Clinical trial NCT06570642: eMOTION: Examining Affective Mechanisms in Physical Activity Engagement
Official title: Using Real-Time Data Capture to Examine Affective Mechanisms as Mediators of Physical Activity Adherence in Interventions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physical Inactivity
Overweight or Obesity
Cancer
Keywords: Affective Response
Psychological Needs
Physical Activity
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-08-26
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Physical Activity: Step Count
timeFrame: Daily total for weeks 1-19
measure: Physical Activity: Minutes
timeFrame: Daily total for weeks 1-19
Secondary outcomes:
measure: Affective Response
timeFrame: Max 2 per 60-min physical activity period during weeks 2-9 and weeks 12-19
measure: Affectively-Charged Motivations
timeFrame: Up to once daily for weeks 2-9 and weeks 12-19
measure: Anticipated Affect
timeFrame: Up to once daily for weeks 2-9 and weeks 12-19
measure: Implicit Attitudes
timeFrame: Up to once daily for weeks 2-9 and weeks 12-19
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Genevieve F Dunton, PhD MPH
role: PRINCIPAL_INVESTIGATOR
References: