MMEETTHHOODDOOLLOOGGYY
The methodology adopted for the study entitled “Prevalence and Risk
Assessment for Cardiovascular Diseases among Young Women and the Impact of Therapeutic Lifestyle Modification” was conducted in four phases and is
discussed under the following headings
3.1 PHASE I PREVALENCE OF CARDIOVASCULAR DISEASE AND IDENTIFICATION OF RISK FACTORS AMONG SELECTED WOMEN
The prevalence of cardiovascular disease among women was studied in two
multi specialty hospitals namely G. Kuppuswamy Naidu Memorial Hospital and Kovai
Medical Center and Hospital situated at Coimbatore district, Tamil Nadu. The
prevalence and the risk factors associated with cardiovascular disease were collected
for a period of six months through primary data.
The inclusion criteria for sample selection was women with a known history of
cardiovascular disease and newly detected patients with cardiovascular disease.
Women who reported of congenital disease and patients who came for repeated visits
were excluded from the study.
3.1.1 Background information and disease profile
A well designed interview schedule (Appendix I) was formulated to elicit
details on socio-economic status, disease profile, dietary and lifestyle pattern. An
interview schedule is a method of data collection with a set of questions to be answered
by the respondents (Kothari, 2009). Details on background information such as age, address, educational status and
occupation were elicited from the women. The disease profile of the women
including the type of the disease, duration, type of treatment, familial pattern and other
associated health problems were elicited. 3.1.2 Details on dietary and lifestyle pattern
3
The dietary and lifestyle pattern was elicited from the women with cardiovascular
disease in order to associate the risk factors of diet and lifestyle pattern with the disease The mean food intake of the women was recorded using a twenty four hour recall
method for three consecutive days. Twenty four hour dietary recall method is a
quantitative method used in nutritional assessment. This method is followed to
document food and beverage consumption and nutrient intake of the subjects. This
method records the daily, self-reported consumption of individuals and is most accurate
when administered more than once for each participant, and at least twice is acceptable
(Ferrari et al., 2002). Hence the twenty four hour recall was recorded for three
consecutive days. In addition to the mean nutrient intake, the dietary modifications followed by the
women with details such as type of diet, fibre rich foods, dairy products,type of fats and
oils, fleshy foods, snacks and beverages and salt intake was recorded using a
structured interview schedule. The per capita consumption of fat and salt was
determined.
TABLE 1
TYPE OF PERSONALITY
Type of personality Characteristics
Type A Ambitiuos,aggressive,business-like,highly competitive,
impatient and time conscious
Type B Patient, relaxed, and easy going
Type AB Type A and B - Ambitiuos, aggressive, business like,
highly competitive, impatient, time conscious, Patient,
relaxed and easy going
Type D Worry, irritability, gloom and lack of self assurance
The adoption of lifestyle pattern by the women with time spent for aerobic
exercise, practice of yoga and meditation, stress pattern and the type of personality was
elicited. The women were categorised as Type A, AB, B or D based on their personality
type as quoted by Williams (2001) is given in Table 1
3.1.3 Anthropometric measurements Using standard procedures, anthropometric measurements such as height,
weight, waist and hip circumference were recorded and the corresponding Body Mass
Index and Waist to Hip Ratio was calculated for all the women.
Height The height of an individual is principally a measure of skeletal body tissue, legs,
pelvis, spine and skull. The subjects were allowed to stand straight on a flat floor
against the wall without footwear. They were made to stand such that their head, back,
shoulder, buttocks and heels touched the wall and their head was positioned erect. A
horizontal scale was gently placed over the head of the subjects without pressing and a
mark was made on the wall. The distance between the position of head and toe was
measured using the non-stretchable fibre glass measuring tape and the height was
recorded for all subjects to the nearest accuracy of 0.1 cm.
Weight
The weight of the women was measured using the bathroom scale with casual
clothing and after removing their footwear. The weight was recorded to the nearest
accuracy of 0.5 kg.
Body Mass Index
The Body Mass Index (BMI) was calculated using the formula
Body Mass Index = )(mHeight
(kgs) Weight 2
The selected women were grouped based on the BMI classification published by
the Health Ministry of India (2008) as given in Table 2
TABLE 2
CLASSIFICATION OF BODY MASS INDEX
Body Mass Index Status Less than16 Chronic Energy Deficiency (CED) III
16.1 – 17.0 CED II
17.1 – 18.5 CED I
18.6 – 20.9 Under weight
21.0 – 23.5 Normal
23.6 – 25.0 At risk of obesity
25.1 – 30.0 Grade I obesity
Above 30 Grade II obesity
Waist Hip Measurements Waist circumference was measured, with the smallest circumference of the waist,
just above the belly button and the hip circumference was measured at its widest
participation of the hips. A stretchable fibre glass measuring tape was used to measure
the waist and hip circumference in centimeters.
Waist to Hip Ratio
Waist to hip ratio (WHR) was calculated using the formula
Waist (centimeters) Waist to Hip Ratio =
Hip (centimeters) Women with a ratio of 0.8 or less were considered safe and above 0.8 were
classified with central obesity (Centers for Disease Control and Prevention, (2009)).
3.1.4 Blood Pressure Blood pressure was
recorded for all the women using a
digital electronic blood pressure
monitor. Two consecutive blood
pressure measurements were taken
and averaged for analysis. A third measurement was taken when the difference
between the two measurements was ≥5 mmHg and subsequently, the mean was
calculated. A five-minute relaxation period between the measurements was maintained.
The classification of blood pressure given by National Cholesterol Education
Programme, 2005 was followed. 3.1.5 Lipid profile
The lipid profile of all the women
with cardiovascular disease was estimated.
Total cholesterol, triglycerides, high density lipoproteins and low density lipoproteins
was analysed using standard procedure
(Appendix II) and the values were
compared against reference values of
National Cholesterol Education
Programme, 2005.The method of analysis for lipid fractions is given in Table 3. Counselling on diet and lifestyle modification was imparted to all the women. A
booklet on “ guidelines for healthy heart” (Appendix III) comprising details such as
general guidelines for heart health, risk factors, dietary modifications, cooking methods,
planning menus, need for regular exercise, stress management and heart friendly
recipes was given to the women as education materials.
TABLE 3
ANALYSIS OF LIPID FRACTIONS
Lipid fractions Method
Total Cholesterol Enzymatic colorimetric test -Cholesterol Oxidase (CHOD) Phenol aminophenazone (PAP)
Triglycerides Enzymatic colorimetric test – glycerol-3-phosphate oxidase (GPO), Phenol aminophenazone(PAP)
High Density Lipoproteins Enzymatic colorimetric test - Polyethylene Glycol (PEG) – Cholesterol Oxidase (CHOD) Phenol Aminophenazone(PAP)
Low Density Lipoproteins Formula: HDL cholesterol – 0.46 X Triglyceride
One hundred heart friendly standardised recipes were included in the booklet. A
standardised recipe is one that has been tested and adapted for use and yield every
time the same results when the exact procedures are carried out with the same type of
equipment, the quantity and quality of ingredients (Philip, 2009).
The nutritive value of the recipes were calculated using Nutritive Value of Indian
foods by ICMR (2007). The recipe booklet was designed with the details of the recipes
such as ingredients, method of preparation and nutritive value of the recipe per serving.
3.2 PHASE II
ASSESSMENT OF RISK FOR CARDIOVASCULAR DISEASE AMONG SELECTED HEALTHY YOUNG WOMEN 3.2.1 Selection of women without cardiovascular disease
Women, especially young women have a greater risk for cardiovascular disease
in the modern day lifestyle and hence the risk among healthy young women for heart
diseases was assessed. Women in the age group of 20 to 40 years were selected as
the target group to assess the heart health risk. This age group was selected because
this is the prime age and women get affected by various physical and psychological
problems.
A total of one thousand
women, 500 employed and 500
unemployed in the age group of 21 to 40
years who had no known history of
cardiovascular disease were
selected using stratified sampling.
Stratified sampling is a sampling method indicating a sample that is not drawn at
random from the whole population, but separately from a number of disjoint strata of the
population in order to ensure a more representative sample (Kothari, 2009).
Five hundred women employed in
two private textile mills namely
namely Sri Iyyan textile mill and
Devi Karunambigai mills, one public
sector namely Bharat Sanchar Nigam
Limited (BSNL), Police Recruitment
School (PRS) and two Business Process
Outsourcing (BPO) namely Shristi
technologies and Alpha systems at Coimbatore were selected by census sampling. All
the women between 20 and 40 years in the selected employment sectors were selected
as the target group. According to Sharma (2007), census sampling includes the data
collected from each and every unit of the population which is the complete set of item
which are of interest in any particular situation.
Five hundred young women from the residential urban areas of Coimbatore
namely Saibaba colony, Ramalingam colony, Bharathi park and Alagesan Road were
selected based on convenience sampling. The women who gave their consent to
participate in the study were selected. 3.2.2 Development of Heart Health Risk Assessment Index A Health Risk Assessment (HRA) is an indicator to estimate the exposure to
chances or likelihood of getting a particular disease. It is a questionnaire, used to create
awareness among individuals to evaluate their health risks (Baker et al., 2007). A
Health Risk Assessment is one of the most widely used screening tools in the field of
health promotion and is the first step in multi-component health promotion programs.
The Centers for Disease Control and Prevention (2009) defines Health Risk
Assessment as a systematic approach to collect information from individuals that
identifies risk factors, provides individualised feedback and links the person with at least
one intervention to promote health, sustain function and prevent disease. The Heart
Health Risk Assessment Index (HHRAI) was developed taking into account the common
risk factors identified among the cardiovascular disease women in phase I and also
supported by research studies (Appendix IV).
The risk factors were categorised into non-modifiable and modifiable factors
(Mahan and Stump, 2008). As age increases, the risk for cardiovascular disease also
increases and a positive family history for cardiovascular disease is a risk factor. Hence,
age and familial history for cardiovascular disease were elicited. Body mass index, waist
to hip ratio, blood pressure, dietary and lifestyle pattern were categorised as the
modifiable factors. The dietary pattern include type of diet, type and quantity of fat
consumed, consumption of fibre rich foods, snacks and junk foods consumption,
consumption of coffee and salt intake were elicited. Lifestyle pattern was elicited with
the type of personality categorised either as type A, AB,B or D, pattern of physical
activity such as exercise, yoga and meditation. The type of stress namely familial,
occupational, environmental and neighborhood stress were used as the risk factors for
the Heart Health Risk Assessment Index. 3.2.3 Allotment of scores for Heart Health Risk Assessment Index
Scores were allotted for the 16 criteria in the Heart Health Risk Assessment
Index. A score is the number of points achieved by a person on a specific scale for a
particular characteristic indicating the rating of the sample. Scores ranging from zero to
ten was awarded to each criteria. The criteria which were normal without risk was given
zero. The score for the criteria with low risk was three and for the medium risk were
alloted five scores. The highest score ten was awarded to the criteria with the highest
risk. An overall score of 48 and less was categorised as low risk. Scores from 49
to 80 were categorised to be medium risk category and scores from 81 to 160 as
high risk for cardiovascular disease. The details of scores for the Heart Health Risk
Assessment Index are given in Table 4.
TABLE 4
HEART HEALTH RISK ASSESSMENT INDEX
Criteria Risk Category Score – 0 Scores – 3 Scores – 5 Scores – 10
Age (years) 20 to 25 26 to 30 31 to 35 36 to 40
Family history No history Third degree Second degree First degree
Body Mass Index 20 – 23.5 23.6 – 25 25.1 – 29.9 >30
Waist to Hip Ratio Less than 0.8 0.81 – 0.85 0.86 – 0.90 More than 0.9
Blood pressure mm/hg <120 /80 120 – 139
/ 80 – 90 140-159/ 91– 99 >160/100
Type of diet Vegetarian Ova vegetarian
Non vegetarian
(Poultry and fish)
Non vegetarian (Meat,poultry,
fish )
Type of fat and oil consumed per day
Combination of MUFA , PUFA,SFA
MUFA and PUFA
MUFA or SFA
SFA as a major
source Amount of visible fat consumed per day
Less than 20 g 21 – 25 g 26 - 30 g More than 30 g
Foods rich in fibre Daily Weekly once Monthly once Rarely
Snacks and junk foods consumption
Rarely Monthly once Weekly once Daily
Coffee consumption per day
No consumption
Less than 3 cups 3 to 5 cups More than 5
cups
Salt intake per day
Less than 5 g 6 to 8 g 9 to10 g More than10 g
Exercise pattern per day 30 minutes 15 minutes 10 minutes Nil
Yoga and meditation per day
30 minutes 15 minutes 10 minutes Nil
Stress pattern Relaxed Mild stress Moderate stress High stress
Type of personality Type B Type AB Type A Type D
TOTAL SCORES 0 Less than 48 49 – 80 81 – 160
RISK CATEGORY Normal Low Medium High
3.2.4 Validation of Heart Health Risk Assessment Index The developed Heart Health Risk Assessment Index was compared and
validated with the standard risk predictor for cardiovascular disease developed for
Framingham Heart Study, National Cholesterol Education Programme, Adult Treatment
Panel III, 2005. The details such as age, blood pressure, total cholesterol and high
density lipoproteins of 30 women with cardiovascular disease and 30 women without cardiovascular disease was compared using the standard risk predictor and the
developed Heart Health Risk Assessment Index. Using correlation analysis, Heart
Health Risk Assessment Index tool was validated.
Factor Analysis was carried out to measure the sample adequacy and the most
significant contributory factors to cardiovascular disease using Keiser –meyer– olkin
method. A total of 15 variables were loaded for factor analysis and the output nearest to
the value one and more than 0.5 were considered positive variables.
3.3 PHASE III
PROMOTION OF THERAPEUTIC LIFESTYLE INTERVENTION AMONG HIGH RISK CARDIOVASCULAR DISEASE WOMEN All the women (n=198) with scores above 81 categorised as high risk were
selected for the therapeutic lifestyle intervention. One thousand women, both employed
and unemployed were assessed for risk of cardiovascular disease with HHRAI. Women
with low risk (n=240) and medium risk (n=562) were given individual counselling based
on the diet and lifestyle modifications.Therapeutic Lifestyle Changes (TLC) are the first
and possibly the most important therapy to treat many chronic health problems.
Therapeutic Lifestyle changes are recommended as the first line of therapy for reducing
the risk of serious health conditions, such as heart disease, stroke, diabetes, arthritis,
osteoporosis and obesity (Gordon et al., 2004).
Adoption of therapeutic lifestyle intervention in the early stages of life can
postpone or delay the onset of the disease and bring behavioural modifications and
hence intervention methods were adopted. A single approach method with one
intervention and a combination approach method with two or more interventions were
adopted. Diet, weight and stress management were adopted as single approach
method. Diet and weight management, diet and stress management and all the three
interventions together namely diet, weight and stress management were adopted for the
combination approach methods. The high risk women with a Body Mass Index above 23.5 and Waist to Hip Ratio
above 0.8 were grouped into seven groups with each group consisting of twenty four
women making up a total of 168 were selected for the intervention for a period of four
months. An informed consent was obtained from all the women to know their willingness
to participate in the study. Six groups were treated as experimental groups and one group (seventh)
served as the control. For the single approach method, groups I, II and III were given
diet management, weight management and stress management respectively. For
groups IV, V and VI, a combination intervention method was adopted namely diet and
weight management, diet and stress management and diet, weight and stress
management respectively. For group VII, no intervention was given.
3.3.1 Diet Management
As the findings of the study in phase I and phase II pointed out that fibre intake
was very low among the selected women, a fibre rich supplement was developed for the
diet intervention. Whole grains and millets rich in fibre were selected. Italian millet
(Setaria itallica), whole wheat (Triticum aestivum) , bajra (Pennisetum typhoideum) and
soya flours (Glycine max), carrots, curry leaves and spices such as turmeric, pepper,
cinnamon and garlic, almonds, groundnut oil and salt were the ingredients selected. The
whole grains and millets were selected for the rich source of fibre, almonds and
groundnut oil for their mono unsaturated fatty acid content, carrots and curry leaves for
the rich source of beta carotene and spices were included for their essential
compounds.
Consumption of nuts is associated with decreased risk of cardiovascular disease
reported Caterina et al.(2006). Spices such as garlic, pepper, turmeric and cinnamon
contain a variety of natural compounds that act as antioxidants, protecting cells from
invasive damage caused by free radicals and hence these advantages were used for
the development of the supplement. The standardised format of the cookies is given
below.
Groundnut oil 3 ml
Turmeric 2 g
Cinnamon 2 g
Salt, Pepper to tase
Three recipes namely porridges, soups and cookies were developed.
The recipes were standardised and evaluated for acceptability by a 30 member panel.
Organoleptic qualities such as appearance, texture, flavor and taste were evaluated
with five point rating scales (Scores five to one with 5 – Extremely, 4 – Very Good,
3- Good, 2- Fair, 1- Poor). The product which was rated with the highest overall
acceptability was finally selected for the diet intervention.
The preparation of cookies is given in figure 1
FIGURE 1
PREPARATION OF COOKIES
LARGE SCALE PREPARATION OF COOKIES IN BAKERY
Dough making
Rolling and Slicing
Baking
Cookies with Italian millet flour, wheat flour, and soya flour in the ratio of 1:1:0.5
obtained the highest overall acceptability and hence was selected for
supplementation. Nutrient analysis was carried out for protein, fat, carbohydrate, total
fibre, iron, sodium, potassium, calcium, mono unsaturated fatty acids, total antioxidant
activity and beta carotene was also estimated using standard procedure (Appendix VI)
The microbial safety of the product was tested through standard plate count method and
the tests were conducted on the initial, fifth, tenth and fifteenth day of storage. The total
viable count for microbial safety was determined by the aerobic colony count by HBP
method for the target micro organisms (Appendix VII)
Four Cookies weighing 25 grams each was given for a period of four months, two
as midmorning and two as evening snack to group I women. Biscuits were prepared
once in five days and were packed in polyethylene covers and were distributed in
person to the target group.
A counselling session was
conducted prior to supplementation and the
women were advised to maintain a food diary
(Appendix VIII) to record their daily intake.
The diary was intended to be as a self
assessment aid and the investigator
periodically monitored the consumption.
In addition to this, emphasis on
balanced diet, role of fibre, antioxidants, type
and quantity of fat to be consumed was imparted
through diet counselling to the women using
power point presentation and pamphlets
(Appendix IX and X) through individual and
group counseling. The booklet with guidelines
for healthy heart was distributed to all the women.
TABLE 5
CONTENTS FOR DIET COUNSELLING
Topic Content Counselling Aid
Food and diet in maintaining health Food and Health
Balanced diet, transition of food habits, ways to burn calories and healthy eating habits Healthy weight, balanced diet, Importance of fibre, antioxidants and prescriptions for a healthy heart
Power point Presentation
Pamphlet
Heart friendly recipes
Heart healthy tips, Recipes
Booklet
A twenty four hour recall method for three consecutive days was recorded to
determine the nutrient intake of the women prior to the intervention. The body weight
and twenty four hour recall was recorded for all the women every month.
3.3.2 Weight Management
Physical inactivity increases the risk of developing heart disease by 1.5
times and doubles the risk of developing type II diabetes and significantly raises the risk
of high blood pressure.
A direct relationship between physical inactivity and cardiovascular mortality for
the development of coronary artery disease is well established. Persons who remain
sedentary have the highest risk for cardiovascular disease mortality, and hence weight
management was taken up as an intervention strategy and group II women were given
aerobic exercises for four months. Women were linked with a fitness centre namely Star
gym at Saibaba Colony and were advised to carry out work outs at the gym.
Aerobic exercises for 30 minutes every day was given for weight management.
Aerobic exercise is any form of exercise that can be sustained for few minutes while the
heart, lungs, and muscles work higher. The women were advised to maintain an activity
diary (Appendix XI) and were periodically monitored by the investigator to check
continuity among the women in the weight management. The details of the equipment
and the activity are given in Table 6 and the video document of the women at weight
management is given in Appendix XII.
TABLE 6
DETAILS OF EQUIPMENT AND PHYSICAL ACTIVITY
EQUIPMENT BENEFIT Tread mill Lower body and cardio Elliptical fitness exerciser Calf and thighs Pedelar Calf and thighs Rowing Arms Cycle Lower body Twister Hip muscles Strength routine Muscle group – biceps, triceps,
gluteous and abdomen Stretch machines Stretching muscles
Women worked out with the equipment such as tread mill for lower body and
cardiac strength for six minutes. In the elliptical fitness exerciser, the work out was for
three minutes and pedelar for four minutes to strengthen calf and thigh muscles.
Rowing to strengthen arms, cycle to relax lower body, twister to hip muscles, strength
routine for muscle group namely biceps, triceps, spinal region and abdomen stretching
machines for stretching and relaxing muscles for 20 minutes with four minutes each.
Enas, 2009 quoted that the work out of 30 minutes every day would burn 100
kilocalories everyday and a reduction of two kilograms every month. Weight was
recorded every month for the women and body mass index was calculated.
3.3.3 Stress Management American Psychiatric Association, (2000), refers stress to mental tension and
highly associated with negative effects on the heart and other parts of the body. Acute
and chronic stress lead to other risk factors and behaviours, such as high blood
pressure and cholesterol levels, physical inactivity and overeating. Hence stress
management was given in two modules with yoga as module I and positive therapy as
module II for group III women for a period of four months.
Module I comprising yoga classes were conducted by a yoga expert. Women
performed yoga for 30 minutes every day for four months. Module II, was conducted
twice a month with the components of positive therapy including deep breathing
exercises, auto suggestions for positive thoughts, counseling, tension releasing
exercises including smile therapy and laughter therapy. The details of the various stress
management namely yoga, positive therapy is presented in Table 7 and video
document of the women at stress management is given in Appendix XIII.
TABLE 7 YOGA AND ITS BENEFIT
Yoga Benefit
Suryanamaskar (sun salutation) Whole body, blood circulation
Ardh halasana Abdomen,legs,spine,reproductive organs
Sarbangasana Nerves, thyroid, circulation
Halasana Spine,nervous system,lungs
Bhujangasana Legs,hips,digestion
Padahastasana Digestion,spine, legs
Shavasana Physical and mental relaxation
Positive therapy Relaxation therapy
Tension releasing exercise Counselling
The interventions with focus to stress management involved yoga, and positive
therapy for 30 minutes every day. The yogas performed were suryanamaskar, ardh
halsana, sarbangasana, halasana, bhujangasana, padahastasana, shavasana for three
minutes each and for a total of 21 minutes and positive therapy for 10 minutes. 3.3.4 Combination approach method
The group IV women were given diet and weight management intervention. This
included diet counselling, supplementation of cookies for four months and regular
aerobic exercises for 30 minutes everyday. Women in the diet and stress management
group (Group V) were given supplementation with the cookies for four months, diet
counselling and yoga for 30 minutes every day along with positive therapy. Women in
the diet, weight and stress management group (Group VI) had all the three approaches
with diet counselling, supplementation, regular physical activity, yoga and positive
therapy.
The seventh group, with no intervention was monitored for a period of four
months.
3.4 PHASE IV IMPACT OF THERAPEUTIC LIFESTYLE MODIFICATION
The impact of the therapeutic lifestyle changes were evaluated by testing for
changes in risk scores of Heart Health Risk Assessment Index, blood pressure and lipid
profile at pre and post intervention for all the 168 women.
Grundy et al. (2000) reported that the newer predictive factors for cardiovascular
disease may significantly increase the numbers benefiting from twenty first century
diagnostics and treatment. Hence, the tests for serum biochemical inflammation
markers of cardiovascular diseases such as homocysteine (chemiluminescence
immunoassay method (CLIA method)), C reactive protein (turbidimetric
immunoassay method) and lipase A (enzymatic method) were carried out for a
subsample of six women each in Group I, IV, V and VI at pre and post intervention
period. Since the groups I, IV, V and VI were given two or three intervention strategies,
these groups alone were tested for the serum biochemical inflammation markers.
Statistical interpretation of data
Statistical analysis such as chi square, t test to find the significant differences in
the groups, Analysis of Variance (ANOVA) and Analysis of Covariance (ANACOVA) to
interpret the significance between and within groups were carried out at different phases
of the study. The post hoc test, namely Least Significant Difference (LSD) to interpret
the groups with least degree of significance was carried for the intervention groups.