Trial Outcomes & Findings for Family Heart Health Program: Randomized, Controlled Trial (NCT NCT00552591)
NCT ID: NCT00552591
Last Updated: 2026-06-30
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
426 participants
Primary outcome timeframe
Baseline to one year
Results posted on
2026-06-30
Participant Flow
Participant milestones
| Measure |
Family Heart-Health Intervention
Assessment of family members of patients with CAD. Provides feedback about risk factors, assistance with goal setting and counselling from health educators. Reports were provided to primary care providers if they exceeded normal ranges. Participants also received printed materials about smoking cessation, healthy eating, weight management, and physical activity.
|
Control Group
Participants received printed materials about smoking cessation, healthy eating, weight management, and physical activity.
|
|---|---|---|
|
Overall Study
STARTED
|
211
|
215
|
|
Overall Study
COMPLETED
|
159
|
157
|
|
Overall Study
NOT COMPLETED
|
52
|
58
|
Reasons for withdrawal
| Measure |
Family Heart-Health Intervention
Assessment of family members of patients with CAD. Provides feedback about risk factors, assistance with goal setting and counselling from health educators. Reports were provided to primary care providers if they exceeded normal ranges. Participants also received printed materials about smoking cessation, healthy eating, weight management, and physical activity.
|
Control Group
Participants received printed materials about smoking cessation, healthy eating, weight management, and physical activity.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
52
|
58
|
Baseline Characteristics
Family Heart Health Program: Randomized, Controlled Trial
Baseline characteristics by cohort
| Measure |
Family Heart-Health Intervention
n=211 Participants
Assessment of family members of patients with CAD. Provides feedback about risk factors, assistance with goal setting and counselling from health educators. Reports were provided to primary care providers if they exceeded normal ranges. Participants also received printed materials about smoking cessation, healthy eating, weight management, and physical activity.
|
Control Group
n=215 Participants
Participants received printed materials about smoking cessation, healthy eating, weight management, and physical activity.
|
Total
n=426 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.0 years
STANDARD_DEVIATION 11.9 • n=20 Participants
|
51.1 years
STANDARD_DEVIATION 11.3 • n=20 Participants
|
51.5 years
STANDARD_DEVIATION 11.6 • n=40 Participants
|
|
Sex: Female, Male
Female
|
128 Participants
n=20 Participants
|
133 Participants
n=20 Participants
|
261 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=20 Participants
|
82 Participants
n=20 Participants
|
165 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
White
|
201 Participants
n=20 Participants
|
205 Participants
n=20 Participants
|
406 Participants
n=40 Participants
|
|
Married or living with partner
|
164 Participants
n=20 Participants
|
172 Participants
n=20 Participants
|
336 Participants
n=40 Participants
|
|
Education
|
14.6 years
STANDARD_DEVIATION 2.6 • n=20 Participants
|
14.7 years
STANDARD_DEVIATION 2.6 • n=20 Participants
|
14.7 years
STANDARD_DEVIATION 2.6 • n=40 Participants
|
|
Family history of premature CAD
|
96 Participants
n=20 Participants
|
95 Participants
n=20 Participants
|
191 Participants
n=40 Participants
|
|
Current daily smoker
|
20 Participants
n=20 Participants
|
19 Participants
n=20 Participants
|
39 Participants
n=40 Participants
|
|
No family doctor
|
9 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
23 Participants
n=40 Participants
|
|
Body Mass Index >/= 30
|
79 Participants
n=20 Participants
|
87 Participants
n=20 Participants
|
166 Participants
n=40 Participants
|
|
Waist circumference >94cm (men) or >80cm (women)
|
64 Participants
n=20 Participants
|
54 Participants
n=20 Participants
|
118 Participants
n=40 Participants
|
|
Lipid lowering therapy
|
42 Participants
n=20 Participants
|
51 Participants
n=20 Participants
|
93 Participants
n=40 Participants
|
|
Antihypertensive therapy
|
67 Participants
n=20 Participants
|
52 Participants
n=20 Participants
|
119 Participants
n=40 Participants
|
|
Smoking cessation pharmacotherapy
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Relation to index patient
Spouse
|
67 Participants
n=20 Participants
|
65 Participants
n=20 Participants
|
132 Participants
n=40 Participants
|
|
Relation to index patient
Offspring
|
98 Participants
n=20 Participants
|
101 Participants
n=20 Participants
|
199 Participants
n=40 Participants
|
|
Relation to index patient
Sibling
|
46 Participants
n=20 Participants
|
49 Participants
n=20 Participants
|
95 Participants
n=40 Participants
|
|
Percent risk of CAD event over next 10year
|
5.9 Percent
STANDARD_DEVIATION 6.6 • n=20 Participants
|
5.8 Percent
STANDARD_DEVIATION 7.6 • n=20 Participants
|
5.9 Percent
STANDARD_DEVIATION 7.1 • n=40 Participants
|
PRIMARY outcome
Timeframe: Baseline to one yearOutcome measures
| Measure |
Family Heart-Health Intervention
n=211 Participants
Assessment of family members of patients with CAD. Provides feedback about risk factors, assistance with goal setting and counselling from health educators. Reports were provided to primary care providers if they exceeded normal ranges. Participants also received printed materials about smoking cessation, healthy eating, weight management, and physical activity.
|
Control Group
n=215 Participants
Participants received printed materials about smoking cessation, healthy eating, weight management, and physical activity.
|
|---|---|---|
|
Ratio of Total Cholesterol to HDL Cholesterol TC/HDL
Baseline
|
4.12 Ratio
Standard Deviation 1.29
|
4.22 Ratio
Standard Deviation 1.26
|
|
Ratio of Total Cholesterol to HDL Cholesterol TC/HDL
at 3 months
|
4.02 Ratio
Standard Deviation 1.25
|
4.02 Ratio
Standard Deviation 1.18
|
|
Ratio of Total Cholesterol to HDL Cholesterol TC/HDL
at 12months
|
4.06 Ratio
Standard Deviation 1.31
|
3.96 Ratio
Standard Deviation 1.09
|
PRIMARY outcome
Timeframe: Baseline to 1 yearOutcome measures
| Measure |
Family Heart-Health Intervention
n=211 Participants
Assessment of family members of patients with CAD. Provides feedback about risk factors, assistance with goal setting and counselling from health educators. Reports were provided to primary care providers if they exceeded normal ranges. Participants also received printed materials about smoking cessation, healthy eating, weight management, and physical activity.
|
Control Group
n=215 Participants
Participants received printed materials about smoking cessation, healthy eating, weight management, and physical activity.
|
|---|---|---|
|
Physical Activity
Baseline
|
91.7 minutes/week
Standard Deviation 102.5
|
88.7 minutes/week
Standard Deviation 99.7
|
|
Physical Activity
at 3months
|
176.4 minutes/week
Standard Deviation 110.9
|
110.6 minutes/week
Standard Deviation 115.3
|
|
Physical Activity
at 12months
|
142.5 minutes/week
Standard Deviation 122
|
118.6 minutes/week
Standard Deviation 109.1
|
PRIMARY outcome
Timeframe: Baseline to 1 yearOutcome measures
| Measure |
Family Heart-Health Intervention
n=211 Participants
Assessment of family members of patients with CAD. Provides feedback about risk factors, assistance with goal setting and counselling from health educators. Reports were provided to primary care providers if they exceeded normal ranges. Participants also received printed materials about smoking cessation, healthy eating, weight management, and physical activity.
|
Control Group
n=215 Participants
Participants received printed materials about smoking cessation, healthy eating, weight management, and physical activity.
|
|---|---|---|
|
Servings of Fruits and Vegetables
Baseline
|
6.3 Servings per day
Standard Deviation 3.0
|
6.5 Servings per day
Standard Deviation 3.1
|
|
Servings of Fruits and Vegetables
at 3 months
|
8.0 Servings per day
Standard Deviation 3.3
|
6.8 Servings per day
Standard Deviation 3.2
|
|
Servings of Fruits and Vegetables
at 12 months
|
7.4 Servings per day
Standard Deviation 3.4
|
6.6 Servings per day
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Baseline to 1 yearOutcome measures
| Measure |
Family Heart-Health Intervention
n=211 Participants
Assessment of family members of patients with CAD. Provides feedback about risk factors, assistance with goal setting and counselling from health educators. Reports were provided to primary care providers if they exceeded normal ranges. Participants also received printed materials about smoking cessation, healthy eating, weight management, and physical activity.
|
Control Group
n=215 Participants
Participants received printed materials about smoking cessation, healthy eating, weight management, and physical activity.
|
|---|---|---|
|
Cholesterol Levels
Baseline - HDL Cholesterol
|
1.33 mmol/L
Standard Deviation 0.38
|
1.30 mmol/L
Standard Deviation 0.34
|
|
Cholesterol Levels
3month - HDL cholesterol
|
1.34 mmol/L
Standard Deviation 0.39
|
1.30 mmol/L
Standard Deviation 0.34
|
|
Cholesterol Levels
12month - HDL cholesterol
|
1.34 mmol/L
Standard Deviation 0.41
|
1.29 mmol/L
Standard Deviation 0.30
|
|
Cholesterol Levels
Baseline - LDL cholesterol
|
3.22 mmol/L
Standard Deviation 0.86
|
3.28 mmol/L
Standard Deviation 0.91
|
|
Cholesterol Levels
3months - LDL cholesterol
|
3.10 mmol/L
Standard Deviation 0.82
|
3.09 mmol/L
Standard Deviation 0.90
|
|
Cholesterol Levels
12months - LDL cholesterol
|
3.11 mmol/L
Standard Deviation 0.82
|
3.04 mmol/L
Standard Deviation 0.92
|
|
Cholesterol Levels
Baseline - Triglycerides
|
1.28 mmol/L
Standard Deviation 0.77
|
1.35 mmol/L
Standard Deviation 0.84
|
|
Cholesterol Levels
3months - Triglycerides
|
1.22 mmol/L
Standard Deviation 0.66
|
1.24 mmol/L
Standard Deviation 0.57
|
|
Cholesterol Levels
12month - Triglycerides
|
1.35 mmol/L
Standard Deviation 0.80
|
1.34 mmol/L
Standard Deviation 0.64
|
|
Cholesterol Levels
Baseline - Total cholesterol
|
5.13 mmol/L
Standard Deviation 0.97
|
5.18 mmol/L
Standard Deviation 1.02
|
|
Cholesterol Levels
3month - Total Cholesterol
|
4.99 mmol/L
Standard Deviation 0.96
|
4.95 mmol/L
Standard Deviation 1.00
|
|
Cholesterol Levels
12month - Total Cholesterol
|
5.03 mmol/L
Standard Deviation 0.98
|
4.93 mmol/L
Standard Deviation 1.01
|
SECONDARY outcome
Timeframe: Baseline to 1 yearOutcome measures
| Measure |
Family Heart-Health Intervention
n=211 Participants
Assessment of family members of patients with CAD. Provides feedback about risk factors, assistance with goal setting and counselling from health educators. Reports were provided to primary care providers if they exceeded normal ranges. Participants also received printed materials about smoking cessation, healthy eating, weight management, and physical activity.
|
Control Group
n=215 Participants
Participants received printed materials about smoking cessation, healthy eating, weight management, and physical activity.
|
|---|---|---|
|
Glucose Levels
Baseline - Glucose
|
5.12 mmol/L
Standard Deviation 0.52
|
5.09 mmol/L
Standard Deviation 0.59
|
|
Glucose Levels
at 3 months
|
5.12 mmol/L
Standard Deviation 0.50
|
5.18 mmol/L
Standard Deviation 0.54
|
|
Glucose Levels
at 12 months
|
5.16 mmol/L
Standard Deviation 0.60
|
5.13 mmol/L
Standard Deviation 0.57
|
SECONDARY outcome
Timeframe: Baseline to 1 yearOutcome measures
| Measure |
Family Heart-Health Intervention
n=211 Participants
Assessment of family members of patients with CAD. Provides feedback about risk factors, assistance with goal setting and counselling from health educators. Reports were provided to primary care providers if they exceeded normal ranges. Participants also received printed materials about smoking cessation, healthy eating, weight management, and physical activity.
|
Control Group
n=215 Participants
Participants received printed materials about smoking cessation, healthy eating, weight management, and physical activity.
|
|---|---|---|
|
Blood Pressure
Baseline - Systolic
|
121.8 mmHg
Standard Deviation 15.3
|
120.4 mmHg
Standard Deviation 16.9
|
|
Blood Pressure
Baseline - Diastolic
|
76.8 mmHg
Standard Deviation 9.0
|
76.3 mmHg
Standard Deviation 9.9
|
|
Blood Pressure
3 months - Systolic
|
116.4 mmHg
Standard Deviation 14.8
|
115.8 mmHg
Standard Deviation 14.8
|
|
Blood Pressure
3 months - Diastolic
|
73.8 mmHg
Standard Deviation 8.3
|
74.2 mmHg
Standard Deviation 9.5
|
|
Blood Pressure
12 months - Systolic
|
118.5 mmHg
Standard Deviation 14.3
|
117.5 mmHg
Standard Deviation 14.7
|
|
Blood Pressure
12 months - Diastolic
|
75.5 mmHg
Standard Deviation 9.5
|
74.8 mmHg
Standard Deviation 8.7
|
SECONDARY outcome
Timeframe: Baseline to 1 yearOutcome measures
| Measure |
Family Heart-Health Intervention
n=211 Participants
Assessment of family members of patients with CAD. Provides feedback about risk factors, assistance with goal setting and counselling from health educators. Reports were provided to primary care providers if they exceeded normal ranges. Participants also received printed materials about smoking cessation, healthy eating, weight management, and physical activity.
|
Control Group
n=215 Participants
Participants received printed materials about smoking cessation, healthy eating, weight management, and physical activity.
|
|---|---|---|
|
Body Mass Index
Baseline
|
29.2 kg/m2
Standard Deviation 5.4
|
29.6 kg/m2
Standard Deviation 6.0
|
|
Body Mass Index
3 months
|
28.2 kg/m2
Standard Deviation 4.8
|
29.4 kg/m2
Standard Deviation 5.9
|
|
Body Mass Index
12 months
|
27.9 kg/m2
Standard Deviation 4.8
|
29.0 kg/m2
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: Baseline to 1 yearOutcome measures
| Measure |
Family Heart-Health Intervention
n=211 Participants
Assessment of family members of patients with CAD. Provides feedback about risk factors, assistance with goal setting and counselling from health educators. Reports were provided to primary care providers if they exceeded normal ranges. Participants also received printed materials about smoking cessation, healthy eating, weight management, and physical activity.
|
Control Group
n=215 Participants
Participants received printed materials about smoking cessation, healthy eating, weight management, and physical activity.
|
|---|---|---|
|
Waist Circumference
Baseline
|
96.3 centimeters
Standard Deviation 13.5
|
97.4 centimeters
Standard Deviation 15.1
|
|
Waist Circumference
at 3 months
|
93.7 centimeters
Standard Deviation 13.7
|
96.2 centimeters
Standard Deviation 14.7
|
|
Waist Circumference
at 12 months
|
92.5 centimeters
Standard Deviation 13.4
|
95.1 centimeters
Standard Deviation 13.8
|
Adverse Events
Family Heart-Health Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place