eMOTION: Examining Affective Mechanisms in Physical Activity Engagement

University of Southern California

Status: Enrolling

Conditions: Overweight or Obesity; Physical Inactivity; Cancer

Treatments: Behavioral: Physical Activity Goals mHealth Intervention; Behavioral: TYPE/CONTEXT enhancement; Behavioral: SAVOR enhancement

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06570642

UP-22-00332

R01CA272933 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 280 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Aged ≥ 18 years
2. Reside in the United States
3. Self-reported BMI ≥ 25
4. Current structured physical activity engagement < 60 minutes per week
5. Own a personal smartphone device
6. Reside in an area with Internet or Wi-Fi connectivity during the study period
7. Able to speak and read in English
8. Interested and willing to start a physical activity program
9. 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
10. 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

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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280 participants in 8 patient groups

Affect (no enhancements) > Intensity

Experimental group

Description:

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.

Treatment:

Behavioral: Physical Activity Goals mHealth Intervention

Intensity > Affect (no enhancements)

Experimental group

Description:

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.

Treatment:

Behavioral: Physical Activity Goals mHealth Intervention

Affect (+ SAVOR + TYPE/CONTEXT) > Intensity

Active Comparator group

Description:

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.

Treatment:

Behavioral: SAVOR enhancement

Behavioral: TYPE/CONTEXT enhancement

Behavioral: Physical Activity Goals mHealth Intervention

Intensity > Affect (+ SAVOR + TYPE/CONTEXT)

Active Comparator group

Description:

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.

Treatment:

Behavioral: SAVOR enhancement

Behavioral: TYPE/CONTEXT enhancement

Behavioral: Physical Activity Goals mHealth Intervention

Affect (+SAVOR) > Intensity

Active Comparator group

Description:

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.

Treatment:

Behavioral: SAVOR enhancement

Behavioral: Physical Activity Goals mHealth Intervention

Intensity > Affect (+SAVOR)

Active Comparator group

Description:

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.

Treatment:

Behavioral: SAVOR enhancement

Behavioral: Physical Activity Goals mHealth Intervention

Affect (+TYPE/CONTEXT) > Intensity

Active Comparator group

Description:

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.

Treatment:

Behavioral: TYPE/CONTEXT enhancement

Behavioral: Physical Activity Goals mHealth Intervention

Intensity > Affect (+TYPE/CONTEXT)

Active Comparator group

Description:

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.

Treatment:

Behavioral: TYPE/CONTEXT enhancement

Behavioral: Physical Activity Goals mHealth Intervention