eMOTION: Examining Affective Mechanisms in Physical Activity Engagement

Not Applicable

Recruiting

• Conditions: Physical Inactivity; Overweight or Obesity; Cancer
• Interventions: Behavioral: Physical Activity Goals mHealth Intervention; Behavioral: SAVOR enhancement; Behavioral: TYPE/CONTEXT enhancement

• Registration Number: NCT06570642
• Lead Sponsor: University of Southern California

Brief 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.

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 Timeline

• Study Start: 2024-08-14
• Study First Submitted: 2024-08-16
• Study First Submitted QC: 2024-08-21
• Study First Posted: 2024-08-26
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-21
• Primary Completion: 2027-01-01
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

Not provided

Exclusion Criteria

1. Inability to provide informed consent due to cognitive disability
2. 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
3. Current pregnancy
4. Referred to the study by another participant or from Reddit.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Intensity > Affect (+SAVOR)	Physical Activity Goals mHealth Intervention	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.
Intensity > Affect (no enhancements)	Physical Activity Goals mHealth Intervention	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.
Intensity > Affect (+ SAVOR + TYPE/CONTEXT)	Physical Activity Goals mHealth Intervention	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.
Affect (+SAVOR) > Intensity	SAVOR enhancement	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.
Affect (+ SAVOR + TYPE/CONTEXT) > Intensity	SAVOR enhancement	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.
Intensity > Affect (+ SAVOR + TYPE/CONTEXT)	TYPE/CONTEXT enhancement	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.
Affect (no enhancements) > Intensity	Physical Activity Goals mHealth Intervention	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.
Affect (+ SAVOR + TYPE/CONTEXT) > Intensity	TYPE/CONTEXT enhancement	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.
Intensity > Affect (+TYPE/CONTEXT)	Physical Activity Goals mHealth Intervention	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.
Affect (+ SAVOR + TYPE/CONTEXT) > Intensity	Physical Activity Goals mHealth Intervention	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.
Intensity > Affect (+ SAVOR + TYPE/CONTEXT)	SAVOR enhancement	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.
Affect (+SAVOR) > Intensity	Physical Activity Goals mHealth Intervention	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.
Affect (+TYPE/CONTEXT) > Intensity	Physical Activity Goals mHealth Intervention	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.
Intensity > Affect (+SAVOR)	SAVOR enhancement	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.
Intensity > Affect (+TYPE/CONTEXT)	TYPE/CONTEXT enhancement	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.
Affect (+TYPE/CONTEXT) > Intensity	TYPE/CONTEXT enhancement	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.

Primary Outcome Measures

Name	Time	Method
Physical Activity: Step Count	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	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.

Secondary Outcome Measures

Name	Time	Method
Affectively-Charged Motivations	Up to once daily for weeks 2-9 and weeks 12-19	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).
Anticipated Affect	Up to once daily for weeks 2-9 and weeks 12-19	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).
Affective Response	Max 2 per 60-min physical activity period during weeks 2-9 and weeks 12-19	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.
Implicit Attitudes	Up to once daily for weeks 2-9 and weeks 12-19	The single-category Implicit Association Test (IAT) will ask participants to match to a conceptual target such as sedentary behavior (e.g., sitting, lying) or physical activity (e.g., walking, running) to affective attributes (e.g., good/bad).If the participant has a strong automatic association between the attribute and conceptual target, then the reaction time will be shorter (representing a favorable implicit attitude). A real-time audibly prompted IAT will be triggered on participants' smartphones in the morning on days a physical activity session is planned (with four reminders sent once every hour if incomplete).

Trial Locations

Locations (1)

University of Southern California; 🇺🇸 Los Angeles, California, United States