eMOTION Formative Study

NCT06125964 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2025-08-14

Study results available
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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.

Conditions

  • Physical Inactivity
  • Overweight or Obesity
  • Cancer

Interventions

BEHAVIORAL

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.

BEHAVIORAL

Affect-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.

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • University of Southern California

    lead OTHER

Principal Investigators

  • Genevieve F Dunton, PhD MPH · University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-06
Primary Completion
2024-05-30
Completion
2024-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06125964 on ClinicalTrials.gov