Technology Based Sedentary Reduction Intervention in Patients With Type 2 Diabetes
Study Details
Study Description
Brief Summary
The purpose of this study is to develop and test a 12-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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The investigators propose to develop and conduct a pilot 2-arm RCT to test a wearable technology-based sedentary behavior reduction intervention in type 2 diabetes patients. Participants 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.
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 Design
Arms and Interventions
| 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.
|
| No Intervention: Control Group The control group will receive usual medical care and American Heart Association's Healthy Living booklet |
Outcome Measures
Primary Outcome Measures
- Level of satisfaction with the intervention assessed by the System Usability Scale and exit-interview [12 weeks]
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 [12 weeks]
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 [Baseline and 12 weeks]
Total daily sedentary time will be measured by 7 days of activPAL 3 device monitoring.
- Changes of prolonged sedentary time [Baseline and 12 weeks]
Prolonged sedentary time (time spent sitting >30mins) will be measured by 7 days of activPAL 3 device monitoring.
- Changes of sit-to-stand transitions [Baseline and 12 weeks]
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 [Baseline and 12 weeks]
Physical activity will be measured by 7 days of activPAL monitoring.
- Changes of cholesterols measured by blood dried spot card [Baseline and 12 weeks]
Fasting cholesterols will be measured by blood dried spot card. For blood samples, participants will fast overnight (at least 8 hours). The trained RA will conduct a finger prick and 8-9 drops of blood will be obtained on a dried blood spot card.
- Changes of insulin levels measured by blood dried spot card [Baseline and 12 weeks]
Insulin levels will be measured by blood dried spot card. For blood samples, participants will fast overnight (at least 8 hours). The trained RA will conduct a finger prick and 8-9 drops of blood will be obtained on a dried blood spot card.
- Changes of HbA1C measured by blood dried spot card [Baseline and 12 weeks]
HbA1c will be measured by blood dried spot card. For blood samples, participants will fast overnight (at least 8 hours). The trained RA will conduct a finger prick and 8-9 drops of blood will be obtained on a dried blood spot card.
- Changes of fasting glucose measured by blood dried spot card [Baseline and 12 weeks]
Fasting glucose will be measured by blood dried spot card. For blood samples, participants will fast overnight (at least 8 hours). The trained RA will conduct a finger prick and 8-9 drops of blood will be obtained on a dried blood spot card.
- Changes of hs-CRP measured by blood dried spot card [Baseline and 12 weeks]
Hs-CRP will be measured by blood dried spot card. For blood samples, participants will fast overnight (at least 8 hours). The trained RA will conduct a finger prick and 8-9 drops of blood will be obtained on a dried blood spot card.
- 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 12 weeks]
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. [Baseline and 12 weeks]
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 [Baseline and 12 weeks]
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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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ages 18 and above
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diagnosed with type 2 diabetes
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self-report of sitting ≥ 8hr/day
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ability to stand and walk
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ownership of a smartphone.
Exclusion Criteria:
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currently using an activity tracker
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currently participating in exercise or other research programs
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non-English speaking
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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
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currently pregnant
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Vanderbilt University | Nashville | Tennessee | United States | 37240 |
Sponsors and Collaborators
- Vanderbilt University
Investigators
- Principal Investigator: Chorong Park, PhD, Vanderbilt University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 221566