Cardiovascular Risk FactorPhase 1RandomAIMNCT03907683

Random Assignment of Intervention Messages for Developing Personalized Decision Rules to Promote Physical Activity

A Phase 1 study testing Short Message with Text and Optional Image in people with Cardiovascular Risk Factor, run by Penn State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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?: Short Message with Text and Optional Image
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 82 participants
Where: 1 siteUnited States
Study dates: 3 Apr 2019to 21 Jul 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 use of a smartphone.
Participants must own and carry an iPhone (running iOS version 10 or higher) or Android (running operating system 7 or higher) smartphone during waking hours.

Who cannot join

Participants engaging in 90 or more minutes of moderate- or greater intensity PA each week.
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

Other trials in United States

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 develop personalized dynamical models of physical activity (PA) under different weather and temporal conditions as well as in response to different types of intervention messages. This approach relies on having extensive observations within the person under varying conditions to develop a dynamical model of how different conditions interact with each other to predict how behavior changes in response to text messages. Complementary sub-models will be estimated for each participant to describe their behavioral responses under different weather conditions. Healthy but insufficiently active young adults (n=80) will wear an activity monitor and receive a variety of randomly-timed and randomly-selected notifications via smartphone. GPS coordinates at the time of messages delivery and receipt are recorded and used to look up weather indices at that location at that time. The work is exploratory/descriptive as we will be developing models to describe participants' responses to messages under different weather conditions. This work is needed to develop the decision rules for a subsequent behavioral intervention that will be developed and tested in a future project.

Conditions: Cardiovascular Risk Factor
Being tested: Short Message with Text and Optional Image

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Short Message with Text and Optional ImageBehavioural
Messages can be up to 256 characters of text and with or without 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 groups in NCT03907683
Study group	Role	What they receive
Random Messaging	Experimental	Participants receive 0-5 messages/day from the Random AIM app. Messages are only delivered outside of a participant-specific Do Not Disturb window (e.g., 11pm-8am). Messages are selected randomly from three content domains: Move More (40%), Sit Less (40%), and Inspirational Quotes Unrelated to Movement (20%). Half of the messages are accompanied by images. Message selection and timing are determined randomly each night for the following day. Receives: Behavioral: Short Message with Text and Optional Image

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Moderate (or Higher) Physical Activity Duration Following Message Receipt
Fitbit-assessed minutes with step counts >= 100 steps/min in 15-minute epochs (steady states represent the change in expected step counts if a message was delivered versus if the message was not delivered)
Measured: 15-minute epochs for the remainder of the walking day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Apr 201921 Jul 2020

First posted9 Apr 2019
Study start3 Apr 2019
Primary completion21 Jul 2020
Study completion21 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 82 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03907683
Sponsor's protocol ID: STUDY00009455
Other IDs: R01HL142732
Acronym: RandomAIM
Status last verified: Oct 2022
First submitted: 5 Apr 2019
Last updated: 4 Nov 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Hojjatinia S, Hojjatinia S, Lagoa CM, Brunke-Reese D, Conroy DE. Person-specific dose-finding for a digital messaging intervention to promote physical activity. Health Psychol. 2021 Aug;40(8):502-512. doi: 10.1037/hea0001117.
PubMed 34618498

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 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: NCT03907683
Acronym / sponsor ID: RandomAIM / STUDY00009455
Conditions: Cardiovascular Risk Factor
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 82 participants (actual)
Lead sponsor: Penn State UniversityUniversity, hospital or other
Study start: 3 Apr 2019 (actual)
Primary completion: 21 Jul 2020 (actual)
Study completion: 21 Jul 2020 (actual)
First posted: 9 Apr 2019 (actual)
Results: Posted 4 Nov 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Random Messaging	Experimental	Behavioral: Short Message with Text and Optional ImageParticipants receive 0-5 messages/day from the Random AIM app. Messages are only delivered outside of a participant-specific Do Not Disturb window (e.g., 11pm-8am). Messages are selected randomly from three content domains: Move More (40%), Sit Less (40%), and Inspirational Quotes Unrelated to Movement (20%). Half of the messages are accompanied by images. Message selection and timing are determined randomly each night for the following day.

Who may qualify

Ages: 18 to 29 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 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 use of a smartphone.
Participants must own and carry an iPhone (running iOS version 10 or higher) or Android (running operating system 7 or higher) smartphone during waking hours.

Key exclusion criteria (6 listed)

Participants engaging in 90 or more minutes of moderate- or greater intensity PA each week.
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
Short Message with Text and Optional ImageMessages can be up to 256 characters of text and with or without 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	Random Messaging

Primary outcome

Change in Moderate (or Higher) Physical Activity Duration Following Message Receipt
Time frame: 15-minute epochs for the remainder of the walking day
Fitbit-assessed minutes with step counts >= 100 steps/min in 15-minute epochs (steady states represent the change in expected step counts if a message was delivered versus if the message was not delivered)

Results and safety

Results posted to the registry on 4 Nov 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Random Messaging	82	80

Primary outcome: Change in Moderate (or Higher) Physical Activity Duration Following Message Receipt

Time frame: 15-minute epochs for the remainder of the walking day. Mean (Standard Deviation). Unit: minutes

Measure	Random Messaging n = 80
Weekday Move More Messages (person-specific steady state estimate)	0.16 (0.69)
Weekday Sit Less Messages (person-specific steady state estimate)	0.13 (0.69)
Weekday Inspirational Quote Messages (person-specific steady state estimate)	0.25 (1.23)
Weekend Move More Messages (person-specific steady state estimate)	0.31 (1.44)
Weekend Sit Less Messages (person-specific steady state estimate)	0.28 (0.95)
Weekend Inspirational Quote Messages (person-specific steady state estimate)	0.11 (1.51)

Random Messaging: Mean Difference (Final Values): 0.16412 (95% CI .0098 to 0.3185), p = 0.037, t-test, 2 sided
Random Messaging: Mean Difference (Net): .12538 (95% CI -0.0274 to 0.2781), p = .106, t-test, 2 sided
Random Messaging: Mean Difference (Net): .24738 (95% CI -.0262 to .5210), p = .076, t-test, 2 sided

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Random Messaging	0 of 82 (0%)	0 of 82 (0%)	0 of 82

Limitations and caveats (from the sponsor): The COVID-19 pandemic was declared in March 2020 during enrollment and data collection. Some participants completed data collection before the pandemic; others completed data collection during the pandemic. The pandemic adversely impacted physical activity worldwide and may have impacted results from this study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34618498Hojjatinia S, Hojjatinia S, Lagoa CM, Brunke-Reese D, Conroy DE. Person-specific dose-finding for a digital messaging intervention to promote physical activity. Health Psychol. 2021 Aug;40(8):502-512. doi: 10.1037/hea0001117.
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 study testing Short Message with Text and Optional 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 4 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: finished, as of the sponsor's last update on 4 Nov 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 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Moderate (or Higher) Physical Activity Duration Following Message Receipt (time frame: 15-minute epochs for the remainder of the walking day). 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 NCT03907683, 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 4 Nov 2022; AzTrials last refreshed its copy on 28 Oct 2026.