Physical InactivityNCT06570642
eMOTION: Examining Affective Mechanisms in Physical Activity Engagement
A study testing Physical Activity Goals mHealth Intervention, TYPE/CONTEXT enhancement and SAVOR enhancement in people with Physical Inactivity and Overweight or Obesity, run by University of Southern California at 1 site in United States.
Trial summary
This early-phase trial will test intervention strategies to influence affective mechanisms underlying physical activity and determine whether changes in those mechanisms result in change in physical activity behavior among inactive adults who are overweight or obese. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity, Overweight or Obesity, Cancer
- What is being tested?
- Physical Activity Goals mHealth Intervention, TYPE/CONTEXT enhancement and SAVOR enhancement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 years
- Reside in the United States
- Self-reported BMI ≥ 25
- Current structured physical activity engagement < 60 minutes per week
- Own a personal smartphone device
- Reside in an area with Internet or Wi-Fi connectivity during the study period
Show all 10Show fewer
- Able to speak and read in English
- Interested and willing to start a physical activity program
- Willing to wear a Fitbit Versa smartwatch provided by the study team everyday continuously (including at work and during physical activity), in place of any Fitbits or smartwatches previously worn, for the duration of the study period
- Able to read the small font on a smartwatch screen without glasses, or willing to carry reading glasses during physical activity for the purpose of reading the smartwatch screen
Who cannot join
- Inability to provide informed consent due to cognitive disability
- Inability 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 or answer brief surveys on the smartwatch for any reason
- Current pregnancy
- Referred to the study by another participant or from Reddit.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Southern California
Los Angeles, California, 90032
Micaela Hewus, MPH, 323-442-8224, micaelag@usc.edu
Rachel C Lyons, MS, 3175187670, rclyons@usc.edu
About this study
Official title: Using Real-Time Data Capture to Examine Affective Mechanisms as Mediators of Physical Activity Adherence in Interventions
This early-phase trial will test intervention strategies to influence affective mechanisms underlying physical activity and determine whether changes in those mechanisms result in change in physical activity behavior among inactive adults who are overweight or obese.
Read the detailed description
This ORBIT model phase 1 trial will examine whether affective mechanisms (1) can be experimentally manipulated in real-world settings; and (2) mediate the relationship between interventions and physical activity behavior. A novel physical activity intervention will be optimized by efficiently disentangling the effects of its core component and two enhancement components on affective mechanisms associated with physical activity engagement.
- Conditions
- Physical Inactivity, Overweight or Obesity, Cancer
- Being tested
- Physical Activity Goals mHealth Intervention, TYPE/CONTEXT enhancement, SAVOR enhancement
- Keywords
- Affective Response, Psychological Needs, Physical Activity
- Medical subject headings
- Sedentary Behavior, Overweight, Obesity, Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity Goals mHealth InterventionBehavioural
On days participants plan to exercise, they engage in two daily goal sessions (morning and evening). Morning sessions provide an activity goal for the day and ask the participant to create a plan, anticipate barriers, and brainstorm solutions for achieving this goal. The affect-based goal condition asks participants to engage in either (1) a type (50% of daily goals) or (2) a context (50% of daily goals) of physical activity that allows them to experience positive affect. Goals focused on context are randomly generated to suggest that the participant performs activity (1) in a place; (2) in a social situation; or (3) while listening to something that makes them feel good. The intensity-based goal condition asks participants to maintain a certain target heart rate range during physical activity. Starting heart rate reflects the approximate age-adjusted heart rate max, with goals progressively increasing from 55% to 70% heart rate max.
TYPE/CONTEXT enhancementBehavioural
TYPE/CONTEXT augments intervention effects by 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 will be used to determine the potential for specific activity types and contexts to satisfy psychological needs; our tailoring algorithm will then recommend the corresponding activity type or context while accounting for reported constraints (e.g., ability, access). These details will be incorporated into a tailored recommendation provided to participants each Sunday as they make activity plans for the upcoming week. Specifically, the program will randomly select either type or context (i.e., location, audio, social) recommendations and will rotate every two weeks. For TYPE, participants' top 3 activity types are recommended; for CONTEXT, participants' top 3 activity contexts are recommended.
SAVOR enhancementBehavioural
SAVOR implements a brief savoring exercise on the smartphone that takes place either after the planned physical activity session or 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 three open-ended prompts. These prompts are drawn from a prompt pool with slightly varied wording to promote a sense of novelty. Savoring prompts will rotate daily and have a day lag built in every week (i.e., Week 1 Monday Savoring Prompts are Week 2 Tuesday Savoring Prompts).
| Study group | Role | What they receive |
|---|---|---|
| Affect (no enhancements) > Intensity | Experimental | Participants receive affect-based goals for the first 8-weeks, then cross-over to receive intensity-based goals for the second 8-weeks. No enhancements are added to the standard mHealth intervention. Receives: Behavioral: Physical Activity Goals mHealth Intervention |
| Intensity > Affect (no enhancements) | Experimental | Participants receive intensity-based goals for the first 8-weeks, then cross-over to receive affect-based goals for the second 8-weeks. No enhancements are added to the standard mHealth intervention. Receives: Behavioral: Physical Activity Goals mHealth Intervention |
| Affect (+ SAVOR + TYPE/CONTEXT) > Intensity | Active comparator | Participants receive affect-based goals for the first 8-weeks. In addition to the standard mHealth intervention, participants engage in both SAVOR and TYPE/CONTEXT enhancements to augment the treatment effects of the affect-based goals condition. Participants then cross-over to receive intensity-based goals for the second 8-weeks. Receives: Behavioral: Physical Activity Goals mHealth Intervention; Behavioral: TYPE/CONTEXT enhancement; Behavioral: SAVOR enhancement |
| Intensity > Affect (+ SAVOR + TYPE/CONTEXT) | Active comparator | Participants receive intensity-based goals for the first 8-weeks, then cross-over to receive affect-based goals for the second 8-weeks. In addition to the standard mHealth intervention, participants engage in both SAVOR and TYPE/CONTEXT enhancements to augment the treatment effects of the affect-based goals condition. Receives: Behavioral: Physical Activity Goals mHealth Intervention; Behavioral: TYPE/CONTEXT enhancement; Behavioral: SAVOR enhancement |
| Affect (+SAVOR) > Intensity | Active comparator | Participants receive affect-based goals for the first 8-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. Participants then cross-over to receive intensity-based goals for the second 8-weeks. Receives: Behavioral: Physical Activity Goals mHealth Intervention; Behavioral: SAVOR enhancement |
| Intensity > Affect (+SAVOR) | Active comparator | Participants receive intensity-based goals for the first 8-weeks, then cross-over to receive affect-based goals for the second 8-weeks. In addition to the standard mHealth intervention, participants engage in the SAVOR enhancement to augment the treatment effects of the affect-based goals condition. Receives: Behavioral: Physical Activity Goals mHealth Intervention; Behavioral: SAVOR enhancement |
| Affect (+TYPE/CONTEXT) > Intensity | Active comparator | Participants receive affect-based goals for the first 8-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. Participants then cross-over to receive intensity-based goals for the second 8-weeks. Receives: Behavioral: Physical Activity Goals mHealth Intervention; Behavioral: TYPE/CONTEXT enhancement |
| Intensity > Affect (+TYPE/CONTEXT) | Active comparator | Participants receive intensity-based goals for the first 8-weeks, then cross-over to receive affect-based goals for the second 8-weeks. In addition to the standard mHealth intervention, participants engage in the TYPE/CONTEXT enhancement to augment the treatment effects of the affect-based goals condition. Receives: Behavioral: Physical Activity Goals mHealth Intervention; Behavioral: TYPE/CONTEXT enhancement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity: Step Count
Daily steps will be calculated from minute-level accelerometer data. Fitbit Versa 3 smartwatches with internal accelerometers are worn for the duration of the study period, except while bathing or charging. Only days with sufficient wear time (defined as ≥ 10-hours of valid data, where no more than 20-minutes per hour has a consecutive step count of zero) are used for analysis.
Measured: Daily total for weeks 1-19
Physical Activity: Minutes
Daily minutes of light, moderate, and vigorous physical activity will be calculated from minute-level accelerometer data. Fitbit Versa 3 smartwatches with internal accelerometers are worn for the duration of the study period, except while bathing or charging. Only days with sufficient wear time (defined as ≥ 10-hours of valid data, where no more than 20-minutes per hour has a consecutive step count of zero) are used for analysis.
Measured: Daily total for weeks 1-19
Secondary outcomes (3)
Affective Response
Event-contingent ecological momentary assessment (EMA) check-ins sent to the smartwatch during physical activity measure affective response. Event-contingent EMA are triggered when Fitbit sensors detect physical activity via moving average heart rate. A ≥30-minute buffer separates the first and second EMA during a single physical activity bout. A maximum of two event-contingent EMA will be sent within any given 60-minute period. Participants are asked to safely pause their activity to answer seven items about their affective response using a 5-point bipolar Likert Scale. Five items (Energetic-Fatigued, Happy-Discouraged, Relaxed-Tense, Excited-Bored, Satisfied-Frustrated) are drawn from Russell's Circumplex Model of Affect; one (Good-Bad) represents core affective valence; and one (Proud-Embarrassed) represents self-conscious emotion.
Measured: Max 2 per 60-min physical activity period during weeks 2-9 and weeks 12-19
Affectively-Charged Motivations
Affectively-charged motivations for physical activity are measured during the morning goal session via REDCap. A text message alerts participants to complete the morning goal session on their smartphone. A single item from the Attraction-Antipathy subscale of the AFFEXX measures affectively-charged motivation by asking, "How do you feel about doing physical activity today?". Participants select a response using a Visual Analogue Scale ranging from 0 (Dread) to 100 (Excited).
Measured: Up to once daily for weeks 2-9 and weeks 12-19
Anticipated Affect
Anticipated affect is measured during the morning goal session via REDCap. A text message alerts participants to complete the morning goal session on their smartphone. A single item asks, "How do you expect to feel during physical activity today?". Participants select a response using a Visual Analogue Scale ranging from 0 (Miserable) to 100 (Thrilled).
Measured: Up to once daily for weeks 2-9 and weeks 12-19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start14 Aug 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The study will use a partial factorial, crossover, within x between subjects design. Participants randomly receive affect- or intensity-based goals for 8-weeks (Part 1), followed by a 2-week washout period, then cross-over to the other condition for 8-weeks (Part 2). During the affect-based goal condition, participants randomly receive one of four combinations of intervention enhancements: TYPE/CONTEXT (with vs. without) x SAVOR (with vs. without). In summary, participants are randomly assigned to one of eight groups based on order and intervention components: (1) intensity \> affect without enhancements; (2) intensity \> affect with TYPE/CONTEXT; (3) intensity \> affect with SAVOR; (4) intensity \> affect with both TYPE/CONTEXT and SAVOR; (5) affect without enhancements \> intensity; (6) affect with TYPE/CONTEXT \> intensity; (7) affect with SAVOR \> intensity; and (8) affect with both TYPE/CONTEXT and SAVOR \> intensity.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Genevieve Dunton, University of Southern California
- Investigators
- Genevieve F Dunton, PhD MPH, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570642
- Sponsor's protocol ID
- UP-22-00332
- Other IDs
- R01CA272933
- Status last verified
- Jun 2025
- First submitted
- 16 Aug 2024
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dunton GF, Hatzinger L, Crosley-Lyons R, Hewus M, Wang WL, Van Dyck D, Huh J. Randomized trial of a digital therapeutics intervention to enhance affective response during physical activity: Protocol for the eMOTION study. Contemp Clin Trials. 2025 Jul;154:107945. doi: 10.1016/j.cct.2025.107945. Epub 2025 May 12.
PubMed 40368026
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Real-Time Data Capture to Examine Affective Mechanisms as Mediators of Physical Activity Adherence in Interventions
- ClinicalTrials.gov ID
- NCT06570642
- Acronym / sponsor ID
- UP-22-00332
- Conditions
- Physical Inactivity, Overweight or Obesity, Cancer
- Keywords
- Affective Response, Psychological Needs, Physical Activity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This early-phase trial will test intervention strategies to influence affective mechanisms underlying physical activity and determine whether changes in those mechanisms result in change in physical activity behavior among inactive adults who are overweight or obese.
Detailed description
This ORBIT model phase 1 trial will examine whether affective mechanisms (1) can be experimentally manipulated in real-world settings; and (2) mediate the relationship between interventions and physical activity behavior. A novel physical activity intervention will be optimized by efficiently disentangling the effects of its core component and two enhancement components on affective mechanisms associated with physical activity engagement.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 8
- Model description
- The study will use a partial factorial, crossover, within x between subjects design. Participants randomly receive affect- or intensity-based goals for 8-weeks (Part 1), followed by a 2-week washout period, then cross-over to the other condition for 8-weeks (Part 2). During the affect-based goal condition, participants randomly receive one of four combinations of intervention enhancements: TYPE/CONTEXT (with vs. without) x SAVOR (with vs. without). In summary, participants are randomly assigned to one of eight groups based on order and intervention components: (1) intensity > affect without enhancements; (2) intensity > affect with TYPE/CONTEXT; (3) intensity > affect with SAVOR; (4) intensity > affect with both TYPE/CONTEXT and SAVOR; (5) affect without enhancements > intensity; (6) affect with TYPE/CONTEXT > intensity; (7) affect with SAVOR > intensity; and (8) affect with both TYPE/CONTEXT and SAVOR > intensity.
| Arm | Type | Receives |
|---|---|---|
| Affect (no enhancements) > Intensity | Experimental | Behavioral: Physical Activity Goals mHealth InterventionParticipants receive affect-based goals for the first 8-weeks, then cross-over to receive intensity-based goals for the second 8-weeks. No enhancements are added to the standard mHealth intervention. |
| Intensity > Affect (no enhancements) | Experimental | Behavioral: Physical Activity Goals mHealth InterventionParticipants receive intensity-based goals for the first 8-weeks, then cross-over to receive affect-based goals for the second 8-weeks. No enhancements are added to the standard mHealth intervention. |
| Affect (+ SAVOR + TYPE/CONTEXT) > Intensity | Active comparator | Behavioral: Physical Activity Goals mHealth Intervention, Behavioral: TYPE/CONTEXT enhancement, Behavioral: SAVOR enhancementParticipants receive affect-based goals for the first 8-weeks. In addition to the standard mHealth intervention, participants engage in both SAVOR and TYPE/CONTEXT enhancements to augment the treatment effects of the affect-based goals condition. Participants then cross-over to receive intensity-based goals for the second 8-weeks. |
| Intensity > Affect (+ SAVOR + TYPE/CONTEXT) | Active comparator | Behavioral: Physical Activity Goals mHealth Intervention, Behavioral: TYPE/CONTEXT enhancement, Behavioral: SAVOR enhancementParticipants receive intensity-based goals for the first 8-weeks, then cross-over to receive affect-based goals for the second 8-weeks. In addition to the standard mHealth intervention, participants engage in both SAVOR and TYPE/CONTEXT enhancements to augment the treatment effects of the affect-based goals condition. |
| Affect (+SAVOR) > Intensity | Active comparator | Behavioral: Physical Activity Goals mHealth Intervention, Behavioral: SAVOR enhancementParticipants receive affect-based goals for the first 8-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. Participants then cross-over to receive intensity-based goals for the second 8-weeks. |
| Intensity > Affect (+SAVOR) | Active comparator | Behavioral: Physical Activity Goals mHealth Intervention, Behavioral: SAVOR enhancementParticipants receive intensity-based goals for the first 8-weeks, then cross-over to receive affect-based goals for the second 8-weeks. In addition to the standard mHealth intervention, participants engage in the SAVOR enhancement to augment the treatment effects of the affect-based goals condition. |
| Affect (+TYPE/CONTEXT) > Intensity | Active comparator | Behavioral: Physical Activity Goals mHealth Intervention, Behavioral: TYPE/CONTEXT enhancementParticipants receive affect-based goals for the first 8-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. Participants then cross-over to receive intensity-based goals for the second 8-weeks. |
| Intensity > Affect (+TYPE/CONTEXT) | Active comparator | Behavioral: Physical Activity Goals mHealth Intervention, Behavioral: TYPE/CONTEXT enhancementParticipants receive intensity-based goals for the first 8-weeks, then cross-over to receive affect-based goals for the second 8-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged ≥ 18 years
- Reside in the United States
- Self-reported BMI ≥ 25
- Current structured physical activity engagement < 60 minutes per week
- Own a personal smartphone device
Key exclusion criteria (4 listed)
- Inability to provide informed consent due to cognitive disability
- Inability 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 or answer brief surveys on the smartwatch for any reason
- Current pregnancy
- Referred to the study by another participant or from Reddit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Activity Goals mHealth InterventionOn days participants plan to exercise, they engage in two daily goal sessions (morning and evening). Morning sessions provide an activity goal for the day and ask the participant to create a plan, anticipate barriers, and brainstorm solutions for achieving this goal. The affect-based goal condition asks participants to engage in either (1) a type (50% of daily goals) or (2) a context (50% of daily goals) of physical activity that allows them to experience positive affect. Goals focused on context are randomly generated to suggest that the participant performs activity (1) in a place; (2) in a social situation; or (3) while listening to something that makes them feel good. The intensity-based goal condition asks participants to maintain a certain target heart rate range during physical activity. Starting heart rate reflects the approximate age-adjusted heart rate max, with goals progressively increasing from 55% to 70% heart rate max. | Behavioural | Affect (+ SAVOR + TYPE/CONTEXT) > Intensity, Affect (+SAVOR) > Intensity, Affect (+TYPE/CONTEXT) > Intensity, Affect (no enhancements) > Intensity, Intensity > Affect (+ SAVOR + TYPE/CONTEXT), Intensity > Affect (+SAVOR), Intensity > Affect (+TYPE/CONTEXT), Intensity > Affect (no enhancements) |
| TYPE/CONTEXT enhancementTYPE/CONTEXT augments intervention effects by 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 will be used to determine the potential for specific activity types and contexts to satisfy psychological needs; our tailoring algorithm will then recommend the corresponding activity type or context while accounting for reported constraints (e.g., ability, access). These details will be incorporated into a tailored recommendation provided to participants each Sunday as they make activity plans for the upcoming week. Specifically, the program will randomly select either type or context (i.e., location, audio, social) recommendations and will rotate every two weeks. For TYPE, participants' top 3 activity types are recommended; for CONTEXT, participants' top 3 activity contexts are recommended. | Behavioural | Affect (+ SAVOR + TYPE/CONTEXT) > Intensity, Affect (+TYPE/CONTEXT) > Intensity, Intensity > Affect (+ SAVOR + TYPE/CONTEXT), Intensity > Affect (+TYPE/CONTEXT) |
| SAVOR enhancementSAVOR implements a brief savoring exercise on the smartphone that takes place either after the planned physical activity session or 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 three open-ended prompts. These prompts are drawn from a prompt pool with slightly varied wording to promote a sense of novelty. Savoring prompts will rotate daily and have a day lag built in every week (i.e., Week 1 Monday Savoring Prompts are Week 2 Tuesday Savoring Prompts). | Behavioural | Affect (+ SAVOR + TYPE/CONTEXT) > Intensity, Affect (+SAVOR) > Intensity, Intensity > Affect (+ SAVOR + TYPE/CONTEXT), Intensity > Affect (+SAVOR) |
Primary outcome
Physical Activity: Step Count
Time frame: Daily total for weeks 1-19
Daily steps will be calculated from minute-level accelerometer data. Fitbit Versa 3 smartwatches with internal accelerometers are worn for the duration of the study period, except while bathing or charging. Only days with sufficient wear time (defined as ≥ 10-hours of valid data, where no more than 20-minutes per hour has a consecutive step count of zero) are used for analysis.
Physical Activity: Minutes
Time frame: Daily total for weeks 1-19
Daily minutes of light, moderate, and vigorous physical activity will be calculated from minute-level accelerometer data. Fitbit Versa 3 smartwatches with internal accelerometers are worn for the duration of the study period, except while bathing or charging. Only days with sufficient wear time (defined as ≥ 10-hours of valid data, where no more than 20-minutes per hour has a consecutive step count of zero) are used for analysis.
3 secondary outcomes
Affective Response
Time frame: Max 2 per 60-min physical activity period during weeks 2-9 and weeks 12-19
Affectively-Charged Motivations
Time frame: Up to once daily for weeks 2-9 and weeks 12-19
Anticipated Affect
Time frame: Up to once daily for weeks 2-9 and weeks 12-19
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Derived from this study: PubMed 40368026Dunton GF, Hatzinger L, Crosley-Lyons R, Hewus M, Wang WL, Van Dyck D, Huh J. Randomized trial of a digital therapeutics intervention to enhance affective response during physical activity: Protocol for the eMOTION study. Contemp Clin Trials. 2025 Jul;154:107945. doi: 10.1016/j.cct.2025.107945. Epub 2025 May 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Genevieve F Dunton, PhD MPH principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity Goals mHealth Intervention, TYPE/CONTEXT enhancement and SAVOR enhancement in people with Physical Inactivity and Overweight or Obesity, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Micaela Hewus, MPH (323-442-7304, micaelag@usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity: Step Count (time frame: Daily total for weeks 1-19). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06570642, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.