NCT05691452

Technology Based Sedentary Reduction Intervention in Patients With Type 2 Diabetes

Completed NA Results posted Last updated 19 March 2025

What this trial tests

NA trial testing Sit Less Program in Type 2 Diabetes in 31 participants. Completed in 30 July 2024.

Timeline

24 January 2023

Primary endpoint
5 January 2024

30 July 2024

Quick facts

Lead sponsor	Vanderbilt University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	31
Start date	24 January 2023
Primary completion	5 January 2024
Estimated completion	30 July 2024
Sites	1 location across United States

Drugs / interventions tested

• Sit Less Program

Conditions studied

• Type 2 Diabetes — all drugs for Type 2 Diabetes →
• Sedentary Behavior — all drugs for Sedentary Behavior →
• Physical Activity — all drugs for Physical Activity →

Sponsor

Vanderbilt University

Who can join

18 and older, any sex, with Type 2 Diabetes or Sedentary Behavior. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

I would recommend the program to family and friends.

Group	Value	95% CI
Cohort 1 - Intervention	5	3 – 5
Cohort 2 - Intervention	4	4 – 5

I enjoyed the sedentary behavior reduction program

Group	Value	95% CI
Cohort 1 - Intervention	5	2 – 5
Cohort 2 - Intervention	4	4 – 5

This program is likely to increase awareness of my sedentary behavior

Group	Value	95% CI
Cohort 1 - Intervention	5	3.5 – 5
Cohort 2 - Intervention	5	4.5 – 5

This program is likely to change attitudes toward my sedentary behavior

Group	Value	95% CI
Cohort 1 - Intervention	5	3.5 – 5
Cohort 2 - Intervention	5	4 – 5

This program is likely to increase intentions/motivation to reduce sedentary behavior

Group	Value	95% CI
Cohort 1 - Intervention	4	3.5 – 5
Cohort 2 - Intervention	5	4 – 5

Participation in this program is likely to reduce sedentary behavior

Group	Value	95% CI
Cohort 1 - Intervention	4	3.5 – 5
Cohort 2 - Intervention	5	4 – 5

Fitbit satisfaction

Group	Value	95% CI
Cohort 1 - Intervention	5	4 – 5
Cohort 2 - Intervention	5	3.5 – 5

Satisfaction on smart water bottle satisfaction

Group	Value	95% CI
Cohort 1 - Intervention	4	2.5 – 5
Cohort 2 - Intervention	4	3 – 4.5

Level of Compliance With the Intervention Assessed by Number of Days the Fitbit Device Was Worn Primary · 8 weeks

The compliance with the intervention will be assessed by number of days the Fitbit device was worn per week.

Group	Value	95% CI
Cohort 1 - Intervention	6.58	6.13 – 6.94
Cohort 2 - Intervention	6.13	5.63 – 7

Changes of Total Daily Sedentary Time Primary · Baseline and 8 weeks

Total daily sedentary time will be measured from 7 days of activPAL 3 device monitoring.

Baseline

Group	Value	95% CI
Cohort 1 - Control	622.5488	± 86.68241
Cohort 1 - Intervention	670.8750	± 99.19531
Cohort 2 - Intervention	640.7781	± 149.77000

Post-intervention

Group	Value	95% CI
Cohort 1 - Control	554.6351	± 68.21266
Cohort 1 - Intervention	602.8750	± 122.18354
Cohort 2 - Intervention	609.5371	± 155.22499

Changes of Prolonged Sedentary Time Primary · Baseline and 8 weeks

Prolonged sitting time (time spent sitting \>60mins) will be measured by 7 days of activPAL 3 device monitoring.

Baseline

Group	Value	95% CI
Cohort 1 - Control	262.978375	± 167.0212359
Cohort 1 - Intervention	226.240200	± 97.8064178
Cohort 2 - Intervention	187.086785	± 110.8965832

Post-intervention

Group	Value	95% CI
Cohort 1 - Control	198.121663	± 140.8557184
Cohort 1 - Intervention	147.582360	± 140.4909207
Cohort 2 - Intervention	165.056000	± 126.7480441

Changes of Sit-to-stand Transitions Primary · Baseline and 8 weeks

Number of sit-to-stand transitions will be measured by 7 days of activPAL 3 device monitoring.

Baseline

Group	Value	95% CI
Cohort 1 - Control	31.25	± 12.510
Cohort 1 - Intervention	42.80	± 9.445
Cohort 2 - Intervention	46.08	± 19.448

Post-intervention

Group	Value	95% CI
Cohort 1 - Control	32.75	± 11.298
Cohort 1 - Intervention	43.20	± 8.167
Cohort 2 - Intervention	45.31	± 15.250

Changes of Physical Activity Measured by 7 Days of activPAL Device Monitoring Secondary · Baseline and 8 weeks

Physical activity will be considered stepping time (minutes), measured by 7 days of activPAL monitoring.

Baseline

Group	Value	95% CI
Cohort 1 - Control	37.547425	± 19.0937877
Cohort 1 - Intervention	63.195200	± 18.4359097
Cohort 2 - Intervention	67.806546	± 18.0175217

Post-intervention

Group	Value	95% CI
Cohort 1 - Control	54.1757038	± 29.75937131
Cohort 1 - Intervention	75.4577200	± 60.05685663
Cohort 2 - Intervention	75.1487769	± 24.21793627

Changes of Confidence in Reducing Sedentary Behavior Measured by Using 6 Items From the Self-Efficacy Questionnaire for Physical Activity and Sedentary Behavior. Secondary · Baseline and 8 weeks

Confidence in reducing sedentary behavior will be measured using 6 items from the Self-Efficacy Questionnaire for Physical Activity and Sedentary Behavior. The items assess the level of confidence for specific sitting behaviors and sedentary breaks. Each item is a likert-type scale, ranging from 1 to 5. Higher scores mean a better outcome.

Baseline

Group	Value	95% CI
Cohort 1 - Control	3.9038	± .68874
Cohort 1 - Intervention	3.7000	± .83666
Cohort 2 - Intervention	3.9038	± .6887

Post-intervention

Group	Value	95% CI
Cohort 1 - Control	3.3750	± 1.22474
Cohort 1 - Intervention	3.8500	± 0.89443
Cohort 2 - Intervention	3.3846	± .89916

Changes of Habit Strength for Sedentary Behavior Assessed by Using the Self-Report Habit Index. Secondary · Baseline and 8 weeks

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 sca

Baseline

Group	Value	95% CI
Cohort 1 - Control	6.2143	± .63430
Cohort 1 - Intervention	6.0857	± 1.18924
Cohort 2 - Intervention	5.2967	± 1.57517

Post-intervention

Group	Value	95% CI
Cohort 1 - Control	5.8214	± 1.10327
Cohort 1 - Intervention	5.5143	± 1.24786
Cohort 2 - Intervention	5.8462	± 1.02430

Changes of 24-hour Mean Glucose Levels Assessed by Continuous Glucose Monitors Secondary · Baseline and 8 weeks

24-hour glucose levels will be measured by the use of a continuous glucose monitor over a 7-day period. The 24-hour glucose control will be evaluated by mean 24-hour glucose levels.

Baseline

Group	Value	95% CI
Cohort 1 - Control	120.7143	± 21.83052
Cohort 1 - Intervention	135.2500	± 29.15905
Cohort 2 - Intervention	129.3846	± 28.43278

Post-intervention

Group	Value	95% CI
Cohort 1 - Control	126.0000	± 56.60094
Cohort 1 - Intervention	115.7500	± 20.51625
Cohort 2 - Intervention	153.5385	± 35.08945

Adverse events — posted to ClinicalTrials.gov

Time frame: 8 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort 1 - Control

Serious: 0/10 (0%)

Deaths: 0/10

Cohort 1 - Intervention

Serious: 0/6 (0%)

Deaths: 0/6

Cohort 2 - Intervention

Serious: 0/15 (0%)

Deaths: 0/15

Other adverse events (1 terms — click to expand)

Reaction	System	Cohort 1 - Control	Cohort 1 - Intervention	Cohort 2 - Intervention
Back pain and anxiety	Musculoskeletal and connective tissue disorders	—	—	—

Data from ClinicalTrials.gov NCT05691452 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.