Active — Not RecruitingNot Applicable

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

United States360 participantsStarted 2023-03-31

Plain-language 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. 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).

Who can participate

Age range

18 Years – 29 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Average daily step counts (6 months)

Timeframe: Change from baseline to 6 months

Trial details

NCT IDNCT05794178

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-30

View on ClinicalTrials.gov More Physical Inactivity trials