Physical InactivityNCT05235360
Factorial Trial Testing Guided Thinking Tasks to Optimize a Physical Activity Intervention
A study testing Episodic future thinking, Positive affect imagery and Action planning in people with Physical Inactivity, run by Southern Methodist University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity
- What is being tested?
- Episodic future thinking, Positive affect imagery and Action planning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2022to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- BMI > 40
- orthopedic problems that would limit physical activity
- self-reported coronary artery disease, stroke, COPD, chronic bronchitis, emphysema, diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Physical Inactivity
- Being tested
- Episodic future thinking, Positive affect imagery, Action planning, High dose, Recent thinking
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Episodic future thinkingBehavioural
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 imageryBehavioural
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 planningBehavioural
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 doseBehavioural
Participants will listen to the audio-recording with the guided thinking tasks 5 times/week.
Recent thinkingBehavioural
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 imageryBehavioural
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 doseBehavioural
Participants will listen to the audio-recording with the guided thinking tasks 1 time/week.
| Study group | Role | What they receive |
|---|---|---|
| Condition 1 | Experimental | 1) Episodic future thinking; 2) Positive affect imagery; 3) Action planning; 4) High intervention dose Receives: Behavioral: Episodic future thinking; Behavioral: Positive affect imagery; Behavioral: Action planning; Behavioral: High dose |
| Condition 2 | Experimental | 1) Episodic future thinking; 2) Positive affect imagery; 3) Action planning; 4) Low intervention dose Receives: Behavioral: Episodic future thinking; Behavioral: Positive affect imagery; Behavioral: Action planning; Behavioral: Low dose |
| Condition 3 | Experimental | 1) Episodic future thinking; 2) Positive affect imagery; 3) High intervention dose Receives: Behavioral: Episodic future thinking; Behavioral: Positive affect imagery; Behavioral: High dose |
| Condition 4 | Experimental | 1) Episodic future thinking; 2) Positive affect imagery; 3) Low intervention dose Receives: Behavioral: Episodic future thinking; Behavioral: Positive affect imagery; Behavioral: Low dose |
| Condition 5 | Experimental | 1) Recent thinking; 2) Positive affect imagery; 3) Action planning; 4) High intervention dose Receives: Behavioral: Positive affect imagery; Behavioral: Action planning; Behavioral: High dose; Behavioral: Recent thinking |
| Condition 6 | Experimental | 1) Recent thinking; 2) Positive affect imagery; 3) Action planning; 4) Low intervention dose Receives: Behavioral: Positive affect imagery; Behavioral: Action planning; Behavioral: Recent thinking; Behavioral: Low dose |
| Condition 7 | Experimental | 1) Recent thinking; 2) Positive affect imagery; 3) High intervention dose Receives: Behavioral: Positive affect imagery; Behavioral: High dose; Behavioral: Recent thinking |
| Condition 8 | Experimental | 1) Recent thinking; 2) Positive affect imagery; 3) Low intervention dose Receives: Behavioral: Positive affect imagery; Behavioral: Recent thinking; Behavioral: Low dose |
| Condition 9 | Experimental | 1) Episodic future thinking; 2) Neutral imagery; 3) Action planning; 4) High intervention dose Receives: Behavioral: Episodic future thinking; Behavioral: Action planning; Behavioral: High dose; Behavioral: Neutral imagery |
| Condition 10 | Experimental | 1) Episodic future thinking; 2) Neutral imagery; 3) Action planning; 4) Low intervention dose Receives: Behavioral: Episodic future thinking; Behavioral: Action planning; Behavioral: Neutral imagery; Behavioral: Low dose |
| Condition 11 | Experimental | 1) Episodic future thinking; 2) Neutral imagery; 3) High intervention dose Receives: Behavioral: Episodic future thinking; Behavioral: High dose; Behavioral: Neutral imagery |
| Condition 12 | Experimental | 1) Episodic future thinking; 2) Neutral imagery; 3) Low intervention dose Receives: Behavioral: Episodic future thinking; Behavioral: Neutral imagery; Behavioral: Low dose |
| Condition 13 | Experimental | 1) Recent thinking; 2) Neutral imagery; 3) Action planning; 4) High intervention dose Receives: Behavioral: Action planning; Behavioral: High dose; Behavioral: Recent thinking; Behavioral: Neutral imagery |
| Condition 14 | Experimental | 1) Recent thinking; 2) Neutral imagery; 3) Action planning; 4) Low intervention dose Receives: Behavioral: Action planning; Behavioral: Recent thinking; Behavioral: Neutral imagery; Behavioral: Low dose |
| Condition 15 | Experimental | 1) Recent thinking; 2) Neutral imagery; 3) High intervention dose Receives: Behavioral: High dose; Behavioral: Recent thinking; Behavioral: Neutral imagery |
| Condition 16 | Experimental | 1) Recent thinking; 2) Neutral imagery; 3) Low intervention dose Receives: Behavioral: Recent thinking; Behavioral: Neutral imagery; Behavioral: Low dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed weekly at Weeks 1-6
Secondary outcomes (1)
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.
Measured: Assessed weekly at baseline and at Weeks 1-6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start14 Feb 2022
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern Methodist University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Kansas Medical Center, University of North Carolina, Charlotte
- Responsible party
- Sponsor
- Investigators
- Austin S. Baldwin, PhD, Principal investigator, Southern Methodist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235360
- Sponsor's protocol ID
- H21-003-BALA
- Other IDs
- R21CA260360
- Status last verified
- Aug 2026
- First submitted
- 13 Jan 2022
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 36074550
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factorial Trial to Test Unique and Combined Effects of Guided Thinking Tasks to Optimize a Physical Activity Intervention Among Underactive Adults
- ClinicalTrials.gov ID
- NCT05235360
- Acronym / sponsor ID
- H21-003-BALA
- Conditions
- Physical Inactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Southern Methodist UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Kansas Medical Center, University of North Carolina, Charlotte
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Condition 1 | Experimental | Behavioral: Episodic future thinking, Behavioral: Positive affect imagery, Behavioral: Action planning, Behavioral: High dose1) Episodic future thinking; 2) Positive affect imagery; 3) Action planning; 4) High intervention dose |
| Condition 2 | Experimental | Behavioral: Episodic future thinking, Behavioral: Positive affect imagery, Behavioral: Action planning, Behavioral: Low dose1) Episodic future thinking; 2) Positive affect imagery; 3) Action planning; 4) Low intervention dose |
| Condition 3 | Experimental | Behavioral: Episodic future thinking, Behavioral: Positive affect imagery, Behavioral: High dose1) Episodic future thinking; 2) Positive affect imagery; 3) High intervention dose |
| Condition 4 | Experimental | Behavioral: Episodic future thinking, Behavioral: Positive affect imagery, Behavioral: Low dose1) Episodic future thinking; 2) Positive affect imagery; 3) Low intervention dose |
| Condition 5 | Experimental | Behavioral: Positive affect imagery, Behavioral: Action planning, Behavioral: High dose, Behavioral: Recent thinking1) Recent thinking; 2) Positive affect imagery; 3) Action planning; 4) High intervention dose |
| Condition 6 | Experimental | Behavioral: Positive affect imagery, Behavioral: Action planning, Behavioral: Recent thinking, Behavioral: Low dose1) Recent thinking; 2) Positive affect imagery; 3) Action planning; 4) Low intervention dose |
| Condition 7 | Experimental | Behavioral: Positive affect imagery, Behavioral: High dose, Behavioral: Recent thinking1) Recent thinking; 2) Positive affect imagery; 3) High intervention dose |
| Condition 8 | Experimental | Behavioral: Positive affect imagery, Behavioral: Recent thinking, Behavioral: Low dose1) Recent thinking; 2) Positive affect imagery; 3) Low intervention dose |
| Condition 9 | Experimental | Behavioral: Episodic future thinking, Behavioral: Action planning, Behavioral: High dose, Behavioral: Neutral imagery1) Episodic future thinking; 2) Neutral imagery; 3) Action planning; 4) High intervention dose |
| Condition 10 | Experimental | Behavioral: Episodic future thinking, Behavioral: Action planning, Behavioral: Neutral imagery, Behavioral: Low dose1) Episodic future thinking; 2) Neutral imagery; 3) Action planning; 4) Low intervention dose |
| Condition 11 | Experimental | Behavioral: Episodic future thinking, Behavioral: High dose, Behavioral: Neutral imagery1) Episodic future thinking; 2) Neutral imagery; 3) High intervention dose |
| Condition 12 | Experimental | Behavioral: Episodic future thinking, Behavioral: Neutral imagery, Behavioral: Low dose1) Episodic future thinking; 2) Neutral imagery; 3) Low intervention dose |
| Condition 13 | Experimental | Behavioral: Action planning, Behavioral: High dose, Behavioral: Recent thinking, Behavioral: Neutral imagery1) Recent thinking; 2) Neutral imagery; 3) Action planning; 4) High intervention dose |
| Condition 14 | Experimental | Behavioral: Action planning, Behavioral: Recent thinking, Behavioral: Neutral imagery, Behavioral: Low dose1) Recent thinking; 2) Neutral imagery; 3) Action planning; 4) Low intervention dose |
| Condition 15 | Experimental | Behavioral: High dose, Behavioral: Recent thinking, Behavioral: Neutral imagery1) Recent thinking; 2) Neutral imagery; 3) High intervention dose |
| Condition 16 | Experimental | Behavioral: Recent thinking, Behavioral: Neutral imagery, Behavioral: Low dose1) Recent thinking; 2) Neutral imagery; 3) Low intervention dose |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- BMI > 40
- orthopedic problems that would limit physical activity
- self-reported coronary artery disease, stroke, COPD, chronic bronchitis, emphysema, diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Episodic future thinkingParticipants 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. | Behavioural | Condition 1, Condition 10, Condition 11, Condition 12, Condition 2, Condition 3, Condition 4, Condition 9 |
| Positive affect imageryParticipants 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. | Behavioural | Condition 1, Condition 2, Condition 3, Condition 4, Condition 5, Condition 6, Condition 7, Condition 8 |
| Action planningParticipants 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. | Behavioural | Condition 1, Condition 10, Condition 13, Condition 14, Condition 2, Condition 5, Condition 6, Condition 9 |
| High doseParticipants will listen to the audio-recording with the guided thinking tasks 5 times/week. | Behavioural | Condition 1, Condition 11, Condition 13, Condition 15, Condition 3, Condition 5, Condition 7, Condition 9 |
| Recent thinkingParticipants 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. | Behavioural | Condition 13, Condition 14, Condition 15, Condition 16, Condition 5, Condition 6, Condition 7, Condition 8 |
| Neutral imageryParticipants 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). | Behavioural | Condition 10, Condition 11, Condition 12, Condition 13, Condition 14, Condition 15, Condition 16, Condition 9 |
| Low doseParticipants will listen to the audio-recording with the guided thinking tasks 1 time/week. | Behavioural | Condition 10, Condition 12, Condition 14, Condition 16, Condition 2, Condition 4, Condition 6, Condition 8 |
Primary outcome
Change in Weekly Physical Activity Minutes Across 6 Weeks (accelerometer-assessed)
Time frame: Assessed weekly at Weeks 1-6
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.
1 secondary outcome
Change in Weekly Physical Activity Minutes Across 6 Weeks (self-reported)
Time frame: Assessed weekly at baseline and at Weeks 1-6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Derived from this study: PubMed 36074550Baldwin 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Austin S. Baldwin, PhD principal investigator
Southern Methodist University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Episodic future thinking, Positive affect imagery and Action planning in people with Physical Inactivity, run by Southern Methodist University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Weekly Physical Activity Minutes Across 6 Weeks (accelerometer-assessed) (time frame: Assessed weekly at Weeks 1-6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05235360, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.