Technology Based Sedentary Reduction Intervention in Patients With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05691452
• Other study ID #: 221566
• Status: Recruiting
• Phase: N/A
• Start date: January 24, 2023
• Est. completion date: November 11, 2024

Study information

• Verified date: January 2024
• Source: Vanderbilt University
• Contact: Chorong Park, PhD
• Phone: 6158755226
• Email: chorong.park[@]vanderbilt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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. Cohort 2 (n=10) and cohort 3 (n=10) participants will participate in the intervention.

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 information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 11, 2024
• Est. primary completion date: November 11, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Physical Activity
• Sedentary Behavior
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of satisfaction with the intervention assessed by the System Usability Scale and exit-interview	Level of satisfaction with the intervention will be assessed by using the 10-item of system usability scale. An exit interview will be conducted by the intervention among subsamples of the intervention group (n =20) during the post-intervention visit. The interview will assess the acceptability of and satisfaction with the intervention, barriers and facilitators to sedentary behavior reduction, and any alternate strategies tried by participants during the study.	8 weeks
Primary	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
Primary	Changes of total daily sedentary time	Total daily sedentary time will be measured by 7 days of activPAL 3 device monitoring.	Baseline and 8 weeks
Primary	Changes of prolonged sedentary time	Prolonged sedentary time (time spent sitting >30mins) will be measured by 7 days of activPAL 3 device monitoring.	Baseline and 8 weeks
Primary	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	Changes of physical activity measured by 7 days of activPAL device monitoring	Physical activity will be measured by 7 days of activPAL monitoring.	Baseline and 8 weeks
Secondary	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.	Baseline and 8 weeks
Secondary	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.	Baseline and 8 weeks
Secondary	Changes of 24-hour 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 and numbers of events and time in hypoglycaemia (glucose < 3.9 mmol/l), euglycaemia (glucose 3.9-7.8 mmol/l), hyperglycaemia (glucose > 7.8 mmol/l) and above target (glucose > 9 mmol/l).	Baseline and 8 weeks