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KHYBER MEDICAL UNIVERSITY

ADVANCED STUDIES & RESEARCH BOARD


BLOCK IV, PDA BUILDING, PHASE-V, HAYATABAD,
KHYBER PAKHTUNKHWA, PESHAWAR, PAKISTAN
091-9217258, 091-9217703 091-9217704, 091-9217258
No: _____________________ Date: ______________________

RESEARCH PROPOSAL TEMPLATE

Title (not to exceed 50 words):


Association of Ischemic Heart Disease with Stress, Diet and Level of Physical Activity of Patients: Hospital Based
Cross Sectional Study in Peshawar.
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
___________________________________________________________________________________________

Name of Candidate: Dr. Aymen Maria ________________________________________________

Name of Supervisor: Dr. Ayesha Imtiaz ________________________________________

Co-Supervisors:

1. ________________________________________________________________________

2. ________________________________________________________________________

3. ________________________________________________________________________

Duration of Project: ___________6 Months_________________________________________________

Institute: Institute Of Public Health.


_______________________________________________________________________________________________
_______________________________________________________________________________________________
_____________________________________________________________________________________

Budget Required: ___________________________________________________________________________

Name & Signature of Student/Scholar: Dr. AYMEN MARIA_________________________________

Name & Signature of the Supervisor: __________________________________________

Name & Signature of Head of Institute: __________________________________________


KHYBER MEDICAL UNIVERSITY
ADVANCED STUDIES & RESEARCH BOARD
BLOCK IV, PDA BUILDING, PHASE-V, HAYATABAD,
KHYBER PAKHTUNKHWA, PESHAWAR, PAKISTAN
091-9217258, 091-9217703 091-9217704, 091-9217258
1. TITLE (not to exceed 50 words): Should reflect objective of the study.

Association of Ischemic Heart Disease with Stress, Diet and Level of Physical Activity of Patients: Hospital Based
Cross Sectional Study in Peshawar.

2. INTRODUCTION: (must include problem statement, background information and rationale 250-300 words)

The world today is seeing a new epidemic that can have a shocking effect unless it is at a standstill. In 2001, 56.5
million people have died in the world.it is a major cause of death and disability. Cardio Vascular Disease would be
the cause of more than half the deaths worldwide by the year 2010. In addition every year less than 20 million
people have an acute myocardial infarction (MI) or stroke but survived. (1)
According to the last World Health Organization statistics, Chronic Non-Communicable Diseases account for 86%
of all deaths in the European Region. Four elements have been identified as causal factors of this burden,
amongst which lack of physical activity (2). Being physically active on a daily basis can reverse the disturbing
prevalence of chronic diseases. In this context the World Health Organization published its Global
Recommendations on Physical Activity for Health in December 2010. (3)

A very large population of Pakistan lives in rural areas and very limited data is available regarding ischemic heart
disease and it is specifically true for the region of Khyber pakhtoonkhwa (4)

There is a large evidence in favour of the risk factors as having causal relationship with ischemic heart disease.
Risk factors are fairly common in Pakistani population (4)

Ischemic heart disease is a preventable disease. According to National Health Survey of Pakistan, it affects one
out of every 3 persons over the age of 45 years in the country. (5)

The prevention of IHD requires in depth understanding of its subtypes and etiological factors in individual
subtypes. In a country with limited resources the need for preventive strategies should be stressed to reduce the
economic burden of this major public health problem. (5)

A study done in a rural area of Khyber pakhtoonkhwa revealed that some of the major and most prominent risk
factors for ischemic heart diseases included physical inactivity and increased BMI. (4)
KHYBER MEDICAL UNIVERSITY
ADVANCED STUDIES & RESEARCH BOARD
BLOCK IV, PDA BUILDING, PHASE-V, HAYATABAD,
KHYBER PAKHTUNKHWA, PESHAWAR, PAKISTAN
091-9217258, 091-9217703 091-9217704, 091-9217258
3. OBJECTIVE(S): (must be stated in measurable terms and starting with an action verb)

General Objectives: To determine the association of Ischemic Heart Disease at Cardiac care units of Tertiary Care
Hospitals, Peshawar.

Specific Objectives:

1. To estimate the risk of low birth weight in teenage mothers.


2. To determine the proportion of premature and intrauterine growth retardation in study group.

4. OPERATIONAL DEFINITIONS: (All variables of study must be clearly defined in detectable terms)

Dependent Variables (outcome):


Independent Variable (Exposure):

5. HYPOTHESIS (If required): (only the alternate hypothesis must be clearly stated aligned with objective)

Ischemic Heart Disease is associated with less physical activity, increased stress and unhealthy dietary habits.
KHYBER MEDICAL UNIVERSITY
ADVANCED STUDIES & RESEARCH BOARD
BLOCK IV, PDA BUILDING, PHASE-V, HAYATABAD,
KHYBER PAKHTUNKHWA, PESHAWAR, PAKISTAN
091-9217258, 091-9217703 091-9217704, 091-9217258
6. MATERIALS AND METHODS:

6a. Study Design: Cross Sectional study

6b. Study Settings: Cardiac Care Units (CCU) of Hayatabad Medical Complex (HMC) and Khyber Teaching
Hospital (KTH), Peshawar. HMC and KTH are post-graduate tertiary care hospitals of Khyber Pakhtunkhwa (KPK).
The stated hospitals have greatly qualified workforce & are equipped with all types of treatment facilities and
receive patients from all regions of Khyber PukhtoonKhwa.

6c. Study Duration: 6 months

6d. Sample Size: (with justification of its calculations and reference used):

Sample size: 330. 110 cases and 220 controls (1: 2 ratio)

Sample size is calculated for case control study using WHO sample size calculator with: Confidence Level: 95%;
Relative precision: 50% (0.50); Anticipated probability of low birth weight in teenage mothers: 32% (0.32);
Anticipated probability of low birth weight in adult mothers: 8% (0.08) and Anticipated Odds ratio: 5.417 and Non-
respondent rate: 10%

6e. Sampling Technique: simple random sampling

7. SAMPLE SELECTION:
7a. Inclusion Criteria: (What type of subjects or material is to be included in the study)

Singleton alive newborn >28 weeks gestation


Newborns admitted in Neonatal Care units within 24 hrs of birth

7b. Exclusion Criteria: (What type of subjects or material is to be excluded from the study and why excluded)

Newborn with recognizable congenital anomalies, newborn with maternal history of gestational diabetes
mellitus, pregnancy induced hypertension, antepartum hemorrhage, chronic infections (T.B) or other co-
morbidities during present pregnancy, newborn of mothers more than 30 years of age or mothers not knowing
their ages will be excluded from study.

Case: Singleton alive newborn with birth weight less than 2.5 kg and gestational age > 28 weeks admitted within
24hrs of birth at neonatal care units of Hayatabad Medical Complex (HMC) and Khyber Teaching Hospital (KTH),
Peshawar.

Control: Singleton alive newborn with birth weight equal to or more than 2.5kg and gestational age > 28 weeks
admitted within 24hrs of birth at neonatal care units of Hayatabad Medical Complex (HMC) and Khyber Teaching
Hospital (KTH), Peshawar
KHYBER MEDICAL UNIVERSITY
ADVANCED STUDIES & RESEARCH BOARD
BLOCK IV, PDA BUILDING, PHASE-V, HAYATABAD,
KHYBER PAKHTUNKHWA, PESHAWAR, PAKISTAN
091-9217258, 091-9217703 091-9217704, 091-9217258
8. DATA COLLECTION PROCEDURE: (Detailed inclusion of subjects and data collection plan, including briefs about
laboratory procedures, surgeries etc. Must clearly explain how the researcher will flow his data collection plan right
from start till finishing the follow up on subjects or material.

Data Collection: Ethical approval will be obtained from the institutional Ethics Committee and permission will
be seeked from head of paediatric departments and administrations of Hayatabad Medical Complex (HMC) and
Khyber Teaching Hospital(KTH), Peshawar. Questionnaire will be tested & changes will be made if required.
Before enrollment in study, the purpose of the study will be explained to participants and Informed consent
(verbal/written) will be taken. Data will be collected by the researcher and assisted by two doctors (one doctor
from each unit) who will be trained for the purpose. The data will be collected through interview technique
using pretested structured questionnaire, anthropometry of newborn and abstraction of medical records, if
required.

A sample of 330 newborns admitted at Neonatal Care units of Khyber Teaching Hospital and Hayatabad Medical
Complex, fulfilling the inclusion & exclusion criteria will be included in the study. For each case 2 controls will be
selected (1: 2 ratio). After enrollment in this study, weight of the newborn will be measured with minimum
clothing on an infant weighing scale in kilograms, by trained doctors. Weighing scale will be checked and zeroed
before weighing. Machine will be standardized from time to time. Birth weight of newborn will be categorized
as Normal birth weight (> 2.5 kg) and Low birth weight (< 2.5 kg), following WHO criteria3. 110 newborns with
birth weight less than 2.5kg will be selected as cases. For each case, two consecutive newborns with birth
weight > 2.5kg admitted at NCU will be selected as control (220). Cases and controls will be matched for socio-
economic status.

Information will be obtained from mothers of the newborn. If the mother cannot give interview, the next of kin
will be interviewed. Data will be collected for maternal age, socioeconomic status, maternal educational status,
total number of pregnancy, parity, inter pregnancy interval, present obstetric history, antenatal visits. Birth
weight, gestational age & sex of the newborn will also be recorded.

Maternal age will be recorded as continuous variable as completed years during present pregnancy. Age will be
confirmed from the mother through interview, from her national identity card as well as from the hospital
records or from age of menarche. In case of disparity, the national identity card will be used (if applicable).
Mothers between 13 - <19 completed years of age are termed teenage mothers16 and mothers between >19 -
<30 years of age are termed as adult mothers8. Antenatal visits during present pregnancy will be categorized as
> 4 visits and < 4 visits, based on the World Health Organization (WHO) and UNICEF criteria that women should
have minimum of four ANC visits with a skilled health care provider18. Information will also be obtained about
gravidity and Inter pregnancy interval.

Socioeconomic status will be assessed on basis of monthly household income in Pakistani Rupee, father
occupation and education status and will be categorized into upper, middle and low socio-economic status
using Modified Kuppuswamys Socioeconomic Status Scale19. Parents education status will be recorded as
categorical variable according to level of education achieved. Father occupation will also be recorded as
categorical variable according to type of occupation.
KHYBER MEDICAL UNIVERSITY
ADVANCED STUDIES & RESEARCH BOARD
BLOCK IV, PDA BUILDING, PHASE-V, HAYATABAD,
KHYBER PAKHTUNKHWA, PESHAWAR, PAKISTAN
091-9217258, 091-9217703 091-9217704, 091-9217258

Gestational age will be estimated on the basis of the last menstrual period and/or a first-trimester ultrasound. If
the age obtained by the two methods differed by more than 5 days, the gestational age given by ultrasound will
be used for the analysis and will be classified according to WHO criteria as Full term (> 37 of gestation),
Premature (28 - 37 weeks of gestation) and intra uterine growth retardation (Full term with birth weight of < 2.5
kg)14. Information will also be obtained about neonatal complications develop after delivery.

9. DATA ANALYSIS PROCEDURE: Detailed description of type of analysis plan according to type of variables and
study design, statistical tests (if required), stratification of confounders/effect modifiers, presentation of results etc
must be clearly mentioned.

Data will be analyzed by using statistical package (SPSS 16.0 version). Descriptive analysis including Mean and
standard deviation for continuous variables and frequencies, proportions and percentages for categorical
variables will be done. Cross tabulations will be done to see the independent variables across the categories of
outcome (LBW, and NBW). For these, results will be compared by using Chi-square test for categorical variables
and t-test for quantitative variables, and p <0.05 is considered significant. Odds ratio will be calculated to
determine risk of low birth weight in association with teen age pregnancy. Method of logistic regression will be
done for the variables found significant on univariate analysis ((p0.25). Adjusted Odds ratio and 95% CIs for
these will be calculated, after adjusting for confounding variables. A cut off of p < 0.05 is taken as significant for
the logistic regression.
KHYBER MEDICAL UNIVERSITY
ADVANCED STUDIES & RESEARCH BOARD
BLOCK IV, PDA BUILDING, PHASE-V, HAYATABAD,
KHYBER PAKHTUNKHWA, PESHAWAR, PAKISTAN
091-9217258, 091-9217703 091-9217704, 091-9217258
10. BIBLIOGRAPHY: In Vancouver style.

Bibliography
1. abbas, dr shahid. cardiovascular diseases in pakistan and its risk factors. [Online]

2. Council, Pakistan Medical and Research. Health profile of the people of Pakistan 1998. islamabad : National
Health Survey of; 1998.

3. organization, world health. www.who.org. [Online] [Cited: june 6, 2015.]

4. prevaence of cardiac diseases in rural areas of peshawar. mehmood ul hassan, zahid aslam awan. lahore : s.n.,
2009, Vol. 19.

5. risk factors in various subtypes of ischemic stroke according to TOAST criteria. nadia aqil, imtiaz begum.
karachi : s.n., 2011, Vol. 21 (5).
KHYBER MEDICAL UNIVERSITY
ADVANCED STUDIES & RESEARCH BOARD
BLOCK IV, PDA BUILDING, PHASE-V, HAYATABAD,
KHYBER PAKHTUNKHWA, PESHAWAR, PAKISTAN
091-9217258, 091-9217703 091-9217704, 091-9217258

16. Young People and Family Planning: Teenage Pregnancy. Fact sheet. United Nation International Children
Emergency Fund (UNICEF). [Cited 14.12. 2013]. Available as:
http://www.unicef.org/malaysia/Teen3.ge_Pregnancies_-_Overview.pdf.

17. Badshah S., Mason L., McKelvie K, et al. Risk factors for low birth weight in the public-hospitals at
Peshawar, NWFP-Pakistan. BMC Public Health 2008; 8:197

18. Childinfo.org: Monitoring the situation of children and women. Antenatal Care. United Nation
International Children Emergency Fund UNICEF, 2013. [cited 14.10.2012]. Available as:
http://www.childinfo.org/antenatal_care.html.

19. Mishra D, Singh HP. Kuppuswamys Socioeconomic Status Scale A revision. Letter to editor. Indian J of
Paediatrics, 2003; 70: 273-274.

Annexure I: Data Collection Instrument


KHYBER MEDICAL UNIVERSITY
ADVANCED STUDIES & RESEARCH BOARD
BLOCK IV, PDA BUILDING, PHASE-V, HAYATABAD,
KHYBER PAKHTUNKHWA, PESHAWAR, PAKISTAN
091-9217258, 091-9217703 091-9217704, 091-9217258
QUESTIONNAIRE

Please tick mark the right answer (where required)

Serial No.:---------------------------- Date: ------------------------------------

Name of Hospital: ---------------------------------------------------------------------------------------

Department: ---------------------------------------------------------------------------------------------

1.Personal Details:

Name of participant: __________________________________________________________

Husband Name: _______________________________________________________________

Date of Birth: ___________________ Age of participant (in years): ______________________

Date/Time of Admission: ________________________________________________________

2. Socio-Economic History:

i. What is your household income per month? (In Pakistani Rupees): _______________________

_____________________________________________________________________________

ii. What level of school education you have received? (Participant):

Uneducated

Primary

Middle

Matric

F.Sc

Grduation

Post graduation
KHYBER MEDICAL UNIVERSITY
ADVANCED STUDIES & RESEARCH BOARD
BLOCK IV, PDA BUILDING, PHASE-V, HAYATABAD,
KHYBER PAKHTUNKHWA, PESHAWAR, PAKISTAN
091-9217258, 091-9217703 091-9217704, 091-9217258
iii. What is the Occupation of your husband?:

Profession

Semi Profession

Clerical, Shop owner, Farmer

Skilled Worker

Semi-skilled Worker

Unskilled worker

Unemployed

iv. What level of school education your husband has received?

Uneducated

Primary School or Literature

Middle School Certificate

High School Certificate

Intermediate or Post High


School Certificate

Graduate or Post graduate

Professional or Honours

3. Obstetric History:

What was your age at marriage?:_________________________________________________

What was your age at first pregnancy?:____________________________________________

How many times did you become pregnant? (including abortions, still births, IUDs, live births):
______________________________________________________________________________

How many alive births do you have?: _____________________________________________

What is the interval between present and previous pregnancy? ___________________________


KHYBER MEDICAL UNIVERSITY
ADVANCED STUDIES & RESEARCH BOARD
BLOCK IV, PDA BUILDING, PHASE-V, HAYATABAD,
KHYBER PAKHTUNKHWA, PESHAWAR, PAKISTAN
091-9217258, 091-9217703 091-9217704, 091-9217258
Present Pregnancy:

What was the date of your last menses (Last menstrual Period)? : _________________________

What was your expected date of delivery? : _________________________________________

Did you receive antenatal care during present pregnancy?

Yes 0 No 1

If yes, how many visits did you make to antenatal clinic? Please specify:__________________

What was the mode of delivery in present pregnancy? : _________________________________

Did any complication occur during/after delivery? : _____________________________________

______________________________________________________________________________

4.Details of Newborn:

Sex of newborn:

Male 0 Female 1

Weight of newborn (In Kilograms):_______________________________________________

Normal Birth Weight 0 Low Birth Weight 1

Gestational Age of newborn (In weeks): ______________________________________

Full term 0 Preterm 0 Intra uterine Growth Retardation 1

Did newborn develop any complication after delivery? :

Yes 0 No 1

If Yes, please specify: ________________________________________________________

_____________________________________________________________________________

Name & Signature of interviewer: _______________________________________________


KHYBER MEDICAL UNIVERSITY
ADVANCED STUDIES & RESEARCH BOARD
BLOCK IV, PDA BUILDING, PHASE-V, HAYATABAD,
KHYBER PAKHTUNKHWA, PESHAWAR, PAKISTAN
091-9217258, 091-9217703 091-9217704, 091-9217258
MODIFIED KUPPUSWAMYS SOCIOECONOMIC STATUS SCALE
SCORE CARD

S. No. CRITERIA SCORE


A Education:

1 Professional or Honours 7
2 Graduate or Post graduate 6
3 Intermediate or Post High School Diploma 5
4 High School Certificate 4
5 Middle School Certificate 3
6 Primary School or Literate 2
7 Illetrate 1

B Occupation:

1 Profession 10
2 Semi-profession 6
3 Clerical, Shop Owner, Farmer 5
4 Skilled Worker 4
5 Semi-skilled Worker 3
6 Unskilled Worker 2
7 Unemployed 1

C Family Income per month (Rs):

1 > 40000 12
2 > 20,000 40,000 10
3 > 15000 20,000 6
4 > 10,000 15000 4
5 > 6000 10,000 3
6 > 2000 6000 2
7 < 2000 1

Total Score Socioeconomic Class

26 29 Upper Class (I)

16 - 25 Upper Middle (II)


Middle
11 15 Lower Middle (III)

5 10 Upper Lower (IV)


Lower
<5 Lower (V)
KHYBER MEDICAL UNIVERSITY
ADVANCED STUDIES & RESEARCH BOARD
BLOCK IV, PDA BUILDING, PHASE-V, HAYATABAD,
KHYBER PAKHTUNKHWA, PESHAWAR, PAKISTAN
091-9217258, 091-9217703 091-9217704, 091-9217258

STUDY PLAN: GANTT CHART

ACTIVITY
MONTH 1 MONTH 2 MONTH 3 MONTH 4 MONTH 5 MONTH 6
(IN MONTHS)

Literature
Search
Proposal
Development &
Approval

Identification &
Orientation of
data collector &
Analyst

Printing Of
Questionnaire

Pilot Study

Data
Collection

Data
Entry & Analysis
Dissertation
Writing
&Printing

Submission &
Approval
KHYBER MEDICAL UNIVERSITY
ADVANCED STUDIES & RESEARCH BOARD
BLOCK IV, PDA BUILDING, PHASE-V, HAYATABAD,
KHYBER PAKHTUNKHWA, PESHAWAR, PAKISTAN
091-9217258, 091-9217703 091-9217704, 091-9217258