Cleveland Kids Run

May 2, 2022 updated by: University Hospitals Cleveland Medical Center

Adherence to a Running and Nutrition Program in Children Aged 8-12 Years: A Pilot Study

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Excercise and Nutrition Program
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.
Behavioral: Excercise and Nutrition Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to program
Time Frame: 12 months
number of subjects who participate in race
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Cleveland Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

May 8, 2016

First Submitted That Met QC Criteria

May 8, 2016

First Posted (Estimate)

May 10, 2016

Study Record Updates

Last Update Posted (Actual)

May 6, 2022

Last Update Submitted That Met QC Criteria

May 2, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHCaseMC 2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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