N/A
N=31
Technology Based Sedentary Reduction Intervention in Patients With Type 2 Diabetes
Type 2 Diabetes · Sedentary Behavior · Physical Activity
Bottom Line
View on ClinicalTrials.gov: NCT05691452 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Level of Satisfaction With the Intervention Assessed by Lyons et al and Burner et al.'s Questionnaires — 5; 4; 5; 4 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sit Less Program (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Level of Satisfaction With the Intervention Assessed by Lyons et al and Burner et al.'s Questionnaires |
5; 4; 5; 4; 5; 5 | — |
| PRIMARY Level of Compliance With the Intervention Assessed by Number of Days the Fitbit Device Was Worn |
6.58; 6.13 | — |
| PRIMARY Changes of Total Daily Sedentary Time |
622.5488; 670.8750; 640.7781; 554.6351; 602.8750; 609.5371 | 0.578 |
| PRIMARY Changes of Prolonged Sedentary Time |
262.978375; 226.240200; 187.086785; 198.121663; 147.582360; 165.056000 | 0.61 |
| PRIMARY Changes of Sit-to-stand Transitions |
31.25; 42.80; 46.08; 32.75; 43.20; 45.31 | 0.674 |
| SECONDARY Changes of Physical Activity Measured by 7 Days of activPAL Device Monitoring |
37.547425; 63.195200; 67.806546; 54.1757038; 75.4577200; 75.1487769 | .013 sig |
| SECONDARY Changes of Confidence in Reducing Sedentary Behavior Measured by Using 6 Items From the Self-Efficacy Questionnaire for Physical Activity and Sedentary Behavior. |
3.9038; 3.7000; 3.9038; 3.3750; 3.8500; 3.3846 | 0.29 |
| SECONDARY Changes of Habit Strength for Sedentary Behavior Assessed by Using the Self-Report Habit Index. |
6.2143; 6.0857; 5.2967; 5.8214; 5.5143; 5.8462 | 0.701 |
| SECONDARY Changes of 24-hour Mean Glucose Levels Assessed by Continuous Glucose Monitors |
120.7143; 135.2500; 129.3846; 126.0000; 115.7500; 153.5385 | 0.376 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- ages 18 and above
- diagnosed with type 2 diabetes
- self-reported HbA1C 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
Data sourced from ClinicalTrials.gov (NCT05691452). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.