Please select the eligibility criteria that correspond to the clinical trial below.
Title: Implementation and Validation of the "5As Framework of Obesity Management" in Primary Care. "5AsT"
Brief Summary: The main goal of this project is to develop, implement and evaluate the 5As Team intervention (5AsT)for healthcare practitioners to improve their weight management patient encounters and improve patient health outcomes. The 5As of Obesity Management suite of tools is a robust, evidence-based approach to weight management, however its implementation and uptake has been heterogeneous in primary care.

This project was co-created by, and will be implemented with, our partners the Southside Primary Care Network (SSPCN). A needs assessment on weight management by the SSPCN revealed the need to change provider practice to increase the number of weight management visits. Despite a robust didactic training session on weight management for all providers, which includes the 5As, the uptake in practice has been highly heterogeneous. Thus, the 5AsT intervention to address the implementation of the 5As of Obesity Management in clinical practice was developed by the collaborative team. The SSPCN consists of 25 autonomous groups of multidisciplinary professionals that provide service to a defined group of patients within the SSPCN.

The 5As Team consists of multidisciplinary providers (Registered Nurse/ Nurse Practitioner, dietician, mental health worker) who work collaboratively. The intervention is a learning collaborative where these 12 different 5AsTs get together to work to address facilitators and barriers to weight management in their settings over a 6 month period. Half of the teams (N=12) will remain as controls and deliver usual care. They serve as a comparison group for the 5AsTs. This mixed methods study's primary outcomes will assess the change in provider practice and the effectiveness of the intervention and implementation.

To assess the impact of 5AsT on patients, we will recruit patients presenting to the central SSPCN programming, We will not intervene directly on patients; we will observe the impact of the 5AsT and SSPCN programming on their health outcomes for a minimum of 6 months, and where possible for 18 months. Data collected includes demographics, weight (BMI), waist circumference, vital signs,and Short Form-12 (SF-12,these measures are routinely measured in the SSPCN), EuroQol-5 dimensions 5 Level (EQ-5D-5L), modified patient assessment of chronic illness (PACIC), and observed adherence to routine clinical care for guideline recommended laboratory monitoring (cholesterol panel, fasting glucose, HbA1c, where appropriate).


Options:
A: 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
B: Inclusion Criteria:

* 85th - 97th percentile BMI
* parent/care giver ability to converse in English
* working telephone

Exclusion Criteria:

* child under current subspecialty care for overweight/obesity
* child currently taking weight-altering medication (at enrollment)
C: 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.
D: Inclusion Criteria:

* Adult patients over 18 years
* BMI ≥ 25
* Enrolling in PCN programs for overweight/ obesity or depression able and willing to give written informed consent in English

Exclusion Criteria:

* Children and pregnant women
* Patients whose obesity is co-managed by an obesity specialist or tertiary care center
* Patients who are unable to participate in regular clinic visits or programs due to geographic, social or physical reasons

Answer: D