An interventional study of Feedback on smartphone in Physical Activity, sponsored by Penn State University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-24.
Sponsored by Penn State University · Not applicable, Interventional, and Prevention
Lack of physical activity is associated with negative health outcomes, including obesity, diabetes, and cardiovascular disease. There are calls from NIH and medical organizations to integrate the use mobile devices, such as smartphones, to provide "e-health" interventions to patients in their daily life. Referred to as Ecological Momentary Interventions [EMI], these innovative mobile methods provide an opportunity for researchers and clinicians to offer tailored intervention material to people at specific times and in specific settings when they may be most in need of such support. To our knowledge no study has used objective ambulatory assessment data to deliver EMI. This preliminary work is to demonstrate the feasibility, and test preliminary efficacy, of using a Bluetooth accelerometer to provide real-time feedback on a smartphone to increase objectively measured steps (i.e., increase activity). A within-person design will be used, including assessment, intervention, and follow-up phases. During the assessment phase objective physical activity (using accelerometers) will be collected. In the intervention phase participants will also receive real-time feedback throughout the day regarding their total steps and personalized step goals. Objectively measured steps and disease status measures will be used to evaluate efficacy.
Lack of physical activity is associated with negative health outcomes, including obesity, diabetes, and cardiovascular disease. A myriad of interventions aimed at increasing daily physical activity (PA) exist. Increasing PA levels has been shown to improve health among patients with cardiovascular and metabolic diseases. Accelerometers and pedometers can be useful tools in such interventions, particularly when used to provide participants with individualized feedback on progress toward PA goals. These programs typically require participants to set PA goals (e.g., number of steps/day), wear pedometers, and record daily activity levels from the pedometers. This process relies heavily on accurate self-reported information and is both time- and effort-intensive for participants, thus limiting acceptability and longer-term viability of this intervention option.
There is an increasing trend in health behavior research to use mobile devices, such as smartphones to provide interventions. These methods - known as Ecological Momentary Interventions [EMI] - are innovative because they allow researchers and clinicians to offered information to people at specific times and in settings when they may be most in need of such support. One way EMI can be tailored is by having participants complete repeated self-report assessments on mobile devices such as smartphones (known as Ecological Momentary Assessment [EMA]), and then using this material to identify times when people are in need of intervention. Although some studies (including recent studies conducted by members of our research team) have developed interventions that use EMA to create real-time interventions that are delivered in daily life, to our knowledge no study has used objective ambulatory assessment data to do so. Using objective data is potentially advantageous because it utilizes passive data collection (requiring little or no input by participants), and thus reduces participant burden and potential concerns regarding accuracy of self-reported data.
The first aim of this study is to establish the feasibility and acceptability of integrating Bluetooth-enabled activity monitor with smartphones to provide real-time feedback regarding physical activity in everyday life. We will evaluate feasibility and acceptability of this intervention method by tracking intervention delivery and participant compliance with EMA. This information will be automatically recorded by smartphone and activity monitor.
The second aim of this work is to provide a preliminary evaluation of the efficacy of delivering real-time feedback based on objectively measured PA. Our primary outcome is number of objectively measured steps. It is expected that participants will increase from their baseline number of steps when receiving personalized feedback and reminders on the smartphones.
2,649 studies on the registry are indexed under Motor Activity; 1,205 are open to participants now.
This study's enrollment of 37 is below the median of 60 across 2,309 interventional studies indexed under Motor Activity.
Browse Motor Activity studies →Penn State University is the lead sponsor of 269 studies on the registry; 52 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 11 (73%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Wear accelerometer only to measure activity levels (steps)
Wear accelerometer and complete Ecological Momentary Assessment (EMA) surveys on smartphone 5 times daily
Wear accelerometer, complete EMA surveys on smartphone 5 times daily, receive intervention
Behavioral: Feedback on smartphone
Receive personalized feedback (EMI) on smartphone regarding physical activity
Number of steps
Time frame: during intervention (~28 days)
BMI
Time frame: Baseline, Post-intervention
blood pressure
Time frame: Baseline
Hemoglobin A1c
Time frame: Baseline
waist-hip ratio
Time frame: Baseline
Perceived Stress
Perceived Stress Scale
Time frame: Baseline, Post-intervention
Depression
Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: Baseline, Post-intervention
Social Support
Social Network Index Survey
Time frame: Baseline, Post-intervention
Satisfaction with Life
Satisfaction with Life Scale
Time frame: Baseline, Post-intervention
Barriers for Physical Activity
Barriers for Physical Activity Questionnaire
Time frame: Baseline, Post-intervention
Social Support and Exercise
Social Support and Exercise Survey
Time frame: Baseline, Post-intervention
Outcomes of Exercise
Outcomes of Exercise Questionnaire
Time frame: Baseline, Post-intervention
Walking measure
Walking Questionnaire
Time frame: Baseline, Post-intervention
Habit Index for Physical Activity
Habit Index for Physical Activity
Time frame: Baseline, Post-intervention
Rumination
Rumination Questionnaire
Time frame: Baseline, Post-intervention
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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