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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03907683
Other study ID # STUDY00009455
Secondary ID R01HL142732
Status Completed
Phase Phase 1
First received
Last updated
Start date April 3, 2019
Est. completion date July 21, 2020

Study information

Verified date October 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 develop personalized dynamical models of physical activity (PA) under different weather and temporal conditions as well as in response to different types of intervention messages. This approach relies on having extensive observations within the person under varying conditions to develop a dynamical model of how different conditions interact with each other to predict how behavior changes in response to text messages. Complementary sub-models will be estimated for each participant to describe their behavioral responses under different weather conditions. Healthy but insufficiently active young adults (n=80) will wear an activity monitor and receive a variety of randomly-timed and randomly-selected notifications via smartphone. GPS coordinates at the time of messages delivery and receipt are recorded and used to look up weather indices at that location at that time. The work is exploratory/descriptive as we will be developing models to describe participants' responses to messages under different weather conditions. This work is needed to develop the decision rules for a subsequent behavioral intervention that will be developed and tested in a future project.


Recruitment information / eligibility

Status Completed
Enrollment 82
Est. completion date July 21, 2020
Est. primary completion date July 21, 2020
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 use of a smartphone. - Participants must own and carry an iPhone (running iOS version 10 or higher) or Android (running operating system 7 or higher) smartphone during waking hours. Exclusion Criteria: - Participants engaging in 90 or more minutes of moderate- or greater intensity PA each week. - 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:
Short Message with Text and Optional Image
Messages can be up to 256 characters of text and with or without 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 Change in Moderate (or Higher) Physical Activity Duration Following Message Receipt Fitbit-assessed minutes with step counts >= 100 steps/min in 15-minute epochs (steady states represent the change in expected step counts if a message was delivered versus if the message was not delivered) 15-minute epochs for the remainder of the walking day
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