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Precision Assignment of Intervention Messages to Promote Physical Activity - Precision AIM

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ClinicalTrials.gov Identifier: NCT04972279
Recruitment Status : Active, not recruiting
First Posted : July 22, 2021
Last Update Posted : August 10, 2022
Sponsor:
Information provided by (Responsible Party):
David E Conroy, Penn State University

Tracking Information
First Submitted Date  ICMJE July 12, 2021
First Posted Date  ICMJE July 22, 2021
Last Update Posted Date August 10, 2022
Actual Study Start Date  ICMJE January 2, 2022
Estimated Primary Completion Date December 15, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2022)
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
Original Primary Outcome Measures  ICMJE
 (submitted: July 12, 2021)
  • Acceptability of messaging at 6 months [ Time Frame: 6 months ]
    Self-reported user experience on the Net Promoter Score
  • eHealth Engagement Scale [ Time Frame: 6 months ]
    Self-reported perceptions of messages being involving and credible
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2021)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Precision Assignment of Intervention Messages to Promote Physical Activity - Precision AIM
Official Title  ICMJE Phase 1 Clinical Trial to Develop a Personalized Adaptive Text Message Intervention Using Control Systems Engineering Tools to Increase Physical Activity in Early Adulthood
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Condition  ICMJE Cardiovascular Risk Factor
Intervention  ICMJE Behavioral: Digital message (text + image)
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).
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Digital message (text + image)
  • 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.
    Intervention: Behavioral: Digital message (text + image)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 12, 2021)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 15, 2022
Estimated Primary Completion Date December 15, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 29 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04972279
Other Study ID Numbers  ICMJE STUDY00016346
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party David E Conroy, Penn State University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Penn State University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David E Conroy, PhD The Pennsylvania State University
PRS Account Penn State University
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP