Technology Based Sedentary Reduction Intervention in Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 2 Diabetes, Sedentary Behavior, Physical Activity

Intervention / Treatment
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* Behavioral: Sit Less Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 by 7 days of activPAL 3 device monitoring. | Baseline and 8 weeks | 
| 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 | 
| 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 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. | 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. | Baseline and 8 weeks | 
| 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 |