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Clinical Trials/NCT06570642
NCT06570642
Recruiting
Not Applicable

Using Real-Time Data Capture to Examine Affective Mechanisms as Mediators of Physical Activity Adherence in Interventions

University of Southern California1 site in 1 country280 target enrollmentAugust 14, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Physical Inactivity
Sponsor
University of Southern California
Enrollment
280
Locations
1
Primary Endpoint
Physical Activity: Step Count
Status
Recruiting
Last Updated
10 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 14, 2024
End Date
June 30, 2027
Last Updated
10 months ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Genevieve Dunton

Chief, Division of Health Behavior Research and Director, USC Real-Time Eating Activity and Children's Health (REACH) Lab

University of Southern California

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

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

Outcomes

Primary Outcomes

Physical Activity: Step Count

Time Frame: 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

Time Frame: 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 Outcomes

  • Affective Response(Max 2 per 60-min physical activity period during weeks 2-9 and weeks 12-19)
  • Affectively-Charged Motivations(Up to once daily for weeks 2-9 and weeks 12-19)
  • Anticipated Affect(Up to once daily for weeks 2-9 and weeks 12-19)

Study Sites (1)

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