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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04972279
Other study ID # STUDY00016346
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date January 2, 2022
Est. completion date December 15, 2022

Study information

Verified date August 2022
Source Penn State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 80
Est. completion date December 15, 2022
Est. primary completion date December 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 29 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


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).

Locations

Country Name City State
United States The Pennsylvania State University University Park Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change in total physical activity volume from run-in period Actigraph-assessed total activity counts during a 1-week monitoring period at baseline versus end of study Baseline and 6 months
Secondary Change in moderate-to-vigorous physical activity duration from run-in period (baseline) to 6 months(baseline) to 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 Baseline and 6 months
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