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Cleveland Kids Run

Primary Purpose

Childhood Obesity

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Excercise and Nutrition Program
Sponsored by
University Hospitals Cleveland Medical Center
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:

  • Participants must be aged 8-12 years old and enrolled in kindergarten through 6th grade in a Cleveland Public School
  • Participants must have at least a B-average or equivalent in the prior academic year
  • Participants must have at least one part or guardian who is able to accompany the participant during exercise and educational sessions
  • Participants must be willing to participate in the Rite Aid Cleveland Marathon Ringling Bros. and Barnum & Bailey Red Nose Run® at the end of the study

Exclusion Criteria:

  • Children who are younger than 8 years or older than 12 years

    • Children whose parents who are unable or unwilling to provide informed consent,
    • Children whose parents are are illiterate or non-English speaking or reading
    • Children whose parents are unable or unwilling to accompany them to educational and exercise sessions
    • Children with a medical condition that prevents them from unmonitored exercise
    • Children who have not maintained an equivalent of a B-average in the prior academic year

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Excercise and Nutrition Program

    Arm Description

    Children and their care givers will receive 5 lectures on nutrition and exercise and will be given a weekly running program. At the end of the study children will be encouraged to participate in an annual 0.25-0.5 mile race.

    Outcomes

    Primary Outcome Measures

    Adherence to program
    number of subjects who participate in race

    Secondary Outcome Measures

    Full Information

    First Posted
    May 8, 2016
    Last Updated
    May 2, 2022
    Sponsor
    University Hospitals Cleveland Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02767830
    Brief Title
    Cleveland Kids Run
    Official Title
    Adherence to a Running and Nutrition Program in Children Aged 8-12 Years: A Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study never started
    Study Start Date
    September 2016 (undefined)
    Primary Completion Date
    July 2017 (Anticipated)
    Study Completion Date
    August 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospitals Cleveland Medical Center

    4. Oversight

    5. Study Description

    Brief Summary
    A 12 month long program focused on making good food choices and exercise directed at 8-12 year olds and their caregivers. The program will consist of monthly educational meetings each teaching a new nutritional and exercise concept. Children will be given weekly exercise schedules and their adherence to the program will be assessed. The study will culminate with an annual children's race in May.

    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
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Excercise and Nutrition Program
    Arm Type
    Experimental
    Arm Description
    Children and their care givers will receive 5 lectures on nutrition and exercise and will be given a weekly running program. At the end of the study children will be encouraged to participate in an annual 0.25-0.5 mile race.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Excercise and Nutrition Program
    Primary Outcome Measure Information:
    Title
    Adherence to program
    Description
    number of subjects who participate in race
    Time Frame
    12 months

    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: Participants must be aged 8-12 years old and enrolled in kindergarten through 6th grade in a Cleveland Public School Participants must have at least a B-average or equivalent in the prior academic year Participants must have at least one part or guardian who is able to accompany the participant during exercise and educational sessions Participants must be willing to participate in the Rite Aid Cleveland Marathon Ringling Bros. and Barnum & Bailey Red Nose Run® at the end of the study Exclusion Criteria: Children who are younger than 8 years or older than 12 years Children whose parents who are unable or unwilling to provide informed consent, Children whose parents are are illiterate or non-English speaking or reading Children whose parents are unable or unwilling to accompany them to educational and exercise sessions Children with a medical condition that prevents them from unmonitored exercise Children who have not maintained an equivalent of a B-average in the prior academic year

    12. IPD Sharing Statement

    Learn more about this trial

    Cleveland Kids Run

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