Type 2 DiabetesNCT06457802
Sit Less Program for Patients With Type 2 Diabetes
A study testing Sit Less Program in people with Type 2 Diabetes and Sedentary Behavior, run by Vanderbilt University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Sedentary Behavior, Sedentary Time
- What is being tested?
- Sit Less Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2024to 20 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- currently using an activity tracker
- currently participating in exercise or other research programs.
- random blood glucose > 300 mg/dL.
- non-English speaking.
- patients classified as unstable (e.g., heart failure, uncontrolled arrhythmia) or have kidney disease that limits daily water intake.
- 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.
- participation in Sit Less Program V1 (IRB #221566).
- currently pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multiple Technology-Based and Individually Tailored Sit Less Program for Patients With Type 2 Diabetes: A Randomized Controlled Trial
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.
Read the detailed description
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.
Specifically, 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.
- Conditions
- Type 2 Diabetes, Sedentary Behavior, Sedentary Time, Physical Activity
- Being tested
- Sit Less Program
- Medical subject headings
- Diabetes Mellitus, Type 2, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sit Less ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Sit Less Group - mHealth intervention | Experimental | 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. Receives: Behavioral: Sit Less Program |
| Control Group - Standard Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Sedentary Behavior Time
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.
Measured: Baseline and 8 weeks post-intervention
Acceptability of the Sedentary Behavior Reduction 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.
Measured: 8 weeks post-intervention
Usability of the Sedentary Behavior Reduction 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.
Measured: 8 weeks post-intervention
Compliance With the Sedentary Behavior Reduction Intervention - Fitbit Usage
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.
Measured: 8 weeks post-intervention
Adherence to Sedentary Behavior Goals
Adherence will be evaluated by tracking the percentage of set sedentary behavior reduction goals met by participants.
Measured: 8 weeks post-intervention
Response Rates to Tailored Text Messages
Compliance will be evaluated by tracking the response rates (percentage) to the tailored text messages sent as part of the intervention.
Measured: 8 weeks post-intervention
Secondary outcomes (9)
Change in Number of Prolonged Sedentary Bouts
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.
Measured: Baseline and 8 weeks post-intervention
Change in Light Physical Activity
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.
Measured: Baseline and 8 weeks post-intervention
Change in 24-Hour Glycemic Control (GMI)
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)
Measured: Baseline and 8 weeks post-intervention
Change in Body Mass Index (BMI)
This measure will evaluate changes in BMI, calculated using participants' height and weight measurements taken at baseline and post-intervention.
Measured: Baseline and 8 weeks post-intervention
Change in Waist Circumference
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.
Measured: Baseline and 8 weeks post-intervention
Change in Blood Pressure
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.
Measured: Baseline and 8 weeks post-intervention
Change in Confidence in Reducing Sedentary Behavior
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.
Measured: Baseline and 8 weeks post-intervention
Change in Habit Strength for Sedentary Behavior
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.
Measured: Baseline and 8 weeks post-intervention
Change in Quality of Life
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.
Measured: Baseline and 8 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start12 Jun 2024
- Primary completion20 Aug 2024
- Study completion20 Aug 2024
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shelagh Mulvaney, Vanderbilt University
- Investigators
- Shelagh Mulvaney, PhD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457802
- Sponsor's protocol ID
- 240549
- Status last verified
- Mar 2025
- First submitted
- 28 May 2024
- Last updated
- 13 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Technology-Based and Individually Tailored Sit Less Program for Patients With Type 2 Diabetes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06457802
- Acronym / sponsor ID
- 240549
- Conditions
- Type 2 Diabetes, Sedentary Behavior, Sedentary Time, Physical Activity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 13 Jun 2024 (actual)
- Results
- Posted 13 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Specifically, 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sit Less Group - mHealth intervention | Experimental | Behavioral: Sit Less ProgramThe 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 | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ages 18 and above
- diagnosed with type 2 diabetes
- self-reported HbA1C<13
- self-report of sitting ≥ 8hr/day
- ability to stand and walk
Key exclusion criteria (8 listed)
- currently using an activity tracker
- currently participating in exercise or other research programs.
- random blood glucose > 300 mg/dL.
- non-English speaking.
- patients classified as unstable (e.g., heart failure, uncontrolled arrhythmia) or have kidney disease that limits daily water intake.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sit Less ProgramThe 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. | Behavioural | Sit Less Group - mHealth intervention |
Primary outcome
Change in Total Sedentary Behavior Time
Time frame: Baseline and 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.
Acceptability of the Sedentary Behavior Reduction Intervention
Time frame: 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.
Usability of the Sedentary Behavior Reduction Intervention
Time frame: 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.
Compliance With the Sedentary Behavior Reduction Intervention - Fitbit Usage
Time frame: 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.
Adherence to Sedentary Behavior Goals
Time frame: 8 weeks post-intervention
Adherence will be evaluated by tracking the percentage of set sedentary behavior reduction goals met by participants.
Response Rates to Tailored Text Messages
Time frame: 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.
9 secondary outcomes
Change in Number of Prolonged Sedentary Bouts
Time frame: Baseline and 8 weeks post-intervention
Change in Light Physical Activity
Time frame: Baseline and 8 weeks post-intervention
Change in 24-Hour Glycemic Control (GMI)
Time frame: Baseline and 8 weeks post-intervention
Change in Body Mass Index (BMI)
Time frame: Baseline and 8 weeks post-intervention
Change in Waist Circumference
Time frame: Baseline and 8 weeks post-intervention
Change in Blood Pressure
Time frame: Baseline and 8 weeks post-intervention
Change in Confidence in Reducing Sedentary Behavior
Time frame: Baseline and 8 weeks post-intervention
Change in Habit Strength for Sedentary Behavior
Time frame: Baseline and 8 weeks post-intervention
Change in Quality of Life
Time frame: Baseline and 8 weeks post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shelagh Mulvaney, PhD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sit Less Program in people with Type 2 Diabetes and Sedentary Behavior, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Sedentary Behavior Time (time frame: Baseline and 8 weeks post-intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.