Effects of Physical Activity on Disease Risk Factors
Primary Purpose
Childhood Obesity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
AKIDS II
Sponsored by
About this trial
This is an interventional prevention trial for Childhood Obesity
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Control
AKIDS II
Arm Description
Sedentary intervention
Physically active group
Outcomes
Primary Outcome Measures
Daily Physical Activity Levels
increase relative to participation in intervention
Secondary Outcome Measures
body composition
attenuation in excess gains in weight and body mass index
biomarkers for cardiometabolic disease
decrease relative to intervention participation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01849315
Brief Title
Effects of Physical Activity on Disease Risk Factors
Official Title
Effects of an Empirically-Based Physical Activity Intervention on Chronic Disease Risk Factors in Children
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Sedentary intervention
Arm Title
AKIDS II
Arm Type
Active Comparator
Arm Description
Physically active group
Intervention Type
Behavioral
Intervention Name(s)
AKIDS II
Intervention Description
Physically active intervention
Primary Outcome Measure Information:
Title
Daily Physical Activity Levels
Description
increase relative to participation in intervention
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
body composition
Description
attenuation in excess gains in weight and body mass index
Time Frame
8 weeks
Title
biomarkers for cardiometabolic disease
Description
decrease relative to intervention participation
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
12. IPD Sharing Statement
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Effects of Physical Activity on Disease Risk Factors
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