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

Southern Methodist University

Status: Unknown

Conditions: Physical Inactivity

Treatments: Behavioral: Neutral imagery; Behavioral: Recent thinking; Behavioral: Low dose; Behavioral: High dose; Behavioral: Episodic future thinking; Behavioral: Action planning; Behavioral: Positive affect imagery

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05235360

H21-003-BALA

R21CA260360 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 192 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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192 participants in 16 patient groups

Condition 1

Experimental group

Description:

1) Episodic future thinking; 2) Positive affect imagery; 3) Action planning; 4) High intervention dose

Treatment:

Behavioral: Action planning

Behavioral: Positive affect imagery

Behavioral: Episodic future thinking

Behavioral: High dose

Condition 2

Experimental group

Description:

1) Episodic future thinking; 2) Positive affect imagery; 3) Action planning; 4) Low intervention dose

Treatment:

Behavioral: Action planning

Behavioral: Positive affect imagery

Behavioral: Low dose

Behavioral: Episodic future thinking

Condition 3

Experimental group

Description:

1) Episodic future thinking; 2) Positive affect imagery; 3) High intervention dose

Treatment:

Behavioral: Positive affect imagery

Behavioral: Episodic future thinking

Behavioral: High dose

Condition 4

Experimental group

Description:

1) Episodic future thinking; 2) Positive affect imagery; 3) Low intervention dose

Treatment:

Behavioral: Positive affect imagery

Behavioral: Low dose

Behavioral: Episodic future thinking

Condition 5

Experimental group

Description:

1) Recent thinking; 2) Positive affect imagery; 3) Action planning; 4) High intervention dose

Treatment:

Behavioral: Action planning

Behavioral: Positive affect imagery

Behavioral: Recent thinking

Behavioral: High dose

Condition 6

Experimental group

Description:

1) Recent thinking; 2) Positive affect imagery; 3) Action planning; 4) Low intervention dose

Treatment:

Behavioral: Action planning

Behavioral: Positive affect imagery

Behavioral: Recent thinking

Behavioral: Low dose

Condition 7

Experimental group

Description:

1) Recent thinking; 2) Positive affect imagery; 3) High intervention dose

Treatment:

Behavioral: Positive affect imagery

Behavioral: Recent thinking

Behavioral: High dose

Condition 8

Experimental group

Description:

1) Recent thinking; 2) Positive affect imagery; 3) Low intervention dose

Treatment:

Behavioral: Positive affect imagery

Behavioral: Recent thinking

Behavioral: Low dose

Condition 9

Experimental group

Description:

1) Episodic future thinking; 2) Neutral imagery; 3) Action planning; 4) High intervention dose

Treatment:

Behavioral: Action planning

Behavioral: Neutral imagery

Behavioral: Episodic future thinking

Behavioral: High dose

Condition 10

Experimental group

Description:

1) Episodic future thinking; 2) Neutral imagery; 3) Action planning; 4) Low intervention dose

Treatment:

Behavioral: Action planning

Behavioral: Neutral imagery

Behavioral: Low dose

Behavioral: Episodic future thinking

Condition 11

Experimental group

Description:

1) Episodic future thinking; 2) Neutral imagery; 3) High intervention dose

Treatment:

Behavioral: Neutral imagery

Behavioral: Episodic future thinking

Behavioral: High dose

Condition 12

Experimental group

Description:

1) Episodic future thinking; 2) Neutral imagery; 3) Low intervention dose

Treatment:

Behavioral: Neutral imagery

Behavioral: Low dose

Behavioral: Episodic future thinking

Condition 13

Experimental group

Description:

1) Recent thinking; 2) Neutral imagery; 3) Action planning; 4) High intervention dose

Treatment:

Behavioral: Action planning

Behavioral: Recent thinking

Behavioral: Neutral imagery

Behavioral: High dose

Condition 14

Experimental group

Description:

1) Recent thinking; 2) Neutral imagery; 3) Action planning; 4) Low intervention dose

Treatment:

Behavioral: Action planning

Behavioral: Recent thinking

Behavioral: Neutral imagery

Behavioral: Low dose

Condition 15

Experimental group

Description:

1) Recent thinking; 2) Neutral imagery; 3) High intervention dose

Treatment:

Behavioral: Recent thinking

Behavioral: Neutral imagery

Behavioral: High dose

Condition 16

Experimental group

Description:

1) Recent thinking; 2) Neutral imagery; 3) Low intervention dose

Treatment:

Behavioral: Recent thinking

Behavioral: Neutral imagery

Behavioral: Low dose