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Effects of Physical Activity on Disease Risk Factors

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ClinicalTrials.gov Identifier: NCT01849315
Recruitment Status : Completed
First Posted : May 8, 2013
Last Update Posted : May 8, 2013
Sponsor:
Information provided by (Responsible Party):
Cheryl Howe, Ohio University

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.

Condition or disease Intervention/treatment Phase
Childhood Obesity Behavioral: AKIDS II Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of an Empirically-Based Physical Activity Intervention on Chronic Disease Risk Factors in Children
Study Start Date : September 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control
Sedentary intervention
Behavioral: AKIDS II
Physically active intervention

Active Comparator: AKIDS II
Physically active group
Behavioral: AKIDS II
Physically active intervention




Primary Outcome Measures :
  1. Daily Physical Activity Levels [ Time Frame: 8 weeks ]
    increase relative to participation in intervention


Secondary Outcome Measures :
  1. body composition [ Time Frame: 8 weeks ]
    attenuation in excess gains in weight and body mass index

  2. biomarkers for cardiometabolic disease [ Time Frame: 8 weeks ]
    decrease relative to intervention participation



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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Responsible Party: Cheryl Howe, Assistant Professor, Ohio University
ClinicalTrials.gov Identifier: NCT01849315     History of Changes
Other Study ID Numbers: 12F011
First Posted: May 8, 2013    Key Record Dates
Last Update Posted: May 8, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
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Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms