Cardiovascular Risk FactorPhase 1/2NCT04972279
Precision Assignment of Intervention Messages to Promote Physical Activity - Precision AIM
A Phase 1/2 study testing Digital message (text + image) in people with Cardiovascular Risk Factor, run by Penn State University at 1 site in United States.
Trial summary
Our goal is to develop personalized decision rules for selecting the frequency, timing, and content of messages to promote physical activity. The objective of this project is to evaluate the acceptability and feasibility of two strategies for calibrating decision rules used to send those messages. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor
- What is being tested?
- Digital message (text + image)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2022to 15 Dec 2022
- Phase
- Phase 1/2
- 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 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants capable of reading, speaking and understanding English and of giving informed consent.
- Participants between the ages of 18-29 years.
- Participants must be free of visual impairment that would interfere with the receipt of text messages on their phone.
- Participants must be willing to wear a Fitbit Versa 3 almost continually (23.5 hours/day) for a 6- month period of time.
- Participants must own an iPhone or Android smartphone that they would be willing to download the custom Precision AIM and Fitbit app onto and sync with a Fitbit Versa 3.
- Participants interested in setting goals to increase their physical activity levels over the 6-month study.
Who cannot join
- Participants engaging in 150 or more minutes of moderate- or greater intensity PA /week as assessed by a research grade accelerometer.
- Participants engaged in organized programs with mandated physical activity (e.g., varsity sports, ROTC).
- Participants with contraindications to normal physical activity on the Physical Activity Readiness Questionnaire.
- Participants who require an assistive device for mobility or have any other condition that may limit or prevent participation in moderate-intensity physical activity.
- Participants who are pregnant or planning to become pregnant within the next 6 months.
- Participants with a prior diagnosis of cancer, cardiovascular disease, diabetes or metabolic syndrome.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Pennsylvania State University
University Park, Pennsylvania, 16802
About this study
Official title: Phase 1 Clinical Trial to Develop a Personalized Adaptive Text Message Intervention Using Control Systems Engineering Tools to Increase Physical Activity in Early Adulthood
Our goal is to develop personalized decision rules for selecting the frequency, timing, and content of messages to promote physical activity. The objective of this project is to evaluate the acceptability and feasibility of two strategies for calibrating decision rules used to send those messages. Participants will wear an activity monitor for the collection of PA data and be randomly assigned to one of two adaptive intervention strategies. The decision rule for each participant will be refined on a monthly basis throughout the 6-month study based upon the accumulating data on how each participant is responding to different messages under different conditions. Our hypothesis is that more intensive intervention strategies will offer a better user experience because the resulting treatments will be experienced as more personalized.
- Conditions
- Cardiovascular Risk Factor
- Being tested
- Digital message (text + image)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital message (text + image)Behavioural
Messages can be up to 256 characters of text with an image. "Move more" and "sit less" messages were written to target established cognitive and affective constructs associated with physical activity (e.g., prompts to action plan, guidance for maximizing pleasure by regulating intensity).
| Study group | Role | What they receive |
|---|---|---|
| Aggressive adaptation strategy | Experimental | Participants receive up to 6 messages/day to support achievement of their behavior change goal. Messages are only delivered outside of a participant-specific Do Not Disturb window (e.g., 11pm-8am). Messages with coordinating images are selected from three content domains: Move More, Sit Less, and Inspirational Quotes Unrelated to Movement within the first month. The decision rule for each participant will be refined on a monthly basis throughout the 6-month study based upon the accumulating data on how each participant is responding to different messages under different conditions. Receives: Behavioral: Digital message (text + image) |
| Moderate adaptation strategy | Experimental | Participants receive up to 3 messages/day to support achievement of their behavior change goal. Messages are only delivered outside of a participant-specific Do Not Disturb window (e.g., 11pm-8am). Messages with coordinating images are selected randomly from three content domains: Move More, Sit Less, and Inspirational Quotes Unrelated to Movement within the first month. The decision rule for each participant will be refined on a monthly basis throughout the 6-month study based upon the accumulating data on how each participant is responding to different messages under different conditions. Receives: Behavioral: Digital message (text + image) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of messaging at 6 months
Self-reported preference for more, no change or fewer messages/day based on participant exit interviews coded by two blinded research assistants
Measured: 6 months
Secondary outcomes (2)
Change in total physical activity volume from run-in period
Actigraph-assessed total activity counts during a 1-week monitoring period at baseline versus end of study
Measured: Baseline and 6 months
Change in moderate-to-vigorous physical activity duration from run-in period (baseline) to 6 months(baseline) to 6 months
Actigraph-assessed min/week of moderate (or higher) physical activity duration during a 1 week monitoring period at baseline versus end of study
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start2 Jan 2022
- Primary completion15 Dec 2022 (estimated)
- Study completion15 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David E Conroy, Penn State University
- Investigators
- David E Conroy, PhD, Principal investigator, The Pennsylvania State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972279
- Sponsor's protocol ID
- STUDY00016346
- Status last verified
- Aug 2022
- First submitted
- 12 Jul 2021
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Clinical Trial to Develop a Personalized Adaptive Text Message Intervention Using Control Systems Engineering Tools to Increase Physical Activity in Early Adulthood
- ClinicalTrials.gov ID
- NCT04972279
- Acronym / sponsor ID
- STUDY00016346
- Conditions
- Cardiovascular Risk Factor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- 15 Dec 2022 (estimated)
- Study completion
- 15 Dec 2022 (estimated)
- First posted
- 22 Jul 2021 (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.
Our goal is to develop personalized decision rules for selecting the frequency, timing, and content of messages to promote physical activity. The objective of this project is to evaluate the acceptability and feasibility of two strategies for calibrating decision rules used to send those messages. Participants will wear an activity monitor for the collection of PA data and be randomly assigned to one of two adaptive intervention strategies. The decision rule for each participant will be refined on a monthly basis throughout the 6-month study based upon the accumulating data on how each participant is responding to different messages under different conditions. Our hypothesis is that more intensive intervention strategies will offer a better user experience because the resulting treatments will be experienced as more personalized.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aggressive adaptation strategy | Experimental | Behavioral: Digital message (text + image)Participants receive up to 6 messages/day to support achievement of their behavior change goal. Messages are only delivered outside of a participant-specific Do Not Disturb window (e.g., 11pm-8am). Messages with coordinating images are selected from three content domains: Move More, Sit Less, and Inspirational Quotes Unrelated to Movement within the first month. The decision rule for each participant will be refined on a monthly basis throughout the 6-month study based upon the accumulating data on how each participant is responding to different messages under different conditions. |
| Moderate adaptation strategy | Experimental | Behavioral: Digital message (text + image)Participants receive up to 3 messages/day to support achievement of their behavior change goal. Messages are only delivered outside of a participant-specific Do Not Disturb window (e.g., 11pm-8am). Messages with coordinating images are selected randomly from three content domains: Move More, Sit Less, and Inspirational Quotes Unrelated to Movement within the first month. The decision rule for each participant will be refined on a monthly basis throughout the 6-month study based upon the accumulating data on how each participant is responding to different messages under different conditions. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants capable of reading, speaking and understanding English and of giving informed consent.
- Participants between the ages of 18-29 years.
- Participants must be free of visual impairment that would interfere with the receipt of text messages on their phone.
- Participants must be willing to wear a Fitbit Versa 3 almost continually (23.5 hours/day) for a 6- month period of time.
- Participants must own an iPhone or Android smartphone that they would be willing to download the custom Precision AIM and Fitbit app onto and sync with a Fitbit Versa 3.
Key exclusion criteria (6 listed)
- Participants engaging in 150 or more minutes of moderate- or greater intensity PA /week as assessed by a research grade accelerometer.
- Participants engaged in organized programs with mandated physical activity (e.g., varsity sports, ROTC).
- Participants with contraindications to normal physical activity on the Physical Activity Readiness Questionnaire.
- Participants who require an assistive device for mobility or have any other condition that may limit or prevent participation in moderate-intensity physical activity.
- Participants who are pregnant or planning to become pregnant within the next 6 months.
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 |
|---|---|---|
| Digital message (text + image)Messages can be up to 256 characters of text with an image. "Move more" and "sit less" messages were written to target established cognitive and affective constructs associated with physical activity (e.g., prompts to action plan, guidance for maximizing pleasure by regulating intensity). | Behavioural | Aggressive adaptation strategy, Moderate adaptation strategy |
Primary outcome
Acceptability of messaging at 6 months
Time frame: 6 months
Self-reported preference for more, no change or fewer messages/day based on participant exit interviews coded by two blinded research assistants
2 secondary outcomes
Change in total physical activity volume from run-in period
Time frame: Baseline and 6 months
Change in moderate-to-vigorous physical activity duration from run-in period (baseline) to 6 months(baseline) to 6 months
Time frame: Baseline and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Individual participant dataSharing planned: No
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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.
David E Conroy, PhD principal investigator
The Pennsylvania State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Digital message (text + image) in people with Cardiovascular Risk Factor, run by Penn State 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 6 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: status not confirmed, as of the sponsor's last update on 10 Aug 2022. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Acceptability of messaging at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2022.