N/A
N=37
eMOTION Formative Study
Physical Inactivity · Overweight or Obesity · Cancer
Bottom Line
View on ClinicalTrials.gov: NCT06125964 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Safety Benchmark: Percentage of Participants Experiencing an Adverse Event — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intensity-Based Goals (Behavioral); Affect-Based Goals (Behavioral); TYPE/CONTEXT Enhancement (Behavioral); SAVOR Enhancement (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Southern California
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety Benchmark: Percentage of Participants Experiencing an Adverse Event |
0; 0; 0; 0; 9; 9 | — |
| PRIMARY Efficacy Benchmark: Percentage of Participants With Increased Physical Activity Enjoyment |
2; 14; 6; 13; 0; 0 | — |
| PRIMARY Accessibility/Usability Benchmark: System Usability Scale Score (0 to 100) for Daily Goal Sessions & Fitbit |
72.4306; 73.0556 | — |
| PRIMARY Accessibility/Usability Benchmark: Percentage of Participants Rating Daily Goal Sessions and Fitbit Interface as Accessible |
1; 34; 1; 3; 32; 1 | — |
| PRIMARY Accessibility/Usability Benchmark: Physical Activity Recommendations Appropriately Consider Reported Constraints |
40; 50; 50; 25 | — |
| PRIMARY Accessibility/Usability Benchmark: Percentage of Participants Rating Savoring Exercises as Accessible |
12; 2; 12; 2 | — |
| PRIMARY Sustainability/Feasibility Benchmark: Fidelity of Auto-detection Algorithm |
1555; 0 | — |
| PRIMARY Sustainability/Feasibility Benchmark: Research Staff Burden |
0; 36; 0; 36 | — |
| PRIMARY Sustainability/Feasibility Benchmark: Satisfaction With Fitbit and Daily Goal Session Components |
30; 6; 0; 24; 12; 0 | — |
| PRIMARY Sustainability/Feasibility Benchmark: Dissatisfaction With TYPE/CONTEXT Recommendations |
10; 3 | — |
| PRIMARY Sustainability/Feasibility Benchmark: Dissatisfaction With SAVOR Questions |
12; 0 | — |
| PRIMARY Equity Benchmark: Accessibility/Usability Approximately Equal for Males vs. Females |
11; 12; 6; 7; 13; 13 | — |
| PRIMARY Equity Benchmark: Efficacy Approximately Equal for Males vs. Females |
6; 10; 11; 8; 0; 1 | — |
| PRIMARY Equity Benchmark: Accessibility/Usability Approximately Equal for White vs. Non-white Participants |
19; 4; 12; 1; 21; 5 | — |
| PRIMARY Equity Benchmark: Efficacy Approximately Equal for White vs. Non-white Participants |
12; 4; 18; 1; 1; 0 | — |
| PRIMARY Equity Benchmark: Accessibility/Usability Approximately Equal for Hispanic vs. Non-Hispanic Participants |
2; 21; 2; 11; 2; 24 | — |
| PRIMARY Equity Benchmark: Efficacy Approximately Equal for Hispanic vs. Non-Hispanic Participants |
1; 15; 3; 16; 0; 1 | — |
| PRIMARY Equity Benchmark: Accessibility/Usability Approximately Equal Across Income Categories |
1; 3; 6; 4; 9; 2 | — |
| PRIMARY Equity Benchmark: Efficacy Approximately Equal Across Income Categories |
0; 1; 8; 3; 4; 3 | — |
| PRIMARY Equity Benchmark: Accessibility/Usability Approximately Equal Across Age Categories |
3; 6; 8; 6; 6; 3 | — |
| PRIMARY Equity Benchmark: Efficacy Approximately Equal Across Age Categories |
5; 2; 4; 5; 4; 7 | — |
| PRIMARY Equity Benchmark: Accessibility/Usability Approximately Equal for Participants With Overweight vs. Obesity |
8; 15; 4; 9; 10; 16 | — |
| PRIMARY Equity Benchmark: Efficacy Approximately Equal for Participants With Overweight vs. Obesity |
5; 11; 6; 13; 1; 0 | — |
| PRIMARY Equity Benchmark: Accessibility/Usability Approximately Equal Across Mobility Categories |
6; 6; 6; 5; 3; 3 | — |
| PRIMARY Equity Benchmark: Efficacy Approximately Equal Across Mobility Categories |
5; 4; 5; 2; 3; 5 | — |
| PRIMARY Equity Benchmark: Accessibility/Usability Approximately Equal Across Physical Constraint Categories |
10; 9; 4; 5; 3; 5 | — |
| PRIMARY Equity Benchmark: Efficacy Approximately Equal Across Physical Constraint Categories |
6; 7; 3; 8; 5; 6 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- adults aged ≥18 years
- residing in the United States
- self-reported BMI ≥ 25
- currently engaging in < 60 minutes per week of structured physical activity
- owning a personal smartphone device
- residing in an area with Internet or Wi-Fi connectivity during the study period
- able to speak and read in English
- interested and willing to start a physical activity program
- willing to wear a Fitbit Versa smartwatch provided by the study team everyday continuously (including at work and during physical activity), in place of any Fitbits or smartwatches they previously wore, for the duration of the study period
- able to read the small font on a smartwatch screen without glasses, or willing to carry reading glasses during physical activity for the purpose of reading the smartwatch screen
Exclusion Criteria
- unable to provide informed consent due to cognitive disability
- unable to engage in one or more key treatment components, including those with medical conditions that preclude physical activity engagement or who cannot wear an accelerometer on the wrist for any reason
- currently pregnant
Data sourced from ClinicalTrials.gov (NCT06125964). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.