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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
Ohio University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

    First Posted
    May 6, 2013
    Last Updated
    May 6, 2013
    Sponsor
    Ohio University
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    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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