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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cardiovascular Risk Factor	Behavioral: Digital message (text + image)	Phase 1; Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: January 2, 2022
• Estimated Primary Completion Date: December 15, 2022
• Estimated Study Completion Date: December 15, 2022

Arms and Interventions

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.	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).
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.	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).

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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
2. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 29 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, Pennsylvania

The Pennsylvania State University

University Park, Pennsylvania, United States, 16802

Sponsors and Collaborators

Penn State University

Investigators

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

More Information

• Responsible Party: David E Conroy, Professor, Penn State University
• ClinicalTrials.gov Identifier: NCT04972279
• Other Study ID Numbers: STUDY00016346
• First Posted: July 22, 2021
• Last Update Posted: August 10, 2022
• Last Verified: August 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No