- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01046201
Pediatric Obesity Research Registry (PORR)
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Individuals between age 1 and 18 years who present to the endocrinology clinic for management of elevated BMI/Obesity (Body Mass Index≥95th percentile of age and gender), will be given the opportunity to read the consent form, have any questions/ concerns addressed prior to obtaining informed consent from the research team (consisting of the PI and the Co-investigators) who are also part of the child's clinical care team. The child's clinician will introduce the study to the parents. The Investigator will obtain written informed consent from the child's parents. The clinical care team/research registry investigators will address any questions and concerns prior to obtaining written informed consent and any future questions and concerns. In this manner, Patients seen at the Phoenix Children's Hospital (PCH) Division of Endocrinology and Diabetes with an obesity diagnosis will be asked to provide their written informed consent to allow their past, current and future identifiable medical record information related to their obese condition to be placed in the Pediatric Obesity Research Registry.
For individuals who respond to Potential advertisement or who contact the research team over the phone, a verbal explanation will be given over the phone and an offer to send a copy of the consent via mail/fax/email, and if interested scheduling a follow up appointment. At the clinic visit, the above noted procedure will be followed.
Studietype
Kontakter og plasseringer
Studiesteder
-
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Arizona
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Phoenix, Arizona, Forente stater, 85016
- Phoenix Children's Hospital
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Individuals between age 1 and 18 years who present to the endocrinology clinic for management of elevated BMI/Obesity
- Individuals between age 1 and 18 years who respond to advertisement or who contact the research team over the phone, for management of elevated BMI/Obesity (Body Mass Index ≥ 95th percentile of age and gender)
Exclusion Criteria:
- A Body Mass Index less than 95th percentile of age and gender
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Obese Children
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Donnie P. Wilson, MD, Phoenix Children's Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 09-034 (Memorial Sloan-Kettering Cancer Center)
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