Evaluation of a Smartphone Intervention to Reduce Sedentary Behavior

Study Overview
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Brief Summary
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Participants (N = 300) will be randomly assigned to: 1) an equipment-only comparison group that receives a smartphone and an activity monitor wristband but does not receive smartphone intervention prompts, or 2) the intervention group who will receive an activity monitor wristband that works in conjunction with a smartphone to reduce sedentary time via smartphone prompts during prolonged sedentary bouts. All participants will be provided with a Fitbit® wristband activity monitor and an Android smartphone on the same day of the week (i.e., Mondays). Participants will complete a 1-week baseline accelerometer and EMA period prior to the start of the intervention. Participants will be followed for 26 weeks after the intervention begins with follow-up visits at 6, 13, and 26 weeks. The primary outcome will be accelerometer-measured time spent in sedentary activity. Sedentary breaks, total active time, and time spent in light, moderate, and vigorous activity will be additionally evaluated as outcomes. Contextual variables and potential treatment mechanisms will be assessed via traditional questionnaire measurement and daily random EMAs at baseline and all follow-up visits. Brief smartphone-based daily diary assessments will be completed daily for the duration of the study.

Official Title
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Evaluation of a Smartphone Intervention to Reduce Sedentary Behavior

Conditions
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Risk Reduction Behavior

Intervention / Treatment
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* Device: Smartphone with prompts
* Device: Wristband
* Device: Smartphone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A score of ≥ 4 on the REALM-SF85 indicating > 6th grade English literacy level, must be at least 18 years of age A BMI ≥ 25 (overweight/obese), not meeting current physical activity guidelines as measured by the 7-Day Physical Activity Recall Do not have a contraindication for physical activity based on the Physical Activity Readiness Questionnaire (PAR-Q) Able to attend all study visits, and possess a valid home address and a functioning telephone number. Exclusion Criteria: Participants who have physical disabilities that restrict lower limb function and/or reading skills below a 7th grade reading level.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Comparison group<br>Equipment only comparison group will use Smartphone and Wristband to monitor sedentary behavior | Device: Wristband<br>* Wristband will monitor activity of all participants<br>* Other names: Fitbit;Device: Smartphone<br>* Smartphone will be used to monitor activity but prompts will not be given to randomly selected participants<br>* Other names: Android;|
| Experimental: Intervention group<br>Intervention group will receive prompts from Smartphone to reduce sedentary behavior using information from Wristband | Device: Smartphone with prompts<br>* Smartphone will be used to prompt randomly selected participants in intervention group to be active<br>* Other names: Android Smartphone;Device: Wristband<br>* Wristband will monitor activity of all participants<br>* Other names: Fitbit;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accelerometer-measured sedentary time | Total accelerometer-measured time spent in sedentary activity | One week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accelerometer-measured sedentary breaks | Accelerometer-measured time spent in sedentary activity | 26 weeks | 
| Accelerometer-measured total active time | Total active time | 26 weeks | 
| Accelerometer-measured time spent in light, moderate, and vigorous activity | Total time spent in light, moderate, and vigorous activity | 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smartphone, sedentary behavior, smartphone intervention