Technology Based Sedentary Reduction Intervention in Patients With Type 2 Diabetes

Not Applicable

Completed

Conditions: Physical Activity
Type 2 Diabetes
Sedentary Behavior

Interventions: Behavioral: Sit Less Program

Registration Number: NCT05691452

Lead Sponsor: Vanderbilt University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 31

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Group	Sit Less Program	The intervention group will target a 120 minute per day reduction in sedentary behavior using an objective activity monitor and mHealth.

Primary Outcome Measures

Name	Time	Method
Level of Satisfaction With the Intervention Assessed by Lyons et al and Burner et al.'s Questionnaires	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	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	Baseline and 8 weeks	Total daily sedentary time will be measured from 7 days of activPAL 3 device monitoring.
Changes of Prolonged Sedentary Time	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	Baseline and 8 weeks	Number of sit-to-stand transitions will be measured by 7 days of activPAL 3 device monitoring.

Secondary Outcome Measures

Name	Time	Method
Changes of Physical Activity Measured by 7 Days of activPAL Device Monitoring	Baseline and 8 weeks	Physical activity will be considered stepping time (minutes), measured by 7 days of activPAL monitoring.
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	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.
Changes of Habit Strength for Sedentary Behavior Assessed by Using the Self-Report Habit Index.	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 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.
Changes of 24-hour Mean Glucose Levels Assessed by Continuous Glucose Monitors	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.