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

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

Tracking Information

• First Submitted Date: July 12, 2021
• First Posted Date: July 22, 2021
• Last Update Posted Date: August 10, 2022
• Actual Study Start Date: January 2, 2022
• Estimated Primary Completion Date: December 15, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Precision Assignment of Intervention Messages to Promote Physical Activity - Precision AIM
• Official Title: 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: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Prevention
• Condition: Cardiovascular Risk Factor

Intervention

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

• 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

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: July 12, 2021): 80
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 15, 2022
• Estimated Primary Completion Date: December 15, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 29 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04972279
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: David E Conroy, Penn State University
• Original Responsible Party: Same as current
• Current Study Sponsor: Penn State University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: David E Conroy, PhD; The Pennsylvania State University

• PRS Account: Penn State University
• Verification Date: August 2022