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Effects of Physical Activity on Disease Risk Factors

Effects of an Empirically-Based Physical Activity Intervention on Chronic Disease Risk Factors in Children

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01849315
Enrollment
13
Registered
2013-05-08
Start date
2012-09-30
Completion date
2013-03-31
Last updated
2013-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Obesity

Brief summary

Obesity is associated with increased risk of heart disease and diabetes (Kim et al., 2010). Appalachian children in Athens County, Ohio, experience higher rates of obesity compared to the national average (20.9% vs. 15.4%), which increases their risk of obesity-related diseases (Montgomery-Reagan, Bianco, Heh, Rettos, & Huston, 2009). Although physical activity (PA) is known to improve fitness and adiposity (Gutin & Owens, 2011; Yin et al., 2009), very little is known about the effects of PA on the progression of chronic disease risk factors (biomarkers) for obesity-related diseases in children, such as inflammatory markers, lipids, and glucose/insulin. This lack of knowledge is due to a limited understanding of the number of calories burned during children's free-play PA. This study will assess the impact of a PA program (ACT) of known energy cost on obesity-related disease markers in 2nd-4th grade children compared to a sedentary control group (SED). The study will recruit children from an after-school program in Athens County elementary schools. Baseline and posttest data will include measures of height, weight, body composition, blood pressure, and physical activity levels. Following baseline measures, children will be randomized into either the ACT or SED group for 8 weeks. The ACT group will play recess-type games previously determined to expend ≥100 calories in 30 minutes. The SED group children will play sedentary-type activities during the same time period. It is hypothesized that the ACT group children will demonstrate significant improvements in PA after 8 weeks compared to the SED group children and that these improvements will be related to positive changes in body weight and body composition.

Interventions

BEHAVIORALAKIDS II

Physically active intervention

Sponsors

Ohio University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
Yes

Inclusion criteria

* Attends participating after school program

Exclusion criteria

* cardiorespiratory, metabolic, and neurological disorders and physical impairments that would prevent them from being physically active, and were not taking any medications that would affect metabolism

Design outcomes

Primary

MeasureTime frameDescription
Daily Physical Activity Levels8 weeksincrease relative to participation in intervention

Secondary

MeasureTime frameDescription
body composition8 weeksattenuation in excess gains in weight and body mass index
biomarkers for cardiometabolic disease8 weeksdecrease relative to intervention participation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026