Effects of Physical Activity on Disease Risk Factors

NCT ID: NCT01849315

Last Updated: 2013-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2013-03-31

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.

Conditions

Childhood Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control

Sedentary intervention

Group Type: PLACEBO_COMPARATOR

AKIDS II

Intervention Type: BEHAVIORAL

Physically active intervention

AKIDS II

Physically active group

Group Type: ACTIVE_COMPARATOR

AKIDS II

Intervention Type: BEHAVIORAL

Physically active intervention

Interventions

AKIDS II

Physically active intervention

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ohio University

OTHER

Sponsor Role: lead

Responsible Party

Cheryl Howe

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

12F011

Identifier Type: -

Identifier Source: org_study_id