RAJIVGANDHIUNIVERSITY OF HEALTH SCIENCES, KARNATAKA,

BANGALORE

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1 / Name of the Candidate and Address (in block letters) / Dr. GURURAJ N A
ROOM NO 102,
KALPATHARU BHAVAN,
A.I.M.S., B.G.NAGAR - 571 448
2. / Name of the Institution /

ADICHUNCHANAGIRI INSTITUTE OF

MEDICAL SCIENCES,
B.G.NAGARA – 571 448.
3. / Course of study and subject / M.D. (COMMUNITY MEDICINE)
4. / Date of admission to Course / 29.04.2010
Research question / What is the prevalence of obesity and its associated risk factors among adult rural population (18 years & above) of Nagamangala Taluk of Mandya Dist, KarnatakaState.
5. / Title of the Topic / “A STUDY OF PREVALENCE OF OBESITY AND ITS ASSOCIATED RISK FACTORS AMONG RURAL ADULT POPULATION (18 YEARS AND ABOVE) OF NAGAMANGALA TALUK OF MANDYA DISTRICT, KARNATAKASTATE.”
6. /
Brief resume of intended work:
6.1 Need for the study
6.2 Review of literature
6.3 Objectives of the study / ANNEXURE – I
ANNEXURE – II
ANNEXURE – III
7. / Materials and methods:
7.1 Source of data
7.2 Method of collection of data
(including sampling procedure,
if any)
7.3 Does the study require any
investigations or interventions
to be conducted on patients or
other animals? If so please
describe briefly.
7.4 Has ethical clearance been
obtained from your institution
in case of 7.3 /

ANNEXURE – IV

ANNEXURE - V
NOT APPLICABLE
NOT APPLICABLE
8. / List of references (About 4 – 6) / ANNEXURE – VI
9. / Signature of candidate
10. / Remarks of the guide / Synopsis has been prepared as per expected standard
11. / Name & Designation of
(in block letters)
11.1 Guide
11.2 Signature:
11.3 Co-Guide (if any)
11.4Signature:
11.5 Head of Department
11.6Signature: / Dr. SURESH LANKESHWAR, M.D.,
PROFESSOR AND HEAD
DEPT. OF COMMUNITY MEDICINE
A.I.M.S., B.G.NAGAR.
Dr. ASIF KHAN., M.D.,
ASSOC. PROFESSOR
DEPT. OF COMMUNITY MEDICINE
A.I.M.S., B.G.NAGARA
------
Dr. SURESH LANKESHWAR, M.D.,
PROFESSOR & HEAD
DEPT. OF COMMUNITY MEDICINE
A.I.M.S., B.G.NAGARA
………………
12. / 12.1 Remarks of the Chairman & Principal
12.2Signature:

ANNEXURE – I

6.1 INTRODUCTION AND NEED FOR THE STUDY

Concept and definition of obesity:

Obesity refers to the presence of excess or abnormal weight of the body due to excess amount of fat in the body. Obesity is a morbid status which predisposes for many important non-communicable diseases causing morbidity, mortality and disability. Obesity is defined as an abnormal growth of adipose tissue due to an enlargement of the fat cell size (hypertrophic obesity) or an increase in fat cell number (hyperplasic obesity) or combination of both. Overweight is usually due to obesity but can arise from other causes such as, abnormal muscle development or fluid retention. Obesity is often expressed in term of body mass index (BMI).1

Magnitude of the Problem

WHO describes obesity as one of most blatantly visible, yet most neglected public health problems that threatens to overwhelm both more and less developed countries.2 WHO has estimated that obesity is prevalent to the extent of 20 – 40% in adults and 10 - 20% among children and adolescents in developed countries.1

The highest rise in number of obese is noted in countries with fast growing economies especially of South East Asia. As many as 250 million people in third world countries suffer from obesity. In India, prevalence of obesity is 12.6% in women and 9.3% in men. In other words, more than 100 million individuals are obese in India. We are truly in midst of obesity epidemic, which has serious health implications.3

According to recent Asia pacific guidelines of obesity-with revised statistics will benefit the additional 15-20%(60-80 million)of Indian population who can now be clinically termed obese under revised measurements.12

Data from population studies such as that in Framingham, USA show that for individuals aged between 30 – 42 years, the risk of death increases by 1 % per annum for each 0.5kg increase in weight, for those aged 50 – 62 years, this figure is 2%. Obesity reduces life expectancy by 7.1 years in men, 15.8 years in women.4 As obesity is key risk factor in many chronic non communicable diseases, the typical time sequence of emergence of chronic diseases following the increased prevalence of obesity is important in public health planning. The first adverse effects of obesity to emerge in population in transition are hypertension, hyperlipidaemia and glucose intolerance. While coronary heart diseases and long term complications of obesity, such as renal failure begin to emerge several years later.1

Today, the shared environmental factors like affluent lifestyle, junk food, sedentary home environment, vanishing old family traditions (with regard to eating, exercise and out door activities) the ready made food, substantially contribute to obesity. The varied lifestyle and dietary habits also play an important role in causation of obesity. India has ignited obesity epidemic which is marked by sudden increase in income having more money at hand for higher purchasing power and being able to spend more on food. Stress, time crunch and sedentary life style all added fuel to fire.3

Assessment of Obesity

Although obesity can be easily assessed at first sight, a precise assessment requires measurements and reference standards. The most widely used criteria are,

  • Body weight & height:

BMI(Body Mass Index)= weight(kg)/(Height in meters)2

Broca index = Height(cm) - 100.

Ponderal index = Height(cm) / Cube root of bodyweight(kg).

Lorentz formula = Ht(cm) – 100 - Ht(cm)-150

2(women) or 4(men)

Corpulence index = Actual weight/Desirable weight.

  • Skin fold thickness
  • Waist circumference and waist hip ratio(WHR)
  • Others like, Densitometry (under water weighing), DEXA scan, USG, Isotope dilution, CT, MRI and Electrical impedance method, these techniques are complex and can not be used for routine or for epidemiological studies.

Among all the methods, BMI is a simplest and world wide accepted index of obesity that is commonly used to classify underweight, overweight and obesity in adults and children, and for males and females. It is defined as weight in kg divided by Ht in meter square (Kg/m2). The risks associated with increasing BMI are continuous and are graded and begin at BMI above 25. A recent FAO/WHO/UNU report gives much needed reference tables for body mass index which can be used internationally as reference standard for assessing the prevalence of obesity in the community.

Obesity as per Asia pacific new guidelines12 (as accepted by Health Ministry of India)

Obesity: BMI ≥ 25 kg/m2

Obesity as per waist circumference,

  • For men ≥ 90 cms.
  • For women ≥ 80 cms.

As per WHO classfication

BMI scale:

Under weight / Normal weight / Over weight / obesity

18.5 25 30 40+

BMI (Body Mass Index) / Status
<18.5 / Under Weight
18.5 to 24.99 / Normal weight
25 to 29.99 / Over weight
30 and above / obesity

Classification of Obesity based on BMI

30 to 34.99…………Grade I obesity

35 to 39.99…………Grade II obesity

≥40……………….....Grade III obesity

Obesity can also be measured as high waist hip ratio (WHR).It is a measure of truncal obesity that focuses on central distribution of body weight and is a more important cardiovascularrisk factor. It has becomeaccepted that a high WHR (>1 in men and >0.85 in women) indicates abdominal fat accumulation.

Waist circumference is a convenient and simple measurement that is unrelated to height and it correlates closely with BMI and WHR and is an approximate index of intra abdominal fat mass and total body fat. Obesity is said to exist when waist circumference > 102cm in men and > 88cm in women.1

As these WHO guidelines are not applicable to Indians, the Health Ministry, Govt of

India has notified guidelines for assessing obesity among Indians.12

Causes of Obesity

Etiology of obesity is complex having multiple causative factors.

Non modifiable risk factors / Modifiable risk factors
  • Age
  • Sex
  • Genetic factors
  • Ethnicity
  • Familial tendency
/
  • Dietary factors
  • Physical inactivity (sedentary life style)
  • Psycho social factors
  • Socioeconomic status
  • Alcohol consumption
  • Endocrine factors
  • Oral contraceptive and other drugs.

  • Age: Obesity can occur at any age, and generally increases with age.
  • Sex: Women have higher rate of obesity than men, although men may have higher rate of obesity.
  • Dietary habits: Over eating, eating more fatty food, preference to sweets (prepared from sugar, jaggery and fat), and eating junk food.
  • Socioeconomic status: obesity is observed in higher proportion among affluent and upper social economic class of people compared to poor and lower social economic class of people.
  • Physical inactivity (sedentary lifestyle): Physical inactivity is strongly associated with occurrence of obesity.
  • Genetic factors: A few rare single gene disorders cause severe childhood obesity. Mutation of melanocortin receptor (mc4r) seen in 5% of early onset obesity, mutation in leptin gene and defects in enzymes processing POMC in hypothalamus are important contributing genetic factors.4
  • Psychosocial factors: Overeating is quite often a symptom of depression, anxiety, frustration.
  • Familial tendency: Obesity frequently runs in families, but this is not necessarily explained by influence of genes.
  • Alcohol consumption: Excess alcohol consumption on regular basis is associated with obesity.
  • Ethnicity: Ethnic groups in many industrialized countries appear to be especially susceptible to development of obesity.
  • Endocrine factors: Hypothyroidism, Cushing’s syndrome, hypothalamic tumours, insulinoma is some of the important endocrinal conditions which cause obesity.
  • Drugs: Tricyclic antidepressants, sulphonyl ureas, Sodium valproate, Beta-blockers, cartico-steroids, insulin and estrogen containing contraceptive pills are associated with increase in body weight and obesity on long term usage.1

Hazards associated with obesity

Obesity is a health hazard and detrimental to well being which is reflected by increased morbidity and mortality.

Increased morbidity: Obesity is positive risk factor in the development of hypertension, diabetes (type 2), gall bladder disease, coronary heart disease and certain type of cancers, especially hormone related (endometrial, ovarian, cervical, breast, prostate) ones. There are in addition, several associated diseases, which although not usually fatal, cause great deal of morbidity in the community. These are varicose veins, abdominal hernia, osteoarthritis of knees, hips and lumbar spine, hyperuricemia and gout, sleep - apnoea, flat feet and psychosocial stresses particularly during adolescence. Obese persons are exposed to increased risk from surgery (increased risk of anesthesia complications). Obesity may lead to lowered fertility, reproductive hormone abnormalities, and polycystic ovarian syndrome. Fetal defects are associated with maternal obesity.1

Increased mortality:Framingham heart study in United States showed a dramatic increase in sudden death among men more than 20% percent overweight as compared with those with normal weight. The increased mortality is brought about mainly by the increased incidence of hypertension and coronary heart disease. There is also an excess number of deaths from renal diseases.1

Obesity is highly stigmatized in many industrialized countries, in terms both of the perceived undesirable bodily appearance and of character defects that it is supposed to indicate and obese people have to contend with a kind of social discrimination.5

WHO estimated that there were 250 million obese adults worldwide with BMI30 and numbers increased to more than 300 million in 2000AD including 115 million in developing countries. The increase to 300 million occurred 25 years sooner than the projected period since 1998. WHO had projected that the number of obese persons would not reach 300 million until 2025. In India obesity is rapidly increasing inthe urban and more affluent classes.There is an urgent need to develop population based educational initiatives as well as individual oriented socio-economic,food and cost effective therapeutic policies to address this epidemic. The present study is undertaken in an attempt to study the prevalence of obesity in rural adult population (18 years and above) of Nagamangala taluk of Mandya district, Karnataka state.

ANNEXURE – II

6.2 REVIEW OF LITERATURE

Obesity is emerging as an important public health problem in India, particularly co - existing with malnutrition. Twenty two million Indians are obese, especially abdominally obese. The rising prevalence of obesity in India had direct correlation with increasing prevalence of obesity related co morbidities.10 Many studies have been conducted regarding the prevalence of obesity. The following were the various findings of some previous studies.

According to the study conducted by Sadhukhan SK, Bhadra M in rural areas of Hoogly district West Bengal, prevalence of obesity among adult male ( >18 years ) was 8%, adult female (>18 years) was 15.3% and the combined obesity for both male and female adults( >18 years) was 11.7% for BMI ≥ 25.7

A study conducted by Agarwal VK, Basannar DR, Sing RP, Dutt M, Abraham D, Mustafa MS in rural population of Maharashtra, prevalence of obesity was reported to the extent of 21.1% in 30 years and above age group (male 22.4% and female 19.6%) for BMI ≥ 25.6

A study conducted by Kokiwar PR, Gopal Rao, Shafee MD in rural community of Andhra Pradesh, prevalence of obesity was reported to the extent of 16.4% in 30 years and above age group (male 14.5% and female 18.2%) for BMI ≥ 25.9

A study conducted by Krishnan A, Shukla DK, Eldho P, Kapoor SK in rural areas of Faridabad district of Haryana, prevalence of obesity was 12.1%, among them 9% in men and 15.2% in women in the age group of 15 to 64 years for BMI ≥ 25.8

A study conducted by Reddy K S, Prabhakaran D, Shah P and Shah B in Rural Haryana Population, prevalence of obesity was reported to the extent of 9.6% in the age group of 35 – 64 years(male 7.8% and female 11.3%).11

ANNEXURE – III

6.3 Objective of the study

  • To assess the prevalence of obesity in rural adults (> 18 years).
  • To assess the associated risk factors for obesity.

ANNEXURE – IV and V

7.0 MATERIAL AND METHODS

7.1. Study area: Rural areas of Nagamangala Taluk of Mandya District,

KarnatakaState

Study Design: Cross sectional study

Study Period: 12 months from Jan 2011 to Dec 2011

Study subjects: Both male and female above 18 years.

Inclusion Criteria: Both male and female above 18 years who are willing to

participate in the study.

Exclusion criteria: Less than 18 years of age and people more than 18 year who are not willing to take part in the study.

Source of data: Data will be obtained from study subjects of rural areas

of Nagamangala taluk of Mandya district.

Institutional Ethical Committee approval and oral consent from study subjects will be taken.

7.2 Method of collection of data:

  1. Personal interview with pretested questionnaire. (Annexure – A)
  2. Anthropometry: Weight in Kg and Height in Meters for calculation of BMI.

Waist circumference measured in cms.

SAMPLE SIZE ESTIMATION

The present study is a qualitative study. The following formula is used for sample size estimation

n = 4pq/L2where n = sample size

P = prevalence of obesity based on previous studies

L = allowable error (10% of p)

Step 1: Based on four previous Indian study reports 6,7,8,9 about obesity (BMI ≥ 25), lowest prevalence is taken up as p=11.7, q is (100 –11.7) and allowable error 10% of p. The expected sample size is

n = 4pq/L2p = 11.7

q = 100 – 11.7 = 88.3

L = 10% of p = 1.17

n = 4 x 11.7 x 88.3

(1.17)2

=3016

Step 2: To compensate sample attrition, 5% (5% of 3016) is added to the calculated

sample size for arriving to final sample size.

Final sample size n = 3016+ 5% of 3016

= 3,166.

SAMPLING PROCEDURE

Stratified Random Sampling Technique will be used in the present study

  • Nagamangala Taluk has 366 villages having rural population of 1,56,786 .
  • The sampling technique in the rural area in the present study consists of (1) random sampling of villages stratified for the population size, followed by (2) coverage of all eligible persons in villages selected.
  • Villages are stratified into 3 strata based on population size

1. Less than 1000 population

2.1000 – 2000 population

3. > 2000 population

  • All villages in group 1 will be selected and from these villages all persons above 18 years both male and female will be selected.
  • From 2 and 3 strata, randomly equal number of villages will be selected until required size of sample is obtained for more than 18 years (male and female) so as to have total sample size from all three strata villages. From all the households(eligible study subjects) in selected villages, information regarding socio-demographic profile, risk factors of obesity and anthropometric measurements(height, weight and waist circumference),will be collected by house to house visit.

PROFORMA APPLICATION FOR ETHICS COMMITTEE APPROVAL

SECTION – A

a. Title of the study / “A STUDY OF PREVALENCE OF OBESITY AND ITS ASSOCIATED RISK FACTORS AMONG RURAL ADULT POPULATION (18 YEARS AND ABOVE) OF NAGAMANGALA TALUK OF MANDYA DISTRICT, KARNATAKASTATE.”
b. Principal investigator (Name & Designation) / Dr. GURURAJ N A
P.G. in COMMUNITY MEDICINE
c. Co investigator (Name & Designation) / NIL
d. Name of Collaborating department/ institutions / NIL
e. Whether permission has been obtained from
thehead of the collaborating
partments/institutions
SECTION B – Summary of the project
SECTION C – Objectives of the study
SECTION D – Methodology / NA
ANNEXURE – VII
ANNEXURE – III
ANNEXURE – IV & V
a. Where the proposed study will be undertaken / RURAL AREAS OF NAGAMANGALA TALUK OF MANDYA DISTRICT
b. Duration of project / 12 months
c. Nature of subject
Does the study involve adult patients?
Does the study involve children?
Does the study involve normal volunteers?
Doses the study involve Psychiatric patients?
Does the study involve pregnant women? / Yes
Yes
Yes
No
No
d. If the study involve healthy volunteered
  1. Will they be institute students?
  2. Will they be institute employees?
  3. Will they be paid?
  4. If they are to paid, how much per session?
/ No
No
No
Not applicable
e. Is the study a part of a multicentral trail? /

No

f. If yes, who is the coordinator?
(Name and designation) has the real been
approved by the ethics committees of the other
centres?
If they study involves the use of drugs, please
indicate whether,
  1. The drug is marketed in India for the indication in which it will be used in the study.
  2. The drug is marketed in India for the indication in which it is proposed to be used.
  3. The drug is marketed in India, but not for the indication in which it is proposed to be used.
  4. Clearance from the Drugs Controller of India has been obtained for.
-Use of drug in healthy volunteers
-Use of drug in patients for a necessary indication
-Phase one and two clinical trails
-Experimental use in patients and healthy volunteers. /

Not applicable

g. How do you propose to obtain in the drugs to
be used in the study?
-Gift from a drug company
-Hospital supplies
-Patients will be asked to purchase
-Other sources (Explain) / Not applicable
h. Funding (if any) for the project
Please state
-None
-Amount
-Source
-To whom payable /

None

i. Does any agency have a vested interest in the
outcome of the project? / No
j. Will the data relating to subjects/Controls be
stored in a computer? /

Yes