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Technology Based Sedentary Reduction Intervention in Patients With Type 2 Diabetes

Primary Purpose

Type 2 Diabetes, Sedentary Behavior, Physical Activity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sit Less Program
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Vanderbilt UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Group

Arm Description

The intervention group will target a 120 minute per day reduction in sedentary behavior using an objective activity monitor and mHealth.

Outcomes

Primary Outcome Measures

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.
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.
Changes of total daily sedentary time
Total daily sedentary time will be measured by 7 days of activPAL 3 device monitoring.
Changes of prolonged sedentary time
Prolonged sedentary time (time spent sitting >30mins) will be measured by 7 days of activPAL 3 device monitoring.
Changes of sit-to-stand transitions
Number of sit-to-stand transitions will be measured by 7 days of activPAL 3 device monitoring.

Secondary Outcome Measures

Changes of physical activity measured by 7 days of activPAL device monitoring
Physical activity will be 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.
Confidence in reducing sedentary behavior will be measured using 6 items from the Self-Efficacy Questionnaire for Physical Activity and Sedentary Behavior.
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.
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).

Full Information

First Posted
January 5, 2023
Last Updated
July 21, 2023
Sponsor
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT05691452
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 24, 2023 (Actual)
Primary Completion Date
November 28, 2023 (Anticipated)
Study Completion Date
November 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Sedentary Behavior, Physical Activity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
The intervention group will target a 120 minute per day reduction in sedentary behavior using an objective activity monitor and mHealth.
Intervention Type
Behavioral
Intervention Name(s)
Sit Less Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Level of satisfaction with the intervention assessed by the System Usability Scale and exit-interview
Description
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.
Time Frame
8 weeks
Title
Level of compliance with the intervention assessed by number of days the Fitbit device was worn
Description
The compliance with the intervention will be assessed by number of days the Fitbit device was worn per week.
Time Frame
8 weeks
Title
Changes of total daily sedentary time
Description
Total daily sedentary time will be measured by 7 days of activPAL 3 device monitoring.
Time Frame
Baseline and 8 weeks
Title
Changes of prolonged sedentary time
Description
Prolonged sedentary time (time spent sitting >30mins) will be measured by 7 days of activPAL 3 device monitoring.
Time Frame
Baseline and 8 weeks
Title
Changes of sit-to-stand transitions
Description
Number of sit-to-stand transitions will be measured by 7 days of activPAL 3 device monitoring.
Time Frame
Baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Changes of physical activity measured by 7 days of activPAL device monitoring
Description
Physical activity will be measured by 7 days of activPAL monitoring.
Time Frame
Baseline and 8 weeks
Title
Changes of confidence in reducing sedentary behavior measured by using 6 items from the Self-Efficacy Questionnaire for Physical Activity and Sedentary Behavior.
Description
Confidence in reducing sedentary behavior will be measured using 6 items from the Self-Efficacy Questionnaire for Physical Activity and Sedentary Behavior.
Time Frame
Baseline and 8 weeks
Title
Changes of habit strength for sedentary behavior assessed by using the Self-Report Habit Index.
Description
Habit strength for sedentary behavior will be assessed by 7 items from the Self-Report Sedentary Behavior Habit Index.
Time Frame
Baseline and 8 weeks
Title
Changes of 24-hour glucose levels assessed by continuous glucose monitors
Description
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).
Time Frame
Baseline and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chorong Park, PhD
Phone
6158755226
Email
chorong.park@vanderbilt.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Abigail M Doyle, BS
Phone
6153436075
Email
abigail.m.doyle@vanderbilt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chorong Park, PhD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37240
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chorong Park, PhD
Phone
615-875-5226
Email
chorong.park@vanderbilt.edu
First Name & Middle Initial & Last Name & Degree
Abigail M Doyle, BS
Phone
6153436075
Email
abigail.m.doyle@vanderbilt.edu
First Name & Middle Initial & Last Name & Degree
Chorong Park, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Technology Based Sedentary Reduction Intervention in Patients With Type 2 Diabetes

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