Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Patient-Spouse Intervention for Self-Managing High Cholesterol
Brief Summary: We examined the effect of a patient-spouse intervention to lower LDL-C by increasing patient treatment adherence. A randomized controlled trial compared a one-year, telephone-based patient-spouse intervention to usual care. The primary outcome was LDL-C measured three times (baseline, 6 months, 11 months); secondary outcomes were adherence to medication, diet, and exercise, also assessed at baseline, 6 months, and 11 months.


Options:
A: Inclusion Criteria:Non-pregnant women between 18 and 34 years old who understood and spoke English and had a measured BMI between 25.0 and 39.9 kg/m2 were eligible for this study. Additional inclusion criteria included having a youngest child between 6 weeks and 3.5 years of age enrolled in one of our three collaborating WIC locations, not planning to become pregnant or change WIC clinics during the study, providing accurate contact information, agreeing to notify researchers with changes in contact information or pregnancy status, willingness to accept randomized participation assignments, being willing to participate in the project for 1.5 years, and consenting to have blood glucose tested via finger stick.

Exclusion Criteria: women with fasting blood glucose greater than 126 mg/dl or random blood glucose greater than 200 mg/dl, self-reported type 1 or 2 diabetes or an eating disorder, or inability to walk more than one block without resting or shortness of breath were excluded. Eligible participants provided their individual telephone and address and a telephone number of one back-up contact (relative, friend, or neighbor).
B: Abbreviations: FBS = fasting blood sugar, SBP = systolic blood pressure, DBP = diastolic blood pressure, LDL = low-density lipoprotein, HDL = high-density lipoprotein, BMI = body mass index, TC = total cholesterol, TG = triglycerides, HbA1c = hemoglobin A1c.

Inclusion Criteria

* The patient has CAD or CAD risk equivalent (abdominal aortic aneurysm, peripheral vascular disease, transient ischemic attack, stroke, diabetes, or FBS ≥ 126 mg/dL × 2) and has at least one of following: SBP ≥ 130 mmHg, DBP ≥ 80 mmHg, LDL ≥ 100 mg/dL, HDL ≤ 40 mg/dL, TG ≥ 150 mg/dL, FBS ≥ 126 mg/dL, BMI ≥ 30, or is a current smoker.
* The patient does not have CAD or CAD risk equivalent but has at least one of the following: SBP ≥ 160 mmHg, DBP ≥ 100 mmHg, LDL ≥ 190 mg/dL, TC ≥ 240 mg/dL, TG ≥ 500 mg/dL, HbA1c ≥ 8.0%, BMI ≥ 35, or is a current smoker.
* The patient does not have CAD or CAD risk equivalent but has at least two of the following: a) SBP ≥ 140 mmHg or DBP ≤ 90 mmHg, b) HDL ≤ 40 mm/dL or TG ≥ 200 mg/dL, c) LDL ≥ 160 mg/dL or TC ≥ 240 mg/dL, d) FBS ≥ 110 mg/dL × 2, or e) male age ≥ 45 or female age ≥ 55 or with positive family history of CAD.

Exclusion Criteria:

* Resident of long-term facility
* Lack of spoken English or Spanish by patient or household member 18 years or older who can serve as an interpreter
* Moving before end of intervention (30 months)
* Age between 35 and 85 (inclusive)
* Significant comorbidities such as: uncontrolled metabolic disorders (renal failure, liver failure, etc.), active symptoms suggesting acute myocardial infarction or decompensated congestive heart failure, Malignancy or other condition limiting life expectancy, psychiatric disorder with active manifestations.
* Substance abuse.
* No telephone or means of contacting patient.
* Family household member already enrolled.
* Homeless and not living with relatives/friends.
* Anticipated absence for more than 4 consecutive months.
* Difficulty coming to appointments approximately every 1-2 months
* Already participating in the Diabetes program
* Currently pregnant or intends to get pregnant the next 3 years.
C: Inclusion Criteria:

* Ethnicity: All ethnic groups;
* Body mass index 25.0-39.9 kg/m2;
* Fasting plasma glucose between 100 and 125 mg/dL;
* Any two of the following: Waist circumference \>40 inches in men, \>35 inches in women (if in Asian American ≥ 35 inches in men; ≥31 inches in women); Triglycerides \>150 mg/dL; High-density lipoprotein cholesterol (HDL-C) \<40 mg/dL in men, \<50 mg/dL in women; Systolic blood pressure \>130 mm Hg or diastolic blood pressure \>85 mm Hg.
* Having a primary care physician (PCP) at the PAMF Los Altos Center;
* Seen in primary or specialty care in the Palo Alto Region at least once in the preceding 24 months;
* A PAMF patient for ≥ 12 months;
* Able and willing to enroll and meet the requirements of the study.

Exclusion Criteria:

* Inability to speak, read or understand English;
* No regular access to a computer with Internet and email capabilities;
* Triglycerides \>400 mg/dL;
* Systolic blood pressure \>160 mm Hg or diastolic blood pressure \>100 mm Hg;
* Initiation or change of drug therapy for elevated blood pressure or abnormal lipid levels within the past 3 months
* Having a medical (e.g., celiac disease) or social condition (e.g., religious beliefs) that precludes dietary changes;
* Having a medical or physical condition that make moderate intensity physical activity (like a brisk walk) difficult or unsafe;
* Use of weight-loss medications in the past 3 months;
* Regular use (\> 5 days/month) of medications that affect appetite or weight (e.g., oral corticosteroids, insulin, certain oral hypoglycemics, certain antidepressants, etc.);
* Currently enrolled in a lifestyle intervention program at PAMF or elsewhere;
* Planning to undergo a bariatric surgery during the study period;
* Diagnosis of Type 1 or Type 2 diabetes mellitus;
* Significant medical co-morbidities, including uncontrolled metabolic disorders (e.g., thyroid, renal, liver), heart disease, stroke, and ongoing substance abuse;
* Renal insufficiency (i.e., GFR \< 60 mL/min/1.73m2)
* Diagnosis of psychiatric disorders that would limit adequate informed consent or ability to comply with study protocol;
* Diagnosis of cancer (other than non-melanoma skin cancer) that was active or treated with radiation or chemotherapy within the past 2 years;
* Diagnosis of a terminal illness and/or in hospice care;
* Pregnant, lactating or planning to become pregnant during the study period;
* Already enrolled or planning to enroll in a research study that would limit full participation in this study or confound the observation and interpretation of the study's findings;
* Family/household member of another study participant or of a study staff member;
* No longer a PAMF patient or planning to transfer care outside of PAMF during the study period;
* Planning to move out of the area during the study period;
* PCP determination that the study is inappropriate or unsafe for the patient;
* Investigator discretion for clinical safety or protocol adherence reasons.
D: Inclusion Criteria:

* veteran
* elevated baseline low-density lipoprotein cholesterol level
* married

Exclusion Criteria:

* no telephone number;
* spouse unwilling to participate;
* patient or spouse cognitively impaired, unable to communicate via telephone, living in nursing home or receiving home health care, or refuses to provide informed consent;
* hospitalized past 3 months;
* survival prognosis less than 1 year;
* active psychosis or dementia; no primary care physician at VA;
* no medical visit to VA in past year;
* enrolled in another study focusing on lifestyle changes

Answer: D