NCT01989104

Brief Summary

The purpose of this study is to measure and link cadence (number of steps taken in a minute) to intensity of physical activity (e.g., low-intensity, moderate-intensity, vigorous-intensity) in children and adolescents (6-20 years-old), and to identify the cadence values corresponding to children's and adolescent's behavior during simulated free-living activities.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 20, 2013

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
5.7 years until next milestone

Results Posted

Study results publicly available

December 1, 2022

Completed
Last Updated

December 1, 2022

Status Verified

November 1, 2022

Enrollment Period

3.3 years

First QC Date

November 14, 2013

Results QC Date

May 9, 2019

Last Update Submit

November 7, 2022

Conditions

Keywords

Indirect calorimetry

Outcome Measures

Primary Outcomes (1)

  • Cadence - Steps Per Minute

    Cadence steps per minute represents an overlooked opportunity to describe the intensity of ambulatory activity.

    1 day

Study Arms (3)

Children

6-12 years of age

Adolescents

13-17 years of age

Young adults

18-20 years of age

Eligibility Criteria

Age6 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Community sample

You may qualify if:

  • to 20 years of age at the time of study enrollment
  • Not limited in the ability to walk

You may not qualify if:

  • Hospitalization for mental illness within the past 5 years.
  • Any condition/medication that may affect heart rate response to exercise testing.
  • Previous history of, or clinical symptoms or signs of, cardiovascular disease, stroke or transient ischemic attacks, chest pain, unusual dyspnea during physical activity/exercise, severe ankle edema, or intermittent claudication.
  • Previous history of musculoskeletal injuries or problems causing severe pain during physical activity or exercise which interferes with daily activities.
  • Participant has a pacemaker or other implanted medical device (including metal joint replacements).
  • Participant is pregnant.
  • Participant is unable to complete all testing (1 or two sessions, as preferred) within a maximal two week period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (2)

  • Gould ZR, Mora-Gonzalez J, Aguiar EJ, Schuna JM Jr, Barreira TV, Moore CC, Staudenmayer J, Tudor-Locke C. A catalog of validity indices for step counting wearable technologies during treadmill walking: the CADENCE-Kids study. Int J Behav Nutr Phys Act. 2021 Jul 16;18(1):97. doi: 10.1186/s12966-021-01167-y.

  • Tudor-Locke C, Schuna JM Jr, Han H, Aguiar EJ, Larrivee S, Hsia DS, Ducharme SW, Barreira TV, Johnson WD. Cadence (steps/min) and intensity during ambulation in 6-20 year olds: the CADENCE-kids study. Int J Behav Nutr Phys Act. 2018 Feb 26;15(1):20. doi: 10.1186/s12966-018-0651-y.

Results Point of Contact

Title
Dr. William Johnson
Organization
Pennington Biomedical Research Center

Study Officials

  • Catrine Tudor-Locke, PhD

    University of Massachusetts, Amherst

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2013

First Posted

November 20, 2013

Study Start

December 1, 2013

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

December 1, 2022

Results First Posted

December 1, 2022

Record last verified: 2022-11

Locations