Arkansas Active Kids! -Objective 3

Physical Activity Clinical Trial

— AAK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03221673
• Other study ID #: 3092-51000-056-04A
• Status: Completed
• Start date: May 18, 2017
• Est. completion date: September 25, 2018

Study information

• Verified date: June 2023
• Source: Arkansas Children's Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: September 25, 2018
• Est. primary completion date: September 25, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Child
• Physical Activity

Locations

Country	Name	City	State
United States	Arkansas Children's Nutrition Center	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
Arkansas Children's Hospital Research Institute	USDA Beltsville Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Correlation between home and neighborhood environments and fitness level	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

External Links

•   Arkansas Children's Nutrition Center webpage