Clinical trial NCT05691452: Technology Based Sedentary Reduction Intervention in Patients With Type 2 Diabetes
Official title: Technology-Based Sedentary Reduction Intervention in Patients With Type 2 Diabetes: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Sedentary Behavior
Physical Activity
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Level of Satisfaction With the Intervention Assessed by Lyons et al and Burner et al.'s Questionnaires
timeFrame: 8 weeks
measure: Level of Compliance With the Intervention Assessed by Number of Days the Fitbit Device Was Worn
timeFrame: 8 weeks
measure: Changes of Total Daily Sedentary Time
timeFrame: Baseline and 8 weeks
measure: Changes of Prolonged Sedentary Time
timeFrame: Baseline and 8 weeks
measure: Changes of Sit-to-stand Transitions
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Changes of Physical Activity Measured by 7 Days of activPAL Device Monitoring
timeFrame: Baseline and 8 weeks
measure: Changes of Confidence in Reducing Sedentary Behavior Measured by Using 6 Items From the Self-Efficacy Questionnaire for Physical Activity and Sedentary Behavior.
timeFrame: Baseline and 8 weeks
measure: Changes of Habit Strength for Sedentary Behavior Assessed by Using the Self-Report Habit Index.
timeFrame: Baseline and 8 weeks
measure: Changes of 24-hour Mean Glucose Levels Assessed by Continuous Glucose Monitors
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Chorong Park, PhD
role: PRINCIPAL_INVESTIGATOR
References: