Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Combined Lifestyle and Medication Intervention to Reduce CVD Risk
Brief Summary: Cardiovascular disease (CVD), including heart disease and stroke, is the leading cause of death in the US. Every year, more than one million Americans have a heart attack, and nearly 800,000 have a stroke. In 2010, heart disease alone is expected to cost the country more than $316 billion in health care and lost productivity.

Both lifestyle changes and medication can reduce the risk of CVD, and this project combines these approaches in the hopes of identifying a practical intervention for use in primary care medical offices. The project combines two previously tested interventions and updates them to meet current guidelines for diet and use of aspirin and cholesterol-controlling drugs (statins).

The research team is delivering the combined intervention in two formats: web-based and counselor-based. Each format has the same content, but the web-based advice is accessed through the Internet by clients at home, a community site, or a primary care office. The other format involves sessions delivered to clients by a counselor either in person at a primary care office or over the telephone. The researchers will compare how effective each format is in reducing participants' risk of coronary heart disease. They will also determine the interventions' effect on participants' diet, physical activity, smoking status, medication adherence, and other health indicators. In addition, the team will compare the two formats' cost-effectiveness and how well the patients, office staff, and clinicians accept the interventions.

Recruited from five family practices, 600 patients representing the geographic and ethnic diversity of North Carolina are taking part in this study. Half the participants are randomly assigned to the web-based intervention; the other half to the counselor-based version. Both groups will also get information on local resources, such as gyms and farmers markets, that can help participants maintain a healthy lifestyle.


Options:
A: Adult patients with type 2 diabetes attending a referral diabetes clinic, who are taking or not taking statins, and give consent to participate. Excluded were patients who had sensory or mental impairments or language barriers that preclude them from using the intervention and therefore participate in this trial.
B: Inclusion Criteria:

* Age 30 years and above
* Personal history of heart attack or stroke
* Presence of other cardiovascular risk factors such as smoking, overweight, diabetes

Exclusion Criteria:

* Mental disability
* Not living in the Study area
C: Inclusion Criteria:

* Currently receiving medical care at Johns Hopkins University
* African American or Caucasian and have diagnosed CVD, defined as a prior myocardial infarction, revascularization procedure for coronary disease, ischemic heart disease, stroke, or have diagnosed type 2 diabetes and not receiving any therapy
* Have either no LDL-C in their medical record during the 12 months prior to study entry or have an LDL greater than or equal to 100 mg/dl on or off lipid lowering pharmacotherapy
* Have either no blood pressure recorded in their medical record during the 12 months prior to study entry or a BP greater than 140/90 mmHg or greater than 130/80 mmHg if the participant is diabetic or has renal insufficiency
* If the participant is diabetic he or she has to either have no HbA1c recorded during the 12 months prior to study entry or HbA1c of 7 percent or greater

Exclusion criteria:

* A serious life-threatening noncardiac comorbidity with a life expectancy of less than 5 years
* A serious physician-recorded psychiatric morbidity that would interfere with the study
* Sufficient neurological impairment that would interfere with the study
D: Inclusion Criteria:

* Established patients
* Men ages 35-79
* Women ages 45-79
* History of CVD (100 participants)
* CHD risk equal or greater than 10%
* elevated CHD risk factor

Exclusion Criteria:

* non-English speaking
* no phone
* treatment of psychosis
* history of alcohol/substance abuse within last 2 years
* pregnancy, breast feeding, or anticipated pregnancy in next 18 months
* history of malignancy, other than non-melanoma skin cancer, that has not been in remission or cured surgically for \>5 years
* recent history (in past year) of hypoglycemic event requiring medical attention
* estimated creatinine clearance less than 30 ml/min

Answer: D