DIABETES MANAGEMENT STRATEGIES

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CHAPTER 3 METHODOLOGY OVERVIEW

INTRODUCTION

As stated in the introduction, the purpose of this study was to develop a nutrition education (NE) programme that would be culturally relevant and tailored to the needs of adults with type 2 DM in a resource limited setting of the Moretele sub-district, and to evaluate the programme’s effectiveness on health outcomes. To achieve this goal, the study was conducted in three different phases using a mixed methods research approach. This chapter gives an overview of the methodology applied in the study. The particular methods applied in the specific phases are extensively discussed in chapters 4, 5 and 6 respectively. This chapter also discusses the study setting and gives the definitions of terms pertaining to the study as a whole.

RESEARCH PERSPECTIVE

Research approach

The study was done in three phases. The phases were (i) needs assessment (phase1), (ii) planning of the NE programme (phase 2), and (iii) implementation and evaluation of the NE programme (phase 3). The research questions addressed in the three phases were as follows:
Question 1 What are the needs for NE in adults with type 2 DM in the Moretele sub-district? Question 2 What are the features (components, activities) of a tailored, cultural relevant NE programme for adults with type 2 DM in the Moretele sub-district?
Question 3 What is the effect of the tailored NE programme on health and associated outcomes of adults with type 2 DM in the Moretele sub-district?
A mixed-methods research design, encompassing both quantitative and qualitative research domains, was used. ^1,2 A combination of approaches was selected as neither alone could address the study research questions adequately.^2,3 The qualitative approach was appropriate for assessing the needs for NE and the preferred features of an NE programme (research
question 1). The qualitative method allowed participants in the study to give views in their own words, rather than as a choice between pre-determined responses. This allowed the researcher to obtain an understanding of the NE needs from the participants’ perspective.⁴ Research question 3 (phase 3) aimed to ascertain the effects of the NE programme on specified outcomes. Therefore a quantitative approach that quantifies phenomena and describes variables in a causal-effect relationship was appropriate.⁴ Research question 2 dealt with the planning of the tailored NE and did not require an empirical investigation.

Research phases

The research phases were conducted sequentially with a consecutive phase being dependent on the previous phase(s). Therefore, the third phase depended on the first and second phases, while the second depended on the first phase. The results from each phase were analysed and discussed separately and then integrated at the end in the summary (see chapter 9).

Phase 1: Nutrition education needs assessment

Phase 1 was the needs assessment phase. The overall goal of the phase was to explore and describe the nutrition education needs of adults with type 2 DM in the study setting. A qualitative research approach based on an interpretive phenomenological⁵ design was used.
Participants in phase 1 included adults (males and females) with non-insulin dependent type 2 DM and the health professionals serving them at the community health centres (CHCs). A convenience purposive^6,7 sample was used with the patients. All health professionals who met the inclusion criteria and agreed to participate were included.
Data were collected using focus group discussions with the diabetic patients and self-administered questionnaires for the health professionals. Data were analysed using frame work analysis based on Krueger’s approach in combination with that of Richie and Spencer.⁸ This phase is discussed in chapter 4.

Phase 2: Planning the nutrition education programme

The aim of this phase was to plan a NE programme that would be culturally relevant and tailored to the needs of adults with type 2 DM in the study setting. The specific objective was to determine the NE features (appropriate theoretical models/theory, NE components, curriculum and content, activities, teaching approaches, etc.) based on the needs assessment and evidence from the literature. The phase also included preparations for the implementation of the NE programme.
Results from phase 1 (NE needs assessment) and evidence from the literature were used to plan the NE programme. Preparations for implementation involved consultations with collaborators, development and pilot testing the education tools/materials and questionnaires for outcome measurements, as well as the training of the facilitators. Phase 2 is discussed in chapter 5.

Phase 3: Implementation and evaluation of the nutrition education programme

The purpose of phase 3 was to implement the planned NE programme and to evaluate the programme’s effectiveness on glycaemic control (primary outcome) and other specific outcomes (dietary behaviours, body mass index, lipid profile, diabetes knowledge and the attitudes toward diabetes and its treatment) (secondary outcomes) in adults with type 2 DM in the study setting.
A randomised controlled trial (RCT) using two groups was implemented. The RCT is the most scientifically rigorous method of hypothesis testing and is regarded as the gold standard for testing the effectiveness of interventions.⁹ One group (intervention) received the NE intervention while the other group (control) received usual medical care. Both groups received the same education materials. The groups were followed up to 12 months. Outcomes were assessed at baseline, six months and 12 months. Post-intervention data were analysed for the participants who completed the study. An intention to treat analysis¹⁰ was also done for HbA_1c that served as the primary outcome.
The NE programme process evaluation was undertaken using both qualitative and quantitative approaches. Data from the process evaluation assisted in an assessment on the extent of the NE programme implementation, and gave insight on the participants experience with the programme. The results were used to explain the outcomes.¹¹’¹²
The outcomes were grouped into primary and secondary outcomes. The primary outcome is considered to be the most important, and is the one usually used to calculate the sample size,¹³ as was done in this study. Glycosylated haemoglobin (HbA_1c) was the primary outcome in this study since glycaemic control is the main goal of diabetes management. The HbA_1c test is considered the gold standard for testing glycaemia as it has been shown to predict the risk for the development of chronic complications in diabetes.¹⁴ All other outcomes that were measured were considered secondary outcomes. These included blood pressure, blood lipids, BMI, dietary behaviours (dietary intake and food related practices), diabetes knowledge and the attitudes toward diabetes and its treatment. Outcomes were also grouped according to the outcome categories of diabetes self-management education (DSME) (see Table 3.1 for DSME based outcomes). These include immediate, intermediate, post-intermediate and long-term outcomes.¹⁵ The immediate outcomes were diabetes knowledge and the attitudes toward diabetes and its treatment. Dietary behaviours were the intermediate outcomes while post-intermediate outcomes were HbA_1c, blood pressure, blood lipids and BMI. These post-intermediate outcomes were also referred to as clinical outcomes. Long-term outcomes were not assessed in this study.
A conceptual framework of the study is graphically presented in Figure 3.1. The definitions of the main concepts of the conceptual framework are given in Table 3.1. Figure 3.2 graphically presents the study phases.

STUDY SETTING AND POPULATION

The study was done in two CHCs, Makapanstad and Mathibestad, in the Moretele sub-district, North West Province, South Africa. The CHCs are approximately 10 km apart and are situated about 80 km north-west of Tswane Metropolitan, Gauteng. Figure 3.3 shows the location of the study site.
Moretele sub-district is divided into 22 wards (sections)¹⁶ and has a population of 184 242 people as per the recent (2011) national census.¹⁷ The average annual household income in the sub-district is R 35 467 (~ R 3000 per month/USD 340). For adults aged 20 years and above, about 10 000 (~9%) have no formal education and approximately 4 900 (~5%) have an education level above matriculation (grade 12). The unemployment rate in the sub-district is 45%.¹⁷ The sub-district has 24 health clinics (two of which are mobile), which are served by one dietitian.¹⁸
The CHCs are managed by professional nurses. General physicians visit the CHCs three times per week to consult with referred cases. Health education at the CHCs (including nutrition) is mainly done by nursing professionals. At the time of the study (2009 to 2011), approximately 160 diabetic patients per CHC were attending on a regular basis as per diabetes registries at the CHCs.
The study population consisted of male and females, aged 40 to 70 years and with non-insulin dependent type 2 DM attending the two CHCs. Thirty one and 82 patients participated in phases 1 (see chapter 4, section 4.7) and 3 (see chapter 7, section 7.2) respectively.

DECLARATION 
ACKNOWLEDGEMENTS.
ABSTRACT
PUBLICATIONS AND PRESENTATIONS ARISING FROM THIS STUDY
LIST OF APPENDICES
LIST OF TABLES
LIST OF FIGURES 
LIST OF ABBREVIATIONS 
PART I: BACKGROUND AND LITERATURE REVIEW
CHAPTER 1 INTRODUCTION AND OUTLINE 
1.1 BACKGROUND
1.2 STATEMENT OF THE PROBLEM
1.3 PURPOSE OF THE STUDY .
1.4 SIGNIFICANCE OF THE STUDY
1.5 THESIS OUTLINE
CHAPTER 2  LITERATURE REVIEW
2.1 INTRODUCTION
2.2 PATHOGENESIS OF TYPE 2 DIABETES MELLITUS
2.3 AETIOLOGY/RISK FACTORS FOR TYPE 2 DIABETES MELLITUS
2.3.1 Genetic factors
2.3.2 Obesity
2.3.3 Environmental and lifestyle factors
2.4 PREVALENCE OF DIABETES
2.4.1 Global prevalence
2.4.2 Prevalence in Africa
2.4.3 Prevalence in South Africa
2.5 IMPACT OF DIABETES
2.5.1 Economic costs
2.5.2 Morbidity and mortality
2.5.4 Quality of life
2.6 DIABETES MANAGEMENT GOALS
2.6.1 Blood glucose control
2.6.2 Blood pressure control
2.6.3 Lipid control
2. 7 DIABETES MANAGEMENT STRATEGIES
2.7.1 Pharmacological treatment
2.7.2 Physical activity
2.7.3 Patient education
2.7.4 Medical Nutrition Therapy
2.7.4.1 Effectiveness of medical nutrition therapy in diabetes management
2.7.4.2 Nutrition recommendations for type 2 diabetes mellitus
2.7.4.2.1 Macronutrients
2.7.4.2.2 Micronutrients
2.7.4.2.3 Energy balance and weight management
2.7.4.3 Barriers to dietary adherence
2.8 DEVELOPING AN EFFECTIVE NUTRITION EDUCATION PROGRAMME
2.8.1 Appropriate goals and outcomes
2.8.2 Target group tailored intervention
2.8.2.1 Literacy level
2.8.2.2 Socio-cultural context
2.8.2.3 Locality of the nutrition education programme
2.8.3 Appropriate implementation approaches and strategies
2.8.3.1 Active involvement of the learner/patient
2.8.3.2 Behaviour focused approach, based on appropriate theories/models
2.8.3.2.1 Health Belief Model
2.8.3.2.2 Trans-Theoretical Model (TTM)
2.8.3.2.3 Social Cognitive Theory (SCT)
2.8.3.2.4 Theory of Planned Behaviour (TPB)
2.8.3.3 Mode and format of programme delivery
2.8.3.4 Provision of social support
2.8.3.5 Suitable programme duration and contact time
2.8.3.6 Follow-up intervention
2.8.4 Competent educator
2.8.5 Appropriate nutrition education content and approach
2.9 EVALUATING NUTRITION EDUCATION PROGRAMMES
2.9.1 Types of evaluations
2.9.1.1 Formative evaluation
2.9.1.2 Process evaluation
2.9.1.3 Summative evaluation
2.9.2 Considerations for nutrition education programme evaluations
2.9.2.1 Process evaluation
2.9.2.2 Outcome evaluation .
2.10 SUMMARY
REFERENCES
PART II: EMPIRICAL INVESTIGATION
CHAPTER 3 .METHODOLOGY OVERVIEW
3.1 INTRODUCTION
3.2 RESEARCH PERSPECTIVE
3.3 STUDY SETTING AND POPULATION
3.4 ETHICAL APPROVAL AND CONSIDERATIONS
3.5 DELIMITATIONS OF THE STUDY
3.6 ASSUMPTIONS
3.7 DEFINITION OF KEY CONCEPTS
REFERENCES
CHAPTER 4  PHASE 1: NUTRITION EDUCATION NEEDS ASSESSMENT 
4.1 INTRODUCTION
4.2 AIM AND OBJECTIVES
4.3 METHODS
4.4 DATA COLLECTION
4.5 DATA PREPARATION AND ANALYSIS
4.6 TRUSTWORTHINESS OF THE DATA
4.7 SOCIO-DEMOGRAPHIC DESCRIPTION OF THE STUDY PARTICIPANTS
4.8 RESULTS
4.9 DISCUSSION
4.10 STRENGTHS AND LIMITATIONS OF PHASE 1
4.11 CONCLUSION ON PHASE 1
4.12 RECOMMENDATIONS FOR PLANNING THE NUTRITION EDUCATION PROGRAMME
REFERENCES
CHAPTER 5  PHASE 2: PLANNING THE NUTRITION EDUCATION PROGRAMME 
5.1 INTRODUCTION
5.2 AIM
5.3 METHOD
5.4 PROCESS
5.5 SUMMARY.
REFERENCES
PHASE 3: IMPLEMENTATION AND EVALUATION OF THE NUTRITION EDUCATION PROGRAMME
CHAPTER 6: AIMS, OBJECTIVES AND METHODS OF PHASE 3
6.1 INTRODUCTION .
6.2 AIM, OBJECTIVES AND HYPOTHESES
6.3 METHOD
6.4 MEASUREMENTS
6.5 PROGRAMME ATTENDANCE AND PROCESS EVALUATION
6.6 DATA MANAGEMENT AND ANALYSIS
6.7 VALIDITY AND RELIABILITY OF THE MEASUREMENTS
6.8 THE NUTRITION EDUCATION PROGRAMME IMPLEMENTATION
CHAPTER 7 RESULTS FOR PHASE 3
7.1 INTRODUCTION
7.2 PARTICIPANTS SOCIO-DEMOGRAPHIC CHARACTERISTICS’
7.3 OUTCOMES
7.4 NUTRITION EDUCATION PROGRAMME PROCESS EVALUATION
CHAPTER 8 DISCUSSION ON PHASE 3 
8.1 INTRODUCTION
8.2 OUTCOMES
8.3 NUTRITION EDUCATION PROGRAMME PROCESS EVALUATION
8.4 STRENGTHS AND LIMITATIONS OF PHASE 3
8.5 CONCLUSIONS
8.6 RECOMMENDATIONS.
REFERENCES
CHAPTER 9 EXECUTIVE SUMMARY, CONCLUSIONS AND RECOMMENDATIONS 
9.1 INTRODUCTION
9.2 AIM AND OBJECTIVES OF THE STUDY
9.3 METHODS
9.4 MAIN FINDINGS
9.5 STRENGTHS AND LIMITATIONS OF THE STUDY
9.6 CONCLUSIONS
9.7 RECOMMENDATIONS FOR FUTURE RESEARCH
9.8 RECOMMENDATIONS FOR PRACTICE
REFERENCES
APPENDICES
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