AzTrials
AzTrials

HealthyAMWALKSNCT02792439

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

An observational study of Healthy, run by TrialX Inc at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy
How many people
200 participants
Where
1 siteUnited States
Study dates
Feb 2016to Dec 2016
Phase
Observational
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

Study population: The study population will be residents of the United States with smart phone

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • TrialX Inc

    New York, New York, 10016

Other trials in United States

About this study

Official title: America Walks: An Observational Study of Walking Behavior Based on Passive Step Tracking Using a Mobile Phone Application

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.

Read the 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.

Conditions
Healthy
Keywords
Fitness, Health kit, Researchkit, Walking

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total step count

    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)

    Measured: 30 days

Secondary outcomes (5)

  1. Average daily step count (baseline, study)

    This will be obtained by averaging the step count data 30 days before enrollment and for the 30 days of the study.

    Measured: 30 days

  2. Correlation between perception and actual walking

    Calculate the correlation between perceived walking activity as measured by survey items and walking activity as determined by the number of actual steps walked

    Measured: 4 months

  3. Total step count (baseline)

    The total step count collected from the history on the device (if supported) obtained by the step count data of 30 days before enrollment

    Measured: 30 days

  4. Standard Deviation of step count

    Measured: 4 months

  5. Ranking of cities by daily Average step count

    All participants will be grouped by their location and location averages will be ranked

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Prospective
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02792439
Sponsor's protocol ID
20152782
Acronym
AMWALKS
Status last verified
Jan 2017
First submitted
27 May 2016
Last updated
13 Jan 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: 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.

Publications

  • Tudor-Locke C, Bassett DR Jr. How many steps/day are enough? Preliminary pedometer indices for public health. Sports Med. 2004;34(1):1-8. doi: 10.2165/00007256-200434010-00001.

    PubMed 14715035

  • Bassett DR Jr, Wyatt HR, Thompson H, Peters JC, Hill JO. Pedometer-measured physical activity and health behaviors in U.S. adults. Med Sci Sports Exerc. 2010 Oct;42(10):1819-25. doi: 10.1249/MSS.0b013e3181dc2e54.

    PubMed 20305579

  • Harada ND, Chiu V, King AC, Stewart AL. An evaluation of three self-report physical activity instruments for older adults. Med Sci Sports Exerc. 2001 Jun;33(6):962-70. doi: 10.1097/00005768-200106000-00016.

    PubMed 11404662

  • Bravata DM, Smith-Spangler C, Sundaram V, Gienger AL, Lin N, Lewis R, Stave CD, Olkin I, Sirard JR. Using pedometers to increase physical activity and improve health: a systematic review. JAMA. 2007 Nov 21;298(19):2296-304. doi: 10.1001/jama.298.19.2296.

    PubMed 18029834

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy, run by TrialX Inc 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 2 inclusion and 1 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 13 Jan 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?

Total step count (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02792439, which also lists 4 linked publications.

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 13 Jan 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in