Cancer, Overweight or Obesity, Physical Inactivity
Conditions
Keywords
Affective Response, Psychological Needs, Physical Activity
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.
Interventions
BEHAVIORALIntensity-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.
BEHAVIORALAffect-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.
BEHAVIORALTYPE/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.
BEHAVIORALSAVOR 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.
Sponsors
National Cancer Institute (NCI)
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Benchmark: Percentage of Participants Experiencing an Adverse Event | Event onset reported as from first day of run-in period (i.e., day 1) to one week post-data collection (week 4) | An adverse event is that which is unexpected, related or possibly related to the study procedures, and serious (adversely affecting the balance of risks and benefits to participation, including incidents that require hospitalization, specialist treatment, or medical intervention). This refers to any adverse event that can be reasonably determined (at least in part) to be due to the study procedures and not due to a participant's underlying medical conditions or risk factor profile alone. This is assessed by official University of Southern California Institutional Review Board reporting procedures. The study's official go/no-go criterion is that less than 1% of participants experience an adverse event during the study. |
| Efficacy Benchmark: Percentage of Participants With Increased Physical Activity Enjoyment | Reported at 3 weeks (i.e., post-study) | During the exit interview, participants compare their experience with physical activity before and after participation in the eMOTION Study and are asked if they personally feel as if the degree of enjoyment they feel while engaging in physical activity changed or stayed the same. The percentage of participants responding affirmatively will be calculated. The go/no-go criterion is that ≥51% of participants in the affect-based conditions report a perceived increase in enjoyment of physical activity. |
| Accessibility/Usability Benchmark: System Usability Scale Score (0 to 100) for Daily Goal Sessions & Fitbit | Reported at 3 weeks (i.e., post-study) | In the Post-Study Questionnaire, participants will rate the usability of the eMOTION Study's daily goal sessions and Fitbit Versa protocol via the System Usability Scale (SUS). The SUS has 10 items, and participants indicate their degree of agreement with each statement on a 5-point Likert scale ranging from strongly disagree (1) to strongly agree (5). The SUS is then scored by summing across items (all items are first rescored to a 0 to 4 scale, and even items are reverse-scored before summing) and then multiplying the sum by 2.5. The study's go/no-go criterion is that both the daily goal sessions and Fitbit protocols receive at least an average score (≥68) on the SUS. |
| Accessibility/Usability Benchmark: Percentage of Participants Rating Daily Goal Sessions and Fitbit Interface as Accessible | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
Countries
United States
Participant flow
Pre-assignment details
Following enrollment, onboarding continued with a baseline questionnaire, a Fitbit smartwatch sent in the mail, and orientation session attendance. Then, a week-long run-in period allowed for assessment components (e.g., Fitbit smartwatch monitoring, check-ins) to be gradually introduced. n=9 participants were lost due to technological issues experienced during onboarding and the run-in period, so N=37 participants were randomly assigned to groups.
Participants by arm
| Arm | Count |
|---|---|
| Intensity Participants receive intensity-based goals for two weeks. No enhancements are added to the standard mHealth intervention.
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. | 9 |
| Affect + TYPE/CONTEXT Participants receive affect-based goals for two weeks. In addition to the standard mHealth intervention, participants engage in the TYPE/CONTEXT enhancement to augment the treatment effects of the affect-based goals condition.
Affect-Based Goals: On days participants plan to exercise, they engage in affect-based goal-setting sessions. Participants are asked to engage in a type or context of physical activity that allows them to experience positive affect.
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. | 10 |
| Affect + SAVOR Participants receive affect-based goals for two weeks. In addition to the standard mHealth intervention, participants engage in the SAVOR enhancement to augment the treatment effects of the affect-based goals condition.
Affect-Based Goals: On days participants plan to exercise, they engage in affect-based goal-setting sessions. Participants are asked to engage in a type or context of physical activity that allows them to experience positive affect.
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. | 9 |
| Affect + TYPE/CONTEXT + SAVOR Participants receive affect-based goals for two weeks. In addition to the standard mHealth intervention, participants engage in the TYPE/CONTEXT and SAVOR enhancements to augment the treatment effects of the affect-based goals condition.
Affect-Based Goals: On days participants plan to exercise, they engage in affect-based goal-setting sessions. Participants are asked to engage in a type or context of physical activity that allows them to experience positive affect.
TYPE/CONTEXT Enhancement: The TYPE/CONTEXT enhancement will augment affect-based treatment effects via tailored recommendations for activity types and contexts that satisfy personally important psychological needs as rated by each participant at baseline (see full description in previous groups)
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) (see full description in previous groups). | 9 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Intensity | Affect + TYPE/CONTEXT | Affect + SAVOR | Affect + TYPE/CONTEXT + SAVOR | Total |
|---|---|---|---|---|---|
| Age, Continuous | 43.67 years STANDARD_DEVIATION 9.042 | 46.30 years STANDARD_DEVIATION 17.327 | 43.11 years STANDARD_DEVIATION 13.004 | 51.56 years STANDARD_DEVIATION 13.106 | 46.16 years STANDARD_DEVIATION 13.422 |
| Body Mass Index (BMI) | 32.3942 kg/m^2 STANDARD_DEVIATION 5.48859 | 35.0256 kg/m^2 STANDARD_DEVIATION 5.72246 | 32.7438 kg/m^2 STANDARD_DEVIATION 4.87365 | 32.7050 kg/m^2 STANDARD_DEVIATION 5.36799 | 33.2660 kg/m^2 STANDARD_DEVIATION 5.26874 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 2 Participants | 0 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 9 Participants | 7 Participants | 9 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Household Income ≥ $125,000 | 5 Participants | 2 Participants | 3 Participants | 0 Participants | 10 Participants |
| Household Income ≤ $44,999 | 1 Participants | 2 Participants | 1 Participants | 3 Participants | 7 Participants |
| Household Income $45,000 to $84,999 | 2 Participants | 2 Participants | 2 Participants | 3 Participants | 9 Participants |
| Household Income $85,000 to $124,999 | 1 Participants | 4 Participants | 1 Participants | 2 Participants | 8 Participants |
| Household Income Unsure | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 3 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 9 Participants | 6 Participants | 9 Participants | 32 Participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 4 Participants | 6 Participants | 20 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 5 Participants | 3 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 10 | 0 / 9 | 0 / 9 |
| other Total, other adverse events | 0 / 9 | 0 / 10 | 0 / 9 | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 | 0 / 10 | 0 / 9 | 0 / 9 |
Outcome results
Primary
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.
Time frame: Reported at 3 weeks (i.e., post-study)
Population: The study protocol and statistical analysis plan pre-specified that treatment arms would be assessed in a combined manner (i.e, as a full sample). This analysis explored the basic accessibility/usability of the primary components (i.e., daily goal sessions, Fitbit Versa) used to deliver the eMOTION Study intervention, which were kept uniform for all participants, regardless of treatment arm (i.e., intensity-based goals, affect + TYPE/CONTEXT, affect + SAVOR, affect + TYPE/CONTEXT + SAVOR).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intensity | Accessibility/Usability Benchmark: Percentage of Participants Rating Daily Goal Sessions and Fitbit Interface as Accessible | Select Fitbit answers | Yes | 33 Participants |
| Intensity | Accessibility/Usability Benchmark: Percentage of Participants Rating Daily Goal Sessions and Fitbit Interface as Accessible | Read Fitbit | No | 1 Participants |
| Intensity | Accessibility/Usability Benchmark: Percentage of Participants Rating Daily Goal Sessions and Fitbit Interface as Accessible | Read Fitbit | Yes | 34 Participants |
| Intensity | Accessibility/Usability Benchmark: Percentage of Participants Rating Daily Goal Sessions and Fitbit Interface as Accessible | Read Fitbit | Missing | 1 Participants |
| Intensity | Accessibility/Usability Benchmark: Percentage of Participants Rating Daily Goal Sessions and Fitbit Interface as Accessible | Understand Fitbit | No | 3 Participants |
| Intensity | Accessibility/Usability Benchmark: Percentage of Participants Rating Daily Goal Sessions and Fitbit Interface as Accessible | Understand Fitbit | Yes | 32 Participants |
| Intensity | Accessibility/Usability Benchmark: Percentage of Participants Rating Daily Goal Sessions and Fitbit Interface as Accessible | Understand Fitbit | Missing | 1 Participants |
| Intensity | Accessibility/Usability Benchmark: Percentage of Participants Rating Daily Goal Sessions and Fitbit Interface as Accessible | Select Fitbit answers | No | 2 Participants |
| Intensity | Accessibility/Usability Benchmark: Percentage of Participants Rating Daily Goal Sessions and Fitbit Interface as Accessible | Select Fitbit answers | Missing | 1 Participants |
| Intensity | Accessibility/Usability Benchmark: Percentage of Participants Rating Daily Goal Sessions and Fitbit Interface as Accessible | Use Fitbit exercise settings | No | 8 Participants |
| Intensity | Accessibility/Usability Benchmark: Percentage of Participants Rating Daily Goal Sessions and Fitbit Interface as Accessible | Use Fitbit exercise settings | Yes | 27 Participants |
| Intensity | Accessibility/Usability Benchmark: Percentage of Participants Rating Daily Goal Sessions and Fitbit Interface as Accessible | Use Fitbit exercise settings | Missing | 1 Participants |
| Intensity | Accessibility/Usability Benchmark: Percentage of Participants Rating Daily Goal Sessions and Fitbit Interface as Accessible | Read daily goals | No | 1 Participants |
| Intensity | Accessibility/Usability Benchmark: Percentage of Participants Rating Daily Goal Sessions and Fitbit Interface as Accessible | Read daily goals | Yes | 34 Participants |
| Intensity | Accessibility/Usability Benchmark: Percentage of Participants Rating Daily Goal Sessions and Fitbit Interface as Accessible | Read daily goals | Missing | 1 Participants |
| Intensity | Accessibility/Usability Benchmark: Percentage of Participants Rating Daily Goal Sessions and Fitbit Interface as Accessible | Understand daily goals | No | 1 Participants |
| Intensity | Accessibility/Usability Benchmark: Percentage of Participants Rating Daily Goal Sessions and Fitbit Interface as Accessible | Understand daily goals | Yes | 34 Participants |
| Intensity | Accessibility/Usability Benchmark: Percentage of Participants Rating Daily Goal Sessions and Fitbit Interface as Accessible | Understand daily goals | Missing | 1 Participants |
Primary
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.
Time frame: Reported at 3 weeks (i.e., post-study)
Population: This analysis only applied to participants who received savoring exercises. The two SAVOR arms (i.e., affect-based goals + SAVOR, affect-based goals + TYPE/CONTEXT + SAVOR) were combined and considered as a single sub-sample (N=18), since both received identical SAVOR treatment components. n=4 of these participants did not remember receiving savoring exercises, so they were excluded from the analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intensity | Accessibility/Usability Benchmark: Percentage of Participants Rating Savoring Exercises as Accessible | Follow savoring exercises | No | 2 Participants |
| Intensity | Accessibility/Usability Benchmark: Percentage of Participants Rating Savoring Exercises as Accessible | Understand savoring exercises | Yes | 12 Participants |
| Intensity | Accessibility/Usability Benchmark: Percentage of Participants Rating Savoring Exercises as Accessible | Understand savoring exercises | No | 2 Participants |
| Intensity | Accessibility/Usability Benchmark: Percentage of Participants Rating Savoring Exercises as Accessible | Follow savoring exercises | Yes | 12 Participants |
Primary
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.
Time frame: Assessed on date of baseline questionnaire completion and at 3 weeks (i.e., post-study)
Population: This analysis only applied to participants who received TYPE/CONTEXT recommendations. The two TYPE/CONTEXT arms (i.e., affect-based goals + TYPE/CONTEXT, affect-based goals + TYPE/CONTEXT + SAVOR) were combined and considered as a single sub-sample (N=18), since both received identical TYPE/CONTEXT treatment components. n=3 of these participants did not remember receiving TYPE/CONTEXT recommendations, so they were excluded from the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intensity | Accessibility/Usability Benchmark: Physical Activity Recommendations Appropriately Consider Reported Constraints | 40 percentage of recommendations | Standard Deviation 54.8 |
| Affect + TYPE/CONTEXT | Accessibility/Usability Benchmark: Physical Activity Recommendations Appropriately Consider Reported Constraints | 50 percentage of recommendations | Standard Deviation 70.7 |
| Affect + SAVOR | Accessibility/Usability Benchmark: Physical Activity Recommendations Appropriately Consider Reported Constraints | 50 percentage of recommendations | Standard Deviation 57.7 |
| Affect + TYPE/CONTEXT + SAVOR | Accessibility/Usability Benchmark: Physical Activity Recommendations Appropriately Consider Reported Constraints | 25 percentage of recommendations | Standard Deviation 50 |
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.
Time frame: Reported at 3 weeks (i.e., post-study)
Population: The study protocol and statistical analysis plan pre-specified that treatment arms would be assessed in a combined manner (i.e, as a full sample). This analysis explored the basic usability of the primary components (i.e., daily goal sessions, Fitbit Versa) used to deliver the eMOTION Study intervention, which were kept uniform for all participants, regardless of treatment arm (i.e., intensity-based goals, affect + TYPE/CONTEXT, affect + SAVOR, affect + TYPE/CONTEXT + SAVOR).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intensity | Accessibility/Usability Benchmark: System Usability Scale Score (0 to 100) for Daily Goal Sessions & Fitbit | Daily Goals Score | 72.4306 score on a scale | Standard Deviation 17.21177 |
| Intensity | Accessibility/Usability Benchmark: System Usability Scale Score (0 to 100) for Daily Goal Sessions & Fitbit | Fitbit Score | 73.0556 score on a scale | Standard Deviation 22.85131 |
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.
Time frame: Reported at 3 weeks (i.e., post-study)
Population: This analysis explored whether participants who received affect-based goals (regardless of the specific TYPE/CONTEXT and/or SAVOR enhancements included) reported increased enjoyment. The three affect-based arms (affect + TYPE/CONTEXT \[n=9\], affect + SAVOR \[n=9\], affect + TYPE/CONTEXT + SAVOR \[n=9\]) were therefore considered to be a single collapsed sub-sample (n=27). This is because we did not have a large enough sample size to compare between the four groups.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intensity | Efficacy Benchmark: Percentage of Participants With Increased Physical Activity Enjoyment | Enjoyment decreased | 0 Participants |
| Intensity | Efficacy Benchmark: Percentage of Participants With Increased Physical Activity Enjoyment | Enjoyment stayed the same | 6 Participants |
| Intensity | Efficacy Benchmark: Percentage of Participants With Increased Physical Activity Enjoyment | Missing | 1 Participants |
| Intensity | Efficacy Benchmark: Percentage of Participants With Increased Physical Activity Enjoyment | Enjoyment increased | 2 Participants |
| Affect + TYPE/CONTEXT | Efficacy Benchmark: Percentage of Participants With Increased Physical Activity Enjoyment | Missing | 0 Participants |
| Affect + TYPE/CONTEXT | Efficacy Benchmark: Percentage of Participants With Increased Physical Activity Enjoyment | Enjoyment stayed the same | 13 Participants |
| Affect + TYPE/CONTEXT | Efficacy Benchmark: Percentage of Participants With Increased Physical Activity Enjoyment | Enjoyment decreased | 0 Participants |
| Affect + TYPE/CONTEXT | Efficacy Benchmark: Percentage of Participants With Increased Physical Activity Enjoyment | Enjoyment increased | 14 Participants |
Primary
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.
Time frame: Reported at 3 weeks (i.e., post-study)
Population: This analysis was concerned with the basic equity of the eMOTION Study intervention related to age, regardless of the specific treatment arm that participants were in. Therefore, participants from the full sample were split into four quartiles based on age.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intensity | Equity Benchmark: Accessibility/Usability Approximately Equal Across Age Categories | Daily goal sessions | Accessible/usable | 3 Participants |
| Intensity | Equity Benchmark: Accessibility/Usability Approximately Equal Across Age Categories | Daily goal sessions | Not accessible/usable | 6 Participants |
| Intensity | Equity Benchmark: Accessibility/Usability Approximately Equal Across Age Categories | Fitbit protocol | Accessible/usable | 6 Participants |
| Intensity | Equity Benchmark: Accessibility/Usability Approximately Equal Across Age Categories | Fitbit protocol | Not accessible/usable | 3 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Accessibility/Usability Approximately Equal Across Age Categories | Daily goal sessions | Not accessible/usable | 3 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Accessibility/Usability Approximately Equal Across Age Categories | Fitbit protocol | Accessible/usable | 6 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Accessibility/Usability Approximately Equal Across Age Categories | Fitbit protocol | Not accessible/usable | 3 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Accessibility/Usability Approximately Equal Across Age Categories | Daily goal sessions | Accessible/usable | 6 Participants |
| Affect + SAVOR | Equity Benchmark: Accessibility/Usability Approximately Equal Across Age Categories | Fitbit protocol | Accessible/usable | 8 Participants |
| Affect + SAVOR | Equity Benchmark: Accessibility/Usability Approximately Equal Across Age Categories | Daily goal sessions | Not accessible/usable | 1 Participants |
| Affect + SAVOR | Equity Benchmark: Accessibility/Usability Approximately Equal Across Age Categories | Fitbit protocol | Not accessible/usable | 1 Participants |
| Affect + SAVOR | Equity Benchmark: Accessibility/Usability Approximately Equal Across Age Categories | Daily goal sessions | Accessible/usable | 8 Participants |
| Affect + TYPE/CONTEXT + SAVOR | Equity Benchmark: Accessibility/Usability Approximately Equal Across Age Categories | Fitbit protocol | Not accessible/usable | 3 Participants |
| Affect + TYPE/CONTEXT + SAVOR | Equity Benchmark: Accessibility/Usability Approximately Equal Across Age Categories | Daily goal sessions | Not accessible/usable | 3 Participants |
| Affect + TYPE/CONTEXT + SAVOR | Equity Benchmark: Accessibility/Usability Approximately Equal Across Age Categories | Daily goal sessions | Accessible/usable | 6 Participants |
| Affect + TYPE/CONTEXT + SAVOR | Equity Benchmark: Accessibility/Usability Approximately Equal Across Age Categories | Fitbit protocol | Accessible/usable | 6 Participants |
Primary
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.
Time frame: Reported at 3 weeks (i.e., post-study)
Population: This analysis was concerned with the basic equity of the eMOTION Study intervention related to annual income, regardless of the specific treatment arm that participants were in. Therefore, participants from the full sample were split into five sub-groups based on income.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intensity | Equity Benchmark: Accessibility/Usability Approximately Equal Across Income Categories | Daily goal sessions | Accessible/usable | 1 Participants |
| Intensity | Equity Benchmark: Accessibility/Usability Approximately Equal Across Income Categories | Daily goal sessions | Not accessible/usable | 2 Participants |
| Intensity | Equity Benchmark: Accessibility/Usability Approximately Equal Across Income Categories | Fitbit protocol | Accessible/usable | 3 Participants |
| Intensity | Equity Benchmark: Accessibility/Usability Approximately Equal Across Income Categories | Fitbit protocol | Not accessible/usable | 0 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Accessibility/Usability Approximately Equal Across Income Categories | Daily goal sessions | Accessible/usable | 3 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Accessibility/Usability Approximately Equal Across Income Categories | Fitbit protocol | Not accessible/usable | 3 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Accessibility/Usability Approximately Equal Across Income Categories | Daily goal sessions | Not accessible/usable | 3 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Accessibility/Usability Approximately Equal Across Income Categories | Fitbit protocol | Accessible/usable | 3 Participants |
| Affect + SAVOR | Equity Benchmark: Accessibility/Usability Approximately Equal Across Income Categories | Fitbit protocol | Not accessible/usable | 3 Participants |
| Affect + SAVOR | Equity Benchmark: Accessibility/Usability Approximately Equal Across Income Categories | Daily goal sessions | Not accessible/usable | 3 Participants |
| Affect + SAVOR | Equity Benchmark: Accessibility/Usability Approximately Equal Across Income Categories | Fitbit protocol | Accessible/usable | 6 Participants |
| Affect + SAVOR | Equity Benchmark: Accessibility/Usability Approximately Equal Across Income Categories | Daily goal sessions | Accessible/usable | 6 Participants |
| Affect + TYPE/CONTEXT + SAVOR | Equity Benchmark: Accessibility/Usability Approximately Equal Across Income Categories | Daily goal sessions | Accessible/usable | 4 Participants |
| Affect + TYPE/CONTEXT + SAVOR | Equity Benchmark: Accessibility/Usability Approximately Equal Across Income Categories | Daily goal sessions | Not accessible/usable | 4 Participants |
| Affect + TYPE/CONTEXT + SAVOR | Equity Benchmark: Accessibility/Usability Approximately Equal Across Income Categories | Fitbit protocol | Not accessible/usable | 3 Participants |
| Affect + TYPE/CONTEXT + SAVOR | Equity Benchmark: Accessibility/Usability Approximately Equal Across Income Categories | Fitbit protocol | Accessible/usable | 5 Participants |
| ≥ $125,000 | Equity Benchmark: Accessibility/Usability Approximately Equal Across Income Categories | Fitbit protocol | Not accessible/usable | 1 Participants |
| ≥ $125,000 | Equity Benchmark: Accessibility/Usability Approximately Equal Across Income Categories | Fitbit protocol | Accessible/usable | 9 Participants |
| ≥ $125,000 | Equity Benchmark: Accessibility/Usability Approximately Equal Across Income Categories | Daily goal sessions | Not accessible/usable | 1 Participants |
| ≥ $125,000 | Equity Benchmark: Accessibility/Usability Approximately Equal Across Income Categories | Daily goal sessions | Accessible/usable | 9 Participants |
Primary
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.
Time frame: Reported at 3 weeks (i.e., post-study)
Population: This analysis was concerned with the basic equity of the eMOTION Study intervention related to mobility, regardless of the specific treatment arm that participants were in. Therefore, participants from the full sample were split into four quartiles based on mobility.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intensity | Equity Benchmark: Accessibility/Usability Approximately Equal Across Mobility Categories | Daily goal sessions | Accessible/usable | 6 Participants |
| Intensity | Equity Benchmark: Accessibility/Usability Approximately Equal Across Mobility Categories | Daily goal sessions | Not accessible/usable | 3 Participants |
| Intensity | Equity Benchmark: Accessibility/Usability Approximately Equal Across Mobility Categories | Fitbit protocol | Accessible/usable | 7 Participants |
| Intensity | Equity Benchmark: Accessibility/Usability Approximately Equal Across Mobility Categories | Fitbit protocol | Not accessible/usable | 2 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Accessibility/Usability Approximately Equal Across Mobility Categories | Daily goal sessions | Not accessible/usable | 3 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Accessibility/Usability Approximately Equal Across Mobility Categories | Fitbit protocol | Accessible/usable | 8 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Accessibility/Usability Approximately Equal Across Mobility Categories | Fitbit protocol | Not accessible/usable | 1 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Accessibility/Usability Approximately Equal Across Mobility Categories | Daily goal sessions | Accessible/usable | 6 Participants |
| Affect + SAVOR | Equity Benchmark: Accessibility/Usability Approximately Equal Across Mobility Categories | Fitbit protocol | Accessible/usable | 7 Participants |
| Affect + SAVOR | Equity Benchmark: Accessibility/Usability Approximately Equal Across Mobility Categories | Daily goal sessions | Not accessible/usable | 3 Participants |
| Affect + SAVOR | Equity Benchmark: Accessibility/Usability Approximately Equal Across Mobility Categories | Fitbit protocol | Not accessible/usable | 2 Participants |
| Affect + SAVOR | Equity Benchmark: Accessibility/Usability Approximately Equal Across Mobility Categories | Daily goal sessions | Accessible/usable | 6 Participants |
| Affect + TYPE/CONTEXT + SAVOR | Equity Benchmark: Accessibility/Usability Approximately Equal Across Mobility Categories | Fitbit protocol | Not accessible/usable | 5 Participants |
| Affect + TYPE/CONTEXT + SAVOR | Equity Benchmark: Accessibility/Usability Approximately Equal Across Mobility Categories | Daily goal sessions | Not accessible/usable | 4 Participants |
| Affect + TYPE/CONTEXT + SAVOR | Equity Benchmark: Accessibility/Usability Approximately Equal Across Mobility Categories | Daily goal sessions | Accessible/usable | 5 Participants |
| Affect + TYPE/CONTEXT + SAVOR | Equity Benchmark: Accessibility/Usability Approximately Equal Across Mobility Categories | Fitbit protocol | Accessible/usable | 4 Participants |
Primary
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.
Time frame: Reported at 3 weeks (i.e., post-study)
Population: This analysis was concerned with the basic equity of the eMOTION Study intervention related to physical constraints, regardless of the specific treatment arm that participants were in. Therefore, participants from the full sample were split into three tertiles based on physical constraints.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intensity | Equity Benchmark: Accessibility/Usability Approximately Equal Across Physical Constraint Categories | Daily goal sessions | Accessible/usable | 10 Participants |
| Intensity | Equity Benchmark: Accessibility/Usability Approximately Equal Across Physical Constraint Categories | Daily goal sessions | Not accessible/usable | 5 Participants |
| Intensity | Equity Benchmark: Accessibility/Usability Approximately Equal Across Physical Constraint Categories | Fitbit protocol | Accessible/usable | 12 Participants |
| Intensity | Equity Benchmark: Accessibility/Usability Approximately Equal Across Physical Constraint Categories | Fitbit protocol | Not accessible/usable | 3 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Accessibility/Usability Approximately Equal Across Physical Constraint Categories | Fitbit protocol | Not accessible/usable | 3 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Accessibility/Usability Approximately Equal Across Physical Constraint Categories | Daily goal sessions | Accessible/usable | 9 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Accessibility/Usability Approximately Equal Across Physical Constraint Categories | Fitbit protocol | Accessible/usable | 9 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Accessibility/Usability Approximately Equal Across Physical Constraint Categories | Daily goal sessions | Not accessible/usable | 3 Participants |
| Affect + SAVOR | Equity Benchmark: Accessibility/Usability Approximately Equal Across Physical Constraint Categories | Fitbit protocol | Not accessible/usable | 4 Participants |
| Affect + SAVOR | Equity Benchmark: Accessibility/Usability Approximately Equal Across Physical Constraint Categories | Daily goal sessions | Not accessible/usable | 5 Participants |
| Affect + SAVOR | Equity Benchmark: Accessibility/Usability Approximately Equal Across Physical Constraint Categories | Fitbit protocol | Accessible/usable | 5 Participants |
| Affect + SAVOR | Equity Benchmark: Accessibility/Usability Approximately Equal Across Physical Constraint Categories | Daily goal sessions | Accessible/usable | 4 Participants |
Primary
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.
Time frame: Reported at 3 weeks (i.e., post-study)
Population: This analysis was concerned with the basic equity of the eMOTION Study intervention related to ethnicity (Hispanic vs. non-Hispanic), regardless of the specific treatment arm that participants were in. Therefore, participants from the full sample were split into two sub-groups based on ethnicity.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intensity | Equity Benchmark: Accessibility/Usability Approximately Equal for Hispanic vs. Non-Hispanic Participants | Daily goal sessions | Accessible/usable | 2 Participants |
| Intensity | Equity Benchmark: Accessibility/Usability Approximately Equal for Hispanic vs. Non-Hispanic Participants | Daily goal sessions | Not accessible/usable | 2 Participants |
| Intensity | Equity Benchmark: Accessibility/Usability Approximately Equal for Hispanic vs. Non-Hispanic Participants | Fitbit protocol | Accessible/usable | 2 Participants |
| Intensity | Equity Benchmark: Accessibility/Usability Approximately Equal for Hispanic vs. Non-Hispanic Participants | Fitbit protocol | Not accessible/usable | 2 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Accessibility/Usability Approximately Equal for Hispanic vs. Non-Hispanic Participants | Fitbit protocol | Not accessible/usable | 8 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Accessibility/Usability Approximately Equal for Hispanic vs. Non-Hispanic Participants | Daily goal sessions | Accessible/usable | 21 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Accessibility/Usability Approximately Equal for Hispanic vs. Non-Hispanic Participants | Fitbit protocol | Accessible/usable | 24 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Accessibility/Usability Approximately Equal for Hispanic vs. Non-Hispanic Participants | Daily goal sessions | Not accessible/usable | 11 Participants |
Primary
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.
Time frame: Reported at 3 weeks (i.e., post-study)
Population: This analysis was concerned with the basic equity of the eMOTION Study intervention related to sex-at-birth (male vs. female), regardless of the specific treatment arm that participants were in. Therefore, participants from the full sample (N=36) were split into two sub-groups based on sex.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intensity | Equity Benchmark: Accessibility/Usability Approximately Equal for Males vs. Females | Daily Goal Session | Accessible/usable | 11 Participants |
| Intensity | Equity Benchmark: Accessibility/Usability Approximately Equal for Males vs. Females | Daily Goal Session | Not accessible/usable | 6 Participants |
| Intensity | Equity Benchmark: Accessibility/Usability Approximately Equal for Males vs. Females | Fitbit Protocol | Accessible/usable | 13 Participants |
| Intensity | Equity Benchmark: Accessibility/Usability Approximately Equal for Males vs. Females | Fitbit Protocol | Not accessible/usable | 4 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Accessibility/Usability Approximately Equal for Males vs. Females | Fitbit Protocol | Not accessible/usable | 6 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Accessibility/Usability Approximately Equal for Males vs. Females | Daily Goal Session | Accessible/usable | 12 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Accessibility/Usability Approximately Equal for Males vs. Females | Fitbit Protocol | Accessible/usable | 13 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Accessibility/Usability Approximately Equal for Males vs. Females | Daily Goal Session | Not accessible/usable | 7 Participants |
Primary
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.
Time frame: Reported at 3 weeks (i.e., post-study)
Population: This analysis was concerned with the basic equity of the eMOTION Study intervention related to BMI status (overweight vs. obese), regardless of the specific treatment arm that participants were in. Therefore, participants from the full sample were split into two sub-groups based on BMI status.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intensity | Equity Benchmark: Accessibility/Usability Approximately Equal for Participants With Overweight vs. Obesity | Daily goal sessions | Accessible/usable | 8 Participants |
| Intensity | Equity Benchmark: Accessibility/Usability Approximately Equal for Participants With Overweight vs. Obesity | Daily goal sessions | Not accessible/usable | 4 Participants |
| Intensity | Equity Benchmark: Accessibility/Usability Approximately Equal for Participants With Overweight vs. Obesity | Fitbit protocol | Accessible/usable | 10 Participants |
| Intensity | Equity Benchmark: Accessibility/Usability Approximately Equal for Participants With Overweight vs. Obesity | Fitbit protocol | Not accessible/usable | 2 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Accessibility/Usability Approximately Equal for Participants With Overweight vs. Obesity | Fitbit protocol | Not accessible/usable | 8 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Accessibility/Usability Approximately Equal for Participants With Overweight vs. Obesity | Daily goal sessions | Accessible/usable | 15 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Accessibility/Usability Approximately Equal for Participants With Overweight vs. Obesity | Fitbit protocol | Accessible/usable | 16 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Accessibility/Usability Approximately Equal for Participants With Overweight vs. Obesity | Daily goal sessions | Not accessible/usable | 9 Participants |
Primary
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.
Time frame: Reported at 3 weeks (i.e., post-study)
Population: This analysis was concerned with the basic equity of the eMOTION Study intervention related to race (white vs. non-white), regardless of the specific treatment arm that participants were in. Therefore, participants from the full sample were split into two sub-groups based on race.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intensity | Equity Benchmark: Accessibility/Usability Approximately Equal for White vs. Non-white Participants | Daily goal sessions | Accessible/usable | 19 Participants |
| Intensity | Equity Benchmark: Accessibility/Usability Approximately Equal for White vs. Non-white Participants | Daily goal sessions | Not accessible/usable | 12 Participants |
| Intensity | Equity Benchmark: Accessibility/Usability Approximately Equal for White vs. Non-white Participants | Fitbit protocol | Accessible/usable | 21 Participants |
| Intensity | Equity Benchmark: Accessibility/Usability Approximately Equal for White vs. Non-white Participants | Fitbit protocol | Not accessible/usable | 10 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Accessibility/Usability Approximately Equal for White vs. Non-white Participants | Fitbit protocol | Not accessible/usable | 0 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Accessibility/Usability Approximately Equal for White vs. Non-white Participants | Daily goal sessions | Accessible/usable | 4 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Accessibility/Usability Approximately Equal for White vs. Non-white Participants | Fitbit protocol | Accessible/usable | 5 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Accessibility/Usability Approximately Equal for White vs. Non-white Participants | Daily goal sessions | Not accessible/usable | 1 Participants |
Primary
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.
Time frame: Reported at 3 weeks (i.e., post-study)
Population: This analysis was concerned with the basic equity of the eMOTION Study intervention related to age, regardless of the specific treatment arm that participants were in. Therefore, participants from the full sample were split into four quartiles based on age.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intensity | Equity Benchmark: Efficacy Approximately Equal Across Age Categories | Efficacious | 5 Participants |
| Intensity | Equity Benchmark: Efficacy Approximately Equal Across Age Categories | Missing | 0 Participants |
| Intensity | Equity Benchmark: Efficacy Approximately Equal Across Age Categories | Not efficacious | 4 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Efficacy Approximately Equal Across Age Categories | Efficacious | 2 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Efficacy Approximately Equal Across Age Categories | Missing | 0 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Efficacy Approximately Equal Across Age Categories | Not efficacious | 7 Participants |
| Affect + SAVOR | Equity Benchmark: Efficacy Approximately Equal Across Age Categories | Not efficacious | 4 Participants |
| Affect + SAVOR | Equity Benchmark: Efficacy Approximately Equal Across Age Categories | Efficacious | 4 Participants |
| Affect + SAVOR | Equity Benchmark: Efficacy Approximately Equal Across Age Categories | Missing | 1 Participants |
| Affect + TYPE/CONTEXT + SAVOR | Equity Benchmark: Efficacy Approximately Equal Across Age Categories | Efficacious | 5 Participants |
| Affect + TYPE/CONTEXT + SAVOR | Equity Benchmark: Efficacy Approximately Equal Across Age Categories | Missing | 0 Participants |
| Affect + TYPE/CONTEXT + SAVOR | Equity Benchmark: Efficacy Approximately Equal Across Age Categories | Not efficacious | 4 Participants |
Primary
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.
Time frame: Reported at 3 weeks (i.e., post-study)
Population: This analysis was concerned with the basic equity of the eMOTION Study intervention related to annual income, regardless of the specific treatment arm that participants were in. Therefore, participants from the full sample were split into five sub-groups based on income.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intensity | Equity Benchmark: Efficacy Approximately Equal Across Income Categories | Efficacious | 0 Participants |
| Intensity | Equity Benchmark: Efficacy Approximately Equal Across Income Categories | Missing | 0 Participants |
| Intensity | Equity Benchmark: Efficacy Approximately Equal Across Income Categories | Not efficacious | 3 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Efficacy Approximately Equal Across Income Categories | Not efficacious | 5 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Efficacy Approximately Equal Across Income Categories | Efficacious | 1 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Efficacy Approximately Equal Across Income Categories | Missing | 0 Participants |
| Affect + SAVOR | Equity Benchmark: Efficacy Approximately Equal Across Income Categories | Not efficacious | 1 Participants |
| Affect + SAVOR | Equity Benchmark: Efficacy Approximately Equal Across Income Categories | Efficacious | 8 Participants |
| Affect + SAVOR | Equity Benchmark: Efficacy Approximately Equal Across Income Categories | Missing | 0 Participants |
| Affect + TYPE/CONTEXT + SAVOR | Equity Benchmark: Efficacy Approximately Equal Across Income Categories | Efficacious | 3 Participants |
| Affect + TYPE/CONTEXT + SAVOR | Equity Benchmark: Efficacy Approximately Equal Across Income Categories | Missing | 0 Participants |
| Affect + TYPE/CONTEXT + SAVOR | Equity Benchmark: Efficacy Approximately Equal Across Income Categories | Not efficacious | 5 Participants |
| ≥ $125,000 | Equity Benchmark: Efficacy Approximately Equal Across Income Categories | Not efficacious | 5 Participants |
| ≥ $125,000 | Equity Benchmark: Efficacy Approximately Equal Across Income Categories | Efficacious | 4 Participants |
| ≥ $125,000 | Equity Benchmark: Efficacy Approximately Equal Across Income Categories | Missing | 1 Participants |
Primary
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.
Time frame: Reported at 3 weeks (i.e., post-study)
Population: This analysis was concerned with the basic equity of the eMOTION Study intervention related to mobility, regardless of the specific treatment arm that participants were in. Therefore, participants from the full sample were split into four quartiles based on mobility.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intensity | Equity Benchmark: Efficacy Approximately Equal Across Mobility Categories | Not efficacious | 3 Participants |
| Intensity | Equity Benchmark: Efficacy Approximately Equal Across Mobility Categories | Missing | 1 Participants |
| Intensity | Equity Benchmark: Efficacy Approximately Equal Across Mobility Categories | Efficacious | 5 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Efficacy Approximately Equal Across Mobility Categories | Efficacious | 4 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Efficacy Approximately Equal Across Mobility Categories | Not efficacious | 5 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Efficacy Approximately Equal Across Mobility Categories | Missing | 0 Participants |
| Affect + SAVOR | Equity Benchmark: Efficacy Approximately Equal Across Mobility Categories | Not efficacious | 4 Participants |
| Affect + SAVOR | Equity Benchmark: Efficacy Approximately Equal Across Mobility Categories | Efficacious | 5 Participants |
| Affect + SAVOR | Equity Benchmark: Efficacy Approximately Equal Across Mobility Categories | Missing | 0 Participants |
| Affect + TYPE/CONTEXT + SAVOR | Equity Benchmark: Efficacy Approximately Equal Across Mobility Categories | Efficacious | 2 Participants |
| Affect + TYPE/CONTEXT + SAVOR | Equity Benchmark: Efficacy Approximately Equal Across Mobility Categories | Missing | 0 Participants |
| Affect + TYPE/CONTEXT + SAVOR | Equity Benchmark: Efficacy Approximately Equal Across Mobility Categories | Not efficacious | 7 Participants |
Primary
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.
Time frame: Reported at 3 weeks (i.e., post-study)
Population: This analysis was concerned with the basic equity of the eMOTION Study intervention related to physical constraints, regardless of the specific treatment arm that participants were in. Therefore, participants from the full sample were split into three tertiles based on physical constraints.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intensity | Equity Benchmark: Efficacy Approximately Equal Across Physical Constraint Categories | Not efficacious | 8 Participants |
| Intensity | Equity Benchmark: Efficacy Approximately Equal Across Physical Constraint Categories | Efficacious | 6 Participants |
| Intensity | Equity Benchmark: Efficacy Approximately Equal Across Physical Constraint Categories | Missing | 1 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Efficacy Approximately Equal Across Physical Constraint Categories | Not efficacious | 5 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Efficacy Approximately Equal Across Physical Constraint Categories | Efficacious | 7 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Efficacy Approximately Equal Across Physical Constraint Categories | Missing | 0 Participants |
| Affect + SAVOR | Equity Benchmark: Efficacy Approximately Equal Across Physical Constraint Categories | Efficacious | 3 Participants |
| Affect + SAVOR | Equity Benchmark: Efficacy Approximately Equal Across Physical Constraint Categories | Missing | 0 Participants |
| Affect + SAVOR | Equity Benchmark: Efficacy Approximately Equal Across Physical Constraint Categories | Not efficacious | 6 Participants |
Primary
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.
Time frame: Reported at 3 weeks (i.e., post-study)
Population: This analysis was concerned with the basic equity of the eMOTION Study intervention related to ethnicity (Hispanic vs. non-Hispanic), regardless of the specific treatment arm that participants were in. Therefore, participants from the full sample were split into two sub-groups based on ethnicity.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intensity | Equity Benchmark: Efficacy Approximately Equal for Hispanic vs. Non-Hispanic Participants | Efficacious | 1 Participants |
| Intensity | Equity Benchmark: Efficacy Approximately Equal for Hispanic vs. Non-Hispanic Participants | Not efficacious | 3 Participants |
| Intensity | Equity Benchmark: Efficacy Approximately Equal for Hispanic vs. Non-Hispanic Participants | Missing | 0 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Efficacy Approximately Equal for Hispanic vs. Non-Hispanic Participants | Efficacious | 15 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Efficacy Approximately Equal for Hispanic vs. Non-Hispanic Participants | Not efficacious | 16 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Efficacy Approximately Equal for Hispanic vs. Non-Hispanic Participants | Missing | 1 Participants |
Primary
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.
Time frame: Reported at 3 weeks (i.e., post-study)
Population: This analysis was concerned with the basic equity of the eMOTION Study intervention related to sex-at-birth (male vs. female), regardless of the specific treatment arm that participants were in. Therefore, participants from the full sample (N=36) were split into two sub-groups based on sex.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intensity | Equity Benchmark: Efficacy Approximately Equal for Males vs. Females | Efficacious | 6 Participants |
| Intensity | Equity Benchmark: Efficacy Approximately Equal for Males vs. Females | Not Efficacious | 11 Participants |
| Intensity | Equity Benchmark: Efficacy Approximately Equal for Males vs. Females | Missing | 0 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Efficacy Approximately Equal for Males vs. Females | Efficacious | 10 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Efficacy Approximately Equal for Males vs. Females | Not Efficacious | 8 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Efficacy Approximately Equal for Males vs. Females | Missing | 1 Participants |
Primary
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.
Time frame: Reported at 3 weeks (i.e., post-study)
Population: This analysis was concerned with the basic equity of the eMOTION Study intervention related to BMI status (overweight vs. obese), regardless of the specific treatment arm that participants were in. Therefore, participants from the full sample were split into two sub-groups based on BMI status.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intensity | Equity Benchmark: Efficacy Approximately Equal for Participants With Overweight vs. Obesity | Efficacious | 5 Participants |
| Intensity | Equity Benchmark: Efficacy Approximately Equal for Participants With Overweight vs. Obesity | Not efficacious | 6 Participants |
| Intensity | Equity Benchmark: Efficacy Approximately Equal for Participants With Overweight vs. Obesity | Missing | 1 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Efficacy Approximately Equal for Participants With Overweight vs. Obesity | Efficacious | 11 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Efficacy Approximately Equal for Participants With Overweight vs. Obesity | Not efficacious | 13 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Efficacy Approximately Equal for Participants With Overweight vs. Obesity | Missing | 0 Participants |
Primary
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.
Time frame: Reported at 3 weeks (i.e., post-study)
Population: This analysis was concerned with the basic equity of the eMOTION Study intervention related to race (white vs. non-white), regardless of the specific treatment arm that participants were in. Therefore, participants from the full sample were split into two sub-groups based on race.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intensity | Equity Benchmark: Efficacy Approximately Equal for White vs. Non-white Participants | Not efficacious | 18 Participants |
| Intensity | Equity Benchmark: Efficacy Approximately Equal for White vs. Non-white Participants | Efficacious | 12 Participants |
| Intensity | Equity Benchmark: Efficacy Approximately Equal for White vs. Non-white Participants | Missing | 1 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Efficacy Approximately Equal for White vs. Non-white Participants | Efficacious | 4 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Efficacy Approximately Equal for White vs. Non-white Participants | Not efficacious | 1 Participants |
| Affect + TYPE/CONTEXT | Equity Benchmark: Efficacy Approximately Equal for White vs. Non-white Participants | Missing | 0 Participants |
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.
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)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intensity | Safety Benchmark: Percentage of Participants Experiencing an Adverse Event | Did not report adverse event | 9 Participants |
| Intensity | Safety Benchmark: Percentage of Participants Experiencing an Adverse Event | Reported adverse event | 0 Participants |
| Affect + TYPE/CONTEXT | Safety Benchmark: Percentage of Participants Experiencing an Adverse Event | Reported adverse event | 0 Participants |
| Affect + TYPE/CONTEXT | Safety Benchmark: Percentage of Participants Experiencing an Adverse Event | Did not report adverse event | 9 Participants |
| Affect + SAVOR | Safety Benchmark: Percentage of Participants Experiencing an Adverse Event | Did not report adverse event | 9 Participants |
| Affect + SAVOR | Safety Benchmark: Percentage of Participants Experiencing an Adverse Event | Reported adverse event | 0 Participants |
| Affect + TYPE/CONTEXT + SAVOR | Safety Benchmark: Percentage of Participants Experiencing an Adverse Event | Reported adverse event | 0 Participants |
| Affect + TYPE/CONTEXT + SAVOR | Safety Benchmark: Percentage of Participants Experiencing an Adverse Event | Did not report adverse event | 9 Participants |
Primary
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.
Time frame: Reported at 3 weeks (i.e., post-study)
Population: This analysis only applied to participants who received SAVOR questions. The two SAVOR arms (i.e., affect-based goals + SAVOR, affect-based goals + TYPE/CONTEXT + SAVOR) were combined and considered as a single sub-sample (N=18), since both received identical SAVOR treatment components. Of these participants, n=4 did not remember receiving TYPE/CONTEXT recommendations, and an additional n=2 did not respond, so they were excluded from the analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intensity | Sustainability/Feasibility Benchmark: Dissatisfaction With SAVOR Questions | Satisfied | 12 Participants |
| Intensity | Sustainability/Feasibility Benchmark: Dissatisfaction With SAVOR Questions | Dissatisfied | 0 Participants |
Primary
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.
Time frame: Reported at 3 weeks (i.e., post-study)
Population: This analysis only applied to participants who received TYPE/CONTEXT recommendations. The two TYPE/CONTEXT arms (i.e., affect-based goals + TYPE/CONTEXT, affect-based goals + TYPE/CONTEXT + SAVOR) were combined and considered as a single sub-sample (N=18), since both received identical TYPE/CONTEXT treatment components. Of these participants, n=3 did not remember receiving TYPE/CONTEXT recommendations, and an additional n=2 failed to respond, so they were excluded from the analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intensity | Sustainability/Feasibility Benchmark: Dissatisfaction With TYPE/CONTEXT Recommendations | Dissatisfied | 3 Participants |
| Intensity | Sustainability/Feasibility Benchmark: Dissatisfaction With TYPE/CONTEXT Recommendations | Satisfied | 10 Participants |
Primary
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.
Time frame: From first full day of intervention (i.e., day 8) to last day of data collection (i.e., day 21)
Population: The study protocol and statistical analysis plan pre-specified that treatment arms would be assessed in a combined manner (i.e, as a full sample). The physical activity auto-detection algorithm was applied uniformly across all participants (N=36), regardless of treatment arm. The number of correctly-triggered surveys were divided by the total number of event-contingent surveys sent during the study (i.e., N=1555) in this analysis.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Intensity | Sustainability/Feasibility Benchmark: Fidelity of Auto-detection Algorithm | Surveys triggered successfully | 1555 Total event-contingent surveys |
| Intensity | Sustainability/Feasibility Benchmark: Fidelity of Auto-detection Algorithm | Surveys not triggered successfully | 0 Total event-contingent surveys |
Primary
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.
Time frame: From first day of run-in period (i.e., day 1) to last day of data collection (i.e., day 21)
Population: The study protocol and statistical analysis plan pre-specified that treatment arms would be assessed in a combined manner (i.e, as a full sample). This analysis focused on the basic sustainability/feasibility of Fitbit-related issues for study staff. Because all participants received Fitbit smartwatches that underwent uniform technological setup and connectivity procedures, each participant's treatment arm was irrelevant.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intensity | Sustainability/Feasibility Benchmark: Research Staff Burden | >1 reminders to sync data? | Yes | 0 Participants |
| Intensity | Sustainability/Feasibility Benchmark: Research Staff Burden | >1 reminders to sync data? | No | 36 Participants |
| Intensity | Sustainability/Feasibility Benchmark: Research Staff Burden | Replacement Fitbit required? | Yes | 0 Participants |
| Intensity | Sustainability/Feasibility Benchmark: Research Staff Burden | Replacement Fitbit required? | No | 36 Participants |
Primary
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.
Time frame: Reported at 3 weeks (i.e., post-study)
Population: The study protocol and statistical analysis plan pre-specified that treatment arms would be assessed in a combined manner (i.e, as a full sample). All participants engaged with the most basic Fitbit and smartphone-based components in the same way, regardless of their treatment arms. All items asked about study elements that were kept uniform across participants.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intensity | Sustainability/Feasibility Benchmark: Satisfaction With Fitbit and Daily Goal Session Components | Daily goal sessions | Missing | 2 Participants |
| Intensity | Sustainability/Feasibility Benchmark: Satisfaction With Fitbit and Daily Goal Session Components | Fitbit app | Satisfied | 33 Participants |
| Intensity | Sustainability/Feasibility Benchmark: Satisfaction With Fitbit and Daily Goal Session Components | Fitbit app | Dissatisfied | 3 Participants |
| Intensity | Sustainability/Feasibility Benchmark: Satisfaction With Fitbit and Daily Goal Session Components | Fitbit app | Missing | 0 Participants |
| Intensity | Sustainability/Feasibility Benchmark: Satisfaction With Fitbit and Daily Goal Session Components | Survey burden | Dissatisfied | 14 Participants |
| Intensity | Sustainability/Feasibility Benchmark: Satisfaction With Fitbit and Daily Goal Session Components | Survey burden | Missing | 0 Participants |
| Intensity | Sustainability/Feasibility Benchmark: Satisfaction With Fitbit and Daily Goal Session Components | Daily goal sessions | Satisfied | 31 Participants |
| Intensity | Sustainability/Feasibility Benchmark: Satisfaction With Fitbit and Daily Goal Session Components | Daily goal sessions | Dissatisfied | 3 Participants |
| Intensity | Sustainability/Feasibility Benchmark: Satisfaction With Fitbit and Daily Goal Session Components | Exercise settings | Dissatisfied | 6 Participants |
| Intensity | Sustainability/Feasibility Benchmark: Satisfaction With Fitbit and Daily Goal Session Components | Survey notifications | Satisfied | 24 Participants |
| Intensity | Sustainability/Feasibility Benchmark: Satisfaction With Fitbit and Daily Goal Session Components | Survey burden | Satisfied | 22 Participants |
| Intensity | Sustainability/Feasibility Benchmark: Satisfaction With Fitbit and Daily Goal Session Components | Exercise settings | Satisfied | 30 Participants |
| Intensity | Sustainability/Feasibility Benchmark: Satisfaction With Fitbit and Daily Goal Session Components | Exercise settings | Missing | 0 Participants |
| Intensity | Sustainability/Feasibility Benchmark: Satisfaction With Fitbit and Daily Goal Session Components | Survey notifications | Dissatisfied | 12 Participants |
| Intensity | Sustainability/Feasibility Benchmark: Satisfaction With Fitbit and Daily Goal Session Components | Survey notifications | Missing | 0 Participants |