A Randomized Controlled Trial of Lifestyle Intervention for Cardiovascular Disease Risk Factors Among Female Residents at the National Guard Residential City, Jeddah, Saudi Arabia, 2015
Phase: NA
Conditions: Cardiovascular Diseases
Sponsor: King Abdullah International Medical Research Center

 
Lifestyle Intervention for Cardiovascular Disease Risk Factors among 
Female Residents of the National Guard Residential City, Jeddah, Saudi 
Arabia: A Randomized Controlled Trial
 
8th of June 2017
 
 
 
 
     
 
Jumana Khouja, Badr Al Jasir, Amina Bargawi and Mohammed Kutbi 
Authored by:
           Community and Preventive Medicine Department,  
         King Abdullah International Medical Research Center.  
  Ministry of National Guard Health Affairs, Jeddah, Saudi Arabia

1
 
 
Abbreviations
 
  
BMI        body mass index
  
BP           blood pressure
  
CHD      coronary heart disease
  
CRP       Coronary Risk Profile
  
CVD       cardiovascular disease
  
FRS        Framingham risk score
  
HDL       high-density lipoprotein
  
LDL        low-density lipoprotein 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

2
 
 
 
Lifestyle Intervention for Cardiovascular Disease Risk Factors among Female Residents 
of the National Guard Residential City, Jeddah, Saudi Arabia: A Randomized Controlled 
Trial 
 
Abstract 
Cardiovascular disease (CVD) remains the major cause of mortality globally. Applying a 
comprehensive interventional program based on the individual’s risk may reduce the incidence 
and complications of CVD; thus, helping to decrease the burden on the healthcare system. This 
study compared the effects of a 3-month intervention involving lifestyle modification and 
physical activity with standard care in women ≥30 years having a moderate-to-high risk of 
CVD, with respect to improving physical activity and cardiovascular disease risk factors at the 
National Guard Residential City in Jeddah, Saudi Arabia, in 2015. The effects of this 
community-based lifestyle program were assessed through a randomized controlled trial. 
Women in the intervention group (n=31) received health education, exercise training, and diet 
counselling as individuals and in groups according to the participant’s risk. Women in the 
control group (n=28) received one health education session at the screening site. The 
Framingham risk score (FRS) was calculated at baseline and at 3 months for both groups. The 
mean participant age was 42±8 years. At the 3-months’ follow-up, reductions were greater in 
the intervention group and the difference between groups was statistically significant (p < 
0.05). Lifestyle intervention program reduced systolic blood pressure (-9.2 mmHg); blood 
glucose (-45mg/dL) and Framingham risk score (-13.6). Linear regression analysis revealed a 
significant improvement in the Framingham risk score (p<0.001). In previously sedentary 
adults, a community-based lifestyle modification program is effective in improving the 10-year 
cardiovascular Framingham risk score in at least up to 3 months among women with moderate-
to-high risk of CVD. 
 
Key Words: Cardiovascular Diseases, Framingham risk score, Life style modification, 
Randomized Controlled Trial 
 
 
 
Jumana Khouja, Badr Al Jasir, Amina Bargawi and Mohammed Kutbi 

3
 
 
1. Introduction 
Cardiovascular disease (CVD) includes various conditions such as hypertension, 
coronary heart disease (CHD), myocardial infarction, angina pectoris, heart failure, and stroke 
(Rambo, 2012). Although CVD incidence and mortality have markedly declined in recent 
decades (Eriksson, 2010), CVD remains the leading cause of death worldwide (Cox et al., 
2013); being responsible for 17.3 million deaths in 2008 (30% of all mortalities) (Alwan, 2011). 
According to the World Health Organization statistics for 2008, most of the mortalities in Saudi 
Arabia were due to non-communicable chronic diseases. Of the 413 deaths per 100,000 
individuals in 2009, 144 (35%) were due to CVD (Alwan, 2011). CHD is one of the main 
health problems in Saudi Arabia, representing the third most common cause of hospital-based 
mortality after accidents and senility (Kumosani and Madani, 2007). 
Women tend to have more CVD in the more developed areas of the world. CVD 
accounted for approximately 0.3 million deaths in 2009 in the United States, and was 
responsible for 1 in every 4 female deaths (Kochanek, 2011). Almost two-thirds (64%) of 
women who die suddenly of CHD have had no previous symptoms (Go et al., 2013). According 
to the World Heart Federation, CVD is the most serious neglected health problem affecting 
women worldwide (Schenck-Gustafsson, 2009). 
Modifiable risk factors that have been clinically proven to influence cardiovascular 
health include diabetes, high blood pressure, hypercholesterolemia, being overweight or obese, 
insufficient physical inactivity (less than 30 minutes of moderate activity 5 times/week or 20 
min of vigorous activity 3 times/week, or the equivalent), unhealthy diet, and smoking. Other 
non-modifiable risk factors include age, gender, family history, and race or ethnicity (Eriksson, 
2010; American Diabetes Association, 2010; Mendis et al., 2011). 
Many interventions have been developed to prevent and treat CVD. Cardiovascular disease 
risk factors can act synergistically to increase the risk of developing heart disease; therefore, 
interventions that focus on modifying multiple risk factors may be more effective in reducing 
risk than those that focus on only one risk factor at a time (Rambo, 2012; American Diabetes 
Association, 2010; Al-Nozha, 2004). 
A multidisciplinary approach combining diet, exercise, and behavioral change can 
improve survival, prevent or reduce recurrent events and procedures, and improve quality of 
life (Rambo, 2012). According to the Centers for Disease Control and Prevention, 6 of 10 
deaths from CVD are preventable (Centers for Disease Control and Prevention, 2013). 
Therefore, it is important to develop more comprehensive approaches for the primary 

4
 
 
prevention of CVD (Schenck-Gustafsson, 2009). The public health burden of a sedentary 
lifestyle necessitates interventions that can reach enough women to make a health impact on a 
wide scale (Pazoki et al., 2007).  
In addition, the Saudi female social culture promotes poor nutritional habits and limits 
physical activity, increasing the risk of CVD. Applying a comprehensive interventional 
program according to the individual’s risk factors may decrease the prevalence of CVD and its 
associated complications, and reduce the burden on the healthcare system. However, this 
concept has not been sufficiently investigated in Saudi Arabia. This study aimed to assess the 
effects of a community-based lifestyle modification program targeting women ≥30 years at 
moderate-to-high risk of CVD. 
 
2. Methods 
The study was conducted in the National Guard Residential City, Jeddah, which 
comprises five geographical sections containing 1229 villas each. A randomized controlled 
trial was conducted from January 1, 2015, to September 6, 2015. All female residents of the 
National Guard Residential City aged 30 years were screened and their Framingham risk 
scores (FRSs) were calculated. To be included in the study, the participants had to be at 
moderate-to-high risk of CVD according to FRS. Those with a low CVD risk according to 
FRS, who were pregnant, or diagnosed with CVD were all excluded. 
The sample size was calculated using the formula for superiority trials: 
n = (Zα + Zβ)2 × (p1 × (1 − p1) + p2 (1 − p2)/(p2 − p1)2 
(Where n is the sample size, α is the probability of type I error = 5%, β is the probability of type 
II error = 80%, p1 is the expected success proportions of sample one and p2 is the expected 
success proportions of sample two). According to an international study (Cox et al., 2013), the 
estimated population was as follows: 
 
For moderate risk: 
Sample size required per group (intervention/control) 
= (1.96 + 0.84)2 × (0.32 × 0.68) + (0.22 × 0.78)/ (0.10)2 = 188 
Total sample size required = 188 × 2 = 376 
 
For high risk: 
Sample size required per group 
= (1.96 + 0.84)2 × (0.38 × 0.62) + (0.13 × 0.87)/ (0.25)2 = 31 

5
 
 
Total sample size required = 31 × 2 = 62 
Thus, 438 participants (376 in the moderate-risk group and 62 in the high-risk group) 
were required to provide a power of 80% with an α of 0.05 to show the study outcome. Each 
arm included 219 participants who were randomly assigned to the intervention or control arm. 
At the start of the study, all the households in the residential city were visited and informed 
about the study by a group of trained research assistants supported by the required documents.  
Women received basic education about CVD and its associated risk factors. The participants 
were interviewed and screened by the researcher and two trained nurses, using the validated 
and widely used Coronary Risk Profile (CRP) questionnaire from Wellsource Inc. (Portland, 
OR, USA) (Wellsource, 2014). The CRP questionnaire was translated to Arabic and tested for 
content and face validity to ensure appropriate clarity and fulfillment of the study objectives. 
Three experts reviewed the final version of the questionnaire and pilot testing was conducted 
among a group of 10 women. The results were reviewed and modifications were applied. The 
questionnaire collects data on health history, smoking habits, physical activity, eating practices, 
and social factors. Data from the CRP questionnaire were used to calculate individualized FRS. 
The risk estimate and factors that influenced cardiovascular disease risk were explained for 
each individual. The total sample size was 616. From the total sample, 85 participants were in 
the moderate- and high-risk groups. The intervention arm included 42 participants; and the 
control arm, 43 participants. 
Eligible participants randomly chose a card that assigned them to the intervention or 
control group. The researcher was blinded to the participants’ group assignment. The 
participants assigned to the intervention arm of the study underwent a lifestyle modification 
program, including exercise training sessions and diet counselling. Those assigned to the 
control arm received one session of health education at the screening site (Figure 1). Eligible 
participants were recruited in April 2015 and received the intervention in May 2015. The 3-
month follow-up was completed at the beginning of September 2015. 
 
 
 
 
 
 
 
 

6
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 1: Flowchart from recruitment to completion of the follow-up of the participants at the 
National Guard Residential City in Jeddah, Saudi Arabia, in 2015 
 
 
 
Randomization (n = 85) 
Intervention group 
(n = 32) 
Control group 
(n = 28) 
One health 
education session 
(n = 28) 
Start of the 
intervention 
(n = 32) 
3-month follow-up 
and examination 
(n = 31) 
3-month follow-up 
and examination 
(n = 28) 
531 women met 
the exclusion 
criteria 
Withdrew 
before the 
intervention 
started 
(n = 25) 
 
Dropped out 
(n = 1) 
616 women aged ≥ 30 years were screened and 
examined at the National Guard Residential City 

7
 
 
 
 
 
2.1 Clinical measurements 
The participant’s weight was measured without shoes and the height was measured 
using a stadiometer. Body mass Index (BMI) was calculated as weight in kilograms divided by 
height in meters squared. Waist circumference was measured in centimeters from the point 
midway between the inferior margin of the last rib and the iliac crest. Blood pressure was 
assessed in the sitting position using a standard mercury sphygmomanometer. A fasting blood 
sample was obtained using the CardioChek PA System, [Polymer Technology Systems, Inc. 
Indianapolis, USA] which provides results on cholesterol, high-density lipoprotein (HDL), 
glucose, and triglyceride levels. The results met the accuracy guidelines established by the 
National Cholesterol Education Program of the National Institutes of Health (Wellsource, 
2014). Blood samples were obtained at baseline and at 3 months. According to the above-
mentioned measures, FRS was calculated to estimate the 10-year risk of a major cardiovascular 
event and for risk categorization into low (<10% FRS), moderate (10%–19% FRS), or high 
risk ≥20% FRS). Those with moderate and high risks were evaluated for their metabolic 
syndrome status. They were classified as having metabolic syndrome if they satisfied 3 of the 
5 following criteria (based on the criteria established by the National Heart, Lung and Blood 
Institute for the diagnosis of metabolic syndrome) (Mosca et al., 2004; Yoon et al., 2012): (1) 
abdominal obesity, determined by increased waist circumference >88 cm in women; (2) 
increased triglyceride levels ≥1.7 mmol/L (150.6 mg/dL); (3) reduced HDL level of <1.30 
mmol/L (50.2 mg/dL); (4) elevated blood pressure ≥130 mmHg systolic or ≥85 mmHg diastolic 
blood pressure; and (5) increased fasting glucose level ≥6.1 mmol/L (109.8 mg/dL). Individuals 
with a high fasting blood glucose level ≥126 mg/dL (7.0 mmol/L), high blood pressure ≥140/90 
mmHg, or total cholesterol level ≥240 mg/dL (6.2 mmol/L) were referred to the primary health-
care center for further assessment by their respective physicians. Nevertheless, they still 
participated in the study. 
2.2. Study intervention 
The participants in the intervention arm of the study received a program of lifestyle 
modification, including health education, exercise training sessions, and diet counselling 

8
 
 
delivered by the researcher, health educator, physiotherapist, and nutritionist. Anthropometric 
measures, blood pressure, blood glucose level, total cholesterol level, triglyceride level, and 
HDL level were measured at baseline and after 3 months. Those assigned to the control arm 
received one session of health education at the screening site and underwent the same 
measurements. 
The intervention was a 1-month program based on the ‘Be Active your way’ (Services, 
2008), developed by the United States Department of Health and Human Services and the 
National Guidelines for Management of Cardio-metabolic Risk Factors (National Guideline, 
2011), developed by the Saudi Ministry of Health. The intervention was conducted in the 
morning and afternoon at the officer’s sports club in the residential city. The initial visit 
included assessment of the participant’s cardiovascular disease risk. The intervention was 
conducted in group and individualized sessions according to the participants’ needs and risk 
status. The lifestyle intervention program was designed to teach women how to incorporate a 
daily 30-minute physical activity of moderate-intensity into their routine and how to select and 
eat nutritious foods. The intervention arm included 31 participants and the intervention’s 
duration for the whole group was 4 weeks. About 10 individuals were included daily. Each 
participant had two visits to undertake the intervention over the period of 4 weeks (once every 
other week). During each visit, a 2-hour face-to-face educational session was conducted. 
During the 2 hours, each participant had to rotate through all the sections (researcher, health 
educator, exercise specialist, and nutritionist) and received different educational materials from 
trained staff. Various motivational measures were considered to keep meetings interesting and 
to boost attendance, such as contests and individual rewards. After the active intervention 
period, the participants were encouraged monthly by phone to maintain at least the 30 minutes 
of physical activity daily, a healthy diet, and to monitor the effect of these modifications on 
their health. 
The participants in the control (n=28) arm of the study received standard care at their 
primary health-care centers and one health education session of 30 minutes about CVD and 
itsrisk factors. They were given information about the prevention of these diseases by adopting 
healthy behaviors, including diet and exercise. 
2.3. Data Analysis 
Data entry and statistical analysis were conducted using the Statistical Package for 
Social Sciences version 22 (IBM, Armonk, NY, USA). Demographic and clinical data were 

9
 
 
analyzed using descriptive statistics, including means, standard deviations, and frequencies. 
Pre- and post-outcome measures were compared using the t-test or repeated-measures analysis 
of variance for continuous data. The effects of the intervention on multiple outcomes were 
evaluated using multiple linear regression techniques. Linear regression analysis was used for 
FRS. This research used an alpha level of 0.05 as the threshold for statistical significance. 
2.4. Ethical considerations 
The study was approved by the Scientific Committee of the Saudi Board Community 
Medicine Residency Program. The research methods and data collection were approved by the 
King Abdullah International Medical Research Center (KAIMRC) Ethics and Scientific 
Committee (Institutional Review Board approval number: RJ13/039/J). All participants 
received detailed information regarding the purpose and nature of the study and provided 
written informed consent before enrollment. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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3. Results 
The mean age of the intervention and control group was 49±6.5 and 48±5.6 years, 
respectively. The proportion of the employed among the participants in the intervention group 
(39%) was significantly greater than that in the control group (11%) (p=0.014). Other 
demographic details are shown in Table 1. 
 
Table 1: Sociodemographic characteristics of the participants (n=59) at the National Guard 
Residential City in Jeddah, Saudi Arabia, 2015 
Sociodemographic characteristic 
Intervention 
group (n = 31) 
Control group  
(n = 28) 
p-value 
Age (years) 
Mean ± SD 
49 ± 6.5 
48 ± 5.6 
0.315  
  
  
  
  
30-39 
1 (3%) 
0 (0%) 
40-49 
16 (52%) 
19 (68%) 
50-59 
12 (39%) 
9 (32%) 
60-69 
2 (7%) 
0 (0%) 
70+ 
  
  
Marital status 
Single 
 
 
  
0.318 
  
  
Married 
31 (100%) 
26 (93%) 
Separated 
0  
1 (3.5%) 
Divorced 
0  
1 (3.5%) 
Education  
Illiterate  
7 (22%) 
16 (57%) 
0.065 
  
  
  
  
  
Read and write  
3 (10%) 
2 (7%) 
Primary 
3 (10%) 
3 (11%) 
Intermediate 
4 (13%) 
2 (7%) 
High school 
5 (16%) 
0 (0%) 
University 
9 (29%) 
5 (18%) 
Occupation  
Housewife 
19 (61%) 
25 (89%) 
0.014*  
  
  
Employee 
12 (39%) 
3 (11%) 
Income/month (SR)  
<5000 
4 (13%) 
9 (32%) 
0.031*  
  
  
5000-10000 
12 (39%) 
14 (50%) 
>10000 
15 (48%) 
5 (18%) 

11
 
 
Data are presented as number and percentage (%). * Statistically significant at p < 0.05 (Chi 
square test). 
 
Data on dietary habits and physical activity showed that 62% of participants did not regularly 
exercise. Approximately 38% habitually missed breakfast. Once-a-day fruit and vegetable 
intake were satisfactory (42% and 46%, respectively). 
 
Table 2: The effect of a community-based lifestyle modification program in the intervention 
(n = 31) and control group (n = 28) status for modifiable risk factors (pre-post) at the 3-months’ 
follow-up at the National Guard Residential City in Jeddah, Saudi Arabia, 2015 
Paired t-test 
Measures  
Control group  
Intervention group 
Risk factor 
Mean 
difference 
95% CI of the 
difference 
(upper to lower) 
 p-value Mean 
difference 
95% CI of the 
difference 
(upper to lower) 
p-value 
BMI (kg/m2) 
-0.1821 
-0.3932 to 
0.0289 
0.088 
-0.832 
-1.302 to -0.362 0.001* 
Waist 
circumference 
(cm) 
-0.143 
-1.898 to 1.613 0.869 
1.871 
-5.036 to 8.778 0.584 
Total 
cholesterol 
(mg/dL) 
4.625 
-10.557 to 
19.807 
0.537 
3.774 
-22.270 to 
29.818 
0.769 
HDL (mg/dL) -1.190 
-6.852 to 4.471 0.670 
5.968 
0.021 to 11.914 0.049* 
LDL (mg/dL) 15.821 
0.633 to 31.010 0.042* 
11.419 
-4.428 to 27.267 0.152 
Triglycerides 
(mg/dL) 
-23.679 
-56.872 to 9.515 0.155 
-1.355 
-35.058 to 
32.348 
0.935 
Systolic BP 
(mmHg) 
-1.714 
-5.943 to 2.515 0.413 
-13.355 
-19.696 to -
7.013 
0.001* 
Diastolic BP 
(mmHg) 
0.214 
-2.367 to 2.796 0.866 
-4.516 
-8.672 to -0.360 0.034* 
Fasting blood 
glucose 
(mg/dL) 
-10.404 
-44.573 to 
23.766 
0.537 
-6.667 
-25.526 to 
12.193 
0.475 
FRS 
3.04286 
0.09271 to 
5.99300 
0.044* 
-4.932 
-6.203 to -3.661 0.001* 
* Statistically significant at p < 0.05. 
CI: confidence interval, BMI: body mass index, HDL: high-density lipoprotein; LDL: low-
density lipoprotein, BP: blood pressure, FRS: Framingham risk score. 
 

12
 
 
As shown in Table 2, five parameters significantly changed with the application of the 
intervention. BMI decreased from 33.7±6.6 kg/m2 to 32.9±6.5 kg/m2 (p<0.001). HDL level 
increased from 40.6±17.4 mg/dL to 46.5±8.8 mg/dL (p=0.049). Systolic blood pressure 
decreased from 141±18.4 mmHg to 127.6±13.9 mmHg (p<0.001), and diastolic blood pressure 
decreased from 91.9±11.5 mmHg to 87.42±9.7 mmHg (p=0.034). In addition, FRS 
significantly changed, decreasing from 13.02±3.3 to 8.1±5.03 (p<0.001). 
 
Table 3: The effects of a community-based lifestyle modification program on the Framingham 
risk score among the intervention and control groups (n=59) at the National Guard Residential 
City in Jeddah, Saudi Arabia, 2015 
Wilcoxon signed-rank test 
n 
Mean 
rank 
Sum of 
ranks 
Z 
p-value 
 
Framingham risk score 
(control group) 
Negative ranks 
7 
7.36 
51.50 
-2.226 
0.026 
Positive ranks 
14 
12.82 
179.50 
Ties 
7 
Framingham risk 
score (intervention 
group) 
Negative ranks 
27 
14.78 
399.00 
-4.464 
0.001 
Positive ranks 
1 
7.00 
7.00 
Ties 
3 
The result of the Wilcoxon signed-rank test (z= −4.46, p<0.001) showed a significant 
difference between the pre and post-intervention results. The 10-year CVD risk score was 
decreased in 27 subjects (87%) but increased in 1 (3%). Three (10%) subjects had the same 
pre- and post-intervention scores (Table 3). 
 
Table 4: Pre-post shift in Framingham category in the intervention and control group (n=59) 
at the National Guard Residential City in Jeddah, Saudi Arabia, 2015 
Chi-square test 
Risk category-post 
p-value 
 
Low 
Moderate 
High 
Risk  
category-pre (control) 
Moderate 2 
10 
7 
0.035 
High 
0 
1 
8 
Risk  
category-pre (intervention) 
Moderate 22 
7 
0 
0.001 
High 
0 
1 
1 
 
The chi-square correlation test revealed a significant difference (p<0.001) in 
Framingham risk category level (low, moderate, and high) in the intervention and control group 
before and after the intervention (Table 4). In the intervention group, 22 women (71%) shifted 
from the moderate to low level, 7 (23%) remained at the moderate level, and 1 (3%) remained 
at the high level. In addition, 1 woman (3%) shifted from the high to moderate level. 

13
 
 
 
Table 5: The 3-months’ effect of the lifestyle modification program on the intervention and 
control groups, with respect to the metabolic syndrome (n = 59) at the National Guard 
Residential City in Jeddah, Saudi Arabia, 2015 
ANOVA 
Variable 
n 
Mean 
SD 
95% Confidence 
Interval for Mean p-value 
Lower 
bound 
Upper 
bound 
Total 
Cholesterol 
(mg/dL) 
Control group 
28 
190.71 
44.500 173.46 
207.97 1.000 
Intervention group 
31 
190.71 
51.436 171.84 
209.58  
BMI (kg/m2) Control group 
28 
30.629 
8.1393 27.472 
33.785 0.236 
Intervention group 
31 
32.916 
6.5225 30.524 
35.309  
HDL 
(mg/dL) 
Control group 
28 
43.93 
11.566 39.44 
48.41 
0.329 
Intervention group 
31 
46.55 
8.820 
43.31 
49.78 
 
Triglycerides 
(mg/dL) 
Control group 
28 
137.36 
52.426 117.03 
157.69 0.086 
Intervention group 
31 
169.84 
84.887 138.70 
200.98  
LDL(mg/dL) Control group 
28 
122.79 
45.867 105.00 
140.57 0.538 
Intervention group 
31 
115.61 
42.943 99.86 
131.36  
Waist 
circumference 
(cm) 
Control group 
28 
105.68 
11.966 101.04 
110.32 0.272 
Intervention group 
31 
102.03 
13.144 97.21 
106.85  
Systolic BP 
(mmHg) 
Control group 
28 
136.93 
12.332 132.15 
141.71 0.009* 
Intervention group 
31 
127.65 
13.956 122.53 
132.76  
Blood glucose  
(mg/dL) 
Control group 
28 
142.36 
66.214 116.68 
168.03 0.003* 
Intervention group 
31 
97.61 
44.369 81.34 
113.89  
FRS 
Control group 
28 
21.6754 
8.46476 18.3931 
24.957 0.001* 
Intervention group 
31 
8.0939 
5.03199 6.2481 
9.939 
 
Metabolic 
syndrome 
Control group 
28 
3.393 
1.031 
2.993 
3.792 
0.906 
Intervention group 
31 
3.354 
1.379 
2.848 
3.861 
 
* Statistically significant at p < 0.05.  
ANOVA: analysis of variance, BMI: body mass index, HDL: high-density lipoprotein; LDL: 
low-density lipoprotein, BP: blood pressure, FRS: Framingham risk score. 
 
Table 5 illustrates the effect of the intervention after 3 months. Significant differences 
were noted in blood pressure (p=0.009) and blood glucose level (p=0.003). However, no 
significant difference was observed in blood lipids levels, BMI, and waist circumference. FRS 
differed significantly (p<0.001) between the intervention and control groups. Table 5 shows 
that metabolic syndrome status did not differ significantly between the intervention and control 
groups after 3 months of the intervention. 
 

14
 
 
A. Table 6:  The 3-months’ effect of the interventional program compared to the control in 
relation to demographics, social factors and co-morbid conditions. Linear regression 
model for the Framingham risk score difference (n = 59) at the National Guard 
Residential City in Jeddah, Saudi Arabia,  2015 
 
Coefficients 
Model 
Unstandardized Coefficients 
Standardized 
Coefficients 
t 
p-value 
 
B 
SE 
Beta 
(Constant) 
1.416 
2.047 
0.692 
0.492 
Intervention  
8.366 
1.621 
0.600 
5.162 
0.000 
Married 
-6.585 
2.384 
-0.306 
-2.762 
0.008 
40-49 years 
3.361 
1.635 
0.229 
2.056 
0.045 
R2: 0.436 
Adjusted R2:0.405 
 
Finally, a linear regression revealed that the intervention showed a statistically 
significant improvement in FRS between the two groups (p < 0.001), when all other co-variates 
were adjusted for. However, being married was a negative predictor of the cardiovascular risk 
difference (Table 6). 
 
4. Discussion 
A randomized controlled trial was conducted to assess the effect of a community-based 
lifestyle modification program in women with a moderate-to-high risk of CVD. The results 
demonstrate that this multidisciplinary intervention, tailored to the individual’s risk, was 
effective in reducing some of the CVD risk factors and the overall FRS, compared to standard 
care in women at moderate-to-high risk of CVD after 3 months. 
The current study showed significant favorable changes in some of the cardiac risk 
factors in the intervention group. BMI reduced by 0.8 kg/m2 and HDL improved by 5.9 mg/dL. 
In addition there were improvements in systolic and diastolic blood pressure by 13.3 and 4.5 
mmHg, respectively. FRS also decreased by 4.9. This agrees with previous Canadian and 
American studies, which showed improvements in the same cardiac risk factors (Cox et al., 
2013; American Diabetes Association, 2010). 
The study also revealed non-favorable changes in some of the cardiac risk factors in the 
control group. Low-density lipoprotein (LDL) worsened by 15.8 mg/dL and FRS increased by 

15
 
 
3.04. Other parameters did not differ significantly. The intervention by the multidisciplinary 
team could have motivated participants in the intervention group to take better charge of their 
health habits compared to the controls. This explanation is in congruence with other 
randomized controlled trials showing the effect of lifestyle intervention on CVD risk (Eriksson, 
2010; Goyer et al., 2013). 
At 3 months, the lifestyle intervention program had decreased systolic blood pressure 
and blood glucose levels. Reductions were significantly greater in the intervention group. This 
result is in accordance with findings from other lifestyle intervention studies (Eriksson, 2010; 
Cox et al., 2013; Pazoki et al., 2007; Goyer et al., 2013; Sarrafzadegan et al., 2013; Ebrahim et 
al., 2006). The intervention and control group also differed regarding blood glucose, which was 
lower in the intervention group by 45 mg/dL, as seen in the ANCHOR study (Cox et al., 2013). 
Although there was an improvement in HDL levels in the intervention group and the LDL level 
worsened in the control group, the intervention did not produce any significant difference in 
the overall blood lipid profile between both groups. These results compare favorably with the 
lifestyle intervention studies conducted by Eriksson et al. (2010), Pazoki et al. (2007), and 
Ebrahim et al. (2006) BMI decreased in the intervention group, but overall, reductions in BMI 
and waist circumference were not significant. The same findings were noted in another 
community-based healthy heart program study conducted in Iran (Pazoki et al., 2007). Rates 
of metabolic syndrome did not differ significantly between the intervention and control groups; 
however, other pre-post interventional studies showed an improvement in the status of 
metabolic syndrome. This could have been achieved through the effect of the behavioral 
counseling which is the cornerstone approach in the literature (Cox et al., 2013). 
Despite this, a significant reduction in FRS was demonstrated at 3 months. It is notable 
that in the intervention group, 71% of women shifted from the moderate to the low risk category 
and 3% of the participants shifted from the high to moderate risk category, thus, underpinning 
the intervention’s effectiveness. This improvement was shown in the pre- and post-intervention 
ANCHOR study (Cox et al., 2013). Moreover, FRS differed significantly between the 
intervention and control groups, decreasing in the intervention group and increasing in the 
control group. This was expected since most of the modifiable risk factors that are included in 
the calculation of FRS improved in the intervention group. This result is consistent with another 
randomized controlled trial on the efficacy of lifestyle intervention in reducing cardiovascular 
disease risk (Goyer et al., 2013). 
The positive predictors that improved outcomes in the intervention group included 
health education, diet counselling, exercise training sessions, and the younger age group. This 

16
 
 
could be due to their enthusiasm to improve their lifestyle and family health in general. 
However, being married was a negative predictor of the cardiovascular disease risk difference. 
The responsibilities of marriage might have made them less interested in improving their 
lifestyle. In agreement with this, some studies which assessed the motives for participating in 
a lifestyle intervention trial showed that participants were younger, single, had a higher level 
of education, and were employed (Lakerveld et al., 2008; Al-Baghli et al., 2010; Tanuseputro 
et al., 2003). Thus, the intervention itself represents a major change for the success of the 
program and for FRS reduction. These results could be helpful for identifying subjects with 
greater chances of successful lifestyle intervention in the development of future programs. 
4.1. Limitations of the study 
The follow-up duration could have been longer to examine the long-term effects of the 
intervention and of participants’ adherence to any acquired lifestyle changes. 
 
5. Conclusion 
This study suggests that a community-based intervention is effective for cardiovascular 
disease risk reduction. The 10-year CVD risk was successfully reduced among participants 
with moderate-to-high cardiovascular risk and without established CVD, by applying a 
comprehensive program tailored to the individual’s risk. The overall FRS was improved by the 
intervention. These results highlight the importance of multifaceted and comprehensive 
interdisciplinary programs that improve cardiovascular disease risk reduction, encourage 
healthy behaviors, and promote active lifestyles in persons at risk of CVD. 
 
Acknowledgements 
This work was supported by the National Guard Health Affairs, represented by the fund 
committee of the King Abdullah International Medical Research Center (KAIMRC). 
 
Conflicts of Interest 
None 

17
 
 
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