Effects of Physical Activity on Disease Risk Factors

NCT01849315 | Completed

• 1 other identifier: 12F011
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Daily Physical Activity Levels

  increase relative to participation in intervention

  8 weeks

Secondary Outcomes (2)

• body composition

  8 weeks

• biomarkers for cardiometabolic disease

  8 weeks

Study Arms (2)

Control

PLACEBO COMPARATOR

Sedentary intervention

Behavioral: AKIDS II

AKIDS II

ACTIVE COMPARATOR

Physically active group

Behavioral: AKIDS II

Interventions

AKIDS II BEHAVIORAL

Physically active intervention

AKIDS II; Control

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Attends participating after school program

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio University: lead

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 6, 2013
• First Posted: May 8, 2013
• Study Start: September 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: May 8, 2013

Record last verified: 2013-05