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Physical Activity and Daily Experiences Study

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ClinicalTrials.gov Identifier: NCT02005042
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):
Penn State University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Physical Activity Behavioral: Feedback on smartphone Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Developing a Real-time, Ecologically Sensitive Physical Activity Intervention Using Smartphones and Bluetooth-enabled Pedometers: Feasibility and Initial Efficacy
Study Start Date : November 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Accelerometer only
Wear accelerometer only to measure activity levels (steps)
No Intervention: Accelerometer plus EMA
Wear accelerometer and complete Ecological Momentary Assessment (EMA) surveys on smartphone 5 times daily
Experimental: Feedback on smartphone
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




Primary Outcome Measures :
  1. Number of steps [ Time Frame: during intervention (~28 days) ]

Secondary Outcome Measures :
  1. BMI [ Time Frame: Baseline, Post-intervention ]
  2. blood pressure [ Time Frame: Baseline ]
  3. Hemoglobin A1c [ Time Frame: Baseline ]
  4. waist-hip ratio [ Time Frame: Baseline ]

Other Outcome Measures:
  1. Perceived Stress [ Time Frame: Baseline, Post-intervention ]
    Perceived Stress Scale

  2. Depression [ Time Frame: Baseline, Post-intervention ]
    Center for Epidemiologic Studies Depression Scale (CES-D)

  3. Social Support [ Time Frame: Baseline, Post-intervention ]
    Social Network Index Survey

  4. Satisfaction with Life [ Time Frame: Baseline, Post-intervention ]
    Satisfaction with Life Scale

  5. Barriers for Physical Activity [ Time Frame: Baseline, Post-intervention ]
    Barriers for Physical Activity Questionnaire

  6. Social Support and Exercise [ Time Frame: Baseline, Post-intervention ]
    Social Support and Exercise Survey

  7. Outcomes of Exercise [ Time Frame: Baseline, Post-intervention ]
    Outcomes of Exercise Questionnaire

  8. Walking measure [ Time Frame: Baseline, Post-intervention ]
    Walking Questionnaire

  9. Habit Index for Physical Activity [ Time Frame: Baseline, Post-intervention ]
    Habit Index for Physical Activity

  10. Rumination [ Time Frame: Baseline, Post-intervention ]
    Rumination Questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005042


Locations
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United States, Pennsylvania
Pennsylvania State University
University Park, Pennsylvania, United States, 16801
Sponsors and Collaborators
Penn State University
Investigators
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Principal Investigator: Kristin Heron, Ph.D. The Pennsylvania State University

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Responsible Party: Penn State University
ClinicalTrials.gov Identifier: NCT02005042     History of Changes
Other Study ID Numbers: CTSI-BENI-Heron
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017

Keywords provided by Penn State University:
Physical activity
Ecological Momentary Assessment
Ecological Momentary Intervention
Accelerometer
Smartphone