Technology Based Sedentary Reduction Intervention in Patients With Type 2 Diabetes

Technology-Based Sedentary Reduction Intervention in Patients With Type 2 Diabetes: A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Physical Activity; Type 2 Diabetes; Sedentary Behavior
• Intervention / Treatment: Behavioral: Sit Less Program

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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37240
      • Vanderbilt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; The intervention group will target a 120 minute per day reduction in sedentary behavior using an objective activity monitor and mHealth.	Behavioral: Sit Less Program; The intervention group will target a 120 minute per day reduction in sedentary behavior using an objective activity monitor and mHealth. Outcomes will be measured at baseline and post-intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of Satisfaction With the Intervention Assessed by Lyons et al and Burner et al.'s Questionnaires	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.	8 weeks
Level of Compliance With the Intervention Assessed by Number of Days the Fitbit Device Was Worn	The compliance with the intervention will be assessed by number of days the Fitbit device was worn per week.	8 weeks
Changes of Total Daily Sedentary Time	Total daily sedentary time will be measured from 7 days of activPAL 3 device monitoring.	Baseline and 8 weeks
Changes of Prolonged Sedentary Time	Prolonged sitting time (time spent sitting >60mins) will be measured by 7 days of activPAL 3 device monitoring.	Baseline and 8 weeks
Changes of Sit-to-stand Transitions	Number of sit-to-stand transitions will be measured by 7 days of activPAL 3 device monitoring.	Baseline and 8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Investigators: Principal Investigator: Chorong Park, PhD, Vanderbilt University

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2023
• Primary Completion (Actual): January 5, 2024
• Study Completion (Actual): July 30, 2024

Study Registration Dates

• First Submitted: January 5, 2023
• First Submitted That Met QC Criteria: January 10, 2023
• First Posted (Actual): January 20, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 14, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: 221566

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No