Clinical trial NCT02792439: America Walks: An Observational Study of Walking Behavior Based on Passive Step Tracking
Official title: America Walks: An Observational Study of Walking Behavior Based on Passive Step Tracking Using a Mobile Phone Application
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Fitness
Health kit
Researchkit
Walking
Lead sponsor: TrialX Inc
Sponsor class: INDUSTRY
First posted: 2016-06-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will be residents of the United States with smart phone

Brief 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 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.

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 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

Primary outcomes:
measure: Total step count
timeFrame: 30 days
Secondary outcomes:
measure: Average daily step count (baseline, study)
timeFrame: 30 days
measure: Correlation between perception and actual walking
timeFrame: 4 months
measure: Total step count (baseline)
timeFrame: 30 days
measure: Standard Deviation of step count
timeFrame: 4 months
measure: Ranking of cities by daily Average step count
timeFrame: 4 months
Other outcomes:
Locations:
city: New York
country: United States
facility: TrialX Inc
state: New York
Study officials:
affiliation: TrialX Inc
name: Chintan O Patel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.