- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04972279
Precision Assignment of Intervention Messages to Promote Physical Activity - Precision AIM
August 8, 2022 updated by: David E Conroy, Penn State University
Phase 1 Clinical Trial to Develop a Personalized Adaptive Text Message Intervention Using Control Systems Engineering Tools to Increase Physical Activity in Early Adulthood
Our goal is to develop personalized decision rules for selecting the frequency, timing, and content of messages to promote physical activity.
The objective of this project is to evaluate the acceptability and feasibility of two strategies for calibrating decision rules used to send those messages.
Participants will wear an activity monitor for the collection of PA data and be randomly assigned to one of two adaptive intervention strategies.
The decision rule for each participant will be refined on a monthly basis throughout the 6-month study based upon the accumulating data on how each participant is responding to different messages under different conditions.
Our hypothesis is that more intensive intervention strategies will offer a better user experience because the resulting treatments will be experienced as more personalized.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
University Park, Pennsylvania, United States, 16802
- The Pennsylvania State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 29 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participants capable of reading, speaking and understanding English and of giving informed consent.
- Participants between the ages of 18-29 years.
- Participants must be free of visual impairment that would interfere with the receipt of text messages on their phone.
- Participants must be willing to wear a Fitbit Versa 3 almost continually (23.5 hours/day) for a 6- month period of time.
- Participants must own an iPhone or Android smartphone that they would be willing to download the custom Precision AIM and Fitbit app onto and sync with a Fitbit Versa 3.
- Participants interested in setting goals to increase their physical activity levels over the 6-month study.
Exclusion Criteria:
- Participants engaging in 150 or more minutes of moderate- or greater intensity PA /week as assessed by a research grade accelerometer.
- Participants engaged in organized programs with mandated physical activity (e.g., varsity sports, ROTC).
- Participants with contraindications to normal physical activity on the Physical Activity Readiness Questionnaire.
- Participants who require an assistive device for mobility or have any other condition that may limit or prevent participation in moderate-intensity physical activity.
- Participants who are pregnant or planning to become pregnant within the next 6 months.
- Participants with a prior diagnosis of cancer, cardiovascular disease, diabetes or metabolic syndrome.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Aggressive adaptation strategy
Participants receive up to 6 messages/day to support achievement of their behavior change goal.
Messages are only delivered outside of a participant-specific Do Not Disturb window (e.g., 11pm-8am).
Messages with coordinating images are selected from three content domains: Move More, Sit Less, and Inspirational Quotes Unrelated to Movement within the first month.
The decision rule for each participant will be refined on a monthly basis throughout the 6-month study based upon the accumulating data on how each participant is responding to different messages under different conditions.
|
Messages can be up to 256 characters of text with an image.
"Move more" and "sit less" messages were written to target established cognitive and affective constructs associated with physical activity (e.g., prompts to action plan, guidance for maximizing pleasure by regulating intensity).
|
Experimental: Moderate adaptation strategy
Participants receive up to 3 messages/day to support achievement of their behavior change goal.
Messages are only delivered outside of a participant-specific Do Not Disturb window (e.g., 11pm-8am).
Messages with coordinating images are selected randomly from three content domains: Move More, Sit Less, and Inspirational Quotes Unrelated to Movement within the first month.
The decision rule for each participant will be refined on a monthly basis throughout the 6-month study based upon the accumulating data on how each participant is responding to different messages under different conditions.
|
Messages can be up to 256 characters of text with an image.
"Move more" and "sit less" messages were written to target established cognitive and affective constructs associated with physical activity (e.g., prompts to action plan, guidance for maximizing pleasure by regulating intensity).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability of messaging at 6 months
Time Frame: 6 months
|
Self-reported preference for more, no change or fewer messages/day based on participant exit interviews coded by two blinded research assistants
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in total physical activity volume from run-in period
Time Frame: Baseline and 6 months
|
Actigraph-assessed total activity counts during a 1-week monitoring period at baseline versus end of study
|
Baseline and 6 months
|
Change in moderate-to-vigorous physical activity duration from run-in period (baseline) to 6 months(baseline) to 6 months
Time Frame: Baseline and 6 months
|
Actigraph-assessed min/week of moderate (or higher) physical activity duration during a 1 week monitoring period at baseline versus end of study
|
Baseline and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David E Conroy, PhD, The Pennsylvania State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 2, 2022
Primary Completion (Anticipated)
December 15, 2022
Study Completion (Anticipated)
December 15, 2022
Study Registration Dates
First Submitted
July 12, 2021
First Submitted That Met QC Criteria
July 12, 2021
First Posted (Actual)
July 22, 2021
Study Record Updates
Last Update Posted (Actual)
August 10, 2022
Last Update Submitted That Met QC Criteria
August 8, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00016346
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiovascular Risk Factor
-
University of Southern DenmarkRegion of Southern Denmark; Odense Patient Data Explorative Network; ENIGMA Solutions... and other collaboratorsActive, not recruitingCardiovascular Risk Factor | Risk CommunicationDenmark
-
University of Split, School of MedicineCompletedCardiovascular Risk Factor | Lifestyle Risk ReductionCroatia
-
University Hospital, BrestRecruiting
-
University Hospitals Cleveland Medical CenterRecruitingCardiovascular Risk FactorUnited States
-
Northwestern UniversityNorthShore University HealthSystem; Case Western Reserve University; Shirley... and other collaboratorsCompleted
-
University of ArizonaTerminatedCardiovascular Risk FactorUnited States
-
Penn State UniversityCompletedCardiovascular Risk FactorUnited States
-
Clinique BizetCompleted
-
University Hospital, BrestCompleted
-
University of DelawareCompleted
Clinical Trials on Digital message (text + image)
-
Penn State UniversityCompletedCardiovascular Risk FactorUnited States
-
University of California, San FranciscoUniversity of WashingtonCompleted
-
University of WashingtonUniversity of Illinois at Chicago; Kenya Medical Research InstituteCompletedHIV Infections | Acquired Immunodeficiency Syndrome | Circumcision, Male | Patient Compliance | Cellular PhoneKenya
-
Texas Tech University Health Sciences CenterTexas Tech UniversityCompletedBreast Cancer FemaleUnited States
-
University of WashingtonUniversity of California, San Francisco; Kenya Medical Research InstituteCompletedHIV Infections | Acquired Immunodeficiency SyndromeKenya
-
Emory UniversityNational Cancer Institute (NCI)RecruitingMalignant Solid Neoplasm | Hematopoietic and Lymphoid System NeoplasmUnited States
-
Wake Forest University Health SciencesCompleted
-
New York City Health and Hospitals CorporationWithdrawn
-
University of PittsburghCompleted
-
Jonsson Comprehensive Cancer CentereHealth International, INC.RecruitingObesity | Malignant NeoplasmUnited States