eMOTION Formative Study

Cancer Clinical Trial

Official title:

Using Real-Time Data Capture to Examine Affective Mechanisms as Mediators of Physical Activity Adherence in Interventions: Formative Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06125964
• Other study ID #: UP-22-00332-formative
• Secondary ID: R01CA272933
• Status: Recruiting
• Phase: N/A
• Start date: October 6, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: May 2024
• Source: University of Southern California
• Contact: Micaela Hewus, MPH
• Phone: 3234428224
• Email: micaelag[@]usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: July 1, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Overweight
• Overweight or Obesity
• Physical Inactivity

Intervention

Behavioral:
• Intensity-Based Goals
On days participants plan to exercise, morning and evening goal sessions ask them to provide an activity goal for the day; create a concrete plan; prompt them to anticipate barriers and brainstorm solutions; and reflect on whether they were able to meet this goal. Intensity-based goals ask participants to maintain a target heart rate range during physical activity based on age-adjusted heart rate (HR) max. Goals progressively increase from 55% to 60% HR max across two weeks. Research staff will show participants how to monitor their heart rate using their Fitbit Versa. For each condition, the Fitbit Versa device will feature a custom watch face with a clock (current local time), the date, current device battery levels, and an exercise button. The exercise button can be pressed whenever a subject wants to engage in physical activity, and provides real-time feedback on heart rate (intensity-based goals only) and exercise duration.
• Affect-Based Goals
On days participants plan to exercise, morning and evening goal sessions ask them to provide an activity goal for the day; create a concrete plan; prompt them to anticipate barriers and brainstorm solutions; and reflect on whether they were able to meet this goal. Affect-based goals ask participants to engage in either a type or context of physical activity that allows them to experience positive affect. Goals focused on context are randomly generated to suggest that the participant performs activity in a place, in a social situation, or while listening to something that makes them feel good. For each condition, the Fitbit Versa device will feature a custom watch face with a clock (current local time), the date, current device battery levels, and an exercise button. The exercise button can be pressed whenever a subject wants to engage in physical activity, and provides real-time feedback on exercise duration while featuring a "smiley face" emoticon.
• TYPE/CONTEXT Enhancement
The TYPE/CONTEXT enhancement will augment affect-based treatment effects by additionally providing tailored recommendations for activity types and contexts that satisfy personally important psychological needs as rated by each participant at baseline. Ratings from a crowdsourced panel of adults on Amazon Mechanical Turk were used to determine the potential for specific activity types and contexts to satisfy psychological needs; our tailoring algorithm recommends the corresponding activity type or context while accounting for reported constraints. Different psychological needs will be selected each day. Tailored recommendations are incorporated immediately following the morning goal module.
• SAVOR Enhancement
The SAVOR enhancement will augment affect-based treatment effects by additionally implementing a brief savoring exercise on the smartphone during the evening goal session (after the self-monitoring module). Participants will respond to questions that are intended to enhance and prolong positive experiences during physical activity. To trigger attentional deployment, a common savoring strategy that involves intensifying experiences by focusing on them, participants will answer open-ended prompts. These prompts are drawn from a prompt pool with slightly varied wording to promote a sense of novelty.

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Benchmark: Percentage of participants experiencing an adverse event	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.	Event onset reported as from first day of run-in period (i.e., day 1) to one week post-data collection (week 4)
Primary	Efficacy Benchmark: Percentage of participants with increased physical activity enjoyment	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.	Reported at 3 weeks (i.e., post-study)
Primary	Accessibility/Usability Benchmark: System Usability Scale score (0 to 100) for Daily Goal Sessions & Fitbit	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.	Reported at 3 weeks (i.e., post-study)
Primary	Equity Benchmark: Accessibility (SUS score) approximately equal between sub-groups	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.	Reported at 3 weeks (i.e., post-study)
Secondary	Accessibility Benchmark: Percentage of participants rating Fitbit interface as accessible	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.	Reported at 3 weeks (i.e., post-study)
Secondary	Sustainability/Feasibility Benchmark: Event-Contingent Fitbit surveys correctly triggered	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.	From first full day of intervention (i.e., day 8) to last day of data collection (i.e., day 21)
Secondary	Sustainability/Feasibility Benchmark: Fitbit device malfunctions	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.	From first day of run-in period (i.e., day 1) to last day of data collection (i.e., day 21)
Secondary	Satisfaction Benchmark: Participants reporting dissatisfaction with Fitbit	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.	Reported at 3 weeks (i.e., post-study)
Secondary	Accessibility Benchmark: Percentage of participants rating smartphone interface as accessible	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.	Reported at 3 weeks (i.e., post-study)
Secondary	Sustainability/Feasibility Benchmark: Repeated syncing reminders	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.	From first full day of intervention (i.e., day 8) to last day of data collection (i.e., day 21)
Secondary	Satisfaction Benchmark: Participants reporting dissatisfaction with smartphone components	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.	Reported at 3 weeks (i.e., post-study)
Secondary	Accessibility Benchmark: Physical activity recommendations (affect-based goals + TYPE/CONTEXT and affect-based goals + TYPE/CONTEXT + SAVOR groups only) appropriately consider participant constraints	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.	Assessed on date of baseline questionnaire completion and at 3 weeks (i.e., post-study)
Secondary	Satisfaction Benchmark: Participants reporting dissatisfaction with physical activity recommendations (affect-based goals + TYPE/CONTEXT and affect-based goals + TYPE/CONTEXT + SAVOR groups only)	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.	Reported at 3 weeks (i.e., post-study)
Secondary	Accessibility Benchmark: Participants report being able to understand and follow savoring prompts (affect-based goals + SAVOR or affect-based goals + TYPE/CONTEXT + SAVOR groups)	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.	Reported at 3 weeks (i.e., post-study)
Secondary	Satisfaction Benchmark: Participants reporting dissatisfaction with savoring questions (affect-based goals + SAVOR or affect-based goals + TYPE/CONTEXT + SAVOR groups)	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.	Reported at 3 weeks (i.e., post-study)