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America Walks: An Observational Study of Walking Behavior Based on Passive Step Tracking (AMWALKS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02792439
First Posted: June 7, 2016
Last Update Posted: January 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
TrialX Inc
  Purpose
America Walks is an observational research study to determine walking behavior of individuals in the United States. The entire study will be conducted virtually by requiring participants to download a mobile phone application (App), The App will leverage the mobile phone's step count sensor technology to automatically determine participants' daily walking activity. Participation is voluntary. Participants can choose not to participate or choose to participate and then stop participating. Participants decision will not result in any penalty or loss of benefits to which they are entitled.

Condition
Healthy

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: America Walks: An Observational Study of Walking Behavior Based on Passive Step Tracking Using a Mobile Phone Application

Further study details as provided by TrialX Inc:

Primary Outcome Measures:
  • Total step count [ Time Frame: 30 days ]
    This is the total step count from enrollment onwards till user completes 30 days, or quits or till end of study (if the participant continues after 30 days)


Secondary Outcome Measures:
  • Average daily step count (baseline, study) [ Time Frame: 30 days ]
    This will be obtained by averaging the step count data 30 days before enrollment and for the 30 days of the study.

  • Correlation between perception and actual walking [ Time Frame: 4 months ]
    Calculate the correlation between perceived walking activity as measured by survey items and walking activity as determined by the number of actual steps walked

  • Total step count (baseline) [ Time Frame: 30 days ]
    The total step count collected from the history on the device (if supported) obtained by the step count data of 30 days before enrollment

  • Standard Deviation of step count [ Time Frame: 4 months ]
  • Ranking of cities by daily Average step count [ Time Frame: 4 months ]
    All participants will be grouped by their location and location averages will be ranked


Enrollment: 200
Study Start Date: February 2016
Study Completion Date: December 2016
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Detailed Description:

This will be the first study to measure walking activity using mobile phones. It is well known that physical activity can promote well-being and help prevent several chronic diseases. It is recommended that an individual should do moderate to vigorous walking for 30 minutes or walk approximately 10,000 steps everyday. Several studies have reported measuring walking activity using self-reported surveys, or pedometers in samples ranging from a dozen to a couple of thousand participants. However these studies have largely required participants to enter their walking data manually, either from memory or from pedometer recordings.

With the rapid availability of activity sensors embedded in smart-phones (such as Apple's iPhone version 5S and up and several Google's Android phone models), it is now possible to track physical activity data passively from the end-user and do so for longer durations as individuals have increasingly begun to use their Phones as a continuous device of use.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The study population will be residents of the United States with smart phone
Criteria

Inclusion Criteria:

  • Be at-least 18 years old (self -reported)
  • Must reside in the United States (50 states and the District of Columbia); this will be self reported by the participant by entering a zip code which will be checked for valid US zip codes.

Exclusion Criteria:

  • Does not have a device that supports Apple HealthKit (iPhone 5s or above) or doesn't not have an Android phone with step count sensors
  Contacts and Locations
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): NCT02792439


Locations
United States, New York
TrialX Inc
New York, New York, United States, 10016
Sponsors and Collaborators
TrialX Inc
Investigators
Principal Investigator: Chintan O Patel, PhD TrialX Inc
  More Information

Additional Information:
Publications:
Responsible Party: TrialX Inc
ClinicalTrials.gov Identifier: NCT02792439     History of Changes
Other Study ID Numbers: 20152782
First Submitted: May 27, 2016
First Posted: June 7, 2016
Last Update Posted: January 13, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All study data will be released on http://trialx.com/americawalksstudy in aggregate manner and findings will submitted for publication in academic journals such as the Journal of American Medical Informatics. Any identifiable participant information will not be revealed publicly in any manner whatsoever.

Keywords provided by TrialX Inc:
Fitness
Health kit
Researchkit
Walking