilt University School of Nursing'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Start of intervention for up to 8 weeks', 'description': '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.', 'eventGroups': [{'id': 'EG000', 'title': 'Sit Less Group - mHealth Intervention', 'description': '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.\n\nSit 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.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group - Standard Care', 'description': "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.", 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Total Sedentary Behavior Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sit Less Group - mHealth Intervention', 'description': '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.\n\nSit 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.'}, {'id': 'OG001', 'title': 'Control Group - Standard Care', 'description': "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."}], 'timeFrame': 'Baseline and 8 weeks post-intervention', 'description': '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.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants completed the study. Change was not assessed as no data was collected for this outcome measure at 8-weeks post intervention.'}, {'type': 'PRIMARY', 'title': 'Acceptability of the Sedentary Behavior Reduction Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sit Less Group - mHealth Intervention', 'description': '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.\n\nSit 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.'}, {'id': 'OG001', 'title': 'Control Group - Standard Care', 'description': "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."}], 'timeFrame': '8 weeks post-intervention', 'description': '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.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants completed the study. Data was not collected for this outcome measure as no questionnaires were completed 8-weeks post intervention.'}, {'type': 'PRIMARY', 'title': 'Usability of the Sedentary Behavior Reduction Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sit Less Group - mHealth Intervention', 'description': '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.\n\nSit 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.'}, {'id': 'OG001', 'title': 'Control Group - Standard Care', 'description': "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."}], 'timeFrame': '8 weeks post-intervention', 'description': '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.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants completed the study. Data was not collected for this outcome measure as no questionnaires were completed 8-weeks post intervention.'}, {'type': 'PRIMARY', 'title': 'Compliance With the Sedentary Behavior Reduction Intervention - Fitbit Usage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sit Less Group - mHealth Intervention', 'description': '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.\n\nSit 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.'}, {'id': 'OG001', 'title': 'Control Group - Standard Care', 'description': "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."}], 'timeFrame': '8 weeks post-intervention', 'description': '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.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants completed the study. Data was not collected for this outcome measure as no questionnaires were completed 8-weeks post intervention.'}, {'type': 'PRIMARY', 'title': 'Adherence to Sedentary Behavior Goals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sit Less Group - mHealth Intervention', 'description': '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.\n\nSit 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.'}, {'id': 'OG001', 'title': 'Control Group - Standard Care', 'description': "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."}], 'timeFrame': '8 weeks post-intervention', 'description': 'Adherence will be evaluated by tracking the percentage of set sedentary behavior reduction goals met by participants.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants completed the study. Data was not collected for this outcome measure as no questionnaires were completed 8-weeks post intervention.'}, {'type': 'PRIMARY', 'title': 'Response Rates to Tailored Text Messages', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sit Less Group - mHealth Intervention', 'description': '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.\n\nSit 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.'}, {'id': 'OG001', 'title': 'Control Group - Standard Care', 'description': "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."}], 'timeFrame': '8 weeks post-intervention', 'description': 'Compliance will be evaluated by tracking the response rates (percentage) to the tailored text messages sent as part of the intervention.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants completed the study. Data was not collected for this outcome measure as no questionnaires were completed 8-weeks post intervention.'}, {'type': 'SECONDARY', 'title': 'Change in Number of Prolonged Sedentary Bouts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sit Less Group - mHealth Intervention', 'description': '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.\n\nSit 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.'}, {'id': 'OG001', 'title': 'Control Group - Standard Care', 'description': "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."}], 'timeFrame': 'Baseline and 8 weeks post-intervention', 'description': '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.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants completed the study. Change was not assessed as no data was collected for this outcome measure at 8-weeks post intervention.'}, {'type': 'SECONDARY', 'title': 'Change in Light Physical Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sit Less Group - mHealth Intervention', 'description': '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.\n\nSit 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.'}, {'id': 'OG001', 'title': 'Control Group - Standard Care', 'description': "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."}], 'timeFrame': 'Baseline and 8 weeks post-intervention', 'description': '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.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants completed the study. Change was not assessed as no data was collected for this outcome measure at 8-weeks post intervention.'}, {'type': 'SECONDARY', 'title': 'Change in 24-Hour Glycemic Control (GMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sit Less Group - mHealth Intervention', 'description': '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.\n\nSit 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.'}, {'id': 'OG001', 'title': 'Control Group - Standard Care', 'description': "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."}], 'timeFrame': 'Baseline and 8 weeks post-intervention', 'description': '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.\n\nUnit of Measure: GMI (Glucose Management Indicator, as a percentage)', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants completed the study. Change was not assessed as no data was collected for this outcome measure at 8-weeks post intervention.'}, {'type': 'SECONDARY', 'title': 'Change in Body Mass Index (BMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sit Less Group - mHealth Intervention', 'description': '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.\n\nSit 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.'}, {'id': 'OG001', 'title': 'Control Group - Standard Care', 'description': "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."}], 'timeFrame': 'Baseline and 8 weeks post-intervention', 'description': "This measure will evaluate changes in BMI, calculated using participants' height and weight measurements taken at baseline and post-intervention.", 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants completed the study. Change was not assessed as no data was collected for this outcome measure at 8-weeks post intervention.'}, {'type': 'SECONDARY', 'title': 'Change in Waist Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sit Less Group - mHealth Intervention', 'description': '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.\n\nSit 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.'}, {'id': 'OG001', 'title': 'Control Group - Standard Care', 'description': "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."}], 'timeFrame': 'Baseline and 8 weeks post-intervention', 'description': '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.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants completed the study. Change was not assessed as no data was collected for this outcome measure at 8-weeks post intervention.'}, {'type': 'SECONDARY', 'title': 'Change in Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sit Less Group - mHealth Intervention', 'description': '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.\n\nSit 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.'}, {'id': 'OG001', 'title': 'Control Group - Standard Care', 'description': "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."}], 'timeFrame': 'Baseline and 8 weeks post-intervention', 'description': '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.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants completed the study. Change was not assessed as no data was collected for this outcome measure at 8-weeks post intervention.'}, {'type': 'SECONDARY', 'title': 'Change in Confidence in Reducing Sedentary Behavior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sit Less Group - mHealth Intervention', 'description': '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.\n\nSit 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.'}, {'id': 'OG001', 'title': 'Control Group - Standard Care', 'description': "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."}], 'timeFrame': 'Baseline and 8 weeks post-intervention', 'description': "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.", 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants completed the study. Change was not assessed as no data was collected for this outcome measure at 8-weeks post intervention.'}, {'type': 'SECONDARY', 'title': 'Change in Habit Strength for Sedentary Behavior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sit Less Group - mHealth Intervention', 'description': '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.\n\nSit 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.'}, {'id': 'OG001', 'title': 'Control Group - Standard Care', 'description': "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."}], 'timeFrame': 'Baseline and 8 weeks post-intervention', 'description': "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.", 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants completed the study. Change was not assessed as no data was collected for this outcome measure at 8-weeks post intervention.'}, {'type': 'SECONDARY', 'title': 'Change in Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sit Less Group - mHealth Intervention', 'description': '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.\n\nSit 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.'}, {'id': 'OG001', 'title': 'Control Group - Standard Care', 'description': "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."}], 'timeFrame': 'Baseline and 8 weeks post-intervention', 'description': '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.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants completed the study. Change was not assessed as no data was collected for this outcome measure at 8-weeks post intervention.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sit Less Group - mHealth Intervention', 'description': '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.\n\nSit 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.'}, {'id': 'FG001', 'title': 'Control Group - Standard Care', 'description': "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."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Early termination of study prior to participant completion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sit Less Group - mHealth Intervention', 'description': '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.\n\nSit 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.'}, {'id': 'BG001', 'title': 'Control Group - Standard Care', 'description': "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."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age (Mean and Range)', 'categories': [{'measurements': [{'value': '62.0', 'groupId': 'BG000', 'lowerLimit': '58', 'upperLimit': '68'}, {'value': '57.5', 'groupId': 'BG001', 'lowerLimit': '42', 'upperLimit': '73'}, {'value': '59.75', 'groupId': 'BG002', 'lowerLimit': '42', 'upperLimit': '73'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Sex/Gender (Count)', 'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/Ethnicity (Count)', 'categories': [{'title': 'White (Not Hispanic or Latino)', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline Total Sedentary Behavior Time', 'classes': [{'categories': [{'measurements': [{'value': '616.39', 'spread': '61.96', 'groupId': 'BG000'}, {'value': '616.39', 'spread': '61.96', 'groupId': 'BG001'}, {'value': '616.39', 'spread': '61.96', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '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 (minutes/day) participants spend sitting or lying down during waking hours each day.', 'unitOfMeasure': 'minutes/day', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'No data analyzed. As only 4 participant were enrolled in this study, no data is reported here, in order to protect and maintain participant privacy/confidentiality.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-05-15', 'size': 501632, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-08-28T15:21', 'hasProtocol': True}, {'date': '2024-06-03', 'size': 311945, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-11-19T16:52', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Single-blind; The participants and the interventionists will be aware of the treatment assignments, but the data collectors will be blinded to the group assignments to reduce bias in data collection and analysis.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study employs a parallel assignment interventional model, wherein participants are randomly allocated to one of two groups: the intervention group or the control group. The intervention group will receive a comprehensive sedentary behavior (SB) reduction program over 8 weeks, utilizing wearable technology, including Fitbit devices and smart water bottles, combined with personalized text message prompts. The control group will receive standard care, consisting of educational materials provided by the American Heart Association, without additional prompts or interventions. The primary goal is to compare the outcomes between these two groups to assess the feasibility, acceptability, and preliminary efficacy of the SB reduction intervention in reducing SB and improving cardiometabolic health and patient-centered outcomes in individuals with type 2 diabetes.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'The PI terminated the study due to unforeseen extenuating personal circumstances. The VUMC IRB approved the early termination of the study on 8/20/2024. The last day the participants received the intervention was 08/20/2024.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-06', 'studyFirstSubmitDate': '2024-05-28', 'resultsFirstSubmitDate': '2024-09-10', 'studyFirstSubmitQcDate': '2024-06-07', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-06', 'studyFirstPostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Total Sedentary Behavior Time', 'timeFrame': 'Baseline and 8 weeks post-intervention', 'description': '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.'}, {'measure': 'Acceptability of the Sedentary Behavior Reduction Intervention', 'timeFrame': '8 weeks post-intervention', 'description': '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.'}, {'measure': 'Usability of the Sedentary Behavior Reduction Intervention', 'timeFrame': '8 weeks post-intervention', 'description': '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.'}, {'measure': 'Compliance With the Sedentary Behavior Reduction Intervention - Fitbit Usage', 'timeFrame': '8 weeks post-intervention', 'description': '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.'}, {'measure': 'Adherence to Sedentary Behavior Goals', 'timeFrame': '8 weeks post-intervention', 'description': 'Adherence will be evaluated by tracking the percentage of set sedentary behavior reduction goals met by participants.'}, {'measure': 'Response Rates to Tailored Text Messages', 'timeFrame': '8 weeks post-intervention', 'description': 'Compliance will be evaluated by tracking the response rates (percentage) to the tailored text messages sent as part of the intervention.'}], 'secondaryOutcomes': [{'measure': 'Change in Number of Prolonged Sedentary Bouts', 'timeFrame': 'Baseline and 8 weeks post-intervention', 'description': '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.'}, {'measure': 'Change in Light Physical Activity', 'timeFrame': 'Baseline and 8 weeks post-intervention', 'description': '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.'}, {'measure': 'Change in 24-Hour Glycemic Control (GMI)', 'timeFrame': 'Baseline and 8 weeks post-intervention', 'description': '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.\n\nUnit of Measure: GMI (Glucose Management Indicator, as a percentage)'}, {'measure': 'Change in Body Mass Index (BMI)', 'timeFrame': 'Baseline and 8 weeks post-intervention', 'description': "This measure will evaluate changes in BMI, calculated using participants' height and weight measurements taken at baseline and post-intervention."}, {'measure': 'Change in Waist Circumference', 'timeFrame': 'Baseline and 8 weeks post-intervention', 'description': '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.'}, {'measure': 'Change in Blood Pressure', 'timeFrame': 'Baseline and 8 weeks post-intervention', 'description': '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.'}, {'measure': 'Change in Confidence in Reducing Sedentary Behavior', 'timeFrame': 'Baseline and 8 weeks post-intervention', 'description': "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."}, {'measure': 'Change in Habit Strength for Sedentary Behavior', 'timeFrame': 'Baseline and 8 weeks post-intervention', 'description': "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."}, {'measure': 'Change in Quality of Life', 'timeFrame': 'Baseline and 8 weeks post-intervention', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes', 'Sedentary Behavior', 'Sedentary Time', 'Physical Activity']}, 'descriptionModule': {'briefSummary': "This randomized controlled trial aims to evaluate an 8-week intervention designed to reduce sedentary behavior (SB) in patients with type 2 diabetes (T2D) using wearable technology. The intervention involves the use of Fitbit devices to prompt standing/walking breaks, a smart water bottle to encourage hydration-related movement, and tailored text messages for behavior reinforcement. Participants will be assessed at baseline and post-intervention for changes in SB, light physical activity, cardiometabolic markers, and patient-centered outcomes. The study seeks to determine the intervention's acceptability and preliminary efficacy in reducing SB and improving health outcomes in T2D patients.", 'detailedDescription': 'The investigators propose to develop and conduct a pilot randomized controlled trial to test a wearable technology-based sedentary behavior (SB) reduction intervention in type 2 diabetes (T2D) patients. The study will recruit 80 participants who will be randomized to either the control group or the intervention group. The 8-week intervention aims to reduce daily SB by at least 120 minutes through the use of Fitbit devices, a smart water bottle, and tailored text messages. Participants will set personalized SB reduction goals and receive prompts to stand or walk, along with hydration reminders from the smart water bottle to encourage movement.\n\nSpecifically, the study aims to: determine the acceptability of the SB reduction intervention in T2D patients by evaluating satisfaction and compliance; evaluate the preliminary efficacy of the intervention on reducing total SB time and numbers of prolonged SB bouts; and explore preliminary effects on light physical activity, cardiometabolic markers (24-hour glycemic control, BMI, waist circumference, blood pressure), and patient-centered outcomes (confidence in reducing SB, habit strength for SB, and quality of life). Outcomes will be measured at baseline and post-intervention using biometric assessments, questionnaires, and continuous glucose monitoring. The study seeks to provide insights into the feasibility and potential health benefits of a technology-driven SB reduction program for T2D patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ages 18 and above\n* diagnosed with type 2 diabetes\n* self-reported HbA1C\\<13\n* self-report of sitting ≥ 8hr/day\n* ability to stand and walk\n* ownership of a smartphone.\n\nExclusion Criteria:\n\n* currently using an activity tracker\n* currently participating in exercise or other research programs.\n* random blood glucose \\> 300 mg/dL.\n* non-English speaking.\n* patients classified as unstable (e.g., heart failure, uncontrolled arrhythmia) or have kidney disease that limits daily water intake.\n* any conditions that prevent standing or walking due to physical or cognitive limitations, such as cognitive impairment, severe pain, problems with lower limbs, or a history of surgeries that limit movement.\n* participation in Sit Less Program V1 (IRB #221566).\n* currently pregnant.'}, 'identificationModule': {'nctId': 'NCT06457802', 'briefTitle': 'Sit Less Program for Patients With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University'}, 'officialTitle': 'A Multiple Technology-Based and Individually Tailored Sit Less Program for Patients With Type 2 Diabetes: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '240549'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sit Less Group - mHealth intervention', 'description': '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.', 'interventionNames': ['Behavioral: Sit Less Program']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group - Standard Care', 'description': "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."}], 'interventions': [{'name': 'Sit Less Program', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Sit Less Group - mHealth intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37240', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Shelagh Mulvaney, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Shelagh Mulvaney', 'investigatorAffiliation': 'Vanderbilt University'}}}}