Factorial Trial Testing Guided Thinking Tasks to Optimize a Physical Activity Intervention

Physical Inactivity Clinical Trial

Official title:

Factorial Trial to Test Unique and Combined Effects of Guided Thinking Tasks to Optimize a Physical Activity Intervention Among Underactive Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05235360
• Other study ID #: H21-003-BALA
• Secondary ID: R21CA260360
• Status: Recruiting
• Phase: N/A
• Start date: February 14, 2022
• Est. completion date: July 2023

Study information

• Verified date: February 2022
• Source: Southern Methodist University
• Contact: Colin Lamb, BA
• Phone: 2147681545
• Email: colinl[@]smu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 192
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Physical Inactivity

Intervention

Behavioral:
• Episodic future thinking
Participants will listen to a guided thinking task directing them to think about themselves at a future, positive event and to imagine the event in vivid and specific detail.
• Positive affect imagery
Participants will listen to a guided thinking task directing them to think about positive feelings and associations about physical activity in specific, personal, and positive detail.
• Action planning
Participants will listen to a guided thinking task directing them to think about the remainder of their week and when, where, and how they plan to attain their remaining activity for the week.
• High dose
Participants will listen to the audio-recording with the guided thinking tasks 5 times/week.
• Recent thinking
Participants will listen to a guided thinking task directing them to think about a regular habit or activity they completed in the past week and to imagine that activity in specific and vivid detail.
• Neutral imagery
Participants will listen to a guided thinking task directing them to imagine physical sensations (i.e., movements, muscles used) of a routine, daily activity (non-physical activity).
• Low dose
Participants will listen to the audio-recording with the guided thinking tasks 1 time/week.

Locations

Country	Name	City	State
United States	Southern Methodist University	Dallas	Texas

Sponsors (4)

Lead Sponsor	Collaborator
Southern Methodist University	National Cancer Institute (NCI), University of Kansas Medical Center, University of North Carolina, Charlotte

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Affective Response to Exercise	The Feeling Scale measures affective responses to exercise on a -5 to +5 scale with higher scores indicated a more positive affective response. It will be assessed during- and post-exercise for the in-person brisk walking sessions. Will be assessed as a putative mechanism.	Assessed weekly at baseline and at Weeks 1-6
Other	Intrinsic Motivation for Exercise	The intrinsic subscale of the Behavioral Regulations in Exercise Questionnaire measures intrinsic motivation using a 0 to 4 response scale with higher scores indicating greater intrinsic motivation. It will be assessed after listening to the audio-recording in-person (post-intervention). Will be assessed as a putative mechanism.	Assessed weekly at baseline and at Weeks 1-6
Other	Delayed Discounting	The rapid delay discounting task will be assessed after listening to the audio-recording in-person (post-intervention). Will be assessed as a putative mechanism.	Assessed weekly at baseline and at Weeks 1-6
Other	Action Planning	The action planning scale (Sniehotta et al., 2005) measures action planning for physical activity on a 1 to 4 scale with higher scores indicating higher levels of planning. It will be assessed after listening to the audio-recording in-person (post-intervention). Will be assessed as a putative mechanism.	Assessed weekly at baseline and at Weeks 1-6
Other	Physical Activity Intentions	The physical activity intentions scale (Conner et al., 2017) measures intentions for physical activity on a 1 to 5 scale with higher scores indicating stronger intentions. It will be assessed after the in-person brisk walking session. Will be assessed as a putative mechanism.	Assessed weekly at baseline and at Weeks 1-6
Primary	Change in Weekly Physical Activity Minutes Across 6 Weeks (accelerometer-assessed)	Amount of weekly moderate-to-vigorous (MVPA) minutes (i.e., minutes of MPVA weighted by intensity) will be determined from accelerometers (ActiGraph wGT3X-BT) worn for one-week periods for six consecutive weeks.	Assessed weekly at Weeks 1-6
Secondary	Change in Weekly Physical Activity Minutes Across 6 Weeks (self-reported)	Amount of weekly self-reported MVPA (i.e., minutes of MPVA weighted by intensity) will be determined using the 7-day Physical Activity Recall (PAR) interview.	Assessed weekly at baseline and at Weeks 1-6