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

NCT04972279 | Unknown Phase 1

• 1 other identifier: STUDY00016346
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Risk Factor

Outcome Measures

Primary Outcomes (1)

• Acceptability of messaging at 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 Outcomes (2)

• Change in total physical activity volume from run-in period

  Baseline and 6 months

• Change in moderate-to-vigorous physical activity duration from run-in period (baseline) to 6 months(baseline) to 6 months

  Baseline and 6 months

Study Arms (2)

Aggressive adaptation strategy

EXPERIMENTAL

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)

Moderate adaptation strategy

EXPERIMENTAL

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)

Interventions

Digital message (text + image) BEHAVIORAL

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).

Aggressive adaptation strategy; Moderate adaptation strategy

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Penn State University: lead

Study Sites (1)

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

Study Officials

• David E Conroy, PhD

  The Pennsylvania State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 22, 2021
• Study Start: January 2, 2022
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: August 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)