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

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.

Study Overview

• Status: Completed
• Conditions: Healthy

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.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • TrialX Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days
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	4 months
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	30 days
Standard Deviation of step count		4 months
Ranking of cities by daily Average step count	All participants will be grouped by their location and location averages will be ranked	4 months

Collaborators and Investigators

• Sponsor: TrialX Inc
• Investigators: Principal Investigator: Chintan O Patel, PhD, TrialX Inc

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Helpful Links

• Links to the Study App

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: May 27, 2016
• First Submitted That Met QC Criteria: June 2, 2016
• First Posted (Estimate): June 7, 2016

Study Record Updates

• Last Update Posted (Estimate): January 13, 2017
• Last Update Submitted That Met QC Criteria: January 12, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Walking; Fitness; Health kit; Researchkit
• Other Study ID Numbers: 20152782

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No