Clinical trial NCT06125964: eMOTION Formative Study
Official title: Using Real-Time Data Capture to Examine Affective Mechanisms as Mediators of Physical Activity Adherence in Interventions: Formative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Inactivity
Overweight or Obesity
Cancer
Keywords: Affective Response
Psychological Needs
Physical Activity
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-11-13
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Treatment components targeting intensity-based goals and affect-based goals will be tested separately in four groups of n=9 participants: (1) intensity-based goal setting alone; (2) affect-based goals + TYPE/CONTEXT; (3) affect-based goals + SAVOR; and (4) affect-based goals + TYPE/CONTEXT + SAVOR.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: 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)
measure: Efficacy Benchmark: Percentage of participants with increased physical activity enjoyment
timeFrame: Reported at 3 weeks (i.e., post-study)
measure: Accessibility/Usability Benchmark: System Usability Scale score (0 to 100) for Daily Goal Sessions & Fitbit
timeFrame: Reported at 3 weeks (i.e., post-study)
measure: Equity Benchmark: Accessibility (SUS score) approximately equal between sub-groups
timeFrame: Reported at 3 weeks (i.e., post-study)
Secondary outcomes:
measure: Accessibility Benchmark: Percentage of participants rating Fitbit interface as accessible
timeFrame: Reported at 3 weeks (i.e., post-study)
measure: Sustainability/Feasibility Benchmark: Event-Contingent Fitbit surveys correctly triggered
timeFrame: From first full day of intervention (i.e., day 8) to last day of data collection (i.e., day 21)
measure: Sustainability/Feasibility Benchmark: Fitbit device malfunctions
timeFrame: From first day of run-in period (i.e., day 1) to last day of data collection (i.e., day 21)
measure: Satisfaction Benchmark: Participants reporting dissatisfaction with Fitbit
timeFrame: Reported at 3 weeks (i.e., post-study)
measure: Accessibility Benchmark: Percentage of participants rating smartphone interface as accessible
timeFrame: Reported at 3 weeks (i.e., post-study)
measure: Sustainability/Feasibility Benchmark: Repeated syncing reminders
timeFrame: From first full day of intervention (i.e., day 8) to last day of data collection (i.e., day 21)
measure: Satisfaction Benchmark: Participants reporting dissatisfaction with smartphone components
timeFrame: Reported at 3 weeks (i.e., post-study)
measure: Accessibility Benchmark: Physical activity recommendations (affect-based goals + TYPE/CONTEXT and affect-based goals + TYPE/CONTEXT + SAVOR groups only) appropriately consider participant constraints
timeFrame: Assessed on date of baseline questionnaire completion and at 3 weeks (i.e., post-study)
measure: Satisfaction Benchmark: Participants reporting dissatisfaction with physical activity recommendations (affect-based goals + TYPE/CONTEXT and affect-based goals + TYPE/CONTEXT + SAVOR groups only)
timeFrame: Reported at 3 weeks (i.e., post-study)
measure: Accessibility Benchmark: Participants report being able to understand and follow savoring prompts (affect-based goals + SAVOR or affect-based goals + TYPE/CONTEXT + SAVOR groups)
timeFrame: Reported at 3 weeks (i.e., post-study)
measure: Satisfaction Benchmark: Participants reporting dissatisfaction with savoring questions (affect-based goals + SAVOR or affect-based goals + TYPE/CONTEXT + SAVOR groups)
timeFrame: Reported at 3 weeks (i.e., post-study)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Genevieve F Dunton, PhD MPH
role: PRINCIPAL_INVESTIGATOR
References: