Cardiovascular Risk Factor
Conditions
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 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.
Interventions
BEHAVIORALShort 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).
Sponsors
Penn State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Moderate (or Higher) Physical Activity Duration Following Message Receipt | 15-minute epochs for the remainder of the walking day | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Random Messaging Participants receive 0-6 messages/day from the Random AIM app. Messages are only delivered outside of a participant-specific Do Not Disturb window (e.g., 11pm-8am). Messages are selected randomly from three content domains: Move More (40%), Sit Less (40%), and Inspirational Quotes Unrelated to Movement (20%). Half of the messages are accompanied by images. Message selection and timing are determined randomly each night for the following day.
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). | 82 |
| Total | 82 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Pregnancy | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Random Messaging |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 82 Participants |
| Age, Continuous | 23.7 years STANDARD_DEVIATION 2.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 78 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 19 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 47 Participants |
| Region of Enrollment United States | 82 participants |
| Sex: Female, Male Female | 55 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 82 |
| other Total, other adverse events | 0 / 82 |
| serious Total, serious adverse events | 0 / 82 |
Outcome results
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)
Time frame: 15-minute epochs for the remainder of the walking day
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Random Messaging | Change in Moderate (or Higher) Physical Activity Duration Following Message Receipt | Weekday Move More Messages (person-specific steady state estimate) | 0.16 minutes | Standard Deviation 0.69 |
| Random Messaging | Change in Moderate (or Higher) Physical Activity Duration Following Message Receipt | Weekday Sit Less Messages (person-specific steady state estimate) | 0.13 minutes | Standard Deviation 0.69 |
| Random Messaging | Change in Moderate (or Higher) Physical Activity Duration Following Message Receipt | Weekday Inspirational Quote Messages (person-specific steady state estimate) | 0.25 minutes | Standard Deviation 1.23 |
| Random Messaging | Change in Moderate (or Higher) Physical Activity Duration Following Message Receipt | Weekend Move More Messages (person-specific steady state estimate) | 0.31 minutes | Standard Deviation 1.44 |
| Random Messaging | Change in Moderate (or Higher) Physical Activity Duration Following Message Receipt | Weekend Sit Less Messages (person-specific steady state estimate) | 0.28 minutes | Standard Deviation 0.95 |
| Random Messaging | Change in Moderate (or Higher) Physical Activity Duration Following Message Receipt | Weekend Inspirational Quote Messages (person-specific steady state estimate) | 0.11 minutes | Standard Deviation 1.51 |
Comparison: Null hypothesis was that the mean steady state response to weekday move more messages would not differ from zerop-value: 0.03795% CI: [0.0098, 0.3185]t-test, 2 sided
Comparison: Null hypothesis was that the mean steady state response to weekday sit less messages would not differ from zerop-value: 0.10695% CI: [-0.0274, 0.2781]t-test, 2 sided
Comparison: Null hypothesis was that the mean steady state response to weekday inspirational quote messages would not differ from zerop-value: 0.07695% CI: [-0.0262, 0.521]t-test, 2 sided
Comparison: Null hypothesis was that the mean steady state response to weekend move more messages would not differ from zerop-value: 0.06295% CI: [-0.0156, 0.6268]t-test, 2 sided
Comparison: Null hypothesis was that the mean steady state response to weekend sit less messages would not differ from zerop-value: 0.1195% CI: [0.0645, 0.4895]t-test, 2 sided
Comparison: Null hypothesis was that the mean steady state response to weekend inspirational quote messages would not differ from zerop-value: 0.52395% CI: [-0.2279, 0.4447]t-test, 2 sided