Arkansas Active Kids! -Objective 3 (AAK)

June 29, 2023 updated by: Elisabet Borsheim, Arkansas Children's Hospital Research Institute

Relationship of Physical Activity and Diet With Socio-demographic, Environmental, and Metabolic Factors in Arkansas Public School Children

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.

Study Overview

Status

Completed

Detailed Description

The purpose of this study is to determine how daily activities, home, neighborhood and school environments affect Arkansas children's health. Children from Central Arkansas ages 7-10 years will be recruited to participate in a variety of physical activity tests including strength, flexibility, balance and endurance. During these tests, participants will perform tasks such as cycling on a stationary bike and extending and flexing their knees on a special type of chair. Body composition will be measured and blood, saliva, urine and stool samples collected. Participants and parents will be asked to complete questionnaires on physical activity, home and neighborhood environment as well as sleeping habits. Finally, participants will wear an accelerometer based monitor that will track their physical activity and sleeping patterns. One in person visit will take place at Arkansas Children's Nutrition Center (Little Rock, AR) and will last up to 8 hours. Reimbursement will be provided.

Study Type

Observational

Enrollment (Actual)

230

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Nutrition Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 10 years (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between fitness level and metabolic health
Time Frame: June 2016-August 2018
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between home and neighborhood environments and fitness level
Time Frame: June 2016-August 2018
Home and neighborhood environments will be assessed via interviewer administered questionnaires. Scores obtained from these questionnaires will be correlated with peak oxygen consumption, strength, flexibility and balance scores.
June 2016-August 2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Elisabet Borsheim, Ph.D., Arkansas Children's Nutrition Center and Arkansas Children's Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2017

Primary Completion (Actual)

September 25, 2018

Study Completion (Actual)

September 25, 2018

Study Registration Dates

First Submitted

June 28, 2017

First Submitted That Met QC Criteria

July 14, 2017

First Posted (Actual)

July 18, 2017

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 29, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 3092-51000-056-04A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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