Childhood ObesityNCT02767830
Cleveland Kids Run
A study testing Excercise and Nutrition Program in people with Childhood Obesity, run by University Hospitals Cleveland Medical Center.
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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Excercise and Nutrition Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Childhood Obesity
- Being tested
- Excercise and Nutrition Program
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Excercise and Nutrition ProgramBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Excercise and Nutrition Program | Experimental | 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. Receives: Behavioral: Excercise and Nutrition Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to program
number of subjects who participate in race
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study startSep 2016
- Primary completionJul 2017 (estimated)
- Study completionAug 2017 (estimated)
Why it stopped: Study never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02767830
- Sponsor's protocol ID
- UHCaseMC 2
- Status last verified
- May 2022
- First submitted
- 8 May 2016
- Last updated
- 6 May 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to a Running and Nutrition Program in Children Aged 8-12 Years: A Pilot Study
- ClinicalTrials.gov ID
- NCT02767830
- Acronym / sponsor ID
- UHCaseMC 2
- Conditions
- Childhood Obesity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 10 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Excercise and Nutrition Program | Experimental | Behavioral: Excercise and Nutrition ProgramChildren 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. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Children who are younger than 8 years or older than 12 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Excercise and Nutrition Program | Behavioural | Excercise and Nutrition Program |
Primary outcome
Adherence to program
Time frame: 12 months
number of subjects who participate in race
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Excercise and Nutrition Program in people with Childhood Obesity, run by University Hospitals Cleveland Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to program (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2022.