eMOTION Formative Study

NCT06125964 | Completed Results

• 2 other identifiers: UP-22-00332-formativeR01CA272933
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Inactivity; Overweight or Obesity; Cancer

Keywords

Affective Response; Psychological Needs; Physical Activity

Outcome Measures

Primary Outcomes (27)

• 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)

• 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)

• 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)

• Accessibility/Usability Benchmark: Percentage of Participants Rating Daily Goal Sessions and Fitbit Interface as Accessible

  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.

  Reported at 3 weeks (i.e., post-study)

• Accessibility/Usability Benchmark: Physical Activity Recommendations Appropriately Consider Reported 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 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.

  Assessed on date of baseline questionnaire completion and at 3 weeks (i.e., post-study)

• Accessibility/Usability Benchmark: Percentage of Participants Rating Savoring Exercises as Accessible

  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.

  Reported at 3 weeks (i.e., post-study)

• Sustainability/Feasibility Benchmark: Fidelity of Auto-detection Algorithm

  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.

  From first full day of intervention (i.e., day 8) to last day of data collection (i.e., day 21)

• Sustainability/Feasibility Benchmark: Research Staff Burden

  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.

  From first day of run-in period (i.e., day 1) to last day of data collection (i.e., day 21)

• Sustainability/Feasibility Benchmark: Satisfaction With Fitbit and Daily Goal Session Components

  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.

  Reported at 3 weeks (i.e., post-study)

• Sustainability/Feasibility Benchmark: Dissatisfaction With TYPE/CONTEXT Recommendations

  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.

  Reported at 3 weeks (i.e., post-study)

• Sustainability/Feasibility Benchmark: Dissatisfaction With SAVOR Questions

  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)

• Equity Benchmark: Accessibility/Usability Approximately Equal for Males vs. Females

  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.

  Reported at 3 weeks (i.e., post-study)

• Equity Benchmark: Efficacy Approximately Equal for Males vs. Females

  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.

  Reported at 3 weeks (i.e., post-study)

• Equity Benchmark: Accessibility/Usability Approximately Equal for White vs. Non-white Participants

  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.

  Reported at 3 weeks (i.e., post-study)

• Equity Benchmark: Efficacy Approximately Equal for White vs. Non-white Participants

  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.

  Reported at 3 weeks (i.e., post-study)

• Equity Benchmark: Accessibility/Usability Approximately Equal for Hispanic vs. Non-Hispanic Participants

  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.

  Reported at 3 weeks (i.e., post-study)

• Equity Benchmark: Efficacy Approximately Equal for Hispanic vs. Non-Hispanic Participants

  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.

  Reported at 3 weeks (i.e., post-study)

• Equity Benchmark: Accessibility/Usability Approximately Equal Across Income Categories

  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.

  Reported at 3 weeks (i.e., post-study)

• Equity Benchmark: Efficacy Approximately Equal Across Income Categories

  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.

  Reported at 3 weeks (i.e., post-study)

• Equity Benchmark: Accessibility/Usability Approximately Equal Across Age Categories

  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.

  Reported at 3 weeks (i.e., post-study)

• Equity Benchmark: Efficacy Approximately Equal Across Age Categories

  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.

  Reported at 3 weeks (i.e., post-study)

• Equity Benchmark: Accessibility/Usability Approximately Equal for Participants With Overweight vs. Obesity

  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.

  Reported at 3 weeks (i.e., post-study)

• Equity Benchmark: Efficacy Approximately Equal for Participants With Overweight vs. Obesity

  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.

  Reported at 3 weeks (i.e., post-study)

• Equity Benchmark: Accessibility/Usability Approximately Equal Across Mobility Categories

  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.

  Reported at 3 weeks (i.e., post-study)

• Equity Benchmark: Efficacy Approximately Equal Across Mobility Categories

  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.

  Reported at 3 weeks (i.e., post-study)

• Equity Benchmark: Accessibility/Usability Approximately Equal Across Physical Constraint Categories

  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.

  Reported at 3 weeks (i.e., post-study)

• Equity Benchmark: Efficacy Approximately Equal Across Physical Constraint Categories

  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.

  Reported at 3 weeks (i.e., post-study)

Study Arms (4)

Intensity

EXPERIMENTAL

Participants receive intensity-based goals for two weeks. No enhancements are added to the standard mHealth intervention.

Behavioral: Intensity-Based Goals

Affect + TYPE/CONTEXT

ACTIVE COMPARATOR

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.

Behavioral: Affect-Based Goals; Behavioral: TYPE/CONTEXT Enhancement

Affect + SAVOR

ACTIVE COMPARATOR

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.

Behavioral: Affect-Based Goals; Behavioral: SAVOR Enhancement

Affect + TYPE/CONTEXT + SAVOR

ACTIVE COMPARATOR

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.

Behavioral: Affect-Based Goals; Behavioral: TYPE/CONTEXT Enhancement; Behavioral: SAVOR Enhancement

Interventions

Intensity-Based Goals BEHAVIORAL

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.

Intensity

Affect-Based Goals BEHAVIORAL

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.

Affect + SAVOR; Affect + TYPE/CONTEXT; Affect + TYPE/CONTEXT + SAVOR

TYPE/CONTEXT Enhancement BEHAVIORAL

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.

Affect + TYPE/CONTEXT; Affect + TYPE/CONTEXT + SAVOR

SAVOR Enhancement BEHAVIORAL

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.

Affect + SAVOR; Affect + TYPE/CONTEXT + SAVOR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Southern California

Los Angeles, California, 90032, United States

Location

MeSH Terms

Conditions

Sedentary Behavior; Overweight; Obesity; Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Behavior; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Genevieve Dunton (Principal Investigator)
• Organization: University of Southern California

dunton@usc.edu

323-442-8224

Study Officials

• Genevieve F Dunton, PhD MPH

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The majority of study staff will be blinded to participant assignment for most of the study period. Data will be analyzed blind to allocation, and participants will be blind to their allocation.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Health Behavior Research and Director, USC Real-Time Eating Activity and Children's Health (REACH) Lab

Model Details: 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.

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 13, 2023
• Study Start: October 6, 2023
• Primary Completion: May 30, 2024
• Study Completion: June 30, 2024
• Last Updated: August 14, 2025
• Results First Posted: August 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)