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

Primary Purpose

Physical Inactivity, Weight Gain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education
Activity tracker
Text messaging (random timing and selection)
Text messaging (precision dosing)
Sponsored by
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Physical Inactivity

Eligibility Criteria

18 Years - 29 Years (Adult)All SexesAccepts 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.

Sites / Locations

  • The Pennsylvania State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Precision AIM

Random AIM

No AIM

Arm 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)

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).

Education + activity monitor

Outcomes

Primary Outcome Measures

Average daily step counts (6 months)
Average daily step counts recorded by Actigraph accelerometer over a 7-day monitoring period

Secondary Outcome Measures

Average daily step counts (12 months)
Average daily step counts recorded by Actigraph accelerometer over a 7-day monitoring period
Average daily step counts (18 months)
Average daily step counts recorded by Actigraph accelerometer over a 7-day monitoring period
Weight (6 months)
Weight (kg) measured by BodyTrace scale
Weight (12 months)
Weight (kg) measured by BodyTrace scale
Weight (18 months)
Weight (kg) measured by BodyTrace scale
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
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
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
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
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
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
Sedentary behavior duration (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)
Average duration of daily sedentary behavior recorded by Actigraph accelerometer over a 7-day monitoring period
Sedentary behavior duration (18 months)
Average duration of daily sedentary behavior recorded by Actigraph accelerometer over a 7-day monitoring period

Full Information

First Posted
March 20, 2023
Last Updated
April 21, 2023
Sponsor
Penn State University
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1. Study Identification

Unique Protocol Identification Number
NCT05794178
Brief Title
Testing Responses of Young Adults to Intervention Messages for Promoting Physical Activity Trial
Acronym
TRY AIM
Official Title
Testing Responses of Young Adults to Intervention Messages (TRY AIM) for Promoting Physical Activity Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2023 (Actual)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
November 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Inactivity, Weight Gain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Precision AIM
Arm Type
Experimental
Arm 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)
Arm Title
Random AIM
Arm Type
Active Comparator
Arm 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).
Arm Title
No AIM
Arm Type
Active Comparator
Arm Description
Education + activity monitor
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Activity tracker
Intervention Description
Fitbit activity tracker and mobile app to provide ad libitum behavioral feedback and self-regulatory support
Intervention Type
Behavioral
Intervention Name(s)
Text messaging (random timing and selection)
Intervention Description
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%])
Intervention Type
Behavioral
Intervention Name(s)
Text messaging (precision dosing)
Intervention Description
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
Primary Outcome Measure Information:
Title
Average daily step counts (6 months)
Description
Average daily step counts recorded by Actigraph accelerometer over a 7-day monitoring period
Time Frame
Change from baseline to 6 months
Secondary Outcome Measure Information:
Title
Average daily step counts (12 months)
Description
Average daily step counts recorded by Actigraph accelerometer over a 7-day monitoring period
Time Frame
Change from baseline to 12 months
Title
Average daily step counts (18 months)
Description
Average daily step counts recorded by Actigraph accelerometer over a 7-day monitoring period
Time Frame
Change from 12 months to 18 months
Title
Weight (6 months)
Description
Weight (kg) measured by BodyTrace scale
Time Frame
Change from baseline to 6 months
Title
Weight (12 months)
Description
Weight (kg) measured by BodyTrace scale
Time Frame
Change from baseline to 12 months
Title
Weight (18 months)
Description
Weight (kg) measured by BodyTrace scale
Time Frame
Change from 12 months to 18 months
Title
Moderate-to-vigorous intensity physical activity duration (6 months)
Description
Average duration of daily moderate (or higher) physical activity recorded by Actigraph accelerometer over a 7-day monitoring period
Time Frame
Change from baseline to 6 months
Title
Moderate-to-vigorous intensity physical activity duration (12 months)
Description
Average duration of daily moderate (or higher) physical activity recorded by Actigraph accelerometer over a 7-day monitoring period
Time Frame
Change from baseline to 12 months
Title
Moderate-to-vigorous intensity physical activity duration (18 months)
Description
Average duration of daily moderate (or higher) physical activity recorded by Actigraph accelerometer over a 7-day monitoring period
Time Frame
Change from 12 months to 18 months
Title
Light intensity physical activity duration (6 months)
Description
Average duration of daily light-intensity physical activity recorded by Actigraph accelerometer over a 7-day monitoring period
Time Frame
Change from baseline to 6 months
Title
Light intensity physical activity duration (12 months)
Description
Average duration of daily light-intensity physical activity recorded by Actigraph accelerometer over a 7-day monitoring period
Time Frame
Change from baseline to 12 months
Title
Light intensity physical activity duration (18 months)
Description
Average duration of daily light-intensity physical activity recorded by Actigraph accelerometer over a 7-day monitoring period
Time Frame
Change from 12 months to 18 months
Title
Sedentary behavior duration (6 months)
Description
Average duration of daily sedentary behavior physical activity recorded by Actigraph accelerometer over a 7-day monitoring period
Time Frame
Change from baseline to 6 months
Title
Sedentary behavior duration (12 months)
Description
Average duration of daily sedentary behavior recorded by Actigraph accelerometer over a 7-day monitoring period
Time Frame
Change from baseline to 12 months
Title
Sedentary behavior duration (18 months)
Description
Average duration of daily sedentary behavior recorded by Actigraph accelerometer over a 7-day monitoring period
Time Frame
Change from 12 months to 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gabby Ryan, MA
Phone
814-865-7935
Email
gabby.ryan@psu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David E Conroy, PhD
Organizational Affiliation
The Pennsylvania State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Constantino M Lagoa, PhD
Organizational Affiliation
The Pennsylvania State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Pennsylvania State University
City
University Park
State/Province
Pennsylvania
ZIP/Postal Code
16802
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David E Conroy, PhD
Phone
814-863-3451
Email
conroy@psu.edu
First Name & Middle Initial & Last Name & Degree
Gabby Ryan, MA
Phone
814-865-7935
Email
gabby.ryan@psu.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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