METHODOLOGY - Shodhgangashodhganga.inflibnet.ac.in/bitstream/10603/6686/8/08_chapter 3.pdf · namely Sri Iyyan textile mill and Devi Karunambigai mills, one public sector namely Bharat

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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.