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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02767830
Other study ID # UHCaseMC 2
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date September 2016
Est. completion date August 2017

Study information

Verified date May 2022
Source University Hospitals Cleveland Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 2017
Est. primary completion date July 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 12 Years
Eligibility 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 RunĀ® 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Excercise and Nutrition Program


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospitals Cleveland Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary Adherence to program number of subjects who participate in race 12 months
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