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

Not Applicable
Recruiting
Conditions
Physical Inactivity
Weight Gain
Interventions
Behavioral: Education
Behavioral: Activity tracker
Behavioral: Text messaging (random timing and selection)
Behavioral: Text messaging (precision dosing)
Registration Number
NCT05794178
Lead Sponsor
Penn State University
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).

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
360
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
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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.
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
No AIMEducationEducation + activity monitor
No AIMActivity trackerEducation + activity monitor
Precision AIMEducationEducation + 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)
Random AIMActivity trackerEducation + 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).
Random AIMText messaging (random timing and selection)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).
Precision AIMActivity trackerEducation + 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)
Precision AIMText messaging (precision dosing)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)
Random AIMEducationEducation + 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).
Primary Outcome Measures
NameTimeMethod
Average daily step counts (6 months)Change from baseline to 6 months

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

Secondary Outcome Measures
NameTimeMethod
Average daily step counts (18 months)Change from 12 months to 18 months

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

Weight (6 months)Change from baseline to 6 months

Weight (kg) measured by BodyTrace scale

Weight (12 months)Change from baseline to 12 months

Weight (kg) measured by BodyTrace scale

Moderate-to-vigorous intensity physical activity duration (6 months)Change from baseline to 6 months

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

Light intensity physical activity duration (18 months)Change from 12 months to 18 months

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

Light intensity physical activity duration (6 months)Change from baseline to 6 months

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

Average daily step counts (12 months)Change from baseline to 12 months

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

Weight (18 months)Change from 12 months to 18 months

Weight (kg) measured by BodyTrace scale

Moderate-to-vigorous intensity physical activity duration (12 months)Change from baseline to 12 months

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

Moderate-to-vigorous intensity physical activity duration (18 months)Change from 12 months to 18 months

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

Light intensity physical activity duration (12 months)Change from baseline to 12 months

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

Sedentary behavior duration (6 months)Change from baseline to 6 months

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

Sedentary behavior duration (12 months)Change from baseline to 12 months

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

Sedentary behavior duration (18 months)Change from 12 months to 18 months

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

Trial Locations

Locations (1)

The Pennsylvania State University

🇺🇸

University Park, Pennsylvania, United States

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