Physical ActivityNCT02005042
Physical Activity and Daily Experiences Study
A study testing Feedback on smartphone in people with Physical Activity, run by Penn State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Feedback on smartphone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or older
- English literate
- A BMI ranging from 25-40 (overweight or obese), based on self-report height and weight
- Not meeting current national physical activity guidelines
- Self-report they are able to walk unassisted, without the help of a wheel chair, walker, cane, crutches, or other walking aids
- Medically cleared to participate by completing screening form
- For women: not currently pregnant or actively trying to get pregnant for duration of study
Who cannot join
- Younger than 18
- Not English literate
- Self-report they are unable to walk unassisted, without the help of a wheel chair, walker, cane, crutches, or other walking aids
- A BMI outside of inclusion range (<25 or >40), based on self-report height and weight
- Meeting current national physical activity guidelines
- Not medically cleared to participate
- For women: currently pregnant or actively trying to get pregnant for duration of study. Pregnant women or those trying to become pregnant will be excluded because pregnancy may interfere with women's ability to go about previously normal activities, and will influence our outcome measures (e.g., BMI).
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennsylvania State University
University Park, Pennsylvania, 16801
About this study
Official title: Developing a Real-time, Ecologically Sensitive Physical Activity Intervention Using Smartphones and Bluetooth-enabled Pedometers: Feasibility and Initial Efficacy
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.
Read the detailed description
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.
- Conditions
- Physical Activity
- Being tested
- Feedback on smartphone
- Keywords
- Physical activity, Ecological Momentary Assessment, Ecological Momentary Intervention, Accelerometer, Smartphone
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feedback on smartphoneBehavioural
Receive personalized feedback (EMI) on smartphone regarding physical activity
| Study group | Role | What they receive |
|---|---|---|
| Accelerometer only | No intervention | Wear accelerometer only to measure activity levels (steps) |
| Accelerometer plus EMA | No intervention | Wear accelerometer and complete Ecological Momentary Assessment (EMA) surveys on smartphone 5 times daily |
| Feedback on smartphone | Experimental | Wear accelerometer, complete EMA surveys on smartphone 5 times daily, receive intervention Receives: Behavioral: Feedback on smartphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of steps
Measured: during intervention (~28 days)
Secondary outcomes (4)
BMI
Measured: Baseline, Post-intervention
blood pressure
Measured: Baseline
Hemoglobin A1c
Measured: Baseline
waist-hip ratio
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristin Heron, Ph.D., Principal investigator, The Pennsylvania State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005042
- Sponsor's protocol ID
- CTSI-BENI-Heron
- Status last verified
- Nov 2017
- First submitted
- 22 Nov 2013
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Real-time, Ecologically Sensitive Physical Activity Intervention Using Smartphones and Bluetooth-enabled Pedometers: Feasibility and Initial Efficacy
- ClinicalTrials.gov ID
- NCT02005042
- Acronym / sponsor ID
- CTSI-BENI-Heron
- Conditions
- Physical Activity
- Keywords
- Physical activity, Ecological Momentary Assessment, Ecological Momentary Intervention, Accelerometer, Smartphone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 9 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Accelerometer only | No intervention | –Wear accelerometer only to measure activity levels (steps) |
| Accelerometer plus EMA | No intervention | –Wear accelerometer and complete Ecological Momentary Assessment (EMA) surveys on smartphone 5 times daily |
| Feedback on smartphone | Experimental | Behavioral: Feedback on smartphoneWear accelerometer, complete EMA surveys on smartphone 5 times daily, receive intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 or older
- English literate
- A BMI ranging from 25-40 (overweight or obese), based on self-report height and weight
- Not meeting current national physical activity guidelines
- Self-report they are able to walk unassisted, without the help of a wheel chair, walker, cane, crutches, or other walking aids
Key exclusion criteria (7 listed)
- Younger than 18
- Not English literate
- Self-report they are unable to walk unassisted, without the help of a wheel chair, walker, cane, crutches, or other walking aids
- A BMI outside of inclusion range (<25 or >40), based on self-report height and weight
- Meeting current national physical activity guidelines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feedback on smartphoneReceive personalized feedback (EMI) on smartphone regarding physical activity | Behavioural | Feedback on smartphone |
Primary outcome
Number of steps
Time frame: during intervention (~28 days)
4 secondary outcomes
BMI
Time frame: Baseline, Post-intervention
blood pressure
Time frame: Baseline
Hemoglobin A1c
Time frame: Baseline
waist-hip ratio
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin Heron, Ph.D. principal investigator
The Pennsylvania State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feedback on smartphone in people with Physical Activity, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of steps (time frame: during intervention (~28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2017.