Physical InactivityNCT06125964
eMOTION Formative Study
A study testing Intensity-Based Goals, Affect-Based Goals and TYPE/CONTEXT Enhancement in people with Physical Inactivity and Overweight or Obesity, run by University of Southern California at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity, Overweight or Obesity, Cancer
- What is being tested?
- Intensity-Based Goals, Affect-Based Goals and TYPE/CONTEXT Enhancement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90032
About this study
Official title: Using Real-Time Data Capture to Examine Affective Mechanisms as Mediators of Physical Activity Adherence in Interventions: Formative Study
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.
Read the 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.
- Conditions
- Physical Inactivity, Overweight or Obesity, Cancer
- Being tested
- Intensity-Based Goals, Affect-Based Goals, TYPE/CONTEXT Enhancement, SAVOR Enhancement
- Keywords
- Affective Response, Psychological Needs, Physical Activity
- Medical subject headings
- Sedentary Behavior, Overweight, Obesity, Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensity-Based GoalsBehavioural
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 GoalsBehavioural
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 EnhancementBehavioural
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 EnhancementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intensity | Experimental | Participants receive intensity-based goals for two weeks. No enhancements are added to the standard mHealth intervention. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Affect-Based Goals; Behavioral: TYPE/CONTEXT Enhancement; Behavioral: SAVOR Enhancement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Reported at 3 weeks (i.e., post-study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start6 Oct 2023
- Primary completion30 May 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Genevieve Dunton, University of Southern California
- Investigators
- Genevieve F Dunton, PhD MPH, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125964
- Sponsor's protocol ID
- UP-22-00332-formative
- Other IDs
- R01CA272933
- Status last verified
- Jul 2025
- First submitted
- 26 Oct 2023
- Last updated
- 14 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hatzinger LA, Crosley-Lyons R, Hewus M, Wang WL, Huh J, Dyck DV, Dunton GF. Delivering and evaluating digital therapeutic interventions to increase physical activity: Formative testing of engagement, compliance, and adherence. Digit Health. 2026 Mar 24;12:20552076261435865. doi: 10.1177/20552076261435865. eCollection 2026 Jan-Dec.
PubMed 41889431Crosley-Lyons R, Hatzinger L, Hewus M, Wang WL, Van Dyck D, Huh J, Hekler E, Dunton GF. An Early-Stage Digital Therapeutic Intervention to Enhance Affective Response During Physical Activity Among Adults With Overweight or Obesity: Benchmark-Driven Formative Testing Study. JMIR Hum Factors. 2026 Feb 20;13:e71472. doi: 10.2196/71472.
PubMed 41719536
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Real-Time Data Capture to Examine Affective Mechanisms as Mediators of Physical Activity Adherence in Interventions: Formative Study
- ClinicalTrials.gov ID
- NCT06125964
- Acronym / sponsor ID
- UP-22-00332-formative
- Conditions
- Physical Inactivity, Overweight or Obesity, Cancer
- Keywords
- Affective Response, Psychological Needs, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 6 Oct 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 13 Nov 2023 (actual)
- Results
- Posted 14 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intensity | Experimental | Behavioral: Intensity-Based GoalsParticipants receive intensity-based goals for two weeks. No enhancements are added to the standard mHealth intervention. |
| Affect + TYPE/CONTEXT | Active comparator | Behavioral: Affect-Based Goals, Behavioral: TYPE/CONTEXT EnhancementParticipants 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 | Active comparator | Behavioral: Affect-Based Goals, Behavioral: SAVOR EnhancementParticipants 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 | Active comparator | Behavioral: Affect-Based Goals, Behavioral: TYPE/CONTEXT Enhancement, Behavioral: SAVOR EnhancementParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensity-Based GoalsOn 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. | Behavioural | Intensity |
| Affect-Based GoalsOn 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. | Behavioural | Affect + SAVOR, Affect + TYPE/CONTEXT, Affect + TYPE/CONTEXT + SAVOR |
| TYPE/CONTEXT EnhancementThe 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. | Behavioural | Affect + TYPE/CONTEXT, Affect + TYPE/CONTEXT + SAVOR |
| SAVOR EnhancementThe 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. | Behavioural | Affect + SAVOR, Affect + TYPE/CONTEXT + SAVOR |
Primary outcome
Safety Benchmark: Percentage of Participants Experiencing an Adverse Event
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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: Accessibility/Usability Approximately Equal for White vs. Non-white Participants
Time frame: 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
Time frame: 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: Accessibility/Usability Approximately Equal for Hispanic vs. Non-Hispanic Participants
Time frame: 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.
Equity Benchmark: Efficacy Approximately Equal for Hispanic vs. Non-Hispanic Participants
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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: Efficacy Approximately Equal Across Age Categories
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41889431Hatzinger LA, Crosley-Lyons R, Hewus M, Wang WL, Huh J, Dyck DV, Dunton GF. Delivering and evaluating digital therapeutic interventions to increase physical activity: Formative testing of engagement, compliance, and adherence. Digit Health. 2026 Mar 24;12:20552076261435865. doi: 10.1177/20552076261435865. eCollection 2026 Jan-Dec.
- Derived from this study: PubMed 41719536Crosley-Lyons R, Hatzinger L, Hewus M, Wang WL, Van Dyck D, Huh J, Hekler E, Dunton GF. An Early-Stage Digital Therapeutic Intervention to Enhance Affective Response During Physical Activity Among Adults With Overweight or Obesity: Benchmark-Driven Formative Testing Study. JMIR Hum Factors. 2026 Feb 20;13:e71472. doi: 10.2196/71472.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Genevieve F Dunton, PhD MPH principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensity-Based Goals, Affect-Based Goals and TYPE/CONTEXT Enhancement in people with Physical Inactivity and Overweight or Obesity, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Benchmark: Percentage of Participants Experiencing an Adverse Event (time frame: Event onset reported as from first day of run-in period (i.e., day 1) to one week post-data collection (week 4)). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06125964, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.