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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Physical Inactivity
• Intervention / Treatment: Behavioral: Episodic future thinking; Behavioral: Positive affect imagery; Behavioral: Action planning; Behavioral: High dose; Behavioral: Low dose; Behavioral: Recent thinking; Behavioral: Neutral imagery

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.

• Study Type: Interventional
• Enrollment (Anticipated): 192
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Colin Lamb, BA; Phone Number: 2147681545; Email: colinl@smu.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75205
      • Recruiting
      • Southern Methodist University
      • Contact: Colin Lamb, BA; Phone Number: 214-768-1545; Email: colinl@smu.edu
      • Principal Investigator: Austin S. Baldwin, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

16

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Condition 1; 1) Episodic future thinking; 2) Positive affect imagery; 3) Action planning; 4) High intervention dose	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.; Behavioral: 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.; Behavioral: 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.; Behavioral: High dose; Participants will listen to the audio-recording with the guided thinking tasks 5 times/week.
Experimental: Condition 2; 1) Episodic future thinking; 2) Positive affect imagery; 3) Action planning; 4) Low intervention dose	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.; Behavioral: 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.; Behavioral: 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.; Behavioral: Low dose; Participants will listen to the audio-recording with the guided thinking tasks 1 time/week.
Experimental: Condition 3; 1) Episodic future thinking; 2) Positive affect imagery; 3) High intervention dose	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.; Behavioral: 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.; Behavioral: High dose; Participants will listen to the audio-recording with the guided thinking tasks 5 times/week.
Experimental: Condition 4; 1) Episodic future thinking; 2) Positive affect imagery; 3) Low intervention dose	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.; Behavioral: 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.; Behavioral: Low dose; Participants will listen to the audio-recording with the guided thinking tasks 1 time/week.
Experimental: Condition 5; 1) Recent thinking; 2) Positive affect imagery; 3) Action planning; 4) High intervention dose	Behavioral: 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.; Behavioral: 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.; Behavioral: High dose; Participants will listen to the audio-recording with the guided thinking tasks 5 times/week.; Behavioral: 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.
Experimental: Condition 6; 1) Recent thinking; 2) Positive affect imagery; 3) Action planning; 4) Low intervention dose	Behavioral: 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.; Behavioral: 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.; Behavioral: Low dose; Participants will listen to the audio-recording with the guided thinking tasks 1 time/week.; Behavioral: 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.
Experimental: Condition 7; 1) Recent thinking; 2) Positive affect imagery; 3) High intervention dose	Behavioral: 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.; Behavioral: High dose; Participants will listen to the audio-recording with the guided thinking tasks 5 times/week.; Behavioral: 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.
Experimental: Condition 8; 1) Recent thinking; 2) Positive affect imagery; 3) Low intervention dose	Behavioral: 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.; Behavioral: Low dose; Participants will listen to the audio-recording with the guided thinking tasks 1 time/week.; Behavioral: 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.
Experimental: Condition 9; 1) Episodic future thinking; 2) Neutral imagery; 3) Action planning; 4) High intervention dose	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.; Behavioral: 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.; Behavioral: High dose; Participants will listen to the audio-recording with the guided thinking tasks 5 times/week.; Behavioral: 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).
Experimental: Condition 10; 1) Episodic future thinking; 2) Neutral imagery; 3) Action planning; 4) Low intervention dose	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.; Behavioral: 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.; Behavioral: Low dose; Participants will listen to the audio-recording with the guided thinking tasks 1 time/week.; Behavioral: 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).
Experimental: Condition 11; 1) Episodic future thinking; 2) Neutral imagery; 3) High intervention dose	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.; Behavioral: High dose; Participants will listen to the audio-recording with the guided thinking tasks 5 times/week.; Behavioral: 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).
Experimental: Condition 12; 1) Episodic future thinking; 2) Neutral imagery; 3) Low intervention dose	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.; Behavioral: Low dose; Participants will listen to the audio-recording with the guided thinking tasks 1 time/week.; Behavioral: 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).
Experimental: Condition 13; 1) Recent thinking; 2) Neutral imagery; 3) Action planning; 4) High intervention dose	Behavioral: 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.; Behavioral: High dose; Participants will listen to the audio-recording with the guided thinking tasks 5 times/week.; Behavioral: 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.; Behavioral: 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).
Experimental: Condition 14; 1) Recent thinking; 2) Neutral imagery; 3) Action planning; 4) Low intervention dose	Behavioral: 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.; Behavioral: Low dose; Participants will listen to the audio-recording with the guided thinking tasks 1 time/week.; Behavioral: 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.; Behavioral: 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).
Experimental: Condition 15; 1) Recent thinking; 2) Neutral imagery; 3) High intervention dose	Behavioral: High dose; Participants will listen to the audio-recording with the guided thinking tasks 5 times/week.; Behavioral: 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.; Behavioral: 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).
Experimental: Condition 16; 1) Recent thinking; 2) Neutral imagery; 3) Low intervention dose	Behavioral: Low dose; Participants will listen to the audio-recording with the guided thinking tasks 1 time/week.; Behavioral: 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.; Behavioral: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Southern Methodist University
• Collaborators: National Cancer Institute (NCI); University of Kansas Medical Center; University of North Carolina, Charlotte
• Investigators: Principal Investigator: Austin S. Baldwin, PhD, Southern Methodist University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2022
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: January 13, 2022
• First Submitted That Met QC Criteria: February 1, 2022
• First Posted (Actual): February 11, 2022

Study Record Updates

• Last Update Posted (Actual): February 28, 2022
• Last Update Submitted That Met QC Criteria: February 24, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: H21-003-BALA; R21CA260360 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be made available, in addition to the study protocol, statistical analysis plan, informed consent, and analytic code. Data will be made available to interested parties after all the initial study analyses and outcomes have been published.
• IPD Sharing Time Frame: Data will be made available one year after study completion.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal and sign a data use agreement. Proposals should be submitted to Austin Baldwin.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No