Clinical trial NCT05235360: Factorial Trial Testing Guided Thinking Tasks to Optimize a Physical Activity Intervention
Official title: Factorial Trial to Test Unique and Combined Effects of Guided Thinking Tasks to Optimize a Physical Activity Intervention Among Underactive Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Physical Inactivity
Lead sponsor: Southern Methodist University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: University of Kansas Medical Center
name: University of North Carolina, Charlotte
First posted: 2022-02-11
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to optimize a novel, audio-recorded physical activity intervention that is scalable. Using principles of the Multiphase Optimization Strategy (MOST) framework, a full factorial study will test the unique and combined effects of different intervention components to identify which combination of components is optimal for increasing physical activity and mechanisms by which the components are or are not effective. This information will inform decisions about an optimal intervention package that is effective, efficient, and minimizes participant burden.

Detailed description: Eligible participants who provide informed consent will be enrolled in a 6-week study. At the baseline session, participants will be randomized to listen to a brief audio-recording of different guided thinking tasks. The audio-recordings are based on combinations of four different intervention components that will be tested in a 2 (positive affect imagery vs. neutral) x 2 (episodic future thinking vs. recent thinking) x 2 (action planning: yes, no) x 2 (dose: high vs. low) factorial trial. Participants will also complete a 30-minute brisk walking session on a treadmill. Participants will return for weekly visits in which they again listen to their assigned audio-recording and complete a 30-minute brisk walking session.

Eligibility criteria: Inclusion Criteria:

* Adults ages 18-64
* Not currently meeting physical activity guidelines (\<150 minutes/week of self-reported moderate-to-vigorous physical activity)
* Capable of providing informed consent
* Access to a smartphone with active data plan
* Willing to attend all study visits and comply with the protocol
* Conversant in English

Exclusion Criteria:

* BMI \> 40
* orthopedic problems that would limit physical activity
* self-reported coronary artery disease, stroke, COPD, chronic bronchitis, emphysema, diabetes

Primary outcomes:
measure: Change in Weekly Physical Activity Minutes Across 6 Weeks (accelerometer-assessed)
timeFrame: Assessed weekly at Weeks 1-6
Secondary outcomes:
measure: Change in Weekly Physical Activity Minutes Across 6 Weeks (self-reported)
timeFrame: Assessed weekly at baseline and at Weeks 1-6
Other outcomes:
measure: Affective Response to Exercise
timeFrame: Assessed weekly at baseline and at Weeks 1-6
measure: Intrinsic Motivation for Exercise
timeFrame: Assessed weekly at baseline and at Weeks 1-6
measure: Delayed Discounting
timeFrame: Assessed weekly at baseline and at Weeks 1-6
measure: Action Planning
timeFrame: Assessed weekly at baseline and at Weeks 1-6
measure: Physical Activity Intentions
timeFrame: Assessed weekly at baseline and at Weeks 1-6
Locations:
city: Dallas
country: United States
facility: Southern Methodist University
state: Texas
Study officials:
affiliation: Southern Methodist University
name: Austin S. Baldwin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baldwin AS, Lamb CL, Geary BA, Mitchell AD, Kouros CD, Levens S, Martin LE. Testing and Optimizing Guided Thinking Tasks to Promote Physical Activity: Protocol for a Randomized Factorial Trial. JMIR Res Protoc. 2022 Sep 8;11(9):e40908. doi: 10.2196/40908.