Please select the eligibility criteria that correspond to the clinical trial below.
Title: Evaluating the Transferability of a Successful, Hospital-based, Childhood Obesity Clinic to Primary Care: a Pilot Study
Brief Summary: Obesity affects one in five children in the UK and undoubtedly causes increased ill health with rising levels of childhood and adolescent diabetes, obesity induced liver disease and increased risk of early heart disease. There are few clinics offering effective treatment for childhood obesity. However, the clinic for childhood obesity at Bristol Royal Hospital for Children (BCH) has been successful in around 83% of cases. This pilot study aims to examine the feasibility of transferring the success of the hospital clinic to primary care in preparation for a full RCT. The study will entail training a practice nurse, community dietician and exercise specialist to deliver the same clinical service in primary care as that offered in BCH. Initial work will gather the views of staff delivering the hospital service and those of patients and parents to identify the crucial components of the intervention that are likely to be needed in primary care and to then to refine the intervention.A pilot trial will examine how feasible it is to recruit patients into the service and get some initial idea as to whether weight management is equally good, patient satisfaction and retention improves and what data needs to be collected for a full economic assessment. If found to be effective, the next step will be to use knowledge gained in this study to design and undertake a more extensive, formal study across Bristol in various primary care settings.This larger study will address how such a service can be delivered across a complete spectrum of primary care populations, so that similar services could be developed across the country.


Options:
A: Inclusion Criteria:

* Participant in the Exclusive Provider Organization (EPO), Managed Care Organization (MCO) and Preferred Provider Organization (PPO) programs of the Louisiana State Employees Group Benefits Health Insurance
* Agree to travel for treatment to the assigned study site
* Agree to randomized treatment assignment
* Male and females age 20-60 years
* Body Mass Index \>40kg/m2 but \< 60 kg/m2
* Females must be non-pregnant and using an approved contraception method
* Complete Blood Count (CBC): normal hematocrit, white count and platelet count, unless waived by Principal Investigator (PI)
* Uric Acid \<9.0 mg/dl
* Normal Creatinine
* Normal Thyroid Stimulating Hormone (TSH)
* Negative urine pregnancy test for women of childbearing potential
* Able to give written informed consent
* Able to comply with study procedures

Exclusion Criteria:

Factors that may limit adherence to interventions or affect conduct of the trial:

* Unable or unwilling to give informed consent or communicate with local study staff
* Hospitalization for psychiatric illness or substance use/abuse within the past year
* Self-report of alcohol or substance abuse within the past twelve months
* Current major depressive episode or history of suicidal behaviors
* Endorsement of significant recent suicidal ideation (as determined by PI)
* Travel plans that do not permit participation
* History of prior bariatric surgery, small bowel resection, or extensive bowel resection
* Current use of chronic systemic corticosteroids, appetite suppressants, antipsychotic medication, herbal medications for weight loss or any medication not approved by the PI.
* Another member of the household is a participant or staff member in the study
* History of eating disorder such as anorexia nervosa, bulimia, or binge eating
* Diagnosis of schizophrenia, other psychotic disorders, bipolar disorder, or personality disorder (as determined by the PI)
* Currently pregnant or nursing or plans to become pregnant in the next five years
* Except for non-melanoma skin cancer, cancer requiring treatment in the past five years, unless the prognosis is excellent
* Self report of Human Immunodeficiency Virus (HIV) positive, hepatitis C or active tuberculosis
* Cardiovascular disease event within the past year
* Severe congestive heart failure (New York Heart Association \[NYHA\] Functional Class III, IV)
* Second degree or greater heart block
* Blood Pressure \>160 systolic or \>100 diastolic on two consecutive visits, unless treated and re-screened
* Based upon responses to psychological screening or an interview, patients may be excluded by the study psychologist.
* Other medical, psychiatric, or behavioral limitations that in the judgment of the investigator may interfere with study participation or the ability to follow the intervention protocol.
* Pregnancy is to be avoided during the study. Women who have not had a hysterectomy or oophorectomy must have a negative urine pregnancy test result at screening. Women of childbearing potential will be allowed to participate if they have undergone tubal ligation, or use one of the following types of contraception: properly used condom or diaphragm, oral contraceptives, hormonal implant, or intrauterine device (IUD). Sexual abstinence may constitute an acceptable birth control method for this study with investigator approval. Women with male partners who have had a successful vasectomy (more than one year of unprotected sexual intercourse without pregnancy) are not required to use additional birth control methods as long as the relationship remains exclusive, and the woman agrees to use an approved contraception method with any other male partner. Questions regarding individual patient contraceptive practices should be directed to the Principal Investigator.
B: Inclusion Criteria:

* 5 to \<18 yrs old on day of recruitment
* Children consulting their general practitioner or other primary care professional with a weight \> 95th percentile

Exclusion Criteria:

* Suspected underlying pathology or syndrome on primary consultation
* Severe learning difficulties
C: Inclusion Criteria:

* Obese
* Metabolic syndrome
* Read and write English
* Planning to stay in treatment with their PCP for the next 3 years
* On stable doses of medications for chronic diseases such as hypothyroidism for 3 years

Exclusion Criteria:

* Unstable health
* Diabetes mellitus
* Severe medical comorbidities that might interfere with their ability to participate in intervention such as severe psychiatric disease or significant heart disease.
D: Inclusion Criteria:

* Patients who have, during the past 2 years, at least 4 documented visits for the targeted diseases group and at least 2 visits for the regular follow-up group

Exclusion Criteria:

* Active mental health problem
* Active psychiatric disorder
* Cancer in the last five years
* Patient with medication that changed in the last 6 months

Answer: B