Real-time Behavioral Interventions

Study Overview
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Brief Summary
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The goal of this study is to adapt an evidence-based sedentary behavior reduction intervention for men and women living in Alabama and determine its feasibility, acceptance, and limited efficacy.

Detailed Description
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The goal of this study is to adapt an evidence-based sedentary behavior reduction intervention for men and women living in Alabama and determine its feasibility, acceptance, and limited efficacy. Community-based Participatory Research methods will be used to adapt an evidence-based curriculum. The adapted curriculum will be delivered via print-based materials and a mobile phone app developed by an external collaborator.

Official Title
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Just-in-Time Adaptive Intervention to Reduce Sedentary Behavior

Conditions
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Cancer, Aging, Comorbidities and Coexisting Conditions

Intervention / Treatment
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* Behavioral: Just-in-Time Adaptive Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • 50 to 75 years old at study enrollment; Currently living in Alabama; Community-dwelling (i.e., not living in an assisted living facility or nursing home); Having access to the internet and a smart phone; Able to perform light-intensity physical activity (i.e., walking); English speaking; Willing to consent to study procedure. Exclusion Criteria: Reporting more than 60 minutes of purposeful physical activity per week; Have an unstable mental condition that prevention study activities. Determined by the Physician Health questionnaire.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 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
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Micro-randomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Secular Image<br>Secular Image | Behavioral: Just-in-Time Adaptive Intervention<br>* Randomized factorial design<br>|
| Experimental: Non-secular image<br>non-secular images | Behavioral: Just-in-Time Adaptive Intervention<br>* Randomized factorial design<br>|
| Experimental: Secular message<br>secular messages | Behavioral: Just-in-Time Adaptive Intervention<br>* Randomized factorial design<br>|
| Experimental: Non-secular message<br>non-secular messages | Behavioral: Just-in-Time Adaptive Intervention<br>* Randomized factorial design<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usage | To percentage of time participants were complying with the study protocol | 16 weeks | 
| The Usage, Satisfaction, Ease of use Questionnaire | Questionnaire that assesses usage, satisfaction, and ease of use of technology. Each subscale has a maximum score of 20, with higher scores indicating a better outcome. | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sedentary time | Accelerometer determined breaks in inactivity during waking hours | Week 0 and Week 16 | 
| Change in light-intensity physical activity | Accelerometer determined activity | Week 0 and Week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical activity, ecological momentary assessment, health-related quality of life, Just-in-time adaptive intervention