NCT03221673

Brief Summary

This is a cross-sectional study aiming to identify how daily activities affect children's body fitness and general health. Also, the study will address how specific behaviors (such as diet and sleep) as well as neighborhood and home environment affect children's metabolic health and fitness level.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
230

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

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

Study Start

First participant enrolled

May 18, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 28, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 18, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2018

Completed
Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

1.4 years

First QC Date

June 28, 2017

Last Update Submit

June 29, 2023

Conditions

Keywords

ExerciseChildrenArkansasPhysical activitySedentary

Outcome Measures

Primary Outcomes (1)

  • Correlation between fitness level and metabolic health

    A fitness test will be performed to determine peak oxygen uptake (VO2 peak, ml/kg per min). Correlations between peak VO2 and different markers of cardiometabolic health (IL-6, triglycerides, non-esterified fatty acids, glucose, insulin concentrations, etc.) will be determined. Other indicators of fitness level such as strength, flexibility and balance will be measured and correlations assessed.

    June 2016-August 2018

Secondary Outcomes (1)

  • Correlation between home and neighborhood environments and fitness level

    June 2016-August 2018

Eligibility Criteria

Age7 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Up to 300 pre-pubertal children ages 7 to 10 years old, both boys and girls, will be recruited from Central Arkansas.

You may qualify if:

  • Ages 7 to 10 years
  • Boys or girls
  • All ethnicities
  • All BMIs (all body types)

You may not qualify if:

  • Severe persistent asthma (determined by daily use of oral/inhaled corticosteroid to keep asthma symptoms under control and/or frequent use of rescue inhaler)
  • Type 2 diabetes mellitus
  • Other pre-existing medical conditions or medications as determined by the investigators to affect the outcomes of interest

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72202, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, stool, saliva, urine

MeSH Terms

Conditions

Motor ActivitySedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Elisabet Borsheim, Ph.D.

    Arkansas Children's Nutrition Center and Arkansas Children's Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 28, 2017

First Posted

July 18, 2017

Study Start

May 18, 2017

Primary Completion

September 25, 2018

Study Completion

September 25, 2018

Last Updated

July 3, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared with researchers outside the study.

Locations