- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03221673
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
Conditions
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
-
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Arkansas
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Little Rock, Arkansas, United States, 72202
- Arkansas Children's Nutrition Center
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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.
Collaborators
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.
Helpful Links
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
Keywords
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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