Please select the arm or intervention descriptions that belong 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: Arm Label: Standard Care plus Wellness Program; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Cognitive Behavioral Treatment, Drug: Nicotine Patch, Behavioral: Wellness Program | Arm Label: Standard Care plus Exercise Program; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Cognitive Behavioral Treatment, Drug: Nicotine Patch, Behavioral: Aerobic Exercise | Intervention Type: BEHAVIORAL; Name: Cognitive Behavioral Treatment; Assigned to Arm(s): Standard Care plus Exercise Program, Standard Care plus Wellness Program | Intervention Type: DRUG; Name: Nicotine Patch; Assigned to Arm(s): Standard Care plus Exercise Program, Standard Care plus Wellness Program | Intervention Type: BEHAVIORAL; Name: Wellness Program; Assigned to Arm(s): Standard Care plus Wellness Program | Intervention Type: BEHAVIORAL; Name: Aerobic Exercise; Assigned to Arm(s): Standard Care plus Exercise Program
B: Arm Label: A; Type: EXPERIMENTAL; Interventions: Other: Allez Hop | Arm Label: B; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Allez Hop; Assigned to Arm(s): A
C: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Mediterranean Diet, Behavioral: Physical Activity, Behavioral: Stress Management, Behavioral: Social Support, Behavioral: Smoking Cessation | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Other: Control group | Intervention Type: BEHAVIORAL; Name: Mediterranean Diet; Assigned to Arm(s): 1 | Intervention Type: BEHAVIORAL; Name: Physical Activity; Assigned to Arm(s): 1 | Intervention Type: BEHAVIORAL; Name: Stress Management; Assigned to Arm(s): 1 | Intervention Type: BEHAVIORAL; Name: Social Support; Assigned to Arm(s): 1 | Intervention Type: BEHAVIORAL; Name: Smoking Cessation; Assigned to Arm(s): 1 | Intervention Type: OTHER; Name: Control group; Assigned to Arm(s): 2
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Behavioral: 12-week risk reduction program, managed by a Heart Health Educator | Arm Label: 2; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: 12-week risk reduction program, managed by a Heart Health Educator; Assigned to Arm(s): 1

Answer: D