Pediatric Obesity Research Registry (PORR)

This study has been terminated.
(To revise protocol for a more concise inclusion/exclusion criteria)
Sponsor:
Information provided by:
Phoenix Children's Hospital
ClinicalTrials.gov Identifier:
NCT01046201
First received: January 7, 2010
Last updated: March 17, 2011
Last verified: March 2011
  Purpose

The Pediatric Obesity Research Registry will function to collect and catalog historical and medical chart related clinical data of patients presenting with pediatric obesity and who agree to participate.


Condition
Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pediatric Obesity Research Registry

Resource links provided by NLM:


Further study details as provided by Phoenix Children's Hospital:

Biospecimen Retention:   Samples Without DNA

Whole Blood


Enrollment: 0
Study Start Date: January 2010
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Obese Children

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Obese patients up to age 18 years treated at Phoenix Children's Hospital

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01046201

Locations
United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Sponsors and Collaborators
Phoenix Children's Hospital
Investigators
Principal Investigator: Donnie P. Wilson, MD Phoenix Children's Hospital
  More Information

No publications provided

Responsible Party: Don P. Wilson, MD, Phoenix Children's Hospital
ClinicalTrials.gov Identifier: NCT01046201     History of Changes
Other Study ID Numbers: 09-034
Study First Received: January 7, 2010
Last Updated: March 17, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obesity
Pediatric Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014