C.O.P.P

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Early identification of patients at risk or experiencing Childhood Obesity, combined with institution of holistic eating patterns, physical activity strategies, may lead to better outcomes. The current study aims to examine the natural history and highlight the complex nature of treating patients who suffer from Childhood Obesity, primarily those who suffer from mild to moderate obesity. Our focus is to also examine the treatment options that are likely to result in the prevention of Type II Diabetes and a reduction of 10% body weight.
Determine the proportion of patients who have Childhood Obesity in community-based specialty practices (e.g., Public School System) but can include primary care practices as well. Describe the prevalence and characteristics of Childhood Obesity associated with Type II Diabetes.
Characterize resource utilization, past Childhood Obesity medical history, Blood Glucose Level, Cultural identification, and patient demographics (e.g., age, weight, gender, other comorbidities, etc) of patients who are at a low vs. moderate risk of Type II Diabetes. Understand Cultural Eating Pattern characteristics that are associated with patients with patients who are at a low risk vs. moderate risk of Type II Diabetes.
This project will be done on a 3-month by 3-month basis over the next three years. That is, the first implementation will be for 3 months, with a projected beginning date of November 1st, 2010 and a projected end date of January 31st, 2010. Next, the 2nd phase of the 3-month period begins May 1st, 2008 and ends July 31st, 2010. The 3rd and final phase of the 3-month period begins November 3rd, 2010 and ends January 30th, 2010. Before and during these 3-month periods, there will be meetings held and many conference calls.
Inclusion criteria: 1. Community-based Public Schools, Community Centers, and Local Hospital Institutions across the U.S. will be asked to participate in the study. Sites will be asked to provide data on Childhood Obesity patients via retrospective review of records. Patients between the 6-12 years of age who have been identified as overweight; Assessed to have a BMI of greater than 20% of the body weight; Under continuous care of a physician for their Childhood Obesity; Patients currently not taking any medications. 5-10 in different geographical regions within the United States Number of sites: Estimated sample size: 100 patient charts Property of the MOER Foundation Medical Coalition
IRB Review: Site Remuneration:

Data Collection: To provide the following information to assess resource capabilities of each practice: A clinical staff member such as the site investigator, study nurse or other dedicated data abstractor(s) who will be responsible for abstracting study data from research charts. A minimum number of Childhood Obesity patients enrolled in their research satellite to qualify 10-20 patients. Committed to completing the tasks within the designated time frame, typically 12 weeks. For sites with local Institutional Review boards (IRB), they will be expected to submit all relevant study-related information and obtain approval prior to beginning the study. The study contract research organization (CRO-The Moer Foundation) and sponsor will help to facilitate this process as appropriate. See additional information below. In addition, sites will be asked to verify staff contact information and responsibilities and to provide feedback on a timeline for time of study start and site initiation, patient selection, and training. IRB approval or Ethics Committee Reviews, either centrally or locally, will be completed as required for all participating study sites. Sites will be compensated $300.00 administrative fee to be provided to each site to cover study-related start up costs. Site-related fees for local IRB review may also be reimbursed upon review and approval.
Training sessions will be mandatory to all participating study sites. Training for study sites will be facilitated with a PowerPoint presentation will be provided prior to or in parallel with their scheduled training session. All participants will have phone access during the training session(s). Study data will be submitted using a site-specific source documents. The information from the source document will then be transferred to case report forms (CRFs). The CRF will be beta-tested in a convenient sample of up to 10 patients at one selected practice.
Exclusion criteria:
1. Diagnosed with Type II Diabetes;
2. Presence of a severe medical condition other than Childhood Obesity including ; Hypertension, Diabetes, heart failure, or cancer;
3. Are current diagnosed with a Eating Disorder;
4. Are known to have a Mental Disorder (e.g. Depression, Bi-Polar or Self Mutilation);
5. Patients documented as noncompliant in following a Nutrional Treatment Plan.
Site Qualification Criteria: Approved research satellites invited to participate in the study will be asked Property of the MOER Foundation Medical Coalition Data will be collected from patient research binder including: patient journals, quizzes, observation logs, questionnaires, and primary care medical records of individual patients meeting the study criteria. Endpoints of interest in this study include data that would be used to characterize uncontrolled Childhood Obesity in the research satellite which would include data on hospital admissions, emergency department visits, medications prescribed, increase of 10% body weight, specialty consults, outpatient visits related to Childhood Obesity, patient symptoms, medical history, and patient demographics.
Paper reports, accessible by each study site and to the study sponsor, of patient enrollment, form completion and analytic trends will be available. The site reports will compare the user’s site to the aggregate site data and will be available periodically to view online or to download and print out. Those sites that do not have Internet access or otherwise whom wish to receive hard copy reports, these will be faxed to the sites that wish them on a periodic basis.
The Moer Foundation, Inc is the CRO for The Childhood Obesity Prevention Study. The Moer Foundation, Inc. will be involved in protocol development, data collection and analysis, and provide study support throughout the study, including a toll-free helpline available for site coordinators and study abstractors.

Description: Study objectives:

1. Early identification of patients at risk or experiencing Childhood Obesity, combined with institution of holistic eating patterns, physical activity strategies, may lead to better outcomes. The current study aims to examine the natural history and highlight the complex nature of treating patients who suffer from Childhood Obesity, primarily those who suffer from mild to moderate obesity. Our focus is to also examine the treatment options that are likely to result in the prevention of Type II Diabetes and a reduction of 10% body weight.Determine the proportion of patients who have Childhood Obesity in community-based specialty practices (e.g., Public School System) but can include primary care practices as well. Describe the prevalence and characteristics of Childhood Obesity associated with Type II Diabetes.

Characterize resource utilization, past Childhood Obesity medical history, Blood Glucose Level, Cultural identification, and patient demographics (e.g., age, weight, gender, other comorbidities, etc) of patients who are at a low vs. moderate risk of Type II Diabetes.Understand Cultural Eating Pattern characteristics that are associated with patients with patients who are at a low risk vs. moderate risk of Type II Diabetes.This project will be done on a 3-month by 3-month basis over the next three years.

That is, the first implementation will be for 3 months, with a projected beginning date of November 1st, 2008 and a projected end date of January 31st, 2009. Next, the 2nd phase of the 3-month period begins May 1st, 2008 and ends July 31st, 2010. The 3rd and final phase of the 3-month period begins November 3rd, 2010and ends January 30th, 2011. Before and during these 3-month periods, there will be meetings held and many conference calls.Duration: Study Sites: Inclusion criteria: Community-based Public Schools, Community Centers, and Local Hospital Institutions across the U.S. will be asked to participate in the study. Sites will be asked to provide data on Childhood Obesity patients via retrospective review of records.Patients between the 6-12 years of age who have been identified as overweight;

Assessed to have a BMI of greater than 20% of the body weight;

Under continuous care of a physician for their Childhood Obesity;

Patients currently not taking any medications.

5-10 in different geographical regions within the United StatesNumber of sites: Estimated sample size: 100 patient chartsProperty of the MOER Foundation Medical Coalition.

IRB Review: Site Remuneration:Site Training:Data Collection:to provide the following information to assess resource capabilities of each practice:A clinical staff member such as the site investigator, study nurse or other dedicated data abstractor(s) who will be responsible for abstracting study data from research charts. A minimum number of Childhood Obesity patients enrolled in their research satellite to qualify 10-20 patients.Committed to completing the tasks within the designated time frame, typically 12 weeks.

For sites with local Institutional Review boards (IRB), they will be expected to submit all relevant study-related information and obtain approval prior to beginning the study. The study contract research organization (CRO-The Moer Foundation) and sponsor will help to facilitate this process as appropriate. See additional information below.In addition, sites will be asked to verify staff contact information and responsibilities and to provide feedback on a timeline for time of study start and site initiation, patient selection, and training.IRB approval or Ethics Committee Reviews, either centrally or locally, will be completed as required for all participating study sites.Sites will be compensated $300.00 administrative fee to be provided to each site to cover study-related start up costs.

Site-related fees for local IRB review may also be reimbursed upon review and approval.Training sessions will be mandatory to all participating study sites. Training for study sites will be facilitated with a PowerPoint presentation will be provided prior to or in parallel with their scheduled training session. All participants will have phone access during the training session(s).Study data will be submitted using a site-specific source documents. The information from the source document will then be transferred to case report forms (CRFs).

The CRF will be beta-tested in a convenient sample of up to 10 patients at one selected practice.

Exclusion criteria: 1. Diagnosed with Type II Diabetes;

2. Presence of a severe medical condition other than Childhood Obesity including ; Hypertension, Diabetes, heart failure, or cancer;

3. Are current diagnosed with a Eating Disorder;

4. Are known to have a Mental Disorder (e.g. Depression, Bi-Polar or SelfMutilation);

5. Patients documented as noncompliant in following a Nutrional Treatment Plan.

Site Qualification Criteria: Approved research satellites invited to participate in the study will be asked Property of the MOER Foundation Medical Coalition.

Study Endpoints:Study Reporting:Study Support:Study contact: Administered by:Study sponsor: Sponsor contact: Data will be collected from patient research binder including: patient journals, quizzes, observation logs, questionnaires, and primary care medical records of individual patients meeting the study criteria.End points of interest in this study include data that would be used to characterize uncontrolled Childhood Obesity in the research satellite which would include data on hospital admissions, emergency department visits, medications prescribed, increase of 10% body weight, specialty consults, outpatient visits related to Childhood Obesity, patient symptoms, medical history, and patient demographics.

Paper reports, accessible by each study site and to the study sponsor, of patient enrollment, form completion and analytic trends will be available. The site reports will compare the user’s site to the aggregate site data and will be available periodically to view online or to download and print out. Those sites that do not have Internet access or otherwise whom wish to receive hard copy reports, these will be faxed to the sites that wish them on a periodic basis. The Moer Foundation, Inc is the CRO for The Childhood Obesity Prevention Study. The Moer Foundation, Inc. will be involved in protocol development, data collection and analysis, and provide study support throughout the study, including a toll-free helpline available for site coordinators and study abstractors.

Sources: http://www.moerfoundation.org /copp

Sources: http://www.massgeneral.org/about/newsarticle.aspx?id=1318

Sources: http://www.nhlbi.nih.gov/health/public/heart/obesity/wecan/news-events/cs_news07.htm

Sources: http://w238.photobucket.com/pbwidget.swf?pbwurl=http://w238.photobucket.com/albums/ff97/dralimyork/CoppMAMay6/2e6fde4a.pbw

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