- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03907683
Random Assignment of Intervention Messages for Developing Personalized Decision Rules to Promote Physical Activity (RandomAIM)
October 7, 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 develop personalized dynamical models of physical activity (PA) under different weather and temporal conditions as well as in response to different types of intervention messages.
This approach relies on having extensive observations within the person under varying conditions to develop a dynamical model of how different conditions interact with each other to predict how behavior changes in response to text messages.
Complementary sub-models will be estimated for each participant to describe their behavioral responses under different weather conditions.
Healthy but insufficiently active young adults (n=80) will wear an activity monitor and receive a variety of randomly-timed and randomly-selected notifications via smartphone.
GPS coordinates at the time of messages delivery and receipt are recorded and used to look up weather indices at that location at that time.
The work is exploratory/descriptive as we will be developing models to describe participants' responses to messages under different weather conditions.
This work is needed to develop the decision rules for a subsequent behavioral intervention that will be developed and tested in a future project.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
82
Phase
- 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
Yes
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 use of a smartphone.
- Participants must own and carry an iPhone (running iOS version 10 or higher) or Android (running operating system 7 or higher) smartphone during waking hours.
Exclusion Criteria:
- Participants engaging in 90 or more minutes of moderate- or greater intensity PA each week.
- 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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Random Messaging
Participants receive 0-5 messages/day from the Random AIM app.
Messages are only delivered outside of a participant-specific Do Not Disturb window (e.g., 11pm-8am).
Messages are selected randomly from three content domains: Move More (40%), Sit Less (40%), and Inspirational Quotes Unrelated to Movement (20%).
Half of the messages are accompanied by images.
Message selection and timing are determined randomly each night for the following day.
|
Messages can be up to 256 characters of text and with or without 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 |
---|---|---|
Change in Moderate (or Higher) Physical Activity Duration Following Message Receipt
Time Frame: 15-minute epochs for the remainder of the walking day
|
Fitbit-assessed minutes with step counts >= 100 steps/min in 15-minute epochs (steady states represent the change in expected step counts if a message was delivered versus if the message was not delivered)
|
15-minute epochs for the remainder of the walking day
|
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
April 3, 2019
Primary Completion (Actual)
July 21, 2020
Study Completion (Actual)
July 21, 2020
Study Registration Dates
First Submitted
April 5, 2019
First Submitted That Met QC Criteria
April 5, 2019
First Posted (Actual)
April 9, 2019
Study Record Updates
Last Update Posted (Actual)
November 4, 2022
Last Update Submitted That Met QC Criteria
October 7, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00009455
- R01HL142732 (U.S. NIH Grant/Contract)
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
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 of DelawareRecruiting
-
University Health Network, TorontoSunnybrook Health Sciences Centre; MOUNT SINAI HOSPITALRecruitingCardiovascular Risk FactorCanada
-
University of DelawareRecruitingCardiovascular Risk FactorUnited States
-
The Cleveland ClinicActive, not recruitingCardiovascular Risk FactorUnited States
-
University of NebraskaCompletedCardiovascular Risk FactorUnited States
-
Oregon Health and Science UniversityCompleted
-
Dawn BrewerNational Institute of Environmental Health Sciences (NIEHS)Completed
-
Penn State UniversityActive, not recruitingCardiovascular Risk FactorUnited States
Clinical Trials on Short Message with Text and Optional Image
-
University of WashingtonUniversity of Illinois at Chicago; Kenya Medical Research InstituteCompletedHIV Infections | Acquired Immunodeficiency Syndrome | Circumcision, Male | Patient Compliance | Cellular PhoneKenya
-
Penn State UniversityActive, not recruitingCardiovascular Risk FactorUnited States
-
University of WashingtonUniversity of California, San Francisco; Kenya Medical Research InstituteCompletedHIV Infections | Acquired Immunodeficiency SyndromeKenya
-
Imperial College LondonBarts & The London NHS Trust; Mid and South Essex NHS Foundation Trust; Royal... and other collaboratorsCompleted
-
Assistance Publique - Hôpitaux de ParisCompletedType 1 DiabetesFrance
-
India Diabetes Research Foundation & Dr. A. Ramachandran...Completed
-
Jonsson Comprehensive Cancer CentereHealth International, INC.RecruitingObesity | Malignant NeoplasmUnited States
-
Boston UniversityNational Institute of Mental Health (NIMH)Active, not recruitingHIV/AIDS | ViolenceSouth Africa
-
Ontario Medical AssociationThe Behavioural Insights TeamCompletedAnxiety | Mental Health Wellness 1 | HappinessCanada
-
NHS LothianQueen Margaret UniversityUnknown