Effects of Physical Activity on Disease Risk Factors

Childhood Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01849315
• Other study ID #: 12F011
• Status: Completed
• Phase: N/A
• First received: May 6, 2013
• Last updated: May 6, 2013
• Start date: September 2012
• Est. completion date: March 2013

Study information

• Verified date: May 2013
• Source: Ohio University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Childhood Obesity
• Pediatric Obesity

Intervention

Behavioral:
• AKIDS II
Physically active intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ohio University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily Physical Activity Levels	increase relative to participation in intervention	8 weeks	No
Secondary	body composition	attenuation in excess gains in weight and body mass index	8 weeks	No
Secondary	biomarkers for cardiometabolic disease	decrease relative to intervention participation	8 weeks	No