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Physical InactivityTRY AIMNCT05794178

Testing Responses of Young Adults to Intervention Messages for Promoting Physical Activity Trial

A study testing Education, Activity tracker and Text messaging (random timing and selection) in people with Physical Inactivity and Weight Gain, run by University of Michigan at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this clinical trial is to test a precision (person-specific and context-sensitive) messaging algorithm for increasing physical activity and slowing weight gain in insufficiently-active young adults. Read more about this study

Who is it for?
Ages 18 to 29 yearsHealthy volunteers can take part
Conditions the study is for
Physical Inactivity, Weight Gain
What is being tested?
Education, Activity tracker and Text messaging (random timing and selection)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
2 sitesUnited States
Study dates
31 Mar 2023to 30 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • own an iPhone or Android smartphone that they would be willing to download the Fitbit app onto and sync with a Fitbit tracker and a custom, AIM app
  • willing to wear a Fitbit tracker almost continually (23.5 hours/day) for a 12- month period of time
  • free of visual impairment that would interfere with the receipt of text messages on their phone
  • capable of reading, speaking and understanding English and of giving informed consent
  • willing to complete a full 18-month study protocol

Who cannot join

  • self-report sufficient aerobic activity to meet 2018 Physical Activity Guidelines for American adults
  • research-grade accelerometer records sufficient aerobic physical activity to meet 2018 Physical Activity Guidelines for American adults
  • living outside the continental US
  • one or more contraindications to physical activity
  • require an assistive device for mobility or have any other condition that may limit or prevent participation in moderate-intensity physical activity
  • pregnant or planning to become pregnant within the next 12 months
Show all 9Show fewer
  • prior diagnosis of cancer, cardiovascular disease, diabetes or metabolic syndrome
  • concurrent participation in another research study involving physical activity or weight loss
  • planning to have surgery or relocate outside the continental US within the next year.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • The Pennsylvania State University

    University Park, Pennsylvania, 16802

Other trials in United States

About this study

Official title: Testing Responses of Young Adults to Intervention Messages (TRY AIM) for Promoting Physical Activity Trial

The goal of this clinical trial is to test a precision (person-specific and context-sensitive) messaging algorithm for increasing physical activity and slowing weight gain in insufficiently-active young adults. The main questions it aims to answer are:

  • Does physical activity increase more when text messages are sent based on a precision rule for selecting and timing messages compared to when the same message content is selected and sent at random or not at all?
  • Do biological or social characteristics of young adults make them more likely to respond positively to the precision messaging intervention than either of the other two interventions?

Participants will be provided with education about health-enhancing physical activity and given an activity tracker to wear for 12 months. They will then be randomly assigned to one of three groups. Participants in one group (Precision AIM) will receive up to 4 messages/day selected and timed based on a person-specific algorithm that forecasts possible message effects periodically throughout the day. Messages will be drawn from one of three content libraries: move more, sit less, or inspirational quotes. Participants in a second group (Random AIM) will receive 4 messages/day selected at random from the same three content libraries and delivered at random times within their availability window. Participants in the third group (No AIM) will receive not motivational messages but will randomly assigned to the Random AIM group will receive up to 4 messages/day drawn at random from three content libraries at randomly-selected times. Step counts and weight will be assessed at baseline, and at 3 months, 6 months, 12 months, and 18 months. Researchers will compare Precision AIM, Random AIM and No AIM groups to see if physical activity increased more and weight gain was slower in Precision AIM than Random AIM or No AIM after 3, 6, and 12 months of intervention, and 6 months after the intervention is complete (18 months).

Being tested
Education, Activity tracker, Text messaging (random timing and selection), Text messaging (precision dosing)
Medical subject headings
Sedentary Behavior, Weight Gain

What participants receive

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

  • EducationBehavioural

    Education about health benefits of physical activity, 2018 US Physical Activity Guidelines, assigned goals tailored to baseline step counts, and worksheet to develop action and coping plans (three of each)

  • Activity trackerBehavioural

    Fitbit activity tracker and mobile app to provide ad libitum behavioral feedback and self-regulatory support

  • Text messaging (random timing and selection)Behavioural

    Four text messages/day at random times within a participant's availability window and drawn at random from one of three content libraries (move more [40%], sit less [40%], inspirational quotes [20%])

  • Text messaging (precision dosing)Behavioural

    Up to four text messages/day within a participant's availability window, timed and selected from one of three content libraries (move more, sit less, inspirational quotes) based on a person-specific dynamic model and contextual data

Study groups in NCT05794178
Study groupRoleWhat they receive
Precision AIMExperimentalEducation + activity monitor + up to 4 text messages/day, each drawn from one of 3 content libraries and timed based on a person- and context-specific algorithm that will be updated monthly based on incoming data (within a participant-defined availability window)
Receives: Behavioral: Education; Behavioral: Activity tracker; Behavioral: Text messaging (precision dosing)
Random AIMActive comparatorEducation + activity monitor + up to 4 text messages/day, each drawn from one of 3 content libraries and timed at random (within a participant-defined availability window).
Receives: Behavioral: Education; Behavioral: Activity tracker; Behavioral: Text messaging (random timing and selection)
No AIMActive comparatorEducation + activity monitor
Receives: Behavioral: Education; Behavioral: Activity tracker

What is being measured

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

  1. Average daily step counts (6 months)

    Average daily step counts recorded by Actigraph accelerometer over a 7-day monitoring period

    Measured: Change from baseline to 6 months

Secondary outcomes (14)

  1. Average daily step counts (12 months)

    Average daily step counts recorded by Actigraph accelerometer over a 7-day monitoring period

    Measured: Change from baseline to 12 months

  2. Average daily step counts (18 months)

    Average daily step counts recorded by Actigraph accelerometer over a 7-day monitoring period

    Measured: Change from 12 months to 18 months

  3. Weight (6 months)

    Weight (kg) measured by BodyTrace scale

    Measured: Change from baseline to 6 months

  4. Weight (12 months)

    Weight (kg) measured by BodyTrace scale

    Measured: Change from baseline to 12 months

  5. Weight (18 months)

    Weight (kg) measured by BodyTrace scale

    Measured: Change from 12 months to 18 months

  6. Moderate-to-vigorous intensity physical activity duration (6 months)

    Average duration of daily moderate (or higher) physical activity recorded by Actigraph accelerometer over a 7-day monitoring period

    Measured: Change from baseline to 6 months

  7. Moderate-to-vigorous intensity physical activity duration (12 months)

    Average duration of daily moderate (or higher) physical activity recorded by Actigraph accelerometer over a 7-day monitoring period

    Measured: Change from baseline to 12 months

  8. Moderate-to-vigorous intensity physical activity duration (18 months)

    Average duration of daily moderate (or higher) physical activity recorded by Actigraph accelerometer over a 7-day monitoring period

    Measured: Change from 12 months to 18 months

  9. Light intensity physical activity duration (6 months)

    Average duration of daily light-intensity physical activity recorded by Actigraph accelerometer over a 7-day monitoring period

    Measured: Change from baseline to 6 months

  10. Light intensity physical activity duration (12 months)

    Average duration of daily light-intensity physical activity recorded by Actigraph accelerometer over a 7-day monitoring period

    Measured: Change from baseline to 12 months

  11. Light intensity physical activity duration (18 months)

    Average duration of daily light-intensity physical activity recorded by Actigraph accelerometer over a 7-day monitoring period

    Measured: Change from 12 months to 18 months

  12. Sedentary behavior duration (6 months)

    Average duration of daily sedentary behavior physical activity recorded by Actigraph accelerometer over a 7-day monitoring period

    Measured: Change from baseline to 6 months

  13. Sedentary behavior duration (12 months)

    Average duration of daily sedentary behavior recorded by Actigraph accelerometer over a 7-day monitoring period

    Measured: Change from baseline to 12 months

  14. Sedentary behavior duration (18 months)

    Average duration of daily sedentary behavior recorded by Actigraph accelerometer over a 7-day monitoring period

    Measured: Change from 12 months to 18 months

Timeline

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

  1. First posted3 Apr 2023
  2. Study start31 Mar 2023
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05794178
Sponsor's protocol ID
STUDY00019311
Other IDs
R33HL164868
Acronym
TRY AIM
Status last verified
Apr 2026
First submitted
20 Mar 2023
Last updated
22 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Education, Activity tracker and Text messaging (random timing and selection) in people with Physical Inactivity and Weight Gain, run by University of Michigan at 2 sites 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 5 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

This study is still under way. Results are not available in the source record yet.

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?

Average daily step counts (6 months) (time frame: Change from baseline to 6 months). 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 NCT05794178.

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 22 May 2026.

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