Type 2 DiabetesNCT05691452

Technology Based Sedentary Reduction Intervention in 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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Type 2 Diabetes, Sedentary Behavior, Physical Activity
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: 31 participants
Where: 1 siteUnited States
Study dates: 24 Jan 2023to 30 Jul 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
Healthy volunteers accepted
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
use of insulin
random blood glucose >300
currently participating in exercise or other research programs
non-English speaking
patients who are classified as unstable (e.g. heart failure, uncontrolled arrhythmia) or have kidney disease that limits daily water intake, or any other conditions contradictory to standing or walking
currently pregnant

Trial locations and contacts

1 site in 1 country.

United States1 site

Vanderbilt University
Nashville, Tennessee, 37240

Other trials in United States

About this study

Official title: Technology-Based Sedentary Reduction Intervention in Patients With Type 2 Diabetes: A Pilot Study

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.

Read the detailed description

The investigators propose to develop and conduct a pilot study to test a wearable technology-based sedentary behavior reduction intervention in type 2 diabetes patients. The participants in the first cohort (n=15), 'Sit Less Version 1' will be randomized to either the control group or the sedentary behavior reduction intervention group. The intervention group will target a 120 minute per day reduction in sedentary behavior using an objective activity monitor and mHealth. The study will have an iterative design process with multiple cohorts. After the first cohort completed the study, we will collect their feedback to modify the Sit Less program. With Sit Less Version 2, Cohort 2 (n=20) participants will participate in the intervention as a single group, without randomization. The Sit Less Version 2 will be 8 weeks long.

Specifically, the study aims to: determine the feasibility and acceptability of the sedentary behavior reduction intervention in type 2 diabetes patients by evaluating reach, retention, satisfaction, and compliance with the intervention; evaluate the preliminary efficacy of the sedentary behavior reduction intervention on changes in sedentary time; and explore preliminary effects of the sedentary reduction intervention on physical activity, cardiometabolic markers and patient-centered outcomes.

Conditions: Type 2 Diabetes, Sedentary Behavior, 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 groups in NCT05691452
Study group	Role	What they receive
Intervention Group	Experimental	The intervention group will target a 120 minute per day reduction in sedentary behavior using an objective activity monitor and mHealth. Receives: Behavioral: Sit Less Program

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 8 weeks
Changes of Total Daily Sedentary Time
Total daily sedentary time will be measured from 7 days of activPAL 3 device monitoring.
Measured: 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.
Measured: 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.
Measured: Baseline and 8 weeks

Secondary outcomes (4)

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.
Measured: 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.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jan 202330 Jul 2024

First posted20 Jan 2023
Study start24 Jan 2023
Primary completion5 Jan 2024
Study completion30 Jul 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.
Publications (1)Papers the sponsor has linked to this study.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05691452
Sponsor's protocol ID: 221566
Status last verified: Mar 2025
First submitted: 5 Jan 2023
Last updated: 19 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Park C, Dietrich MS, Larsen B, Mayberry LS, Doyle A, Ahn S, Jean J, Maquiling K, Mogos MF, Muchira JM, Mulvaney S. Feasibility and Preliminary Efficacy of a "Sit Less" Program Leveraging Fitbit Tracking and Tailored Text Messages in Cardiometabolic Disease: Findings From 2 Parallel Randomized Controlled Trials in Coronary Artery Disease and Type 2 Diabetes. JMIR Mhealth Uhealth. 2026 Aug 25;14:e56497. doi: 10.2196/56497.
PubMed 42641078

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes Mellitus
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Enrolling by invitation
MTM2MTG Pilot Ancillary Study
Diet, Healthy, HbA1c
Active, not recruiting
Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources
PreDiabetes, Diabetes Mellitus, Type 2
Not yet recruitingPhase 1/2
A Study Testing the Safety and Possible Benefits of an Ear Injection of a New Compound, Paliroden, in People With Type 2 Diabetes Who Have Difficulty Understanding Speech in Noisy Situations
Cochlear Synaptopathy
Not yet recruitingPhase 1
A Research Study to Check the Safety of NNC9836-0001 When Given to Healthy Participants and Participants With Type 2 Diabetes
Diabetes Mellitus, Type 2

All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Technology-Based Sedentary Reduction Intervention in Patients With Type 2 Diabetes: A Pilot Study
ClinicalTrials.gov ID: NCT05691452
Acronym / sponsor ID: 221566
Conditions: Type 2 Diabetes, Sedentary Behavior, Physical Activity
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Vanderbilt UniversityUniversity, hospital or other
Study start: 24 Jan 2023 (actual)
Primary completion: 5 Jan 2024 (actual)
Study completion: 30 Jul 2024 (actual)
First posted: 20 Jan 2023 (actual)
Results: Posted 19 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Intervention Group	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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: 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 (7 listed)

currently using an activity tracker
use of insulin
random blood glucose >300
currently participating in exercise or other research programs
non-English speaking

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	Intervention Group

Primary outcome

Level of Satisfaction With the Intervention Assessed by Lyons et al and Burner et al.'s Questionnaires
Time frame: 8 weeks
Acceptability of the Sit Less program will be assessed using satisfaction surveys and exit interviews with Sit Less group participants. The surveys combined items from two questionnaires: Lyons et al., which measured overall program satisfaction (e.g., "I would recommend the program"), ease of use, and intention to continue using each program component, and Burner et al., which evaluated the text messaging component, including content relevance, motivational impact, frequency, and timing. Satisfaction with the overall program will be evaluated with six items like "I would recommend the program" and "The program is likely to reduce sedentary behavior." All responses will be made on a Likert-type scale from 1 (strongly disagree) to 5 (strongly agree). Higher scores mean higher levels of satisfaction.
Level of Compliance With the Intervention Assessed by Number of Days the Fitbit Device Was Worn
Time frame: 8 weeks
The compliance with the intervention will be assessed by number of days the Fitbit device was worn per week.
Changes of Total Daily Sedentary Time
Time frame: Baseline and 8 weeks
Total daily sedentary time will be measured from 7 days of activPAL 3 device monitoring.
Changes of Prolonged Sedentary Time
Time frame: Baseline and 8 weeks
Prolonged sitting time (time spent sitting >60mins) will be measured by 7 days of activPAL 3 device monitoring.
Changes of Sit-to-stand Transitions
Time frame: Baseline and 8 weeks
Number of sit-to-stand transitions will be measured by 7 days of activPAL 3 device monitoring.

4 secondary outcomes

Changes of Physical Activity Measured by 7 Days of activPAL Device Monitoring
Time frame: 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.
Time frame: Baseline and 8 weeks
Changes of Habit Strength for Sedentary Behavior Assessed by Using the Self-Report Habit Index.
Time frame: Baseline and 8 weeks
Changes of 24-hour Mean Glucose Levels Assessed by Continuous Glucose Monitors
Time frame: Baseline and 8 weeks

Results and safety

Results posted to the registry on 19 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1 - Control	10	8
Cohort 1 - Intervention	6	5
Cohort 2 - Intervention	15	13

Primary outcome: Level of Satisfaction With the Intervention Assessed by Lyons et al and Burner et al.'s Questionnaires

Time frame: 8 weeks. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Cohort 1 - Intervention n = 5	Cohort 2 - Intervention n = 13
I would recommend the program to family and friends.	5 (3 to 5)	4 (4 to 5)
I enjoyed the sedentary behavior reduction program	5 (2 to 5)	4 (4 to 5)
This program is likely to increase awareness of my sedentary behavior	5 (3.5 to 5)	5 (4.5 to 5)
This program is likely to change attitudes toward my sedentary behavior	5 (3.5 to 5)	5 (4 to 5)
This program is likely to increase intentions/motivation to reduce sedentary behavior	4 (3.5 to 5)	5 (4 to 5)
Participation in this program is likely to reduce sedentary behavior	4 (3.5 to 5)	5 (4 to 5)
Fitbit satisfaction	5 (4 to 5)	5 (3.5 to 5)
Satisfaction on smart water bottle satisfaction	4 (2.5 to 5)	4 (3 to 4.5)

Primary outcome: Level of Compliance With the Intervention Assessed by Number of Days the Fitbit Device Was Worn

Time frame: 8 weeks. Median (Inter-Quartile Range). Unit: days per week

Measure	Cohort 1 - Intervention n = 5	Cohort 2 - Intervention n = 15
Value	6.58 (6.13 to 6.94)	6.13 (5.63 to 7)

Primary outcome: Changes of Total Daily Sedentary Time

Time frame: Baseline and 8 weeks. Mean (Standard Deviation). Unit: minutes

Measure	Cohort 1 - Control n = 8	Cohort 1 - Intervention n = 5	Cohort 2 - Intervention n = 13
Baseline	622.5488 (86.68241)	670.8750 (99.19531)	640.7781 (149.77000)
Post-intervention	554.6351 (68.21266)	602.8750 (122.18354)	609.5371 (155.22499)

Cohort 1 - Control vs Cohort 1 - Intervention: Mean Difference (Net): 20.05 (95% CI -50.68 to 90.78), p = 0.578, Regression, Linear

Primary outcome: Changes of Prolonged Sedentary Time

Time frame: Baseline and 8 weeks. Mean (Standard Deviation). Unit: minutes

Measure	Cohort 1 - Control n = 8	Cohort 1 - Intervention n = 5	Cohort 2 - Intervention n = 13
Baseline	262.978375 (167.0212359)	226.240200 (97.8064178)	187.086785 (110.8965832)
Post-intervention	198.121663 (140.8557184)	147.582360 (140.4909207)	165.056000 (126.7480441)

Cohort 1 - Control vs Cohort 1 - Intervention: Mean Difference (Net): -21.2 (95% CI -101.9 to 59.5), p = 0.61, Regression, Linear

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1 - Control	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Cohort 1 - Intervention	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Cohort 2 - Intervention	0 of 15 (0%)	1 of 15 (6.7%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42641078Park C, Dietrich MS, Larsen B, Mayberry LS, Doyle A, Ahn S, Jean J, Maquiling K, Mogos MF, Muchira JM, Mulvaney S. Feasibility and Preliminary Efficacy of a "Sit Less" Program Leveraging Fitbit Tracking and Tailored Text Messages in Cardiometabolic Disease: Findings From 2 Parallel Randomized Controlled Trials in Coronary Artery Disease and Type 2 Diabetes. JMIR Mhealth Uhealth. 2026 Aug 25;14:e56497. doi: 10.2196/56497.
Individual participant dataSharing planned: No

Related trials for Type 2 Diabetes

Recruiting
Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes Mellitus
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Enrolling by invitation
MTM2MTG Pilot Ancillary Study
Diet, Healthy, HbA1c
Active, not recruiting
Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources
PreDiabetes, Diabetes Mellitus, Type 2
Not yet recruitingPhase 1/2
A Study Testing the Safety and Possible Benefits of an Ear Injection of a New Compound, Paliroden, in People With Type 2 Diabetes Who Have Difficulty Understanding Speech in Noisy Situations
Cochlear Synaptopathy
Not yet recruitingPhase 1
A Research Study to Check the Safety of NNC9836-0001 When Given to Healthy Participants and Participants With Type 2 Diabetes
Diabetes Mellitus, Type 2

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.

Chorong Park, 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 7 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: finished, as of the sponsor's last update on 19 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 19 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?

Level of Satisfaction With the Intervention Assessed by Lyons et al and Burner et al.'s Questionnaires (time frame: 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05691452, which also lists 1 linked publication.

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 19 Mar 2025.