Cleveland Kids Run
Primary Purpose
Childhood Obesity
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Excercise and Nutrition Program
Sponsored by
About this trial
This is an interventional prevention trial for Childhood Obesity
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
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
NCT ID
NCT02767830
First Posted
May 8, 2016
Last Updated
May 2, 2022
Sponsor
University Hospitals Cleveland Medical Center
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Withdrawn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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