Technology-Based Sedentary Reduction Intervention in Patients With Type 2 Diabetes: A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Vanderbilt University
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Level of Satisfaction With the Intervention Assessed by Lyons et al and Burner et al.'s Questionnaires
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
Intervention Group
The intervention group will target a 120 minute per day reduction in sedentary behavior using an objective activity monitor and mHealth.
Intervention: Sit Less Program (Behavioral)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Changes of Physical Activity Measured by 7 Days of activPAL Device Monitoring(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.(Baseline and 8 weeks)
- Changes of Habit Strength for Sedentary Behavior Assessed by Using the Self-Report Habit Index.(Baseline and 8 weeks)
- Changes of 24-hour Mean Glucose Levels Assessed by Continuous Glucose Monitors(Baseline and 8 weeks)
Investigators
Chorong Park
Assistant Professor
Vanderbilt University