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Dietary Factors and Type 2 Diabetes Mellitus in Urban Saudi Adults by Lena Al Khudairy A thesis submitted in partial fulfilment of the requirements for the degree of Doctor of Philosophy in Health Sciences University of Warwick, Warwick Medical School May 2014 i I dedicate this thesis to my beloved parents, Ghassan Al Khudairy and Rajaa Al Sayed for their unconditional love and for their selfless and invaluable support throughout my course of study ii Table of contents List of tables viii List of figures x Acknowledgements xi Declaration xiii Abbreviations xiv Abstract xvi Introduction 1 1.1. Introduction 1 1.2. Overview of the thesis structure 2 Background 5 2.1. Country profile 5 2.2. The health care system in Saudi Arabia 7 Literature review 9 3.1. Overview on the prevalence of Type 2 diabetes in Saudi Arabia 9 3.2. Complications and co-morbidities 12 3.3. Potential risk factors for the increased prevalence of diabetes in Saudi Arabia 14 Aims and objectives 33 4.1. Aims and objectives of this project 33 Dietary factors and T2DM in the Middle East: what is the evidence for an association? – A systematic review 35 5.1. 35 Background 5.2. 37 Materials and Methods 5.3. 39 Results 5.4. 55 Methodological Quality of Included Studies 5.5. 62 Discussion 5.6. 67 Conclusion The biomarkers screening in Riyadh (2009) survey methods 68 6.1. Biomarkers Research Program 68 6.2. 69 Collaboration 6.3. 70 The Biomarkers Screening in Riyadh Survey (2009) study design 6.4. 70 The Biomarkers Screening in Riyadh Survey (2009) study setting 6.5. 70 Ethical approval for the Biomarkers Screening in Riyadh Survey (2009) 6.6. Participant selection of the Biomarkers Screening in Riyadh Survey 70 (2009) 6.7. 71 Data collection of the Biomarkers Screening in Riyadh Survey (2009) 6.8. Socio-demographic measurements and medical history 71 6.9. Anthropometric measurements 71 6.10. Dietary measurements 72 6.11. Biochemical and physiological measurements 73 6.12. Clinical diagnosis of chronic conditions 74 6.13. Variables included in the dataset provided by the Saudi collaborators 74 6.14. Data storage, preparation and cleaning 75 6.15. Dietary measurements preparation and cleaning 76 6.16. Dietary data entry 77 iii 6.17. Field work activities 77 Descriptive characteristics of the 2631 participants of this project 82 7.1. Materials and methods 82 7.2. Statistical analysis 83 7.3. Results 84 A) Socio-demographic characteristics 86 B) Anthropometric and lifestyle behaviour characteristics 88 C) Blood pressure and lipid parameters 91 D) Cardiovascular profile 91 E) Diabetes-related profile 92 F) Reproductive profile and the prevalence gestational diabetes history in females 96 7.4. Discussion 97 Dietary factors and T2DM: the role of anthropometric measures 109 8.1. Methods 109 8.2. Statistical analysis 111 8.3. Results 112 A) Correlations between anthropometric measurements for the overall sample 112 B) Odds ratio of T2DM prevalence by anthropometric measurements in the overall sample 114 C) Odds ratio of T2DM prevalence by anthropometric measurements - sex- stratified analyses 116 8.4. Discussion 120 Dietary factors and T2DM: calibration study and association of selected food items with T2DM 126 Section 1 Calibration of the food frequency questionnaire against two 24-hour dietary recalls 127 9.1.1. 127 Methods A) Study setting 127 B) Ethical approval 128 C) Dietary assessment methods 128 D) Rationale behind the choice of the reference tool (24-hour dietary recall) 128 E) Food frequency questionnaire structure 130 F) 24-hour dietary recall structure 130 G) Number of recalls and which days 131 H) Sample size calculation 132 I) Selection of potential participants 133 J) Invitation of potential participants 134 K) Incentives 134 L) Mode of administration 136 M) Sequence of questionnaire administration 136 N) The FFQ interview 136 O) 24-hour dietary recall interview 137 9.1.2. Analysis 139 A) Nutritional analysis 139 B) Statistical analysis 141 9.1.3. Results 143 A) Response rate 143 iv B) Comparison of the FFQ with 24 hour recalls 145 9.1.4. 9.1.4. Discussion 148 Section 2 Dietary factors and T2DM, the role of selected food and beverages and T2DM 152 9.2.1. Methods 152 A) Nutritional tool – the FFQ 152 B) Food items selection 152 C) Sample selection 153 9.2.2. Analysis 154 A) Nutritional analysis 154 B) Statistical analysis 155 9.2.3. Results 157 A) Descriptive characteristics 157 B) Associations between selected food items and T2DM in the overall sample 163 C) Associations between beverage intake and T2DM in the overall sample 165 D) Sex stratified associations between selected food items and T2DM 166 E) Sex stratified associations between beverage intake and T2DM 166 9.2.4. Discussion 172 Dietary factors and T2DM: the role of dietary biomarkers 177 10.1. Methods 177 A) Biomarkers selection 177 B) Sample size calculation 178 C) Sample selection 178 D) Biochemical analysis 179 10.2. Statistical analysis 181 10.3. Results 182 A) Comparison between the sub-sample and the original cohort 182 B) Descriptive characteristics of the sub-sample 184 Section 1 Vitamin D and T2DM 187 10.1.1. Results 187 A) Sex stratified characteristics across tertiles of 25 (OH) D 187 B) Correlates of 25 (OH) Dlevels 191 C) Interaction between 25(OH) D and covariates (age and BMI) 193 D) Mean levels of 25(OH)Dand diabetes 194 10.1.2. Discussion 195 Section 2 Selenium and T2DM 203 10.2.1. Results 203 A) Sex-specific characteristics across tertiles of selenium 203 B) Correlates of serum Se 204 C) Interaction between serum Se levels and covariates (age and BMI) 208 D) Mean levels of serum Se across diabetes groups 208 10.2.2. Discussion 209 Cultural barriers to healthy eating in Saudi adults with and without T2DM 214 11.1. Rational 214 Section 1 The pilot study of the cultural barriers to healthy eating questionnaire 216 11.1.1. Methods 216 A) Rational for the pilot study and questionnaire development 216 B) Questionnaire structure 217 C) Study setting 218 v D) Selection of participants 218 E) Interview structure 218 F) Analysis plan 219 11.1.2. Lessons learnt from the pilot study 221 A) Study setting 221 B) Sample selection 221 C) Interview structure 221 D) Questionnaire format 222 E) Questions content and format 222 F) Incentives 223 G) Analysis 223 H) Back translation 224 Section 2 Cultural barriers to healthy eating and T2DM 225 11.2.1. Methods 225 A) Study setting 225 B) Sampling plan 226 C) Selection of potential participants 227 D) Invitation of potential participants 228 E) Incentives 228 F) Mode of administration 228 G) Questionnaire structure 229 H) Interview structure 229 11.2.2. Data analysis 230 A) Data preparation and data entry 230 B) Qualitative data (the first section of the questionnaire – free text data) 231 C) Quantitative data analysis 238 11.2.3. Results 240 A) Response rate 240 B) Section one: Qualitative findings (free text data) 241 C) Section two. Quantitative findings: barriers to healthy eating questionnaire (closed-ended questions) 259 D) Section three. Dietary misconceptions in T2DM questionnaire (closed- ended questions) 262 11.2.4. Discussion 270 Discussion 276 12.1. Principal findings of this project 276 12.2. Strengths and limitations of this project 283 12.3. Comparison with previous studies 287 12.4. Implications for policy 302 12.5. Implications for practice 304 12.6. Implications for research 305 12.7. Conclusion 306 12.8. Scientific outputs 308 References 310 Appendix 1: The Biomarkers Screening Survey (2009) questionnaire 467 Appendix 2: The Biomarkers Screening Survey (2009) food frequency questionnaire 471 Appendix 3: Agreement between the Saudi collaborators and Warwick Medical School for the purpose of this project 483 Appendix 4: Ethical approval for the Biomarkers Screening Survey (2009) in English and Arabic copy 485 vi Appendix 5: Comparison* between participants with (n = 2631) and without dietary data (n = 529) 487 Appendix 6: Comparison* between participants that were aware of their diabetes and unaware of their diabetes at the time of the 2009 survey for anthropometric measures 488 Appendix 7: Odds ratio for T2DM prevalence: NDM vs. Unaware of T2DM (at the time of the 2009 survey) in comparison to NDM vs. T2DM (both aware and unaware of T2DM) 489 Appendix 8: Ethical approval from the Ethics Committee of the College of Medicine Research Centre, King Saud University, Riyadh, KSA 490 Appendix 9: Ethical approval from the Biomedical Research Ethics Committee of the University of Warwick 492 Appendix 10: The food frequency questionnaire administered in the calibration study 493 Appendix 11: The 24 hour questionnaire used in the calibration study 497 Appendix 12: Comparison* between participants that were unaware of T2DM and aware of T2DM 498 Appendix 13: The pilot study questionnaire 499 Appendix 14: The modified questionnaire used in this project 503 Appendix 15: Visual examples on the process of qualitative analysis 507 vii List of tables Table 3.1. Epidemiological studies on the prevalence of T2DM in Saudi Arabia 11 Table 3.2. The prevalence of T2DM in Gulf countries 11 Table 3.3. Diabetes profile in Saudi Arabia 12 Table 3.4. Common complications of T2DM in Saudi Arabia 13 Table 5.1. Association of energy, nutrients, foods, and beverages with T2DM 41 Table 5.2. Association between dietary patterns and T2DM 44 Tables 5.3. Association between lifestyle factors and T2DM in intervention studies 47 Table 5.4. Methodological quality of the cohort study and case-control studies 55 Table 6.1. Field work activities 78 Table 7.1. Baseline characteristics of the overall sample 85 Table 7.2. Socio-demographic characteristics 87 Table 7.3. Anthropometric characteristics and lifestyle behaviours 89 Table 7.4. Blood pressure and lipid parameters 93 Table 7.5. Cardiovascular profile 94 Table 7.6. Diabetes profile 95 Table 7.7. Reproductive profile 96 Table 8.1. Pearson correlation coefficients between anthropometric measurements of the baseline sample 113 Table 8.2. Sex stratified correlations between anthropometric measurements 113 Table 8.3. Odds ratio (95% CI) of T2DM prevalence by anthropometric measures of the overall sample 115 Table 8.4. Odds ratio (95% CI) of T2DM prevalence by anthropometric 117 measures stratified by sex Table 9.1. Participating PHCCs in the current study 127 Table 9.2. Descriptive characteristics of respondents, and non-respondents, and original cohort 144 Table 9.3. Correlations between the FFQ and the two 24-hour dietary recalls 147 Table 9.4. Variance components of the food intakes estimated by two 24 hour recalls 148 Table 9.5. Descriptive characteristics of the sample 158 Table 9.6. Descriptive characteristics stratified by sex and diabetes status 161 Table 9.7. Association between food variables and T2DM in the overall sample 163 Table 9.8. Association between beverages variables and T2DM in the overall sample 165 Table 9.9. Sex stratified associations between food intake and T2DM 167 Table 9.10. Sex stratified associations between beverage intake and T2DM 170 Table 10.1. Comparison of characteristics between the sub-sample and the original cohort 183 Table 10.2. Descriptive characteristics of the sub-sample 185 Table 10.3. Characteristics stratified by sex across tertiles of 25 (OH) D 189 Table 10.4. Pearson correlation coefficients between 25 (OH) D and covariates for the overall sub-sample 191 Table 10.5. Sex stratified correlations between 25 (OH) D and covariates 192 Table 10.6. Testing for interaction between 25 (OH) Dand age 193 Table 10.7. Testing for interaction between 25(OH) Dand BMI 193 viii Table 10.8. Prevalence of diabetes across 25(OH) D in males (by the median of 194 age) Table 10.9. Analysis of mean levels of 25(OH)D across diabetes groups (95% CI) 194 Table 10.10. Sex-specific characteristics across tertiles of serum Se 205 Table 10.11. Pearson correlation coefficients between Se and covariates for the overall sub-sample 207 Table 10.12. Sex stratified correlations between Se and covariates 207 Table 10.13. Testing for interaction between serum selenium and age 208 Table 10.14. Testing for interaction between serum selenium and BMI 208 Table 10.15. Analysis of mean levels of serum Se across diabetes groups (95% CI) 209 Table 11.1. Participating PHCC’s in the pilot study 218 Table 11.2. Participating PHCC’s in the current study 225 Table 11.3. Coding frame for question 1: How would you describe a healthy diet? 233 Table 11.4. Coding frame for question 4: Do you which know the foods that people eat less to prevent diabetes? 235 Table 11.5. Descriptive characteristics of the respondents and non respondents 240 Table 11.6. Summary of themes and definitions for the overall data 243 Table 11.7. Barriers to healthy eating for the overall sample 259 Table 11.8. Barriers to healthy eating stratified by sex and diabetes 261 Table 11.9. Dietary misconceptions for the overall sample 262 Table 11.10. Dietary misconceptions stratified by sex and diabetes 267 ix
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