Please select the eligibility criteria that correspond to the clinical trial below.
Title: Family Heart Health Program: Randomized, Controlled Trial
Brief Summary: Background: Family members (spouses, siblings, offspring) of patients with coronary heart disease (CHD) may themselves be at increased risk for developing CHD for genetic, biochemical and/or behavioural reasons. Targeted approaches aimed at family members of those with established CHD may be a cost-effective way to identify high-risk persons and link them to effective risk factor modification. During pilot testing we found 29% of family members of patients recently hospitalized at our institution had ≥ 3 CHD risk factors. Encouragingly, they indicated high levels of "readiness" to change underlying risk behaviours such as cigarette smoking and physical inactivity. We have developed a 12-week family heart health program featuring a personal plan for achieving risk factor goals and weekly contact with a heart health educator. This intervention needs to be fully tested.

Research Aims:

In this study, we will:

1. Compare the effects of a targeted family heart health (FHH) screening, counselling and follow-up program versus usual care (UC) for reducing participants total cholesterol/high density lipoprotein (TC/HDL) ratio 52 weeks after program entry, in family members of patients recently hospitalized with CHD;
2. Compare the effects of the FHH program versus UC on modifiable components comprising the Framingham score, including: smoking status; systolic blood pressure; total cholesterol; and high density lipoprotein cholesterol;
3. Compare the effects of the FHH program versus UC on: lifestyle-related factors (dietary patterns, leisure time exercise, body composition); medication use (anti-lipemic medications, anti-hypertensive medications, pharmacotherapies for smoking cessation); and use of healthcare resources (physician visits, hospitalization days, number of laboratory and diagnostic tests and procedures).


Options:
A: Inclusion Criteria:

1. Aged between 18 and 65 years old
2. Capable of providing informed consent, attend all study visits and comply with the protocol
3. Daily smoker for at least one year and currently smoke an average of at least 10 cigarettes per day
4. Report a motivation to quit smoking in the next month of at least 5 on a 10-point scale
5. Score of 20 or greater on 16-item Anxiety Sensitivity Index
6. Physically inactive as defined as participating in moderate-intensity exercise less than 2 days/week (duration must be 30 minutes or less each time)

Exclusion Criteria:

1. Use of other tobacco products
2. General medical condition(s) that contraindicate exercise
3. Resting blood pressure of ≥ 160 systolic and/or 100 diastolic who are not receiving treatment for high blood pressure
4. Blood lipid levels ≥ 240 mg/dl with LDL-C ≥ 160 mg/dl or triglyceride levels ≥ 300 mg/dl (individuals receiving medical treatment for lipid abnormalities with lipid levels above the cut-offs will be eligible with physician written approval)
5. Body mass index ≥40
6. Currently suicidal or high suicide risk
7. Current or past psychotic disorders of any type, or comorbid psychiatric conditions that are relative or absolute contraindications to the use of any treatment option in the study protocol
8. Currently pregnant, planning on becoming pregnant in the next year, or current breastfeeding
9. Alcohol or drug dependence; abuse of depressants, dissociative anesthetics, hallucinogens, opioids, or cocaine within the last 6 months
10. Psychotherapy initiated within the past three months, or ongoing psychotherapy of any duration directed specifically toward the treatment of anxiety or mood disorder other than general supportive therapy
11. Current use of any psychotherapy or pharmacotherapy for smoking cessation not provided by the researchers, including Chantix, Zyban, Welbutrin and Nortriptyline.
B: Inclusion Criteria:

1. Current daily smoker \>10 or more cigarettes per day
2. Having smoked (on average \> 10 cigarettes/day) regularly for at least 3 years
3. Age between 18 and 65 years
4. Sedentary lifestyle defined as less than 20 minutes a day of moderate-intensity physical assessed by the Swiss Baseline Questionnaire.

Exclusion Criteria:

1. Current pharmacological agent use to quit smoking
2. Medical problems that would alter training responses: arthritis, heart disease, and orthopedic problems
3. Presence of an unstable medical condition
4. Current or recent major cardiovascular event, such as recent myocardial infarction (\>12 months) or stroke, angina pectoris, major arrhythmia
5. Current psychiatric illness
6. Alcohol (\> 4 drinks/day for men and \> 3 drink/d. for women), or/and other substance abuse
7. Current or planned pregnancy
8. Systematic skin disease
C: Inclusion Criteria:

* Type 2 diabetes
* Postmenopausal
* Latina

Exclusion criteria:

* Cognitive impairment or inability to comprehend program
* Has other life-threatening illnesses
* Planning to move from the area during the study
D: Inclusion Criteria:

* Spouse, offspring or sibling of patient hospitalized at UOHI within the past 5 years for:

  1. Acute coronary syndrome (ACS);
  2. Elective percutaneous coronary intervention (PCI); or
  3. Bypass surgery (CABG);
* Willing to provide informed consent;
* At least one of the following modifiable risk factors:

  1. Current smoker;
  2. Systolic blood pressure ≥ 140 and or Diastolic BP ≥ 90 and/or currently on medication to treat high blood pressure;
  3. Total cholesterol/HDL-cholesterol ratio ≥ 5.0 and/or on antilipemic medication;
  4. Abdominal obesity (for men, waist circumference \> 102 cm; for women, waist circumference \> 88cm);
  5. Physical Inactivity \[\<150 min mod, 5-7 d/week or \<100 min vig, 4-7 d/week\]
* Geographically available for assessment, intervention and follow-up.

Exclusion Criteria:

1. Unable to understand English or French;
2. History of diabetes mellitus or any atherosclerotic disease;
3. Fasting glucose ≥ 7.0 mmol/L at screening;
4. Presence of life threatening illness (e.g., known or suspected cancer or other disease with a life expectancy of less than five years);
5. Chronic kidney disease and/or undergoing dialysis;
6. Active liver disease;
7. Pregnant or planning to become pregnant within the next year;
8. Cognitive impairment;
9. Other family member already participating in study.

Answer: D