Clinical trial NCT05794178: Testing Responses of Young Adults to Intervention Messages for Promoting Physical Activity Trial
Official title: Testing Responses of Young Adults to Intervention Messages (TRY AIM) for Promoting Physical Activity Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physical Inactivity
Weight Gain
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Average daily step counts (6 months)
timeFrame: Change from baseline to 6 months
Secondary outcomes:
measure: Average daily step counts (12 months)
timeFrame: Change from baseline to 12 months
measure: Average daily step counts (18 months)
timeFrame: Change from 12 months to 18 months
measure: Weight (6 months)
timeFrame: Change from baseline to 6 months
measure: Weight (12 months)
timeFrame: Change from baseline to 12 months
measure: Weight (18 months)
timeFrame: Change from 12 months to 18 months
measure: Moderate-to-vigorous intensity physical activity duration (6 months)
timeFrame: Change from baseline to 6 months
measure: Moderate-to-vigorous intensity physical activity duration (12 months)
timeFrame: Change from baseline to 12 months
measure: Moderate-to-vigorous intensity physical activity duration (18 months)
timeFrame: Change from 12 months to 18 months
measure: Light intensity physical activity duration (6 months)
timeFrame: Change from baseline to 6 months
measure: Light intensity physical activity duration (12 months)
timeFrame: Change from baseline to 12 months
measure: Light intensity physical activity duration (18 months)
timeFrame: Change from 12 months to 18 months
measure: Sedentary behavior duration (6 months)
timeFrame: Change from baseline to 6 months
measure: Sedentary behavior duration (12 months)
timeFrame: Change from baseline to 12 months
measure: Sedentary behavior duration (18 months)
timeFrame: Change from 12 months to 18 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: University Park
country: United States
facility: The Pennsylvania State University
state: Pennsylvania
Study officials:
affiliation: University of Michigan
name: David E Conroy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Pennsylvania State University
name: Constantino M Lagoa, PhD
role: PRINCIPAL_INVESTIGATOR
References: