RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES KARNATAKA, BANGALORE

ANNEXURE – II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. Name of the candidate and address ABIN P. SIMON (in block letters) I YEAR M. Sc. NURSING DR. M. V. SHETTY COLLEGE OF NURSING VIDYANAGAR MANGALORE – 575013.

2. Name of the Institution DR. M. V. SHETTY COLLEGE OF NURSING VIDYANAGAR MANGALORE – 575013.

3. Course of Study and Subject M. Sc. NURSING COMMUNITY HEALTH NURSING

4. Date of Admission to the Course 22.06.2011

5. Title of the study

AN EVALUATORY STUDY TO ASSESS THE EFFECTIVENESS

OF INFORMATION GUIDE SHEET ON HEART SMART DIET

AMONG CLIENTS WITH HYPERTENSION IN SELECTED

URBAN AREA OF MANGALORE CITY.

6. Brief resume of the intended work

1 6.1 Need for the study

“It was not raining when Noah built the ark-plan ahead”

Health is one of those terms which most people find it difficult to define although they are confident of its meaning. During the past few decades there has been a reawakening that health is a fundamental human right, and a worldwide social goal; that it is essential to the satisfaction of basic human needs and to an improved quality of life; and it is to be attained by all people. In the last five decades the global population has more than doubled, so as the diseases too1.

Interestingly hypertension is one of the chronic diseases which have shown in the largest decline in mortality in some countries during the past four decades. It is often called as ‘Silent Killer’ because it can remain undetected for years. Hypertension is the abnormal elevation of blood pressure. Blood pressure is the pressure exerted on the artery walls by the blood flowing through it. Blood pressure has two readings, systolic and diastolic pressure, which is expressed in millimetres of mercury (mm of Hg). The normal level of blood pressure is 120/80 mm of Hg. The World Health Organisation criterion for Hypertension is B.P ≥160/90 mm of Hg. The higher the blood pressure, the greater the risk and lower the expectancy for life2.

Currently one third of the global deaths are caused by cardiovascular diseases. The World Health Organisation estimates that globally about 600 million people are suffering with hypertension and are at risk of heart attack, stroke, and heart failure. About 15-37 percent of adult population in the world has hypertension. A study by American Heart Association shows about 140 million people in America suffer from hypertension. Worldwide, high blood pressure is estimated to cause 7.1 million deaths every year, about 13% of the global fatality total. Across World Health Organisation regions researches shows that 62% of strokes and 49% of heart attacks are caused by, high blood pressure. Hypertension causes 5 million premature deaths a year worldwide3.

Hypertension is a major public health problem in India and other developing

2 countries. It has been a significant problem and contributor to other cardiovascular diseases4. An ICMR study regarding the prevalence of hypertension in urban and rural residents demonstrated 29% and 25% respectively. Various studies estimates a prevalence rate of hypertension among urban population is 36.4% and for rural population is 21.2% in India8.

Cardiovascular disease contributed to 2.3 million deaths in India in 1990 and is projected to double by the year 2020. Hypertension is directly responsible for 57% of stroke deaths and 24% of coronary heart diseases deaths in India. In an evaluation of multiple examinations in various Indian populations, there appear to be higher levels in urban versus rural subjects, with a strong correlation between changing lifestyle factors and the increase in hypertension in India10. Among different states in India, Karnataka occupies eighth place with regard to population. In India, about 30% of people live in cities and Karnataka state 34.0% of people live in urban communities9. Studies show that a higher prevalence of 69% and 55% was recorded among elderly populations aged sixty and above in the urban and rural areas respectively during past few years in some of the south Indian states3.

Hypertension cannot be cured but can be controlled through lifestyle changes and prescriptive medications. Even though medications to treat hypertension are available researches shows that modest lifestyle and dietary changes can help treat and often delay or prevent hypertension. Hypertension is considered as a serious and common problem in the community, so it is necessary to create an awareness regarding this ‘silent killer.’ Studies shows that change in the dietary pattern will help to stop or decline the incidence of hypertension2.

The ‘Heart Smart Diet’ is a physician-recommended diet for people with hypertension. This modified plan of diet contains the food items which are newly added and excluded from normal daily eating menu6,7. A study conducted by National Institutes of Health has been proven to lower blood pressure by this modified diet. In addition to being a low salt (or low sodium) plan, the Heart Smart Diet provides additional benefits to reduce blood pressure. This diet contains high fibre, potassium, calcium, and magnesium, low to moderate fat and it is also rich in fruits, vegetables, and whole grains The diet is a healthy plan, designed for the whole family7.

An experimental study on ‘A dietary approach to prevent hypertension’ was conducted among African Americans. The objective of the study was to find out the

3 effectiveness of change in dietary pattern on hypertension. Participants of the study were 459 adults with untreated systolic blood pressure <160 mm of Hg and diastolic blood pressure 80-95 mm of Hg. After a three week run-in a control diet typical of Americans, they were randomised to 8 week receiving the control diet. The controlled diet lowered the systolic blood pressure significantly in the total group by 11.6/5.3 mm of Hg. The researcher concluded that control diet may offer an alternative to drug therapy in clients with hypertension and as a population approach, may prevent hypertension11.

An experimental study on ‘Effects of Comprehensive Lifestyle Modification on Diet, Weight, Physical Fitness, and Blood Pressure Control’ was conducted in Maryland. Study was objected to compare the 18-month effects of 2 multi component behavioural interventions versus advice only on hypertension status, lifestyle changes, and blood pressure. 810 samples were selected for the study with pre-hypertension. Reductions in blood pressure at 18 months were greater for participants in the established and the established plus Dietary Approach to Stop Hypertension groups than for the advice only group. The researcher concluded that persons with pre-hypertension and stage 1 hypertension can sustain multiple lifestyle modifications that improve control of blood pressure and could reduce the risk for chronic disease12.

The investigator, during his posting observed many people in the urban community with Hypertension. Even though they are educated they are not bothered of ‘what to eat, what not to eat’ in order to keep their heart safe. This is due to the sedentary life style habits. These clients are following hypertensive medications strictly but not practicing the modified diet plan except a reduction in salt consumption. It is the responsibility of a community health nurse to educate the community regarding this serious problem. Thus the investigator felt the need to provide an information guide sheet which can provide information regarding ‘Heart Smart Diet’ for the clients with hypertension to keep their heart safe as hypertension is the major risk factor for stroke and other cardiovascular diseases.

6.2 Review of literature

A qualitative study on ‘Perception on hypertension among migrants in Delhi’ was

4 conducted in Delhi. This study used a grounded approach to develop an understanding about how disadvantaged migrants in Delhi view hypertension. Data were collected by snowball sampling and through in-depth interviews with key-informants and focus group discussions with community members. A total of 14 key informants were selected. It is identified that several factors like old and middle age, dietary habits, obesity, physical activity, tensions, etc are responsible for increasing prevalence of hypertension. Participants emphasized on the dietary aspects in terms of low salt diet, vegetarian diet, avoiding fried and commercially available foods and exercises by means of walking and yoga. The researcher concluded that hypertension was perceived as a common and serious problem in the community and recommended the need for awareness campaigns and mass-screening programmes for hypertension. Awareness regarding the risk factors should be made accessible to the public through various means such as Information, Education and Communication campaigns, along with provision of primary health services and proper referral4.

A prospective cohort study on ‘Association between a Dietary Approach to Stop Hypertension-like diet and mortality in adults with hypertension’ evaluated the association between diet and Mortality in 5,532 hypertensive adults in the Third National Health and Nutrition Examination Survey in New York, U.S.A. Hypertension was determined by self- report, medication use, or BP measurement. Diet was ascertained by 24-hour dietary recall using nine nutrient targets. The primary outcome was all-cause mortality. Secondary outcomes included specific causes of mortality like cardiovascular disease, ischemic Heart disease, stroke, and cancer. Of the 5,532 participants, 391 (7.1%) consumed a Dietary Approach to Stop Hypertension-like diet. During an average of 8.2 person-years of follow- up, there were 1,537 all-cause deaths; this included 312 cancer deaths and 788 cardiovascular deaths, of which 447 were due to ischemic heart disease and 142 were due to stroke. After adjusting for multiple confounders, a Dietary Approach to Stop Hypertension- like diet was Associated with lower mortality from all causes (hazard ratio 0.69, 95% Confidence interval 0.52-0.92, P = 0.01) and stroke (Hazard Ratio 0.11, 95% Confidence Interval 0.03-0.47, P = 0.003). Mortality risk from cardio vascular disease (Hazard Ratio 0.92, 95% Confidence Interval 0.63-1.35, P = 0.67), ischemic heart disease (Hazard Ratio

0.77, 95% Confidence Interval 0.47-1.24, P = 0.28), and cancer (Hazard Ratio 0.51, 95% Confidence Interval 0.23-1.10, P = 0.09) did not reach statistical significance. The study findings for specific causes of mortality are mixed and researcher concludes that

5 consumption of a Dietary Approach to Stop Hypertension-like diet is associated with lower all-cause mortality in Adults with hypertension13.

A Randomised controlled factorial trial of dietary advice for patients with a single high blood pressure reading was conducted in Southampton. The objective of the study was to assess the effect of brief interventions during the "watchful waiting" period for hypertension. Design used for study was Factorial trial. 296 patients with blood pressure > 160/90 mm Hg were randomly selected and were grouped by three factors: an information booklet; low sodium, high Potassium and salt; prompt sheets for high fruit, vegetable, fibre; and low fat. The study shown that blood pressure was not affected by the booklet. Among those with lower fruit and vegetable consumption (< 300 g per day), prompts increased fruit and vegetable consumption and also carotenoid concentrations (difference 143 (16 to 269) mmol/l, P < 0.03) but did not decrease blood pressure. The researched concluded like during watchful waiting, over and above the effect of brief advice and monitoring, an information booklet, lifestyle prompts, and low sodium salt do not reduce blood pressure. Researcher suggests that brief interventions-particularly lifestyle prompts-can make useful changes in diet and help control weights which are likely to reduce the long term risk of stroke14.

A cross-sectional survey on ‘Association of trans fatty acids and clarified butter intake with higher risk of coronary artery disease in rural and urban populations with low fat consumption’ included 1769 rural and 1806 urban randomly selected subjects between 25-64 years of age from Moradabad in North India. Analysis among urban and rural subjects consuming moderate to high fat diets showed that subjects eating trans fatty acids plus clarified butter or those consuming clarified butter as total visible fat had a significantly higher prevalence of coronary artery disease compared to those consuming clarified butter plus vegetable oils in both rural (9.8, 7.1 vs. 3.0%) and urban (16.2, 13.5 vs. 11.0%) men as well as in rural (9.2, 4.5 vs. 1.5%) and urban (10.7, 8.8 vs. 6.4%) women. Univariate and multivariate regression analysis with adjustment for age showed that sedentariness in women, body mass index in urban men and women, milk and clarified butter plus trans fatty acids in both rural and urban in both sexes were significantly associated with coronary artery disease. The researcher concluded that it is possible that lower intake of total visible fat (20 g/day), decreased intake of milk, increased physical activity and cessation of smoking may benefit some populations in the prevention of coronary artery disease5.

6 6.3 Statement of the problem

“An evaluatory study to assess the effectiveness of Information Guide Sheet on Heart Smart Diet among clients with Hypertension in selected urban area of Mangalore City.”

6.4 Objectives of the study

The objectives of the study are to:

 Assess the pre-test knowledge scores of clients with hypertension regarding Heart Smart Diet by using structured knowledge questionnaire.

 Determine the effectiveness of information guide sheet regarding Heart Smart Diet among clients with Hypertension by using same structured questionnaire.

 Find the association between pre-test knowledge scores regarding Heart Smart Diet among clients with hypertension and selected demographic variables.

6.5 Operational definitions

1. Assess: Evaluate the value, importance or quality of (Oxford Dictionary).

In this study it refers to the act of determining knowledge regarding Heart Smart Diet among clients with hypertension by using structured knowledge questionnaire.

2. Effectiveness: Producing the intended effect (Oxford Dictionary).

In this study it refers to the extent to which the information guide sheet has achieved desired effect as evidenced by gain in post test score of knowledge achieved by clients with hypertension regarding Heart Smart Diet.

3. Knowledge: Information or awareness gained through experience or education (Oxford Dictionary).

In this study it refers to awareness of clients with hypertension regarding Heart Smart Diet, as measured by structured knowledge Questionnaire.

7 4. Heart smart diet: Heart smart diet is one that incorporates plenty of fruits, vegetables and whole grains that helps in reducing the risk of coronary heart disease, high cholesterol and other complications associated with excess consumption of fatty or overly processed foods (www.heartsmartdiet.com/pub med/articlereview.html).

In this study it refers to the modified diet plan which is composed of whole grains, plenty of fruits and vegetables for the persons suffering with hypertension in order to avoid complications of hypertension and to make heart safe which is done through the administration of an information guide sheet.

5. Client: A person using the service of a professional or an organization (Oxford Dictionary)

In this study it refers to the person who has blood pressure ≥140/90 mm of Hg and is diagnosed with hypertension from 0-5 years, not associated with any other complications of hypertension and is on hypertensive medications, to whom which the investigator is giving knowledge regarding Heart Smart Diet.

6. Hypertension: Hypertension means transitory or sustained elevation of systemic arterial blood pressure to a level likely to induce cardiovascular damage or other adverse consequences. (Med lexicon’s medical dictionary).

In this study it refers to the elevated reading of blood pressure. i.e. ≥ 140/90 mm of Hg which is measured by a standard device, Sphygmomanometer.

7. Urban area: A town or a city (Oxford Dictionary).

In this study it refers to the geographical area coming under urban areas of Mangalore city corporation limit. This is a coastal area of Mangalore. The area is easily reachable and is near about 14 km from the college and the people in this area are interested to know more about health aspects.

8. Information guide sheet: It is a guideline which provides knowledge about heard or discovered facts to somebody (Oxford Dictionary).

In this study it refers to the guidelines provided to the persons with hypertension containing a 7 day modified menu plan for the clients with hypertension in order to reduce hypertension thereby reducing the risk of getting cardiac problems.

8 6.6 Assumptions

The investigator assumes that:

1. Clients with hypertension will have minimal knowledge regarding Heart Smart Diet.

2. Clients with hypertension will be practicing the modified diet plan as advised by the Physician.

3. Heart Smart Diet will reduce the risk of cardiac problems in clients with hypertension.

4. The information guide sheet on Heart Smart Diet will bring some changes in the knowledge among clients with hypertension in order to reduce its risk.

6.7 Hypotheses

Hypothesis will be tested at 0.05 level of statistical significance.

H1: There is a significant difference between the mean knowledge scores of pre-test and post-test regarding Heart Smart Diet among clients with hypertension.

H2: There will be a significant association between the pre-test knowledge score regarding Heart Smart Diet among clients with Hypertension and selected demographic variables.

6.8 Delimitations

The study is delimited to:

 50 subjects with hypertension who fulfil the inclusion criteria..

 the selected urban area of Mangalore only.

9  samples of 30-60 years of age group.

7. Material and methods

7.1 Source of data

The data will be collected from the clients with hypertension who fulfil the inclusion criteria.

7.1.1 Research design

The research design selected for this study is Quasi experimental design, with one group pre test and post test.

Pictorial representation:

Sample Pre test Intervention Post test Effectiveness.

I O1 X O2 E

The clients Assessment Administration Assessment of E= O2 – O1 with known of pre- of information knowledge on case of existing guide sheet on Heart Smart hypertension. knowledge Heart Smart Diet by using regarding Diet. same Heart Smart structured Diet by using knowledge structured questionnaire. knowledge questionnaire.

7.1.2 Setting

The study will be conducted in a selected urban area at Mangalore, Dakshina Kannada, Karnataka. Which comes under the limits of Mangalore city corporation and it is a coastal area also. The investigator selected this area because this area was allotted for different batches of U.G and P.G students of the institution for the urban community field experience. The Urban community is easily accessible from the college.

7.1.3 Population

10 The population consists of clients with hypertension (BP≥140/90 mm of Hg), diagnosed from 0-5 years, not associated with any complications of hypertension and is on hypertensive medications and are staying in the selected urban area of Mangalore city.

7.2 Method of data collection

Sample: The samples selected are with Blood Pressure ≥ 140/90 mm of Hg from selected urban area.

7.2.1 Sampling procedure

The samples are selected by purposive sampling method.

7.2.2 Sample size

In this study the researcher has planned to take 50 clients with hypertension from the selected urban area as the sample.

7.2.3 Inclusion criteria for sampling

Clients with hypertension who are:

 residing in the urban area.

 both male and female with Blood Pressure ≥ 140/90 mm of Hg.

 with age group 30-60 years.

 available at the time of data collection.

 willing to participate in the study.

 able to read and write Kannada.

7.2.4 Exclusion criteria for samplings

Clients with hypertension who:

 already have knowledge regarding Heart Smart Diet.

 work as a health care professional.

11  are having any complications of hypertension and suffer from any other chronic illness.

7.2.5 Instruments intended to be used

A structured knowledge questionnaire to assess the knowledge regarding Heart Smart Diet.

7.2.6 Data collection method

Step 1: The data will be collected from sample after obtaining permission from the concerned authorities of the selected urban community at Mangalore.

Step 2: The samples will be selected by using purposive sampling technique, based on inclusion criteria.

Step 3: The objectives of the study will be explained and their written consent will be taken.

Step 4: Assessing the knowledge of participants by using a structured knowledge questionnaire.

Step 5: Information Guide Sheet regarding Heart Smart Diet will be given to participants and are motivated to strictly follow the modified dietary regimen.

Step 6: Post-test will be conducted for all the participants on the eighth day of the intervention.

Step 7: Prepare the data for the analysis by using different statistical methods.

7.2.7 Plan for data analysis

Collected data will be analysed by using descriptive and inferential statistics.

7.3 Does the study require any investigations or interventions to be conducted on patients, or other animals? If so please describe briefly.

Yes, blood pressure will be measured using standard device, Sphygmomanometer and information guide sheet regarding Heart Smart Diet will also be administered.

12 7.4. Has ethical consideration been obtained from the institution in case of the above?

Yes, ethical clearance has been obtained from the ethical committee of the institution. Consent from samples will be taken at the time of data collection.

8. References

1. Park K. Park’s textbook of preventive and social medicine. 20th ed. New Delhi, India: M/s. Banarsidas Bhanot Publishers; 2009.

2. Anderson J, Young L, Long E. Food science and human nutrition. Diet and Hypertension 318(9).

3. World Health Organization (WHO) Publications – Cardiovascular Diseases. [online] [2004]. Available from: URL:http://www.who.int/cardiovascular_diseases/en/

4. Yadlapalli KS. Perceptions on hypertension among migrants in Delhi, India: a qualitative study. [online]. Available from:

13 URL:http://creativecommons.org/licenses/ by/ 2.0.

5. Singh RB, Niaz MA, Ghosh S, Beegom R, Rastogi V, Sharma JP, Dube GK. Association of trans fatty acids and clarified butter intake with higher risk of coronary artery disease in rural and urban populations with low fat consumption. Int J Cardiol 1996 Oct 25; 56(3):289-98.

6. Heart Smart Diet Plan Review. [online]. Available from: URL:http://www.ehow.com/about_ 5329678_heart-smart-diet-plans.

7. The DASH Diet Eating Plan. [online]. Available from: URL:http://theDASHeatinplan. family-education//www.pubmed.com.

8. National Cardiovascular Disease Database. Supported by Ministry of Health & Family Welfare, Government of India and World Health Organization. IC HEALTH. No: SE/04/233208.

9. Area and population of Karnataka. [online]. Available from: URL:http://www.karnataka.com/profile/area.html

10. Race-based therapy for hypertension: possible benefits and pitfalls: hypertension in Asian individuals. [online]. Available from: URL:www.medspace.com/view article/584366-9.

11. Dodani S. Community-based participatory research approaches for hypertension control and prevention in churches. Int J Hypertens 2011;2011:273120.

12. Effects of comprehensive lifestyle modification on diet, weight, physical fitness, and blood pressure control: 18-month results of a randomized trial. [online]. Available from: URL:http://www.annals.org/content/144/7/485.short.

13. Parikh A, Lipsitz SR, Natarajan S. Association between a DASH-like diet and mortality in adults with hypertension: findings from a population-based follow-up

14 study. Am J Hypertens 2009 Apr;22(4):350.

14. Little P, Kelly J, Barnett J, Dorward M, Margetts B, Warm D. Randomised controlled factorial trial of dietary advice for patients with a single high dose blood pressure reading in primary care. BMJ 2004 May;328(7447):1054.

15 9. Signature of the candidate

10. Remarks of the guide

11. Name and designation of (in block letters)

11.2 Guide PROF. (MRS.) VIMALA PRASAD VICE PRINCIPAL & H. O. D COMMUNITY HEALTH NURSING, DR. M. V. SHETTY COLLEGE OF NURSING, KAVOOR, VIDYANAGAR MANGALORE -575 013.

11.2 Signature

11.3 Co-guide (if any)

11.4 Signature

12 12.1 Head of the department PROF. (MRS.) VIMALA PRASAD H.O.D, COMMUNITY HEALTH NURSING, DR. M. V. SHETTY COLLEGE OF NURSING, KAVOOR, VIDYANAGAR MANGALORE -575 013.

12.2 Signature

13. 13.1 Remarks of the Chairman and Principal

13.2 Signature

16