eMOTION Formative Study

Not Applicable

Completed

Conditions: Cancer
Physical Inactivity
Overweight or Obesity

Registration Number: NCT06125964

Lead Sponsor: University of Southern California

Brief 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.

Detailed Description: The eMOTION Study is a two-part ORBIT model phase 1 trial. The first part of the eMOTION Study, the Formative Study, will iteratively test and refine the implementation of a novel treatment to manipulate affective mechanisms during physical activity among individuals at higher risk for cancer due to overweight or obesity. Acceptability and feasibility of content, delivery, device usage, engagement, and achieving clinically meaningful changes in affective mechanisms will be addressed. Treatment components targeting intensity-based goals and affect-based goals will be tested separately in four groups.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 47

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Safety Benchmark: Percentage of Participants Experiencing an Adverse Event	Event onset reported as from first day of run-in period (i.e., day 1) to one week post-data collection (week 4)	An adverse event is that which is unexpected, related or possibly related to the study procedures, and serious (adversely affecting the balance of risks and benefits to participation, including incidents that require hospitalization, specialist treatment, or medical intervention). This refers to any adverse event that can be reasonably determined (at least in part) to be due to the study procedures and not due to a participant's underlying medical conditions or risk factor profile alone. This is assessed by official University of Southern California Institutional Review Board reporting procedures. The study's official "go/no-go" criterion is that less than 1% of participants experience an adverse event during the study.
Efficacy Benchmark: Percentage of Participants With Increased Physical Activity Enjoyment	Reported at 3 weeks (i.e., post-study)	During the exit interview, participants compare their experience with physical activity before and after participation in the eMOTION Study and are asked if they personally feel as if the degree of enjoyment they feel while engaging in physical activity changed or stayed the same. The percentage of participants responding affirmatively will be calculated. The "go/no-go criterion" is that ≥51% of participants in the affect-based conditions report a perceived increase in enjoyment of physical activity.
Accessibility/Usability Benchmark: System Usability Scale Score (0 to 100) for Daily Goal Sessions & Fitbit	Reported at 3 weeks (i.e., post-study)	In the Post-Study Questionnaire, participants will rate the usability of the eMOTION Study's daily goal sessions and Fitbit Versa protocol via the System Usability Scale (SUS). The SUS has 10 items, and participants indicate their degree of agreement with each statement on a 5-point Likert scale ranging from "strongly disagree" (1) to "strongly agree" (5). The SUS is then scored by summing across items (all items are first rescored to a 0 to 4 scale, and even items are reverse-scored before summing) and then multiplying the sum by 2.5. The study's go/no-go criterion is that both the daily goal sessions and Fitbit protocols receive at least an average score (≥68) on the SUS.
Accessibility/Usability Benchmark: Percentage of Participants Rating Daily Goal Sessions and Fitbit Interface as Accessible	Reported at 3 weeks (i.e., post-study)	The degree of accessibility of the daily goal sessions and fitbit interface for the study will also be assessed in the exit interview. Specifically, participants are asked a series of questions about whether they were able to read, understand, and select answers for Fitbit watch face surveys and use the exercise settings. They are also asked if they were able to red and understand the daily goal sessions on their phone. The go/no-go criterion is that at least 51% of participants respond affirmatively for each facet.
Accessibility/Usability Benchmark: Physical Activity Recommendations Appropriately Consider Reported Constraints	Assessed on date of baseline questionnaire completion and at 3 weeks (i.e., post-study)	Participants are asked to indicate whether they have any constraints limiting their engagement in specific physical activity types or contexts as part of the baseline questionnaire. They also rate the relative importance of each of the psychological needs to them personally at baseline. For participants who receive the TYPE/CONTEXT enhancement with the affect-based goals, an algorithm produces physical activity recommendations based on their psychological needs that also considers their reported constraints. During the exit interview, participants in this group are asked whether they were able to follow the physical activity recommendations. The go/no-go criterion is that there is no pattern between the number of constraints reported at baseline and participants' reported ability to follow activity recommendations; therefore, we qualitatively compared the mean percentage of recommendations that participants could follow across constraint quartiles.
Accessibility/Usability Benchmark: Percentage of Participants Rating Savoring Exercises as Accessible	Reported at 3 weeks (i.e., post-study)	During the exit interview, participants who received the SAVOR enhancement with the affect-based goals will be asked whether they were generally able to understand and follow the savoring questions they received. The go/no-go criterion for accessibility is that ≥51% of participants reported being able to understand and follow the savoring questions.
Sustainability/Feasibility Benchmark: Fidelity of Auto-detection Algorithm	From first full day of intervention (i.e., day 8) to last day of data collection (i.e., day 21)	Event-contingent surveys are triggered when Fitbit sensors detect physical activity via sufficiently-elevated 10-min rolling average heart rate (i.e., 55 to 60% of age-adjusted heart rate maximum). Using Fitabase data exports, the investigators will determine the percentage of correctly triggered surveys. The go/no-go criterion is that the auto-detection algorithm for physical activity correctly triggers event-contingent surveys ≥51% of the time.
Sustainability/Feasibility Benchmark: Research Staff Burden	From first day of run-in period (i.e., day 1) to last day of data collection (i.e., day 21)	This benchmark determines if the level of burden for research staff is sustainable/feasible related to Fitbit technological and connectivity issues. Staff track Fitbit inventory and document technical difficulties that require a replacement device, as well as record all instances where they have to remind participants to sync the data in their Fitbit app due to \> 48 h elapsing without data reaching Fitabase servers. Go/no-go criteria are that, over the course of the study, \< 25% of participants need a replacement Fitbit due to technological issues and \< 25% of participants are sent repeated (i.e., \>1) reminders to sync their data.
Sustainability/Feasibility Benchmark: Satisfaction With Fitbit and Daily Goal Session Components	Reported at 3 weeks (i.e., post-study)	The Delighted-Terrible Scale was used to assess how participants felt about the study's Fitbit and smartphone functions in the post-study questionnaire. Items asked how they felt about the Fitbit smartwatch exercise settings, notifications to complete surveys, and survey frequency and length (i.e., burden); as well as how they felt about the smartphone-based daily goal sessions and Fitbit app. Response options are: feeling delighted (7), pleased (6), mostly satisfied (5), mixed- about equally satisfied and dissatisfied (4), mostly dissatisfied (3), unhappy (2), terrible (1) -- OR -- neutral- neither satisfied nor dissatisfied (a), or never thought about it (b). The go/no-go criterion is that \<70% of participants report feeling dissatisfied (considered to be a score of 1, 2, or 3) with any of the items.
Sustainability/Feasibility Benchmark: Dissatisfaction With TYPE/CONTEXT Recommendations	Reported at 3 weeks (i.e., post-study)	During the post-study questionnaire, participants who received recommendations for the specific types or contexts of physical activity to do (i.e., were in the affect-based goals + TYPE/CONTEXT or affect-based goals + TYPE/CONTEXT + SAVOR groups) will complete the Delighted-Terrible Scale. They are asked how they felt about the physical activity type/context recommendations they received. Response options are feeling delighted (7), pleased (6), mostly satisfied (5), mixed- about equally satisfied and dissatisfied (4), mostly dissatisfied (3), unhappy (2), terrible (1) -- OR -- neutral- neither satisfied nor dissatisfied (a), or never thought about it (b). The go/no-go criterion is that \<70% of participants report feeling dissatisfied (score of 1 to 3) with physical activity recommendations.
Sustainability/Feasibility Benchmark: Dissatisfaction With SAVOR Questions	Reported at 3 weeks (i.e., post-study)	During the post-study questionnaire, participants in the affect-based goals + SAVOR or affect-based goals + TYPE/CONTEXT + SAVOR groups will complete the validated Delighted-Terrible Scale. They are asked how they felt about the savoring questions they received. Response options are: feeling delighted (7), pleased (6), mostly satisfied (5), mixed- about equally satisfied and dissatisfied (4), mostly dissatisfied (3), unhappy (2), terrible (1) -- OR -- neutral- neither satisfied nor dissatisfied (a), or never thought about it (b). The go/no-go criterion is that \<70% of participants report feeling dissatisfied (score of 1 to 3) with savoring questions.
Equity Benchmark: Accessibility/Usability Approximately Equal for Males vs. Females	Reported at 3 weeks (i.e., post-study)	Equity was explored based on whether accessibility/usability were approximately the same between males vs. females. The percentage of participants who rated the daily goal sessions and Fitbit protocol as sufficiently accessible/usable (i.e., scored the daily goal sessions and Fitbit protocol at-or-above the System Usability Scale's validated cutoff of 68) were calculated.
Equity Benchmark: Efficacy Approximately Equal for Males vs. Females	Reported at 3 weeks (i.e., post-study)	Equity was explored based on whether efficacy was approximately the same between males vs. females. The percentage of participants who reported experiencing (i.e., efficacious) or not experiencing (i.e., not efficacious) an increase in enjoyment for physical activity during the study were calculated.
Equity Benchmark: Efficacy Approximately Equal for Hispanic vs. Non-Hispanic Participants	Reported at 3 weeks (i.e., post-study)	Equity was explored based on whether efficacy was approximately the same between Hispanic vs. non-Hispanic participants. The percentage of participants who reported experiencing (i.e., efficacious) or not experiencing (i.e., not efficacious) an increase in enjoyment for physical activity during the study were calculated.
Equity Benchmark: Accessibility/Usability Approximately Equal Across Income Categories	Reported at 3 weeks (i.e., post-study)	Equity was explored based on whether accessibility/usability was approximately the same between various income categories. The percentage of participants who rated the daily goal sessions and Fitbit protocol as sufficiently accessible/usable (i.e., scored the daily goal sessions and Fitbit protocol at-or-above the System Usability Scale's validated cutoff of 68) were calculated.
Equity Benchmark: Efficacy Approximately Equal Across Income Categories	Reported at 3 weeks (i.e., post-study)	Equity was explored based on whether efficacy was approximately the same between various income categories. The percentage of participants who reported experiencing (i.e., efficacious) or not experiencing (i.e., not efficacious) an increase in enjoyment for physical activity during the study were calculated.
Equity Benchmark: Accessibility/Usability Approximately Equal Across Age Categories	Reported at 3 weeks (i.e., post-study)	Equity was explored based on whether accessibility/usability was approximately the same between age quartiles. The percentage of participants who rated the daily goal sessions and Fitbit protocol as sufficiently accessible/usable (i.e., scored the daily goal sessions and Fitbit protocol at-or-above the System Usability Scale's validated cutoff of 68) were calculated.
Equity Benchmark: Accessibility/Usability Approximately Equal for White vs. Non-white Participants	Reported at 3 weeks (i.e., post-study)	Equity was explored based on whether accessibility/usability was approximately the same between white vs. non-white participants. The percentage of participants who rated the daily goal sessions and Fitbit protocol as sufficiently accessible/usable (i.e., scored the daily goal sessions and Fitbit protocol at-or-above the System Usability Scale's validated cutoff of 68) were calculated.
Equity Benchmark: Efficacy Approximately Equal for White vs. Non-white Participants	Reported at 3 weeks (i.e., post-study)	Equity was explored based on whether efficacy was approximately the same between white vs. non-white participants. The percentage of participants who reported experiencing (i.e., efficacious) or not experiencing (i.e., not efficacious) an increase in enjoyment for physical activity during the study were calculated.
Equity Benchmark: Efficacy Approximately Equal Across Age Categories	Reported at 3 weeks (i.e., post-study)	Equity was explored based on whether efficacy was approximately the same between age quartiles. The percentage of participants who reported experiencing (i.e., efficacious) or not experiencing (i.e., not efficacious) an increase in enjoyment for physical activity during the study were calculated.
Equity Benchmark: Accessibility/Usability Approximately Equal for Participants With Overweight vs. Obesity	Reported at 3 weeks (i.e., post-study)	Equity was explored based on whether accessibility/usability was approximately the same between participants with overweight vs. obesity. The percentage of participants who rated the daily goal sessions and Fitbit protocol as sufficiently accessible/usable (i.e., scored the daily goal sessions and Fitbit protocol at-or-above the System Usability Scale's validated cutoff of 68) were calculated.
Equity Benchmark: Efficacy Approximately Equal for Participants With Overweight vs. Obesity	Reported at 3 weeks (i.e., post-study)	Equity was explored based on whether efficacy was approximately the same between participants with overweight vs. obesity. The percentage of participants who reported experiencing (i.e., efficacious) or not experiencing (i.e., not efficacious) an increase in enjoyment for physical activity during the study were calculated.
Equity Benchmark: Accessibility/Usability Approximately Equal Across Mobility Categories	Reported at 3 weeks (i.e., post-study)	Equity was explored based on whether accessibility/usability was approximately the same between mobility quartiles. The percentage of participants who rated the daily goal sessions and Fitbit protocol as sufficiently accessible/usable (i.e., scored the daily goal sessions and Fitbit protocol at-or-above the System Usability Scale's validated cutoff of 68) were calculated.
Equity Benchmark: Efficacy Approximately Equal Across Mobility Categories	Reported at 3 weeks (i.e., post-study)	Equity was explored based on whether efficacy was approximately the same between mobility quartiles. The percentage of participants who reported experiencing (i.e., efficacious) or not experiencing (i.e., not efficacious) an increase in enjoyment for physical activity during the study were calculated.
Equity Benchmark: Accessibility/Usability Approximately Equal Across Physical Constraint Categories	Reported at 3 weeks (i.e., post-study)	Equity was explored based on whether accessibility/usability was approximately the same between physical constraint tertiles. The percentage of participants who rated the daily goal sessions and Fitbit protocol as sufficiently accessible/usable (i.e., scored the daily goal sessions and Fitbit protocol at-or-above the System Usability Scale's validated cutoff of 68) were calculated.
Equity Benchmark: Efficacy Approximately Equal Across Physical Constraint Categories	Reported at 3 weeks (i.e., post-study)	Equity was explored based on whether efficacy was approximately the same between physical constraint categories. The percentage of participants who reported experiencing (i.e., efficacious) or not experiencing (i.e., not efficacious) an increase in enjoyment for physical activity during the study were calculated.
Equity Benchmark: Accessibility/Usability Approximately Equal for Hispanic vs. Non-Hispanic Participants	Reported at 3 weeks (i.e., post-study)	Equity was explored based on whether accessibility/usability was approximately the same between Hispanic vs. non-Hispanic participants. The percentage of participants who rated the daily goal sessions and Fitbit protocol as sufficiently accessible/usable (i.e., scored the daily goal sessions and Fitbit protocol at-or-above the System Usability Scale's validated cutoff of 68) were calculated.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): University of Southern California
🇺🇸
Los Angeles, California, United States
University of Southern California
🇺🇸Los Angeles, California, United States