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

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University of Michigan

Status

Enrolling

Conditions

Physical Inactivity
Weight Gain

Treatments

Behavioral: Text messaging (random timing and selection)
Behavioral: Activity tracker
Behavioral: Text messaging (precision dosing)
Behavioral: Education

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05794178
STUDY00019311
R33HL164868 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment

360 estimated patients

Sex

All

Ages

18 to 29 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

360 participants in 3 patient groups

Precision AIM
Experimental group
Description:
Education + 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)
Treatment:
Behavioral: Education
Behavioral: Text messaging (precision dosing)
Behavioral: Activity tracker
Random AIM
Active Comparator group
Description:
Education + 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).
Treatment:
Behavioral: Education
Behavioral: Text messaging (random timing and selection)
Behavioral: Activity tracker
No AIM
Active Comparator group
Description:
Education + activity monitor
Treatment:
Behavioral: Education
Behavioral: Activity tracker

Trial contacts and locations

2

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Central trial contact

Ann Mehringer

Data sourced from clinicaltrials.gov

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