Research proposal sample

CHAPTER TWO

LITERATURE REVIEW

• Introduction

This chapter reviews literature related to effects of antiretroviral drugs on nutritional status of adult who have been on drugs for 6-10 weeks aged 18-50 years.

2.1 Effects of specific ARV drugs on nutrition status

ARVs interact with food and nutrition and result in positive and negative outcomes(Castlemanet al, 2004). Some positive effects of ARVs on dietary intake are intensehunger and craving for certain foods. This is because the body is starting to rebuilditself and needs the energy that comes from food (Alliance, 2007). On the other hand,the side the negative effects that arise from taking of ARVs include nausea, tastechanges, mouth ulceration, loss of appetite, abdominal pain, constipation, flatulence,headache, diarrhoea and vomiting which are common especially in the early stage oftreatment (FANTA, 2004; Hoffmann et al., 2006).

These problems lead to reducedfood intake or reduced nutrient absorption that exacerbates weight loss and nutritionalproblems experienced by PLHIV (Table 2.2). Moreover a study in the USA showedthat 30% of drug interruption in the first 90 days is attributed to nausea, vomiting, andother gastrointestinal effects of ARVs (Chen et al., 2003). This drug interruption canlead to health deterioration and risks of malnutrition in patients.

Source: National Antiretroviral Treatment and Care Guidelines for Adults and

Children (MOH, 2003).

Antiretrovirals (ARVs) are medicines used to treat HIV infection. They reduce theamount of HIV (the viral load) in the body, which protects the immune system andallows it to recover. ARV treatment is a lifelong treatment (Alliance, 2007).

According to a report by United States president’s emergency plan for AIDS relief,about 145,000 individuals were receiving ARVs by September 2008 (PEPFAR,2009).

HIV positive patients, who are eligible to start ART, start with the first lineregimens. A first line ART is an antiretroviral drug regimen that is recommended forpatients who have never been exposed to ARVs or those who were on treatment butstopped all drugs at once for more than three months (MOH, 2003). In initiating ofART a three drug combination should be used. This combination may contain two Nucleo Reverse Transcriptase Inhibitors (NRTIs) plus one Non Nucleo Reverse Transcriptase Inhibitors (NNRTI) or a Protease Inhibitors (PI) (MOH, 2003).

2.2 Relationships between Dietary Patterns and ARVS on nutritional status

Having proper nutrition in HIV/AIDS includes; consuming diversified or variety offoods that will provide the body with the necessary energy, protein, fats, vitamins andminerals (MOH, 2006). According to the Kenyan national guidelines on nutrition andHIV/AIDS (2006), dietary intake along with regular exercise, controlling weight,avoiding alcohol intake, smoking and other narcotic drugs are makeup nutritionrelated healthy life styles.

Dietary diversity, the consumption of an adequate variety of food groups, is an aspectof dietary quality and can be considered an indicator of general nutritional adequacy (Nontobekoet al., 2008). Low dietary diversity is associated with specific nutrient deficiencies. The main reason for promoting food diversification is that, no single food except breast milk contains all the nutrients the body needs in the right quantities and combinations (MOH, 2006). Another study by Bukusubaet al. (2007) noted that there is very low dietary diversity in developing countries, the majority of studied households reported consuming fewer than six food groups (low quality diet)moreover their daily diet was dominated by one main staple food group mainly cereals. According to FANTA (2004), maintaining adequate nutritional status means consuming a variety and adequate quantity of foods to meet energy, protein, and micronutrients needs. PLHIV should eat balanced and diverse diets consisting of starchy staples with cooked legumes, nuts and animal foods, fat and oil, fruits, and vegetables.

A study by Nontobekoet al (2008) showed that in South Africa, diets for PLHIV were significantly less diverse than those of HIV negative individuals. However a balanced diet will ensure that the individual consumes sufficient nutrients to maintain energy, normalize weight, and ensure the body’s proper functioning. The main types of food people need to live a healthy life include energy-providing foods (i.e.carbohydrates, fats), body-building foods (i.e., proteins, minerals), and protective foods (i.e., vitamins, minerals) (FANTA, 2004).

2.2 .1 Energy Giving Foods

This includes the carbohydrates, fats and oils that are in food groups like cereals, tubers, and plantain. Staples are good sources of energy. Staple foods should be the part of every meal and form the base and largest part of daily meals.

Cereals

Cereals are one of the staple foods in Africa and other parts of the world. Examples of cereals are maize, sorghum, millet, rice etc. Some cereals such as millet and sorghum contain some proteins and iron. However, they don’t contain adequate nutrients on their own. Nutrients from staple foods may not be available to the body unless eaten in combination with other foods (MOH, 2006b).

Tubers & Plantain

Tubers are known as good sources of energy. The most common tubers and roots that are consumed in Uganda are mattoke (plantain,) sweet potatoes, cassava, yams, are among others (MOH, 2006b).

Fats/Oils and Dairy products

Fats and oils are the richest sources of energy. One gram of fat provides twice the energy of one gram of carbohydrate. Therefore people only need small amount of fats because excessive consumption of fats may predispose individuals to obesity and heart disease. Vegetable oils are obtained from corn, simsim, sunflower, cotton seed, shear butter, palm oil and margarine. Animal source fats include butter, cheese, whole milk, fatty meat and fish (including fish oil) (MOH, 2006a). Fat also facilitate absorption and utilization of some essential vitamins such as A, E, D and K.

2.2.2 Body-Building Foods

Proteins are referred to as body-building foods. They are essential for cell growth, support the function and formation of the general structure of all tissues, including muscles, bones, teeth, skin and nails. The two main types of proteins are: plant source of proteins and animal source proteins. Plant source proteins include beans and peas of different varieties, green grams, groundnuts, soybeans and simsim. Whereas animal source proteins include meat, milk (including products like cheese, yoghurt and fermented milk), fish and eggs. Other sources of protein include nsenene(grasshoppers) and white ants. Williams et al. (2003) found that high protein diets areassociated with increased gain of Body cell mass among HIV positive persons.

Legumes

MOH (2006) recommends including legumes in everyday diet as frequently as possible. Legumes include beans, peas, lentils, groundnuts, and soybeans. Legumes provide nutrients that are needed to develop and repair the body as well as building strong muscles. As compared to animal products, legumes provide cheaper source of protein and energy. Legumes when eaten with staple foods such as maize, millet, sorghum and rice, improve quality the diet. Legumes are also rich in other essential nutrients including: the B vitamins, vitamin E, iron, and calcium.

Animal Products

Animal products supply good quality proteins, vitamins, minerals and extra energy.

Micronutrients in animal products include iron, vitamin A, selenium and zinc that strengthen muscles and immune system. Animal products include beef, chicken, fish, eggs, offal and milk (MOH, 2006b).

2.2.3 Protective Foods

Fruits and vegetables are known as protective foods because they provide vitamins and minerals that are important in strengthening the immune system. Vegetables and fruits are also major sources of fibre and roughage required for bowel movement and prevention of constipation (MOH, 2006a).

Vegetables

Vegetables add taste, flavour and colour to our meals. Common vegetables include:doodo, nnakati, malakwang, eboo, spinach, kale (sukumawiki), pumpkin leaves,cowpea leaves, carrots, cassava leaves, and green peppers. Cabbage is a vegetable thatis important mainly as roughage. Vegetables contain useful immune substances calledbeta-carotenes. In many cases, vegetables are seasonal in availability, quality andprices (MOH, 2006a). Kristy (2003) noted that HIV patients who consume of highfibre foods have shown lower fat deposition in their bodies.

Fruits

A variety of fruits grow in Uganda. The deep yellow or orange coloured fruits arericher in vitamins, particularly beta-carotenes and vitamin A. Such fruits includeavocadoes, mangoes, pawpaw, pumpkin, passion fruit, pineapple and jackfruit.

Oranges, lemons and other citrus fruits are rich sources of vitamin C. Like vegetables, most fruits in Uganda are seasonal (MOH, 2006a). Fruits are known as good sources of antioxidant substances (FANTA, 2004).

2.3 Variation in anthropometric indices during the duration of 6-10 weeks

It is important to understand what body compartments are in order to understand the changes in body composition. According to the fact sheet published by ROWETT Research Institute (2002), it was stated that; a healthy normal weight person has major component of water. Compared to water, the protein and fat components are small.

The remaining body compartments are the bones and minerals. The non-fat compartment of body composition is termed as fat free Mass (FFM) and exists primarily as the chief structural and functional component of the human body.

The FFM compartment consists (in proportions) of water (72%), protein (21%) and bone minerals (7%). Furthermore, FFM can be broken down to body cell mass (BCM) and extracellular tissue (ECT). Body cell mass is associated with survival and is primarily made up of muscles and organs, which process nutrients and medications.

While the ECT compartment is comprised of structure and transport (such as bone, collagen and fluids outside of the body cell mass). Phase angle is calculated and appears to reflect the ratio of body compartments (Zanetaet al., 2003). Components like proteins, body water and fat can be measured by a portable and user friendly machine called Bioelectric Impedance Analysis (BIA) machine while bone minerals can be measured by dual-energy x-ray absorpiometry (DEXA) (Wanke, 2002). Typically, an adult has around 2-4 kg of body weight only from bone.

The fat compartment of the body is termed fat mass (FM) and will vary considerably between individuals in terms of absolute amount. Fat mass consists of 20% water and80% adipose tissue however in obese persons; it could be the largest component of the body. Table 2.1 shows an obese man has almost twice the amount of adipose tissue on his body, compared to the lean man.

 Need for Assessment of body composition

In most HIV clinics in Kampala and Uganda at large, patients are weighed almost atevery visit however measuring weight alone can be a misleading indicator ofnutritional status because lean body mass is lost in preference to fat and in addition toit, there is no way to distinguish between body fat (BF), and lean body mass (LBM)when weight measurements alone are used (Wankeet al., 2002).

Serial weight measurements have been used by the Centers for Disease Control and Prevention (CDC) as a way to identify the wasting syndrome and predict the development of AIDS (Tamsin and et al., 2003). However, Kotleret al. (1989)showed that measurement of body weight alone failed to identify dramatic losses in body cell mass and other body composition parts. Thus, further measures of body composition are also needed, to identify losses or gains of lean body mass, body fat or body cell mass associated with increased mortality or/and nutrition intervention in patients with HIV (Tamsin, 2003).

Optimally, clinicians should try to prevent weight loss as well as treat it. Weight loss is often the first sign of a new AIDS-defining illness (Reiter, 1996). Patients should beweighed at every visit and their weight trends recorded on a graph. Because lean body mass is lost in preference to fat, weight alone can be a misleading indicator of nutritional status and clinical course (Reiter, 1996).

Methods of assessing of body composition in HIV/AIDS

Anthropometric measurements like skin fold thickness is the most widely used technique for estimating body fat and regional muscle mass. Using in-expensivecalibrated-controlled tension callipers and semi flexible tape measures, the techniqueis inexpensive and particularly handy for use in many field environments (Wankeetal.,2002). The validity of skinfold measurement is dependent on two assumptions.

First, subcutaneous adipose tissue thickness represents a constant proportion of totalbody fat. Second, skinfold sites selected for measurements reflect averagesubcutaneous adipose thickness (Ludyet al., 2005). Use of BMI in body compositionis also important because it measures person’s fat content, BMI is widely used toscreen for obesity. However, BMI can not differentiate, between lean and fat.

As11such, it is not able to distinguish between a body builder and an obese individual, (Wankeet al., 2002). Wankeet al also reported on the importance of MUAC in estimating of muscle mass that the measures of mid-upper arm circumference are correlated to measures of muscle mass. In general anthropometry is based on a two component model of body composition, and provides estimates of fat and fat-free mass only.

Bioelectric Impedance Analysis (BIA) has great potential for the use in estimatingbody composition. BIA measures the opposition of body tissues to the flow of a smallalternating current (Kotler, 1996). BIA is recommended in measurement of bodycomposition (ultimately lean body mass) in individuals and those with chronicconditions such as HIV infection (NIH, 1994). It is preferred because it’s rapid andeasy to perform. Portability of BIA machine also allows it to be used in a variety ofsettings including medical offices and hospitals (Wankeet al., 2002). Other bodycomposition assessment methods like Dual energy x-ray absorptiometry (DEXA),Isotope dilution methods, imaging techniques (CT and MRI) and total body potassiumcounting (TBK) in assessment of body composition.

CHAPTER THREE

METHODOLOGY

3.0 Introduction

This section presents the methodology which consists of the research design, area of study, study population, sample population and selection, sampling technique, data collection method, data quality control, data collection procedures and limitations of the study.

3.1 Research design

Qualitative and quantitative purposive, random, research designs were used. The researcher used the above methods because many aspects was covered in the study, Qualitative research method was used because it collects information within a short time while quantitative was through interview to cross check what has been given.

3.2       Study Area and population

The study was carried out in Bweyogerere health center III and the study involved a total population of 120, this consisted mainly of nurses, patients and clinicians.

3.3Sample Size, determination and sampling procedure

Mugenda and Mugenda (2003), argue that it is impossible to study the whole targeted population and therefore the researcher took a sample of the population. A sample is a subset of the population that comprises members selected from the population. Using Krejcie and Morgan’s (1970) table for sample size determination approach, a sample size of 92 respondents was selected from the total population of 120.

According to (Amin, 2005) sampling involves selecting a sample of the population in such a way that samples of the same size have equal chances of being selected.

The respondents were selected using purposive sampling techniques. Berg (2006) purposive sampling is where the researcher chooses the sample based on what they think would be appropriate for the study, According to Amin, (2003) A Purposive sampling technique was used because it’s cheap.

3.4Data type and source

The type of data was both primary and secondary, Primary data was obtained from the questionnaires administered on the target respondents to gain opinions and practices on the topic of the study. Secondary data is data which has been collected by individuals or agencies for purposes other than those of a particular research study. It is data developed for some purpose other than for helping to solve the research problem at hand (bell, 1997). This comprised of literature related to effects of antiretroviral drugs on nutritional status of adult aged 18-50 years in relation to the case study. Secondary data was sourced because it yields more accurate information than obtained through primary data, and it is also cheaper.

3.5 Data Collection Instruments

The major instrument for data collection was questionnaires. Surveys were just one part of a complete data collection and evaluation strategy. The major method of data collection for the study was the survey, which was done using selected instruments like questionnaires. The questionnaire provided respondents with ample time to comprehend the questions raised and hence, they were able to answer factually.

3.5.1 Questionnaires

The questionnaire was used to collect quantitative data. The researcher administered the questionnaires to respondents in different respondents, which was designed basing on study objectives and questions. Respondents read and wrote the questionnaires themselves. The questionnaires were close ended and were considered convenient because they were administered to the literate and its anonymous nature fetched unhindered responses.

3.6 Measurement of Variables

A five point Likert ordinal scales ranging from; strongly agree was assigned 5, strongly Agree, 4 agree, Not Sure assigned 3, Disagree allocated 2 and strongly disagree allotted 1 to obtain responses on the variables. The Likert ordinal scale has been used by numerous scholars who have conducted similar studies such as Bowling, (2007).

The structured questions were measured using the following variables;

The study has antiretroviral drugs as its independent variable and nutritional status as its dependent variable.

3.7Data collection procedures

Upon receiving the University permission to carry out research, the area of study was visited for purposes of familiarization.  The researcher sought permission from staff and once allowed to proceed with research, questionnaires were issued and interviews were carried out with the selected respondents.

3.8Quality control of data instruments

The instrument was taken to the supervisor to check its correctness there after pilot study was carried out to find out if it measured what it is meant for.

3.9 Data processing, presentation and analysis

The raw data was coded, edited, and arranged ready for analyzing only completed raw data was be analyzed using statistical packages like excel and SPSS.

3.10     Ethical Considerations

The researcher presented a letter of introduction, to the management of Bweyogerere Health centre III, when allowed he proceeded to administer the research instruments.  Consent letter was obtained from the respondents before they are engaged in the study.  This was after the study has been thoroughly explained to them and confidentiality was ensured that the investigation is purely for research purposes.

3.12 Anticipated Limitations of the study

The researcher faced the following challenges in the course of the study;

• Lack of enough time to interview all the respondents, but this was solved by budgeting for it appropriately.
• Language as other respondents felt comfortable expressing themselves in local languages like luganda.
• Lack of enough money to the respondents, this didn’t affect the study as the respondents were persuaded that the research is meant for academic purposes.