eMOTION Formative Study

University of Southern California

Status: Completed

Conditions: Overweight or Obesity; Physical Inactivity; Cancer

Treatments: Behavioral: SAVOR Enhancement; Behavioral: Intensity-Based Goals; Behavioral: Affect-Based Goals; Behavioral: TYPE/CONTEXT Enhancement

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06125964

UP-22-00332-formative

R01CA272933 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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47 participants in 4 patient groups

Intensity

Experimental group

Description:

Participants receive intensity-based goals for two weeks. No enhancements are added to the standard mHealth intervention.

Treatment:

Behavioral: Intensity-Based Goals

Affect + TYPE/CONTEXT

Active Comparator group

Description:

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.

Treatment:

Behavioral: TYPE/CONTEXT Enhancement

Behavioral: Affect-Based Goals

Affect + SAVOR

Active Comparator group

Description:

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.

Treatment:

Behavioral: Affect-Based Goals

Behavioral: SAVOR Enhancement

Affect + TYPE/CONTEXT + SAVOR

Active Comparator group

Description:

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.

Treatment:

Behavioral: TYPE/CONTEXT Enhancement

Behavioral: Affect-Based Goals

Behavioral: SAVOR Enhancement