A survey of the recent strategies for the dietary control of diabetes in the Middle East

INTRODUCTION

Significant changes in the political and socio-economic climates have been the hallmark of the last decade in the many of the countries in the Middle East especially those located in the territories of the Arabian Gulf. These changes have impacted in no small way on the demographics of the affected countries. Notable are the obvious shifts in age distribution and a perceptible increase in healthy life expectancy. Furthermore, there have been alterations in the conventional lifestyles of the people living in these countries perhaps due largely to westernization, rapid urbanization and industrialization (Abdella et al 1995). It is also worth mentioning that disease types, trends and or their prevalence have also changed dramatically. Prominent among these is diabetes.

Diabetes – delineation

The incidence and prevalence of diabetes have consistently increased in the last 20 years; these changes have paralleled environmental transformation as well as the adjustments to changes above mentioned (Abdella et al 1995; Zimmet et al 1977). The current projection of the World Health Organisation (WHO 2007) indicates that there will be further increases in the prevalence of diabetes in the Middle East. A working committee of the WHO on diabetes defined the disease as ‘

a metabolic disorder of multiple aetiology characterized by chronic hyperglycaemia with disturbances of carbohydrate, fat and protein metabolism resulting from defects in insulin secretion, insulin action, or both; the effects being long-term damage, dysfunction and failure of various organs’

(Alberti and Zimmet 1998). Diabetes is caused by a lack of the hormone insulin, which is produced by the β-islet cells of the pancreas. Glucose is the primary energy source for all cells and is provided by digestion of carbohydrates from the diet. Insulin enhances the body cells’ uptake of glucose from blood plasma. Hence, defects in insulin secretion, insulin action, or, most commonly, both leads to decreased uptake of glucose by the cells and an increase in blood glucose levels. Sustained increases in blood glucose level will lead to the excretion of glucose in the urine when such increases exceed the renal threshold of the molecule. This in turn leads to the typical symptoms of diabetes: excessive production of urine (polyuria) and extreme thirst (polydipsia). Fatty acids from fat stores are metabolized as an alternative energy source when the body senses a lack of glucose, the result is weight loss and fatigue – other common symptoms of diabetes (Maitra and Abbas 2004). The clinical profile of diabetes varies minimally between the countries of the Middle East. In Kuwait for example, because of the marked disparity between individuals in their age of diabetes onset, mode of presentation, and the degree of obesity, the clinical profile of the disease is heterogeneous (Abdella et al 1995).

Diabetes mellitus is not a single disease entity, but rather a group of metabolic disorders sharing the common underlying feature of hyperglycemia. Type 1 (early-onset diabetes or insulin-dependent diabetes (IDDM) and Type 2 (maturity-onset diabetes or non-insulin-dependent diabetes (NIDDM) diabetes are well known types and are characterized by the different metabolic processes of the disease (Alberti and Zimmet, 1998). Type 2 accounts for about 80% of the disease worldwide. The chronic hyperglycemia and attendant metabolic dysregulation may be associated with secondary damage in multiple organ systems, especially the kidneys, eyes, nerves, and blood vessels (Maitra and Abbas 2004).

The Role of Diet in the Management of Diabetes

Nutritional therapy is an integral part of the management of diabetes and plays a vital role in helping people with diabetes achieve and maintain optimal blood glucose level (United Kingdom (UK) Prospective Diabetes Study Group (UKPDS), 1990; Delahanty, 1998). The nutritional management of patients is based on evidence-based principles and recommendations for the treatment and prevention of diabetes and related complications (American Diabetes Association, 2002). These recommendations are based on evidence published in the international literature and from consensus and expert opinion as required (Ha and Lean, 1998). The benefit of tight control of both blood glucose and blood pressure in people with type 1 and type 2 diabetes has been demonstrated in several well controlled randomized large-scale studies (Diabetes Control and Complications Trial Research Group, 1993; UKPDS 1998a,1998b). Generally, the objectives of strategies for the dietary control of diabetes are complementary to the aims of medical treatment. Dyson (2002) reported that these includes but not limited to the following:

1. Maintaining blood glucose within predetermined target range
2. Minimizing the risk of hypoglycaemia for those patients taking insulin or oral hypoglycaemic agents
3. Achieving weight loss in the obese patient
4. Reducing the risk of long-term complications of diabetes
5. Maintaining blood pressure and lipid levels within predetermined target ranges
6. Improving and maintaining suitable quality of life. (Dyson 2002)

Rationale for the project

Contemporary management of diabetes places emphasis on the individual patient’s responsibility for diabetes control of blood sugars and of food consumption. The concept of self-care with regard to a recommended diet is thus considered important in order for patients to maintain normoglycaemia and reduce or prevent diabetes-related complications (Rubin and Peyrot, 1992; Rubin et al, 1997). The diabetic patient is expected to monitor his/her carbohydrate metabolism, energy expenditure and the effects of insulin or recommended medicaments on blood pressure and sugar levels. This inevitably demands a level of understanding about diabetes and of the effect of diet on the progression and or management of the disease. This survey will explore the individual patients’ approach to control or support the pharmacotherapeutic management of his/her diabetes using diet. The study will shed light on diabetic patient’s adherence to guideline dietary recommendations in the Middle East or on novel dietary strategies for the control of the disease. The results of this study is essential to health policies makers in the region and pivotal for governmental strategies to minimize the burden of the diabetic epidemics in the Middle East.

Using Kuwait as First Port of Call for the Middle East Diabetes Diet Study (MEDDS)

The middle east comprise a large region that covers parts of northern Africa, southwestern Asia, and south eastern Europe consisting of Bahrain, Cyprus, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, Sudan, Syria, Turkey, United Arab Emirates, and Yemen. The ‘Middle East Diabetes Diet Study’ (MEDDS) will focus on Kuwait in its first phase. Implementation of the study in other countries of the Middle East will stem from its success in Kuwait following appropriate modifications to adapt the study tools to the settings and subjects of these countries.

Description of First Target site:

Kuwait is a relatively small country, (17, 818 km

²

in surface area) and is situated in the North Eastern part of the Arabian Peninsula. Kuwait shares the north and west borders with Iraq, is bordered on the south by Saudi Arabia and on the east by the Arabian Gulf. Total population of Kuwait in 2005 was 2, 867, 000 and over 88% of these were aged 15 and over; percent Urban population out of total population was 100% during the same period (WHO 2007). The prevalence of diabetes in Kuwait was 104,000 in 2000 and the projection for the year 2030 is 319,000; this will amount to about 44% of the projected total population (WHO 2007).

AIM AND OBJECTIVES

Aim:

The aim of this proposal is to develop a plan for the conduct of a cross-sectional survey of the recent (< 5yrs) strategies used for the dietary control of diabetes in the Middle East.

Objectives:

1. To purposely select a panel of experienced diabetes practitioners/clinicians to conceive questions assessing patients’ knowledge of their diabetes and the effects of their food types and feeding pattern on glycaemia and blood pressure control (in 11 main domains)
2. To develop and validate a diabetes-diet questionnaire tool for the study
3. To implement the diabetes-diet instrument during a face to face semi-structured interview designed to further explore recent dietary strategies for the control of diabetes
4. To administer a 7-day diet dairy to respondents.
5. Repeat the survey in other countries of the Middle East

METHODOLOGY

Development of Study Instruments

An initial list of 11 patient’s knowledge domains as shown below will be used:

1. Basic knowledge about diabetes
2. Knowledge of patient’s own current management if involving pharmacotherapy
3. Consumption of olives, fruits and vegetables, nuts and cereals in recent times.
4. The intake of legumes in cooked foods in the last 5 years
5. Recent intake of dairy and meat products.
6. Consumption of alcohol/wine in the last 5 years
7. Knowledge of other food types consumed recently
8. Knowledge of feeding pattern in recent times
9. Knowledge of occurrences of diabetes complications and or hospitalisations in the last 5 years
10. Knowledge of the effect of food types and pattern of intake on control of blood pressure in the last 5 years
11. Knowledge of the effect of food types and pattern of intake on the control of blood glucose in the last 5 years

Under each domain, important points regarding each topic will be identified. To ensure content validity, a panel of 10 senior practitioners in the area of diabetes management will be identified and asked to participate in diabetes-diet (MEDDS) instrument development phase (Kline 1986; Streiner and Norman 1989). The expert reviewers will include 2 pharmacists involved in care of diabetes patients, 3 diabetes staff nurses, 3 diabetes specialist dietitians and 2 consultants in the area of diabetes. These will be identified based on their records of diabetes patient care experiences and on their knowledge of the factors impacting on the progression of the disease. The diabetes-diet (MEDDS) instrument’s content experts will rate each of the topic domains and indicate the percentage weight of each domain within the entire study tool. Between 6 and 12 multiple-choice questions will be created for each domain, with a focus on information ranked by the experts as most important for the objectives of the study. The multiple-choice question format is chosen because it is easy to administer and it will be easy to psychometrically validate the ensuing instrument (Kline 1986). Each multiple choice question will have 4 possible responses, namely one correct answer and 3 distracters. However, in order to fully capture any emerging theme, respondents will be allowed time to comment freely on the questions and the multiple choices in a semi-structured interview. These will then be transcribed for analysis. Existing questions from previous studies may be harnessed and modified by the panel. The expert panel will also rank the questions within the domain in descending order based on its relative importance to patients’ diabetes diet requirement/knowledge. After the initial item bank is compiled, the expert panel members will be asked to rank the overall quality of each item on a scale of 1 to 5 (1 = poor, 5 = excellent) in terms of how well it tested each information point. These rankings will be used to eliminate questions and create a 20-30 item pilot instrument. An item bank will be developed based on this information. Questions will be written at 7th grade reading level as determined by the Flesch/Flesch-Kincaid Readability Tests calculated from Dave Taylor and Intuitive systems (2007). Respondents will also be asked to fill a 7-day diet diary.

Inclusion criteria

• Adult volunteers aged 18-85, living in the study site with not less than 3 years diagnosis of type 1 or type 2 diabetes.
• Since retinal and vascular problems associated with diabetes mellitus are common, attempts will be made to administer the tools also in carers of blind diabetic patients.

Exclusion criteria

• Anyone diagnosed with a mental illness as it may be difficult to determine the truthfulness of information collected from these patients.

• Patients who are deaf; this is because a researcher and the interviewee would need to be proficient in sign language for any meaningful interview to take palce

Data-collection tools

Three data-collection tools will eventually be used; (1) the diabetes diet questionnaire (MEDDS tool), (2) a semi-structured interview using validated questions developed by the experts group and (3) a health diary. The interview and diet questionnaire will be the main data source. The semi-structured interview will last for 20 -30 minutes and will be conducted to further explore dietary trends for the control of diabetes in the last 5 years; this will be done at any location convenient for the respondents. The MEDDS questionnaire will be self or researcher administered during the face-to-face interview. A team of 8 interviewers will be trained by the researchers for 4 days before the start of data collection. The questionnaire will be translated into the local language of the study site. The study tools will be pre-tested for about 1 week in diabetes patients across age and sex variables of the target diabetic cohort as shown by Abdella et al (1995) for diabetic Kuwaiti. Larger scale administration of the instrument will be for 6 months following the pre-test period.

Study population

Based on the household registry linked to databases of diabetes organisations in Kuwait, the survey will stratify the area of Kuwait into seven strata according to the degree of urbanization, geographic location, and administrative boundaries. Townships or districts will be selected from each stratum with the selection probability being proportional to its size. Sample selection will involve the use of multi-stage cluster random sampling procedure at the district level to select sub districts and zones from where the study sample could be drawn. In each district, the area will be sub-divided into sub districts from which 3 zones will be selected based on population size. Within the selected zones, households will be randomly numbered, and houses assigned ‘even numbers’ will be selected into the final sample.

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Instrument Administration

Diabetes patients or their carer (as may be necessary) will be identified for face-to-face semi-structured interview, the administration of the diet questionnaire and the filling of a diet diary in the final sample population. Knowledge of dietary recommendations for the management of their diabetes will be investigated; types of food as well as feeding pattern in the last 5 years will be evaluated for each diabetes type. Answers will also be sought to questions that will provide insight into patients recent general daily energy intake and expenditure; daily amount of carbohydrate and protein in the diet, control of blood pressure and glucose levels in the last 5 years. Respondents will also provide insights into changes in local custom for dietary control of diabetes. Following the interview and administration of the diet questionnaire, each participant will be given a 7-day diet diary to complete after each meal or at the end of each day. It will be explained that the diet diary should contain food types and time of eating and all dietary tactics taken to maintain normal blood glucose level (4–7 mmol/litre). The diet diary will further explore the truthfulness of information provided in the interview/ questionnaire as well as shed light on how the respondents have presented their recent self-care dietary strategies for the control of their diabetes.

The Use of Interpreters

Linguistic competency is central to cross-cultural studies and problems that may arise due to the researchers not understanding the local language could be overcome by the use of an interpreter (Davies, 1999). It may also be reassuring for the respondents to see someone with whom they share the same culture and language during the interview periods (Freed, 1988). Interpreters will either provide verbatim translation during the face to face interview or conduct the interview independently following adequate training (Baker, 1981).

Psychometric Analysis of the Questionnaire for the Dietary Control of Diabetes

Ensuring content and construct validity are appropriate methods to develop a knowledge instrument. Questionnaire validity is ideally established by comparing the new instrument being developed with an established recognized standard. There are no such standard for the target patients of this study. Reliability is also a vital attribute of a sound knowledge instrument. The diabetes-diet (MEDDS) instrument will be said to be reliable when scores are consistent over time within a site or as implementation moves from one site/country to another. The variability of the instrument’s results should in this case be due to true differences among the individuals patients that will be enrolled into the study (Streiner and Norman 1989).

Content Validity

Content validity refers to the extent to which a set of items reflects the intended content domain (De vellis 1991). A systematic approach to identifying important domains and developing specific items based on consultations amongst experienced practitioners in the management of diabetic patients will ensure the content validity of the ‘Middle East Diabetes Diet Survey’ (MEDDS) instrument’. This method follows those employed by Zeolla et al (2006) in determining patients’ knowledge of the management of their disease.

Construct Validity

Construct validity determines the instrument’s ability to function for its intended purpose (Kline 1986). The ‘contrasted group’ method will be used in this study to determine the construct validity of the MEDDS tool (Kline 1986).

Reliability of the Diet Questionnaire

A proportion of the diabetic patients recruited into the study will be followed-up after 4 months and urged to complete the diet questionnaire only. The time elapse is considered sufficient to reduce the impact of recall (Streiner and Norman 1989). A correlation coefficient will be calculated between the test scores from each administration. A coefficient of 0.80 or higher is considered acceptable for demonstrating test–retest reliability (Streiner and Norman 1989).

Hypothesis for Construct Validity

If the MEDDS instrument is a valid tool to assess the recent approaches for the dietary control of diabetes, patients managed for diabetes, should be more knowledgeable and achieve significantly higher scores than those not diagnosed or managed for the disease. To confirm this hypothesis, the response of diabetic patients to the final instrument will be compared with responses of age-matched subjects without diabetes in the same setting. Construct validity would be confirmed if the mean generated score for diabetic subjects were significantly higher than those not diagnosed or managed for diabetes.

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Statistical and Data Analysis

Statistical analyses will be by SPSS version 14. The results of the pre-test will be excluded from the analysis. Student’s

t

-test will be used to compare the differences in mean scores of patients managed and not managed for diabetes. Using chi-square (

²

), demographics characteristics will be compared between patients managed and not managed for diabetes. Pearson’s correlation coefficient will be used for the test–retest reliability analysis. Descriptive statistics will be used to report patient demographics. The interview transcripts and the health diaries will be deliberated upon on more than one occasion to fully understand patients’ self care approach and identify individual patient’s dietary care strategies. Themes emerging from the interview will then be compared with dietary patterns observed in the 7-day diet diary and the diet questionnaire. Following a detailed analysis of the results of all 3 tools, perceptions of respondents’ conformity to recommended dietary regimen or their general philosophy/strategy of managing diabetes with diet will be reached.

ETHICAL CONSIDERATION

The study qualitative paradigm protocol will be submitted for review and approval by the local ethics committee for the study region. A covering letter describing the goals of the study will be provided to patients agreeing to participate. The purpose of the study will be very carefully explained to the respondents and their consent will be individually obtained before the study tools are administered. Each participant will also complete a brief demographic questionnaire. In cases of identified illiteracy, the information contained in the form will be read by the study interpreter and informed consent sought. All respondents will assured of anonymity, confidentiality and that they could withdraw from participation in the study at any time.

EXPECTED OUTPUT

Interventions to prevent diabetes in the Middle East should include culturally appropriate and effective ways to improve the nutritional adequacy of the diet in line with international guidelines for the dietary control of diabetes. The result of the study will indicate the knowledge gaps if any in the study population. Tight glycaemia control associated with certain food types and feeding strategies identified in the study may become basis for its recommendation and use in other parts of the world for the control of the worldwide diabetes epidemic.

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