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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Weight Gain; Physical Inactivity
• Intervention / Treatment: Behavioral: Education; Behavioral: Activity tracker; Behavioral: Text messaging (precision dosing); Behavioral: Text messaging (random timing and selection)

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Pennsylvania
    • University Park, Pennsylvania, United States, 16802
      • The Pennsylvania State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 29 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Precision AIM; 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)	Behavioral: Education; 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); Behavioral: Activity tracker; Fitbit activity tracker and mobile app to provide ad libitum behavioral feedback and self-regulatory support; Behavioral: Text messaging (precision dosing); 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
Active Comparator: Random AIM; 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).	Behavioral: Education; 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); Behavioral: Activity tracker; Fitbit activity tracker and mobile app to provide ad libitum behavioral feedback and self-regulatory support; Behavioral: Text messaging (random timing and selection); 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%])
Active Comparator: No AIM; Education + activity monitor	Behavioral: Education; 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); Behavioral: Activity tracker; Fitbit activity tracker and mobile app to provide ad libitum behavioral feedback and self-regulatory support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average daily step counts (6 months)	Average daily step counts recorded by Actigraph accelerometer over a 7-day monitoring period	Change from baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average daily step counts (12 months)	Average daily step counts recorded by Actigraph accelerometer over a 7-day monitoring period	Change from baseline to 12 months
Average daily step counts (18 months)	Average daily step counts recorded by Actigraph accelerometer over a 7-day monitoring period	Change from 12 months to 18 months
Weight (6 months)	Weight (kg) measured by BodyTrace scale	Change from baseline to 6 months
Weight (12 months)	Weight (kg) measured by BodyTrace scale	Change from baseline to 12 months
Weight (18 months)	Weight (kg) measured by BodyTrace scale	Change from 12 months to 18 months
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	Change from baseline to 6 months
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	Change from baseline to 12 months
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	Change from 12 months to 18 months
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	Change from baseline to 6 months
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	Change from baseline to 12 months
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	Change from 12 months to 18 months
Sedentary behavior duration (6 months)	Average duration of daily sedentary behavior physical activity recorded by Actigraph accelerometer over a 7-day monitoring period	Change from baseline to 6 months
Sedentary behavior duration (12 months)	Average duration of daily sedentary behavior recorded by Actigraph accelerometer over a 7-day monitoring period	Change from baseline to 12 months
Sedentary behavior duration (18 months)	Average duration of daily sedentary behavior recorded by Actigraph accelerometer over a 7-day monitoring period	Change from 12 months to 18 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Constantino M Lagoa, PhD, The Pennsylvania State University; Principal Investigator: David E Conroy, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2023
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: March 20, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Weight Gain; Sedentary Behavior; Equipment and Supplies; Socioeconomic Factors; Population Characteristics; Electrical Equipment and Supplies; Diagnostic Equipment; Wearable Electronic Devices; Educational Status; Fitness Trackers
• Other Study ID Numbers: STUDY00019311; R33HL164868 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No