Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effectiveness of PRECEDE Model for Health Education on Cardiovascular Risk Reduction in Patients With Type 2 Diabetes Mellitus
Brief Summary: BACKGROUND: Individual health education is considered to be essential in the overall care of patients with type 2 diabetes (DM2), although there is some uncertainty regarding its metabolic control benefits. There have been very few randomized studies on the effects of individual education on normal care in DM2 patients with a control group, and none of these have assessed the long-term results. Therefore, this study aims to use this design to assess the effectiveness of the PRECEDE (Predisposing, Reinforcing, Enabling, Causes in Educational Diagnosis, and Evaluation) education model in the metabolic control and the reduction of cardiovascular risk factors, in patients with type 2 diabetes.

METHODS: An open community randomized clinical trial will be carried out in 8 urban community health centers in the Northeastern Madrid (Spain). Six hundred patients with DM2 will be randomized in two groups: PRECEDE or conventional model for health promotion education. The main outcome measures is glycated hemoglobin A1C, body mass index (BMI), blood pressure, lipids and control criteria during the 2-year follow-up period.


Options:
A: Inclusion Criteria:

* Body mass index (BMI) between 25.0 and 39.9 kg/m2

Exclusion Criteria:

* Reports losing more than 5% of current body weight in the 6 months before study entry
* Participated in a research project involving weight loss or physical activity in the 6 months before study entry
* Pregnant during the 6 months before study entry, currently breastfeeding, or planning to become pregnant in the 18 months after study entry
* Current treatment for any medical condition that could affect body weight (e.g., diabetes mellitus, cancer)
* History of heart attack or heart surgery, including bypass or angioplasty
* Currently taking medication that would affect heart rate or blood pressure responses to exercise (e.g., beta blockers)
* Currently taking medication that could affect metabolism or change body weight (e.g., synthroid)
* Currently being treated for psychological issues or has taken psychotropic medications in the 6 months before study entry
B: Inclusion Criteria:

* Older than 30 years of age, with previously diagnosed DM2 (cardinal clinical, plus random blood glucose \> 200 mg/dl or oral glucose of \> 200 mg/dl at 2 h, twice, or plasma fasting glucose of \> 126 mg/dl on two occasions or being diagnosed previously, received specific treatment for DM2)

Exclusion Criteria:

* Gestational diabetes
* Patients involved in clinical trials
* Patients with life expectancy less than 1 year (according to clinical judgment)
* Patients who refused to participate
* Homebound patients Patients meeting criteria for inclusion and not meeting any exclusion criteria were invited to participate, and were included after accepting and signing an informed consent form.
C: Inclusion Criteria:

1. Age 18 years or older;
2. Body mass between 30 and 55 kg/m2
3. One or more CHD risk factors: Systolic blood pressure between 130 and 200 mmHg; Diastolic blood pressure between 80 and 105 mmHg; Total cholesterol \> 180 mg/dL; LDL cholesterol \> 120 mg/dL; HDL Cholesterol \< 40 mg/dL; Triglycerides \> 150 mg/dL; HbA1c between 6.0 and 11.5%; Fasting plasma glucose between 95 and 400 mg/dL; Diagnosis of Type 2 diabetes
4. Residing in catchment area of the Fair Oaks Adult Clinic and receiving primary care at Fair Oaks Adult Clinic.

Exclusion Criteria:

1. Inability to speak Spanish;
2. Unwilling to attempt weight loss;
3. Significant medical co-morbidities, including uncontrolled metabolic disorders (e.g., thyroid, diabetes, renal, liver), unstable heart disease, advanced heart failure, and ongoing substance abuse;
4. On greater than 10 prescription medications;
5. Psychiatric disorders requiring antipsychotics or multiple medications;
6. Body weight change \> 25 lbs. in the preceding 3 months;
7. Pregnant, planning to become pregnant, or lactating less than six months;
8. Family household member already enrolled in the study;
9. Intends to or is enrolled in a study that would limit full participation in VAFO;
10. Participants who are unwilling to have home visits by study staff;
11. Resident of a long term care facility;
12. Plans to move during the study period (24 months post-randomization);
13. Investigator discretion for clinical safety or adherence reasons (e.g., unstable housing, chronic pain).
D: Inclusion Criteria:

* 18-65 years older men \& women
* Body mass index 25.0-39.9
* Ability to provide informed consent

Exclusion Criteria:

* Type I Diabetes
* Type II diabetes taking insulin
* Surgery or Hospitalization in last year (unless minor outpatient surgery)
* Blood pressure \>159/94
* Cancer (other than non-melanoma skin cancer) in last 5 years
* History of bariatric surgery
* Current treatment with herbal, over-the-counter, or prescription weight loss drugs
* Current treatment with ant-metabolite medications or other medications that affect weight
* Current pregnancy or breastfeeding, or plans pregnancy in next 18 months gastrointestinal disorders including ulcerative colitis, Crohn's disease, malabsorption syndromes)
* Chronic renal insufficiency
* Chronic liver disease
* History of anorexia nervosa, bulimia, laxative abuse
* Current alcohol or substance abuse
* Chronic heart failure, New York Heart Association Class III or IV
* Uncontrolled arrythmia
* Uncontrolled hyper- or hypothyroidism
* Large weight loss of 20 or more kilograms in the past year
* Hospitalization for mental illness within the past 5 years or currently undergoing treatment for severe mental illness
* Center for Epidemiologic Studies Depression Scale Score ≥ 16
* Musculoskeletal problems interfering with exercise.
* Autoimmune or collagen vascular diseases.
* Immunodeficiency diseases or a positive Human immunodeficiency virus test
* Unable to give informed consent

Answer: B