Clinical trial NCT03221673: Arkansas Active Kids! -Objective 3
Official title: Relationship of Physical Activity and Diet With Socio-demographic, Environmental, and Metabolic Factors in Arkansas Public School Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Physical Activity
Child
Keywords: Exercise
Children
Arkansas
Physical activity
Sedentary
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: USDA Beltsville Human Nutrition Research Center
First posted: 2017-07-18
Enrollment: 230
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation between fitness level and metabolic health
timeFrame: June 2016-August 2018
Secondary outcomes:
measure: Correlation between home and neighborhood environments and fitness level
timeFrame: June 2016-August 2018
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Nutrition Center
state: Arkansas
Study officials:
affiliation: Arkansas Children's Nutrition Center and Arkansas Children's Research Institute
name: Elisabet Borsheim, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: