The eMOTION Study is a two-part ORBIT model phase 1 trial. The first part, called the Formative Study, will assess acceptability and feasibility of a novel physical activity intervention in adults at increased risk for cancer due to overweight or obesity.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Safety Benchmark: Percentage of Participants Experiencing an Adverse Event
Timeframe: Event onset reported as from first day of run-in period (i.e., day 1) to one week post-data collection (week 4)
Efficacy Benchmark: Percentage of Participants With Increased Physical Activity Enjoyment
Timeframe: Reported at 3 weeks (i.e., post-study)
Accessibility/Usability Benchmark: System Usability Scale Score (0 to 100) for Daily Goal Sessions & Fitbit
Timeframe: Reported at 3 weeks (i.e., post-study)
Accessibility/Usability Benchmark: Percentage of Participants Rating Daily Goal Sessions and Fitbit Interface as Accessible
Timeframe: Reported at 3 weeks (i.e., post-study)
Accessibility/Usability Benchmark: Physical Activity Recommendations Appropriately Consider Reported Constraints
Timeframe: Assessed on date of baseline questionnaire completion and at 3 weeks (i.e., post-study)
Accessibility/Usability Benchmark: Percentage of Participants Rating Savoring Exercises as Accessible
Timeframe: Reported at 3 weeks (i.e., post-study)
Sustainability/Feasibility Benchmark: Fidelity of Auto-detection Algorithm
Timeframe: From first full day of intervention (i.e., day 8) to last day of data collection (i.e., day 21)
Sustainability/Feasibility Benchmark: Research Staff Burden
Timeframe: From first day of run-in period (i.e., day 1) to last day of data collection (i.e., day 21)
Sustainability/Feasibility Benchmark: Satisfaction With Fitbit and Daily Goal Session Components
Timeframe: Reported at 3 weeks (i.e., post-study)
Sustainability/Feasibility Benchmark: Dissatisfaction With TYPE/CONTEXT Recommendations
Timeframe: Reported at 3 weeks (i.e., post-study)
Sustainability/Feasibility Benchmark: Dissatisfaction With SAVOR Questions
Timeframe: Reported at 3 weeks (i.e., post-study)
Equity Benchmark: Accessibility/Usability Approximately Equal for Males vs. Females
Timeframe: Reported at 3 weeks (i.e., post-study)
Equity Benchmark: Efficacy Approximately Equal for Males vs. Females
Timeframe: Reported at 3 weeks (i.e., post-study)
Equity Benchmark: Accessibility/Usability Approximately Equal for White vs. Non-white Participants
Timeframe: Reported at 3 weeks (i.e., post-study)
Equity Benchmark: Efficacy Approximately Equal for White vs. Non-white Participants
Timeframe: Reported at 3 weeks (i.e., post-study)
Equity Benchmark: Accessibility/Usability Approximately Equal for Hispanic vs. Non-Hispanic Participants
Timeframe: Reported at 3 weeks (i.e., post-study)
Equity Benchmark: Efficacy Approximately Equal for Hispanic vs. Non-Hispanic Participants
Timeframe: Reported at 3 weeks (i.e., post-study)
Equity Benchmark: Accessibility/Usability Approximately Equal Across Income Categories
Timeframe: Reported at 3 weeks (i.e., post-study)
Equity Benchmark: Efficacy Approximately Equal Across Income Categories
Timeframe: Reported at 3 weeks (i.e., post-study)
Equity Benchmark: Accessibility/Usability Approximately Equal Across Age Categories
Timeframe: Reported at 3 weeks (i.e., post-study)
Equity Benchmark: Efficacy Approximately Equal Across Age Categories
Timeframe: Reported at 3 weeks (i.e., post-study)
Equity Benchmark: Accessibility/Usability Approximately Equal for Participants With Overweight vs. Obesity
Timeframe: Reported at 3 weeks (i.e., post-study)
Equity Benchmark: Efficacy Approximately Equal for Participants With Overweight vs. Obesity
Timeframe: Reported at 3 weeks (i.e., post-study)
Equity Benchmark: Accessibility/Usability Approximately Equal Across Mobility Categories
Timeframe: Reported at 3 weeks (i.e., post-study)
Equity Benchmark: Efficacy Approximately Equal Across Mobility Categories
Timeframe: Reported at 3 weeks (i.e., post-study)
Equity Benchmark: Accessibility/Usability Approximately Equal Across Physical Constraint Categories
Timeframe: Reported at 3 weeks (i.e., post-study)
Equity Benchmark: Efficacy Approximately Equal Across Physical Constraint Categories
Timeframe: Reported at 3 weeks (i.e., post-study)