eMOTION Formative Study
- Conditions
- CancerPhysical InactivityOverweight or Obesity
- Interventions
- Behavioral: Affect-Based GoalsBehavioral: Intensity-Based GoalsBehavioral: SAVOR EnhancementBehavioral: TYPE/CONTEXT Enhancement
- 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
- 37
- 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
- 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
- Arm && Interventions
Group Intervention Description Affect + SAVOR SAVOR Enhancement Participants receive affect-based goals for two weeks. In addition to the standard mHealth intervention, participants engage in the SAVOR enhancement to augment the treatment effects of the affect-based goals condition. Affect + TYPE/CONTEXT TYPE/CONTEXT Enhancement Participants receive affect-based goals for two weeks. In addition to the standard mHealth intervention, participants engage in the TYPE/CONTEXT enhancement to augment the treatment effects of the affect-based goals condition. Affect + TYPE/CONTEXT + SAVOR Affect-Based Goals Participants receive affect-based goals for two weeks. In addition to the standard mHealth intervention, participants engage in the TYPE/CONTEXT and SAVOR enhancements to augment the treatment effects of the affect-based goals condition. Intensity Intensity-Based Goals Participants receive intensity-based goals for two weeks. No enhancements are added to the standard mHealth intervention. Affect + TYPE/CONTEXT + SAVOR SAVOR Enhancement Participants receive affect-based goals for two weeks. In addition to the standard mHealth intervention, participants engage in the TYPE/CONTEXT and SAVOR enhancements to augment the treatment effects of the affect-based goals condition. Affect + TYPE/CONTEXT Affect-Based Goals Participants receive affect-based goals for two weeks. In addition to the standard mHealth intervention, participants engage in the TYPE/CONTEXT enhancement to augment the treatment effects of the affect-based goals condition. Affect + SAVOR Affect-Based Goals Participants receive affect-based goals for two weeks. In addition to the standard mHealth intervention, participants engage in the SAVOR enhancement to augment the treatment effects of the affect-based goals condition. Affect + TYPE/CONTEXT + SAVOR TYPE/CONTEXT Enhancement Participants receive affect-based goals for two weeks. In addition to the standard mHealth intervention, participants engage in the TYPE/CONTEXT and SAVOR enhancements to augment the treatment effects of the affect-based goals condition.
- 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.
Equity Benchmark: Accessibility (SUS score) approximately equal between sub-groups Reported at 3 weeks (i.e., post-study) Equity is defined as SUS scores for daily goal sessions and Fitbit protocol (i.e., accessibility) that are approximately equal between sex, race, ethnicity, age, BMI, income, and able-bodied groups. While this cannot be tested statistically due to a lack of power in the Formative Study to compare groups of subjects, the investigators will compare average scores to ensure that the intervention yields similar effects regardless of sex, race, ethnicity, age, BMI, income, and able-bodied. The go/no-go criterion is that SUS scores will be approximately equal between groups.
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.
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.
- Secondary Outcome Measures
Name Time Method Accessibility Benchmark: Percentage of participants rating Fitbit interface as accessible Reported at 3 weeks (i.e., post-study) The degree of accessibility of the 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. The go/no-go criterion is that at least 51% of participants respond affirmatively for each facet.
Sustainability/Feasibility Benchmark: Fitbit device malfunctions From first day of run-in period (i.e., day 1) to last day of data collection (i.e., day 21) Another go/no-go criterion for the sustainability/feasibility of the study's Fitbit component will assess (via participant tracking) whether fewer than 25% of participants need to be mailed a new Fitbit device due to device issues over the course of the study.
Satisfaction Benchmark: Participants reporting dissatisfaction with Fitbit Reported at 3 weeks (i.e., post-study) During the post-study questionnaire, participants will complete the validated Delighted-Terrible Scale. Directions specify that they will be asked "about specific elements of the Fitbit smartwatch features." 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). Fitbit items ask how they felt about the exercise settings on the smartwatch; how they felt about notifications they received to complete smartwatch surveys; and how they felt about the frequency and length of these surveys. The go/no-go criterion is that \<70% of participants report feeling dissatisfied (score of 1 to 3) with any of the Fitbit items.
Sustainability/Feasibility Benchmark: Event-Contingent Fitbit surveys correctly triggered 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 moving average heart rate max. 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.
Accessibility Benchmark: Percentage of participants rating smartphone interface as accessible Reported at 3 weeks (i.e., post-study) The degree of accessibility of the smartphone interface for the study will also be assessed in the exit interview. Specifically, participants are asked two questions about whether they were able to read and understand questions for daily goal sessions on their smartphone. Go/no-go criteria will be that at least 51% of participants answer affirmatively for both questions.
Sustainability/Feasibility Benchmark: Repeated syncing reminders From first full day of intervention (i.e., day 8) to last day of data collection (i.e., day 21) Participants are asked to keep the Fitbit app on their smartphone open in order to allow study data from the app to sync with Fitabase servers. Researchers will check Fitabase servers multiple times per day to ensure adequate syncing, and if a participant's device has not been synced for a few days, they receive a text asking them to open and sync the app. Go/no-go criteria for this benchmark are that \<25% of participants need to be sent more than one reminder to open their Fitbit app and sync their study data, as recorded by researchers in participant tracking forms.
Accessibility Benchmark: Participants report being able to understand and follow savoring prompts (affect-based goals + SAVOR or affect-based goals + TYPE/CONTEXT + SAVOR groups) Reported at 3 weeks (i.e., post-study) During the exit interview, participants in the affect-based goals + SAVOR or affect-based goals + TYPE/CONTEXT + SAVOR groups will be asked whether they were generally able to understand and follow the savoring questions they received. The go/no-go criterion is that ≥51% of participants in this group reported being able to understand and follow the savoring questions.
Satisfaction Benchmark: Participants reporting dissatisfaction with physical activity recommendations (affect-based goals + TYPE/CONTEXT and affect-based goals + TYPE/CONTEXT + SAVOR groups only) 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 validated Delighted-Terrible Scale. They are asked how they felt about the physical activity 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.
Satisfaction Benchmark: Participants reporting dissatisfaction with savoring questions (affect-based goals + SAVOR or affect-based goals + TYPE/CONTEXT + SAVOR groups) 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.
Satisfaction Benchmark: Participants reporting dissatisfaction with smartphone components Reported at 3 weeks (i.e., post-study) During the post-study questionnaire, participants will complete the validated Delighted-Terrible Scale. Directions specify that they will be asked about their experiences using their smartphone for the eMOTION Study. 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). Smartphone items ask how they felt about completing the daily goal sessions on their smartphone and Fitbit smartphone app. The go/no-go criterion is that \<70% of participants report feeling dissatisfied (score of 1 to 3) with any of the smartphone items.
Accessibility Benchmark: Physical activity recommendations (affect-based goals + TYPE/CONTEXT and affect-based goals + TYPE/CONTEXT + SAVOR groups only) appropriately consider participant 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 are placed in the affect-based goals + TYPE/CONTEXT or affect-based goals + TYPE/CONTEXT + SAVOR groups, 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 the number of constraints reported at baseline is not associated with participants' reported ability to follow activity recommendations.
Trial Locations
- Locations (1)
University of Southern California
🇺🇸Los Angeles, California, United States