Technology Based Sedentary Reduction Intervention in Patients With Type 2 Diabetes

NCT05691452 | Completed Results

• 1 other identifier: 221566
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; Sedentary Behavior; Physical Activity

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• 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

Study Arms (1)

Intervention Group

EXPERIMENTAL

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

Interventions

Sit Less Program BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37240, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Sedentary Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Results Point of Contact

• Title: Dr. Chorong Park
• Organization: Vanderbilt University School of Nursing

chorong.park@vanderbilt.edu

6153436075

Study Officials

• Chorong Park, PhD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: January 20, 2023
• Study Start: January 24, 2023
• Primary Completion: January 5, 2024
• Study Completion: July 30, 2024
• Last Updated: March 19, 2025
• Results First Posted: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)