Using mHealth to Optimize Glycemic Control in Adults With Type 2 Diabetes in Nakuru County: A Proof-of-Concept Randomized Controlled Trial
Phase: NA
Conditions: Diabetes
Sponsor: KU Leuven

i 
 
 
  
Using mHealth to Optimize Glycemic Control in Adults with Type 2 Diabetes in Nakuru County: A Proof-of-
Concept Randomized Controlled Trial 
 
 
Principal Investigator and PhD Student  
Name:    
Moses Mokaya  
Address:   
Legume Centre of Excellence in Food and Nutrition Security, Jomo Kenyatta University of 
Agriculture and Technology and KU Leuven 
P.O. Box 62000 – 00200, Nairobi, Kenya  
Telephone: 
+254 721 299 189 
E-mail:  mmokaya@gmail.com  
 
  
Co-Principal Investigators and Supervisors 
Name:    
Dr. Florence Kyallo  
Address:   
Department of Human Nutrition Sciences, Jomo Kenyatta University of Agriculture and 
Technology, P.O. Box 62000 – 00200, Nairobi, Kenya  
Telephone:   
+254 722 693 523 
E-mail:   fkyallo@jkuat.ac.ke 
 
Name:   
Prof. Dr. Ir. Christophe Matthys   
Address:  
Clinical and Experimental Endocrinology, Department of Chronic Diseases and 
Metabolism, KU Leuven, Herestraat 49, 3000 Leuven 
Telephone:  
+32 16342655             E-mail:  christophe.matthys@uzleuven.be   
 
Name:   
Prof. Dr. Roman Vangoitsenhoven 
Address:  
Clinical and Experimental Endocrinology, Department of Chronic Diseases and 
Metabolism. KU Leuven, , Herestraat 49, 3000 Leuven 
Telephone:  
+32 16193235  
E-mail:  roman.vangoitsenhoven@kuleuven.be  
 
Name:    
Dr. Janai Ondieki 
Address:   
Department of Surgery, School of Medicine, Jomo Kenyatta University of Agriculture and 
Technology, P.O. Box 62000 – 00200, Nairobi, Kenya  
Telephone:   
+254 724 925 705 
E-mail:   janaimariita@gmail.com  
 
 
 
 
 
 
 
August 2021 
 
 
Version 3: 17/08/2021 
 
 

ii 
 
 
Table of Contents 
List of Figures ................................................................................................................................................. iii 
List of Tables .................................................................................................................................................. iii 
List of acronyms ............................................................................................................................................. iv 
Abstract .......................................................................................................................................................... v 
1 
Introduction/Background ...................................................................................................................... 1 
2 
Statement of the Problem ..................................................................................................................... 2 
3 
Review of Literature .............................................................................................................................. 3 
3.1 
Evidence on the use of mHealth in management of type 2 diabetes ............................................ 3 
3.1.1 
Use of text messaging in mHealth interventions for patients with type 2 diabetes .................. 4 
3.1.2 
Mobile phone applications in patients with type 2 diabetes ..................................................... 4 
3.2 
Evidence on using glycated hemoglobin (HbA1c) in measurement of glycemic control ............... 5 
3.3 
Evidence on the role of food literacy on type 2 diabetes .............................................................. 5 
3.4 
Development of an intervention using the behavior change wheel model ................................... 6 
3.5 
Research Objectives ...................................................................................................................... 7 
4 
Conceptual Framework and Operationalization .................................................................................... 8 
4.1 
Operational definition of independent and dependent variables ................................................. 8 
4.1.1 
Definition of independent variables .......................................................................................... 8 
4.1.2 
Definition of dependent variables ............................................................................................. 9 
5 
Hypotheses/research questions ............................................................................................................ 9 
6 
Study design and sampling strategy ...................................................................................................... 9 
6.1 
Study design .................................................................................................................................. 9 
6.2 
Participants .................................................................................................................................... 9 
6.2.1 
Setting of the study ................................................................................................................... 9 
6.2.2 
Inclusion and exclusion Criteria ................................................................................................. 9 
6.3 
Sample size .................................................................................................................................. 10 
6.4 
Sampling design ........................................................................................................................... 10 
6.5 
Recruitment ................................................................................................................................. 10 
6.6 
Randomization ............................................................................................................................ 11 
6.7 
Blinding ........................................................................................................................................ 11 
6.8 
Interventions ............................................................................................................................... 11 
6.8.1 
Intervention group .................................................................................................................. 11 
6.8.2 
Control group .......................................................................................................................... 12 
6.9 
Outcomes .................................................................................................................................... 17 
6.9.1 
Primary outcome measures .................................................................................................... 17 
6.9.2 
Secondary Outcome measures ................................................................................................ 17 
7 
Data Collection .................................................................................................................................... 17 
7.1 
Quantitative Instruments ............................................................................................................ 17 

iii 
 
7.1.1 
Socio-demographic and health history questionnaire ............................................................. 18 
7.1.2 
Self-perceived food literacy questionnaire .............................................................................. 18 
7.1.3 
Anthropometric measurements .............................................................................................. 18 
7.1.4 
Body composition .................................................................................................................... 18 
7.1.5 
Blood samples ......................................................................................................................... 18 
7.1.6 
Interactive text messaging....................................................................................................... 19 
7.2 
Training of research assistants and piloting ................................................................................ 19 
7.3 
Management of data quality during fieldwork ............................................................................ 20 
7.4 
Ethical issues ............................................................................................................................... 21 
8 
Data Processing and Analysis .............................................................................................................. 22 
8.1 
Data coding, entry, and editing; transcription of qualitative data generated ............................. 22 
8.2 
Plan for analysis of quantitative data .......................................................................................... 22 
9 
Plan for communicating findings of the study ..................................................................................... 22 
9.1 
Dissemination strategy ................................................................................................................ 22 
9.2 
Outline for research report ......................................................................................................... 22 
9.3 
Involvement of stakeholders in the study ................................................................................... 22 
9.4 
Likely policy implications that might arise from the study .......................................................... 23 
9.5 
Limitations of the study design and methods of data analysis .................................................... 23 
9.6 
Major assumptions in the study .................................................................................................. 23 
10 Management and Organization of the Study ...................................................................................... 24 
10.1 
Team members, their roles, and management procedures in the study .................................... 24 
10.2 
Other resources and facilities that will be availed for the study ................................................. 24 
10.3 
Schedule of activities ................................................................................................................... 24 
10.4 
Budget ......................................................................................................................................... 25 
11 References ........................................................................................................................................... 27 
 
 
List of Figures 
Figure 1. The Behavior Change Intervention design process ......................................................................... 7 
Figure 2. Conceptual Framework for dietary behavior outcomes and food literacy concepts ...................... 8 
Figure 3. Study timeline ............................................................................................................................... 12 
 
List of Tables  
Table 1. Text Messages Schedule ................................................................................................................ 11 
Table 2. Text messages for specific target behaviors .................................................................................. 13 
Table 3. Study Team Members and Roles ................................................................................................... 24 
Table 4. Schedule of Activities ..................................................................................................................... 24 
Table 5. Budget ............................................................................................................................................ 25 
 
 
 
 

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List of acronyms 
AIDS:   
Acquired Immune Deficiency Syndrome  
AMREF ESRC:  African Medical Research Foundation Ethics and Scientific Research Committee 
BCW: 
 
Behavior Change Wheel 
FPG: 
 
Fasting plasma Glucose 
GDPR:  
General Data Protection Regulation  
HbA1c:   
Glycated Haemoglobin  
HDL-C:   
High-density lipoprotein-cholesterol 
HIC 
 
High Income Countries  
HIV:  
 
Human Immunodeficiency Virus 
JKUAT:  
Jomo Kenyatta University of Agriculture and Technology 
KDDA:  
Kenya Defeat Diabetes Association 
KEMRI:  
Kenya Medical and Research Institute  
LMIC:   
Low- and middle-income countries  
MIC:  
 
Middle-income countries 
MOH:  
Ministry of Health  
NACOSTI:  
National Council for Science Technology and Innovation  
RCT:  
 
Randomized controlled trial 
TC: 
 
Total cholesterol  
TG: 
 
Triglycerides 
WHO:   
World Health Organization 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

v 
 
Abstract  
Background 
Approximately 552,400 (2.2%) adults aged between 20-79 years in Kenya have type 2 diabetes, 36.0% of 
the adults have undiagnosed diabetes. Diabetes considerably increases the risk to all-cause mortality and 
accompanying treatment leads to heavy economic costs. The use of mHealth in managing type 2 diabetes 
has been associated with increased adherence to diabetes medication, reduction in morbidity and 
increased self-monitoring of blood glucose in patients with type 2 diabetes.  
 
Objectives 
The objective of this study is to evaluate the efficacy of a diet-related mHealth intervention on glycated 
hemoglobin in adults with type 2 diabetes.  
 
Methods 
The mHealth intervention will be delivered using one-way and two-way mobile text messages that were 
systematically developed using the behavior change wheel to facilitate food literacy. The text messages are 
loss- or gain-framed to increase influences behavioral decisions. The primary outcome of this proof-of-
concept randomized controlled trial will be glycated hemoglobin. Secondary outcomes include: i) 
anthropometric measurements (BMI, waist-hip ratio, and bioelectric Impendence analysis); ii) dietary 
intake of fruits, vegetables and legumes; iii) food literacy scores and iv) mHealth user satisfaction. 
Assessments shall be conducted at baseline, 3 months (primary endpoint) and 6 months (follow-up). To 
identify between-group differences, the generalized linear models will be determined using analysis of 
covariance through the intention-to-treat principle. 
 
Study duration  
This will be a 12-week intervention, that will be followed by a follow-up of the study cohort for another 12 
weeks. 
 
Budget 
It is estimated that this study will cost approximately Kes 2,483,540. 
 

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1 
Introduction/Background  
Diabetes is a serious, long-term condition that develops when the body cannot produce adequate or any 
insulin or cannot effectively use the insulin. Type 2 Diabetes contributes to 90% of all diagnosed cases of 
diabetes and is attributed to ageing and the nutrition transition (1). In 2019, approximately 463 million 
people were estimated to have diabetes globally, and it is expected that the prevalence will rise to 578 
million by 2030 (2). In the African region, an estimated19.4 million adults aged 20–79 years had diabetes in 
2019, representing a regional prevalence of 3.9%. The proportion of undiagnosed diabetes is high globally, 
where more than one in two (59.7%) people living with diabetes are uninformed of their condition. In the 
African region, the prevalence of diabetes is higher in urban (5.9%) compared to that in rural areas 
(2.4%)(3). Further, glycemic control, which is an important treatment outcome for type 2 diabetes, remains 
comparatively low in LMICs.  A recent cross-sectional study on health system performance for people with 
diabetes analyzed the cascade of care in 28 LMICs (4). This study showed that only 22.8% of persons with 
diabetes receiving treatment with lifestyle modification advice achieve glycemic control.  
In Kenya, it is estimated that 552,400 (2.2%) adults aged between 20-79 years have diabetes. Further, more 
than a third (36.0%) of the adults in the same age-group are not aware that they have diabetes. Kenya also 
has the second highest proportion of deaths (88.4%) in Africa related to type 2 diabetes for people aged 
below 60 years. In 2019 alone, 8,081 deaths were attributed to diabetes. The prevalence of type 2 diabetes 
in Kenya is higher in urban areas (3.4%) compared to rural areas (1.9%) (5). The prevalence of diabetes is 
higher among persons in the highest wealth quintile (5.2%) compared to those in the lowest wealth quintile 
(1.0%). In Nakuru County, the prevalence of type 2 diabetes among people aged 50 years and above is 6.5% 
(6).  
Diabetes considerably increases the risk to all-cause mortality globally. Cardiovascular disease (CVD) 
mortality associated with diabetes is higher in low- and middle-income countries (LMICs) compared to high 
income countries (HIC). A recent cohort study (7) with 143,567 adults aged 35–70 years reported higher 
CVD rates among people with diabetes in LMICs (LIC 10.3, MIC 9.2, per 1,000 person-years, P < 0.001) 
compared to HIC (8.3 per 1,000 person-years, P < 0.001). Cardiovascular mortality was also higher in LMICs 
(LIC 10.3, MIC 9.2 person-years, P < 0.001) compared to HIC (1.0 per 1,000 person-years, P < 0.001). 
Diabetes treatment leads to heavy economic costs, with approximately USD 727 billion spent per year 
globally on diabetes healthcare (8). In Kenya, USD 70.5 Million was spent in expenditures related to diabetes 
care (9), translating to approximately USD 324 per person with diabetes per year (2). This increasing 
epidemic points to a dire need for global, regional, and in-country approaches to find suitable solutions to 
forestall further adversity. 
It has been proven that multi-disciplinary, patient-centered, and well-coordinated models facilitate 
diabetes self-management (10). Various diabetes care guidelines recommend individualization of care to 

2 
 
enable attainment of treatment outcomes, reduce of hospitalizations and adverse clinical events and 
improving the quality of life (11–13). To implement recommendations, systemic and financial barriers need 
to be overcome. Hence, governments and relevant stakeholders need to invest in high-quality, team-based 
diabetes care to optimize modern technological advancements (14).   
Technological advancement and diabetes technology may use the versatile nature of mobile phones and 
appliances (mHealth) to support diabetes. The recent increase in mobile phone ownership and use in LMICs 
(15–17) has resulted in a commensurate rise in the use of mHealth in behavior change interventions (17–
22). In Kenya, the use of mHealth showed increased adherence to diabetes medication, significantly 
reduced in morbidity and increased self-monitoring of blood glucose in patients with type 2 diabetes 
(21,22). mHealth has the potential to address gaps in accessibility and coverage. mHealth is associated with 
positive effects on clinical outcomes, compliance and quality of life in type 2 diabetes (23–25). Despite there 
being many studies that have shown changes in treatment outcomes for type 2 diabetes in Kenya, there is 
a dearth of evidence on the use of theory-driven mHealth interventions on diabetes care.  
The most common approach to diabetes care has been focusing on behavior change and lifestyle 
modification. However, a recent systematic review and meta-analysis (26) provided evidence that changing 
dietary environment had a greater reduction in HbA1c: 0.5% (5.5 mmol/mol [95% CI -0.65, -0.34]) compared 
to 0.32% (3.5 mmol/mol [95% CI -0.40, -0.23]) for interventions that intended to change behavior. This 
review (26) suggested four strategies to refine the efficacy of dietary behavior interventions in treatment 
of type 2 diabetes. These strategies include more robust reporting of content and frequency of behavior 
change techniques (BCTs), intervention fidelity (the extent to which an intervention was delivered as 
conceived and planned) and alignment of the intervention with behavior change theory. (27) 
This study seeks to use interactive mHealth to optimize glycemic control through dietary behavior and food 
literacy in people with type 2 diabetes in Nakuru County, Kenya.  
2 
Statement of the Problem  
The prevalence of type 2 diabetes in Kenya is rising and by 2045, it is projected that nearly 1.5 million people 
will have diabetes. The application of mHealth in diabetes care  has gained prominence globally, but little 
is known on how this novel approach will affect treatment and management of diabetes in LMICs settings. 
Further, the use of the behavior change wheel model has been associated with notable improvements in 
various aspects of diabetes self-care. In addition, our systematic review showed that mHealth interventions 
lack engagement and sub-optimally apply behavior change theories.    
These gaps in diabetes care in Kenya, where the increased availability and use mobile telephones creates 
an important opportunity for sustainable and locally suitable interventions in diabetes care. This proof-of-
concept randomized controlled trial will use mHealth, one-way and interactive mobile text messages to 
optimize glycemic control in adults with type 2 diabetes. It is anticipated that the findings from this trial will 

3 
 
provide information on how mobile technology can be applied to support dietary behavior modification 
among adults with type 2 diabetes in a Kenya.   
3 
Review of Literature  
This section reviews literature on use of mHealth in type 2 diabetes care, glycemic control, food literacy 
and using the behavior change wheel model to develop an intervention. 
3.1 
Evidence on the use of mHealth in management of type 2 diabetes  
Diabetes management in LMICs is influenced by a complex interplay between individual factors, the socio-
cultural and physical environment, the health system and other related drivers coupled with lack of health 
insurance and poor‐income levels (28–30). To address challenges in diabetes self-care in LMICs, the 
principles of collaboration, education, standardization, resource optimization and technological innovation 
need to be considered (31). Technological innovation includes using diabetes technology and the versatile 
nature of mobile phones and appliances to support self-care.  
According to the World Bank (32), there are 104 per 100 people mobile phone subscriptions globally. 
Further, over 93.2% of the world’s population is now covered by a mobile broadband network (33). In Africa, 
there are 76 per 100 people mobile phone subscriptions with 88.4% of the population covered by mobile 
broadband network (33). Following the high ownerships and use of mobile technologies followed by their 
innovative application to address health, mHealth is a fast-growing and evolving field that provides a 
potential for chronic disease management.  
Increased availability and use of mobile phones has facilitated the application of mHealth in behavior 
change interventions (17–20). mHealth is defined as medical and public health practice that is supported 
by mobile devices, like mobile phones, patient monitoring devices, personal digital assistants (PDAs), and 
other wireless devices (34). In LMICs, mHealth has been shown to address gaps in accessibility and coverage 
and resulted in positive effects on clinical outcomes, compliance and quality of life in type 2 diabetes (23–
25). mHealth is also influencing delivery and management of health services and information (35). The 
increased accessibility  to mHealth has expanded the possibilities of personalization and citizen-centered 
public health and medical care. mHealth has effectively been applied in various fields of healthcare, 
including maternal and child health(36), chronic disease management (37) and HIV/AIDS (38). 
The potential of mHealth interventions to improve care and management of diabetes has resulted in 
numerous empirical studies. Two meta-analyses, which included mainly studies from HICs, suggested that 
mHealth interventions for diabetes have clinically meaningful changes of more than 0.5% change of HbA1c 
(39,40). A pooled effect on HbA1c from three studies on mobile phone–based interventions showed a larger 
effect of up to 20.5% (40). Further, mHealth interventions have been shown to be cost-effective (41) despite 
being criticized for having meager user satisfaction ratings and usability challenges (42). Most of the studies 
are however conducted in HICs. Additionally, mHealth has been associated with changes in clinical 

4 
 
outcomes, improved adherence to treatment and communication with providers, decreased travel time, 
easier access to expert advice and cost-effective diabetes education in LMICs (43). Further, our systematic 
review on interventions in LMICs showed that mHealth has the potential to change HbA1c in clinically 
significant margins (44). The operational and socio-cultural framework in LMIC is dissimilar from that in high 
income countries. Therefore, more methodologically sound interventions to determine the efficacy of well-
designed interventions in these settings are required (43).   
3.1.1 
Use of text messaging in mHealth interventions for patients with type 2 diabetes  
Text messaging is convenient, does not require internet access and is commonly used among most mobile 
phone users, irrespective of their socioeconomic status (45) and is not affected by racial disparities (46). 
Evidence shows that interventions using text messaging successfully reach most population subsets, 
including the high-risk and hard-to-reach (47,48). Text messaging has also improved self-care and glycemic 
control in racially and ethnically diverse populations with low socioeconomic status (49–51). A recent survey  
in Kenya on the use of smartphone and social media in emerging economies identified text messaging as 
the most popular social activity among phone users. The survey showed that 85% of Kenyans had sent text 
messages in the past 12 months (52).  
However, there is a lack of evidence on how health literacy interventions using text messaging affects adults 
with type 2 diabetes (53). Nelson, et al., 2016 (54) examined the association between health literacy status 
and engagement using text messaging, and suggested that user experience is important in the development 
of engaging mHealth interventions.  
Studies in LMICs have shown that using text messaging is beneficial to treatment and have full patient 
satisfaction. An Egyptian study (55)  suggested an up to 1.0% HbA1c reduction, considerable improvements 
in adherence to medication, self-efficacy and resulted in increased knowledge and participant satisfaction. 
Another study in Iraq showed a 0.7% HbA1c reduction after  a 6 month SMS intervention, accompanied by 
a correlated improvement in knowledge score and satisfaction ratings (56). 
3.1.2 
Mobile phone applications in patients with type 2 diabetes 
Mobile applications (apps) are commonly referred to as a type of application software designed to run on 
a mobile device, such as a smartphone or Tablet computer. The prominence of health‐related smartphone 
apps started in 2010, and studies have illustrated the potential of smartphone apps in complementing 
diabetes care (57). Mobile health apps have the possibility to support patients in managing diabetes 
through monitoring of blood glucose, diet, and exercise as well as to increase adherence to diabetes 
management and self-monitoring. Evidence from meta-analyses suggest that mobile apps can support 
improvement of blood glucose control and strengthen the self‐care perceptions in people with diabetes by 
increasing health knowledge (58,59). A recent systematic review and meta-analysis shows that SMS-based 

5 
 
mhealth interventions produced the highest effects on treatment when compared with smartphone apps-
based services (60).  
3.2 
Evidence on using glycated hemoglobin (HbA1c) in measurement of glycemic control  
Glycated hemoglobin (HbA1c) is the average plasma glucose over the previous eight to twelve weeks (61). 
This test can be conducted at any time of the day and does not require any specific prior preparation, such 
as fasting. This flexibility makes HbA1C a more preferred and recommended diagnostic test for measuring 
glycemic control in people with diabetes (62–64). The recommended cut-off point for diagnosing diabetes 
using HbA1c is 6.5% (48mmol/mol). However, a value >6.5% does not necessarily imply diagnosis of 
diabetes while levels between 5.7 and less than 6.5%, infer a pre-diabetes range.  
Using HbA1c is advantageous because it avoids the day-to-day variability of glucose values, and the need 
for the patient to fast prior to the test. However, differences in precision of HbA1c measurement between 
laboratories and global inconsistency remain problematic  concerns for this test (62). Additionally, HbA1C 
is influenced by erythropoiesis, altered haemoglobin, glycation, erythrocyte destruction and assays (65).  
Despite the expectation that low HbA1C reduces all-cause mortality, some studies have shown increased 
risk of mortality and cardiac events, depicting a U-shaped correlation (66,67). The reason for the higher 
mortality risk is however not clearly known but may be explained by hypoglycemia and a possible direct 
adverse effect of administered pharmacological glucose-lowering agents.  Further, other studies have 
revealed that the there is an increased risk of mortality associated with low HbA1c values (68–70). High 
levels of HbA1C increases the risk to cardiovascular conditions, diabetes complications and other 
debilitating health outcomes as compared to normal ranges of HbA1C. Hence, various guidelines (71–74) 
recommend reducing HbA1c levels to less than 7% and emphasize the value of achieving the low HbA1C 
through individualized treatment approaches based on specific patient characteristics (75,76). 
3.3 
Evidence on the role of food literacy on type 2 diabetes  
Vidgen et al. (77) define food literacy as ‘a collection of inter-related knowledge, skills and behaviors 
required to plan, manage, select, prepare and eat food to meet needs and determine intake’. In this 
definition, food literacy is composed of 4 components: (i) Planning and management; ii) Selection; iii) 
preparation and iv) eating. Recently, Fisher et al., (78) redefined food literacy in the South African context 
as   ‘Food literacy refers to an individual’s knowledge, skills and behavior as demonstrated through the 
sourcing, consumption as well as the nutritional, economic, safety and social aspects of food’. The two 
definitions agree on the broader significance of knowledge, skills, and behavior. However, the new South 
African definition emphasizes on sourcing of food, nutritional value, safety, economic and social aspects 
related to food consumption. It has also been advanced that food literacy is influenced by interdependent 
intrinsic attributes (79). In this perspective, intrinsic factors include food skill, knowledge, and self-efficacy 
while extrinsic attributes are ecological or socio-cultural drivers. Using a combination of the described 
components (77) and attributes (79) food literacy can be defined as  ‘the interrelated combination of 

6 
 
knowledge, skills and self-efficacy on food planning, food selection, food preparation, eating and evaluating 
information about food with the ultimate goal of developing a lifelong healthy, sustainable and gastronomic 
relationship with food’ (80). 
Food literacy has the potential to connect food and nutrition-related knowledge, cooking skills, and 
capability to promote and develop relevant knowledge to facilitate dietary behavior change (81). In 
Australia, food literacy interventions have been shown to provide individuals with skills that contribute to 
health (77,81). Similarly, an Irish study showed that lower diabetes nutrition knowledge was linked to lower 
intakes of fruits and vegetables and consumption of foods with higher dietary glycemic index (82). A positive 
correlation between health literacy and diabetes knowledge has also been inferred in patients with type 2 
diabetes, as described in a recent systematic review (83).   
There is a dearth of information on food literacy of people with type 2 diabetes in Kenya. However, one 
study on nutrition knowledge in  people with type 2 diabetes revealed that 69.3% had low nutrition 
knowledge and 81.4% of the  people did not know the meaning of a balanced diet (84).  
3.4 
Development of an intervention using the behavior change wheel model 
Behavior change interventions are defined as organized sets of activities that are designed to change 
specific behavior patterns (85). Generally, these patterns are measured based on prevalence or incidence 
of the behaviors in specific populations. Human behavior change is complex given that it is determined by 
the intricate interactions between the individuals’ environment and a diverse set of social drivers (86). 
There is increasing recognition that the design of behavior change interventions should be based on 
relevant theories (87–89). The value of using behavior change theories and behavior change techniques 
(BCTs)  in mHealth interventions is known (90,91). However, their application in LMICs  is sub-optimal (92).  
Recently, the behavior change wheel (BCW) (86) has been applied in the design and implementation 
mHealth interventions (93–95). BCW allows users to design and decide on interventions and policies based 
on an analysis of the specific behavior. It also takes into consideration the processes that need to be altered 
to effect the behavior change, and provides the interventions and policies needed to change the processes 
(86).  
The BCW outlines three stages  of designing interventions as illustrated in Figure 1 below.  

7 
 
 
Figure 1. The Behavior Change Intervention design process 
Source: Adapted from The Behavior Change Wheel, A guide to Designing Interventions (p 25) by Michie, 
S., et al. 2014. 
 
3.5 
Research Objectives  
The objective of this study is to evaluate the efficacy of a diet-related mHealth intervention on glycated 
hemoglobin among adults with type 2 diabetes.  
By using one-way and interactive mobile telephone messages, this intervention seeks to achieve the 
following specific objectives:  
1. Reduce glycated hemoglobin by at least 0.3% after 12 weeks 
2. Increase food literacy scores as measured by the self-perceived food literacy scale  
 
 
 
 
 
 
 
 
 
 
 
 
 

8 
 
4 
Conceptual Framework and Operationalization  
The theoretical framework (Figure 2) of dietary behavior and food literacy is founded on the four 
components of food literacy in Vidgen et al. (77) and the attributes of food literacy described by Perry et 
al., (79).  The four components of food literacy include planning, selection, preparation and eating, while 
the attributes are skills, knowledge, and self-efficacy. Vidgen definition. (77) has been criticized for its 
emphasis on knowledge and excludes functional skills (96). Our operational definition therefore 
amalgamates a wider scope of definition of food literacy. Based on findings from our qualitative study 
conducted in the same population, it was found that two components of food literacy presented as the 
highest-ranking barriers to health dietary intake. We therefore developed the conceptual framework based 
on selection and eating of healthy dietary diet. BCW is applied to systematically identify the theoretical 
domains framework, intervention functions and behavior change techniques that were used to develop  
text messages for the intervention. It is anticipated that the text messages will influence changes selection 
and eating of healthy diets that will result in a reduction in HbA1C.  
 
 
Figure 2. Conceptual Framework for dietary behavior outcomes and food literacy concepts 
4.1 
Operational definition of independent and dependent variables  
4.1.1 
Definition of independent variables 
i. 
 Food literacy:   the interrelated combination of knowledge, skills and self-efficacy on food planning, 
selecting foods, food preparation, eating and evaluating information about food with the ultimate 
goal of developing a lifelong healthy, sustainable and gastronomic relationship with food (80). 
ii. 
Attribute of food literacy: quality or feature considered as a characteristic or integral part of food 
literacy (79,97) 
iii. 
Psychological  capability: The mental capacity, knowledge or psychological skill to engage in the 
necessary thought (85) 
 
 
 
 
Identification of problem 
in behavioral terms: 
Unhealthy dietary 
patterns  
Qualitative study: 
Determination of 
barriers and facilitators 
to health dietary intake: 
• Selection of unhealthy 
food 
• Eating unhealthy 
diets 
Determination of 
• Theoretical Domains 
Framework 
• Intervention Functions 
• Behavior Change 
Techniques 
Text 
messages 
Reduction 
of HBA1c 
by 0.3% 

9 
 
iv. 
Physical capability: The capacity, physical skill, strength, or stamina to perform an activity (85) 
v. 
Physical opportunity: The opportunity offered by the environment (85) 
vi. 
Social Opportunity: The cultural milieu, social cues and interpersonal influences that direct the 
way we think about things (85) 
vii. 
Reflective  Motivation: Processes such as evaluating and planning (85) 
viii. 
Automatic motivation: The emotions, reactions, desires  and impulses arising from associative 
learning and/or innate dispositions (85) 
4.1.2 
Definition of dependent variables  
Glycated hemoglobin (HbA1c) is the average plasma glucose over the previous eight to twelve weeks (61).  
5 
Hypotheses/research questions  
We hypothesize that using mHealth influences food literacy and dietary behavior hence reducing HbA1c 
by at least 0.3% in 12 weeks among adults with type 2 diabetes. 
6 
Study design and sampling strategy  
6.1 
Study design 
This will be a proof-of-concept randomized controlled trial (RCT) using mobile text messaging to optimize 
glycemic control in adults with type 2 diabetes.  
6.2 
Participants  
6.2.1 
Setting of the study  
This study will be conducted in Nakuru County, located 157km North-West of Nairobi, Kenya (Appendix 1). 
Nakuru County covers an area of 7,495 km2 and has 11 administrative Sub-Counties including Nakuru Town 
East, Nakuru Town West, Naivasha, Molo, Gilgil, Njoro, Kuresoi North, Kuresoi South, Rongai, Nakuru North 
and Subukia (98). The county is estimated to have a population of nearly 2 million people (99)  and an 
estimated prevalence of 2.4% of type 2 diabetes among adults aged ≥50 years (6).  
6.2.2 
Inclusion and exclusion Criteria 
Participants will be eligible for inclusion into the study if they meet the following criteria:  
a. adults over the age of 18 years; 
b. diagnosed the type 2 diabetes within the previous 1 year and obtaining care at a 
participating level 4 hospital; 
c. able to read English or Swahili Language (self-reported).  
d. currently own and able to read and send mobile text messages using any phone; 
Participants will be excluded if they: 
a) are on dialysis; 
b) are pregnant;  

10 
 
c) are unable to use mobile phone because of mental or visual impairment or any other 
reason.  
 
6.3 
Sample size 
Hypothesis testing was not the objective of this study. However, for an effect size of 0.60, at a power of 
0.80 and at an alpha level of 0.05, a sample size of 25 in each group has been used to results in a 1% 
reduction of HbA1c levels at post-test compared with pre-test (100). We therefore determined a sample 
size of 60 a-priori (n=30 intervention, n=30 control arm) to assess feasibility of text messaging in optimizing 
glycemic control. It is anticipated that this proof-of-concept study will obtain parameters that will be used 
in determining a robust power calculation for a fully powered efficacy trial, as it has been applied elsewhere 
in Bucci et al. (101).  
6.4 
Sampling design  
Nakuru county has 18 level 4 hospital(102). Purposive sampling will be used to select two hospitals, one in 
a rural setting, and another in an urban setting. Multistage random sampling with then be applied to 
randomly assign 15 participants in either the intervention or control arms using simple random sampling in 
each of the selected hospitals.  
 
6.5 
Recruitment  
The officers-in-charge of the non-communicable disease clinics shall be enlisted to help in the recruitment 
of participants. The officers will receive the recruitment procedure guidelines prior to the onset of the study 
to ensure a standard approach in all the hospitals. During the clinic visits, the participants will be asked to 
participate in the study. Possible study participants will be given details on the study and asked to 
acknowledge their willingness to participate within 7 days. The recruitment is planned to take place 
between 15th July to 15th August 2021.  
Due the COVID-19 disease the following precautionary measures shall be ensured by the research team, 
participants and hospital staff during recruitment, training and all activities in this study:  
1. The study shall provide personal protective equipment (PPE) for all study participants and 
researchers.  
2. Regular and thorough washing of hands with soap and water, or alcohol-based hand sanitizer 
provided by the research.  
3. Maintaining a distance of at least 1 meter (5 feet) between yourself and anyone (who is 
coughing or sneezing), avoiding handshakes or hugging.  
4. Persons with a cough or sneezing should stay home or keep a social distance but avoid mixing 
with others in a crowd.  

11 
 
5. Maintain good respiratory hygiene by covering your mouth and nose while coughing and 
sneezing with a handkerchief, tissue, or into flexed elbow.  
6. Stay at home if you feel unwell with symptoms like fever, cough and difficulty in breathing.  
7. All study participants should at all times wear a face mask to reduce the chances of transmission 
of the virus.  
8. Any cases regarding the disease will be reported using the call line facility number 719. Correct 
messages to be relayed to the participants (if need be) will be received from *719#  
9. Surfaces used during the research activities (e.g. desks, tables) and objects will be wiped with 
disinfectant regularly.  
10. Surfaces used during the research activities (e.g. desks, tables) and objects will be wiped with 
a disinfectant regularly. 
 
6.6 
Randomization  
We will apply simple random sampling through a computer-generated list of random numbers. The hospital 
diabetes registers from the two selected hospitals will be used to select patients on regular diabetes care 
from the hospital patient records. The patients will then be assigned numbers and randomly selected.  
6.7 
Blinding  
Blinding of the participants, care providers or the research team is not possible because the intervention 
requires identification of participants to receive text messages.  
6.8 
Interventions  
6.8.1 
Intervention group  
The intervention group will receive a total of 43 text messages as tabulated in Table 1 below. Text messages 
were developed using the BCW through a systematic process linked to specific behavior change techniques 
(Table 2). The text messages will provide practical information or guidance to influence selection and eating 
healthy diet for type 2 diabetes care. The text messages were either loss- or gain-framed to increase 
influence on behavioral decisions (103). Additionally, the participants will receive a text message to rate 
their ability on selection of food and eating of healthy diet based on the messages received in the month.  
The combination of the one-way and two-way messages in this group are  designed to increase engagement 
of the participants.  
 
Table 1. Text Messages Schedule 
Message type 
Message format 
Frequency  
Total number of messages  
Introductory message 
One-way 
Once 
1 
Clinic Appointment  
One-way 
1 message per month  
3 
Selection of healthy food  
One-way 
3 messages per week 
18 
Eating healthy diet  
One-way 
3 messages per week 
18 
Evaluation message 
Interactive  
1 message per month  
3 

12 
 
 
6.8.2 
Control group 
The control group will continue receiving standard care in the hospitals. The control group shall receive a 
reminder text messages one day before the routine clinic appointment. The clinic appointment dates shall 
be derived from the hospital where the participant receives routine diabetes care. 
 
Figure 3 describes the study timeline and workflow. At the beginning of the intervention, both the control 
and intervention groups will receive introductory text messages. Text messages shall consist of personalized 
salutation (using the preferred name of the participant) sent to the officially registered mobile numbers. 
The messages shall be sent between 10am and 3pm through the Africa’s Talking ®  
Application Programming Interface (API). 
 
 
 
Figure 3. Study timeline 
 
 
 
 

13 
 
Table 2. Text messages for specific target behaviors 
COM-B 
Components  
What needs to happen 
for the target behavior 
to occur?  
Behavior Change 
Technique  
 
Text No 
Text Messages  
Physical 
capability 
Be able to select  
healthy food   
Instructions on 
how to perform 
behavior  
S 1   
 
 
 
To meet nutrient needs within calorie limits, choose a variety of nutrient-dense foods across and 
within all food groups in recommended amounts. Energy dense foods include vegetables, fruits, whole 
grains, beans, nuts and seeds, and lean protein — when prepared with little or no saturated fats, 
added sugars and sodium 
S 2 
 
 
 
There are 5 food groups: (1)Vegetables and legumes or beans 
(2)Fruit; (3)Lean meats and poultry, fish, eggs, nuts and seeds, legumes or beans;(4) Grain (cereal) 
foods, mostly wholegrain or high cereal fiber varieties (5) Milk, yoghurt, cheese or alternatives, mostly 
reduced fat. 
S 3 
 
Reduce foods and beverages that are high in added sugars to better control your blood sugar.  To 
avoid added sugars, check for words like brown sugar, corn sweetener, corn syrup, dextrose, fructose, 
and high-fructose corn syrup. These are added sugars 
S 4 
Reduce or avoid foods and beverages that are high in saturated fat like whole milk, cream, butter, 
cheese, meat, palm oil and coconut oil. Instead, select low-fat milk and use healthier plant-based oils.  
S 5 
 
Instead of selecting canned fruit or bottled juices, buy fresh juice or fruits as they are energy dense 
and have fiber that helps in blood sugar control. Fresh fruits are also cheaper.  
Be able to eat healthy 
food diet 
E1 
 
 
 
 
 
 
To ensure you eat a healthy diet, try to eat the following food servings most days of the week:  
(1) Vegetables and legume beans: Like 5-6 medium cups of managu, or mixed vegetables, or 2 
tomatoes.  
(2) Fruits: Like 2 medium size apples, bananas, oranges or pear. 
(3)Lean meats and poultry, fish, eggs, nuts and seeds, legumes or beans: Like 200g raw meat or fish, or 
2 eggs, or 60g of nuts or 300g beans ; 
(4) Whole meal grain (cereal) foods: Like 60–90 g of Ugali, bread, chapati  
(5) Milk, yoghurt, cheese or alternatives: like 500 ml milk or yoghurt 
E 2 
Most processed carbohydrate foods release glucose more quickly than whole grain carbohydrates. Eat 
whole grain carbohydrates which produce a slower rise in blood glucose levels, which are called low-
glycemic index (GI) foods and result in better blood glucose control.  
E 3 
Low GI foods include some posho milled unga, high-fiber breads and whole meal cereals  githeri,  most 
fruits, legumes, and low-fat dairy products 
E 4 
Eating vegetables before a carbohydrate rich meal has been shown to have beneficial effects on blood 
sugar levels. This practice slows down the speed at which carbs are absorbed into the bloodstream 
and may benefit both short- and long-term blood sugar control.  

14 
 
E 5 
Eat fruits instead of making fruit juice. Fruits contain fiber and various plant compounds. Sugar from 
fruits is generally digested very slowly and do not cause increases in blood sugar levels.  
E 4 
 
Limit pork, lamb, beef meats: instead, eat plant-based proteins like beans, green peas, green grams or 
animal proteins like eggs or fish.  Pork, lamb, beef meats contain saturated fats 
E 6 
Limit lard/bacon /chicken fat/butter, instead, vary with liquid vegetable-based oils: Use olive oil or 
vegetable oil for cooking.  Limit lard, bacon, chicken fat and butter contain saturated fats 
E 7 
Eat regular meals and spread out your servings of energy giving foods evenly throughout the day. This 
helps you can maintain energy levels without causing large rises in blood glucose levels. 
Psychological 
capability 
Know healthy food  
Information about 
health 
consequences 
S 6 
The amount of  carbohydrate in your meal has the greatest effect on blood glucose levels. Avoid big 
servings  of carbohydrates in your meal and ensure most of your energy giving foods are composed of 
whole meal or high fiber. Make vegetables and fruits take the larger portion of your plate.  
S 7 
There are two main types of fat: saturated and unsaturated.  Too much saturated fat in foods like   
fatty meat, sausages and  butter can increase the amount of cholesterol in the blood, which increases 
your risk of developing heart disease.  
S 8 
Instead of selecting foods with saturated fats, select foods with unsaturated fats like nuts, seeds, 
seafood, and avocados. 
S 9 
Some food items like sauces have hidden sugar and salt, therefore it is wise to avoid tomato sauces, 
fat-free salad dressings, and condiments. Instead of sauces. To improve the taste of your food, select 
preferred spices, herbs, onions, or other low-energy flavorings 
Advanced planning 
skills to ensure 
selection of food 
healthy food 
S 10 
Select whole or minimally processed foods, which help to control your blood glucose 
S 9 
Make an eating plan each week – this is the key to fast and easy meal preparation. This will also 
ensure that you plan for healthy diets and better controlled blood glucose.  
S 11 
Plan to have meals with plenty of vegetables and fruit. Your goal is to fill half your plate with 
vegetables and fruit at every meal. Choose colored fruits  like oranges, mangoes, loquats, plums and 
vegetables like managu, carrots and tomatoes.  
Know the composition 
of the plate model  
E 8 
Start with a 9-inch dinner plate  
Fill half with non-starchy vegetables, such as managu, Sukuma wiki, green beans, broccoli, cauliflower, 
cabbage, and carrots. 
Fill one quarter with a lean protein, such as chicken, fish, legumes or beans, or eggs. 
Fill one quarter with whole meal carbohydrate foods: grains, starchy vegetables (such as potatoes and 
peas), rice, pasta, beans, fruit, and yogurt. A cup of milk also counts as a carb food. 
Social 
Opportunity 
Change cultural habits 
on portion size 
-Goal setting 
(behavioral) 
-Restructuring the 
physical 
environment 
S 12 
 
Controlled portion sizes of food are important to reducing calorific intake. To control your portion 
sizes, plan to use a smaller plate size when serving meals. 
S 13 
Your health is a personal responsibility. When eating, try to avoid places that may entice you to eat 
excessive food. Eat most of your meals at home for better control of healthy food and your blood 
sugar 

15 
 
Reflective 
motivation  
Intend to select 
healthy diet  
-Information 
about health 
consequences 
-prompts/cues 
S 14 
Make your shopping list ahead of time and do not go shopping while hungry. This helps you to  buy 
healthier items but also save money and select healthier foods. 
S 15 
Intend to purchase less saturated and unhealthy fats by using oils like canola, corn, olive, peanut, 
safflower, soybean, and sunflower oils. Unsaturated oils that are healthy and are also naturally present 
in nuts, seeds, seafood, and avocados. 
S 16 
Intend to select healthy dietary pattern by selecting foods and beverages that have low or no added 
sugars, saturated fat, and/or sodium. Check food labels to check the nutrient content of the food 
items.  
S 17 
Instead of purchasing processed grade 1 flour or unga, use posho mill unga. It contains fiber and other 
plant extracts that are important to the body and blood sugar control.  
Intend to prioritize 
eating healthy diet  
 
E 9 
Small changes to more nutrient-dense, single food and beverage choices combine to become a 
nutrient dense meal, and can lead to a whole day made up of nutrient-dense meals and snacks, 
increasing you blood sugar control 
E 10 
Place fresh and locally available low-carbohydrates fruits on the table or where they are easy to reach 
to increase intake of fruits. This enables you to eat healthy and avoid unhealthy snacking.  
E 11 
To reduce salt intake, ensure that salt in added to food when cooking. Avoid having saltshakers on the 
table when eating 
E 12 
A supportive family enables you to eat healthy meals. Enlist your family members to support you to 
encourage your intake of healthy meals by planning meals and eating together.  
E 13 
Portion sizes of food affect the calories consumed. Plan to control your portion sizes by using smaller 
plates and ensuring that you apply the plate model in serving your various foods 
E 14 
Water is important to prevent dehydration and aid in the digestion of food and absorption of 
nutrients. To increase water intake, flavor your water with fruits like lemon or orange.  
Automatic 
motivation  
Establish routines and 
habits to select 
healthy diet  
Instructions on 
how to perform 
behavior 
S 18 
Keep a food diary for a few days to evaluate what you eat every day. Note how you were feeling when 
you ate – hungry, not hungry, tired, or stressed? 
Create a list of “cues” by reviewing your food diary to become more aware when you’re “triggered” to 
eat for reasons other than hunger. 
Is there anything else you can do to avoid the cue or situation? If you cannot avoid it, do something 
differently that would be healthier.  
Replace unhealthy habits with new, healthy ones 
Restructuring the 
physical 
environment 
Prompts/Cues 
S 18 
Replace white rice with whole grains foods or brown rice. This ensures that better blood sugar control.  
 
E 15 
Eat smaller meals more often. Eat at least three meals a day with snacks in between. When you wait 
too long to eat you are more likely to make unhealthy food choices. 

16 
 
 
 
Establish routines and 
habits to serve and eat 
healthy diet  
E 16 
Make a routine of eating healthy snacks like groundnut or almonds, yogurt, or yogurt with berries, 
hard-boiled eggs, avocado, or fruit slices. These snacks help you to maintain you blood sugar and 
reduce extra energy intakes.  
E 17 
Eating at home, or carrying safe food when traveling ensures that you eat healthy diets that make you 
control our blood sugar 
E 18 
Alcohol consumption can worsen diabetes-related medical complications, such as disturbances in fat 
metabolism, nerve damage, and eye disease. Avoid of limit alcohol to have optimal blood sugar 
control 
Two-way messages  
Month 1 
Looking at the messages you have received this month, rate your confidence in selecting of healthy diets  
1  2  3  4  5  
Month 2  
Looking at the messages you have received this month, rate your ability to eat healthy dietary choices 
for diabetes care 
1  2  3  4  5 
Month 3 
Looking at the messages you have received this month, rate your general knowledge relating to 
selection and eating of health diet 
1  2  3  4  5 

17 
 
6.9 
Outcomes  
6.9.1 
Primary outcome measures 
The primary outcome measure is HbA1c which shall be measured at baseline and at the end of the 
intervention. HbA1c will be measured using a high-performance liquid chromatography technique using 
Variant II (Bio-Rad, Montreal, Quebec, Canada). FPG will be analysed by the glucose oxidase method using 
a Hitachi 7600 (Hitachi, Hitachi, Japan). 
 
6.9.2 
Secondary Outcome measures  
Secondary outcome measures will include biochemical, anthropometric and behaviour change 
measurements shall be measured at baseline and endline (end of week 12). Additionally, user-satisfaction 
shall be assessed at 12 weeks and 24 weeks post-intervention.  
 
Biochemical measurements will include fasting plasma Glucose (FPG), total cholesterol (TC), triglycerides 
(TG), and high-density lipoprotein-cholesterol (HDL-C). FPG will be analysed by the glucose oxidase method 
using a Hitachi 7600, while TC, TG, HDL-C will be measured using the automatic blood analyser (Hitachi 736-
40). Lab testing and analysis will be conducted at the Lancet laboratories, Kenya using standard procedures. 
 
Anthropometric measurements will include weight, height, waist and hip circumferences that shall be 
measured by trained research assistants, and shall follow the CDC Anthropometry Procedures Manual 
(104). Additionally, bioelectrical impedance analysis shall be taken to determine body fat using the  
 
Behaviour change shall be measured by changes in dietary intake of legumes, fruits and vegetables and 
through the mHealth Satisfaction Questionnaire (Appendix 6). The mHealth Satisfaction Questionnaire will 
be adopted from the questionnaire for assessing user satisfaction with mobile health apps (105).  
7 
Data Collection  
7.1 
Quantitative Instruments  
Various tools will be used to collect data. The socio-demographic and health questionnaire (Appendix 3), 
the food frequency questionnaire (Appendix 4) and the self-perceived food literacy questionnaire 
(Appendix 5) will be administered on all participants after enrolment. The socio-demographic and health 
questionnaire and the food frequency questionnaires have been piloted and used in studies in Kenya, while 
the self-perceived food literacy questionnaire shall be piloted during the study. These tools will be 
administered by trained research personnel in either Swahili or English, depending on the preference of 
the participant.  

18 
 
7.1.1 
Socio-demographic and health history questionnaire 
This study will utilize the electronic socio-demographic and health history questionnaire (Appendix 4) that 
was previously used in a sister study conducted in Makueni County, Kenya (Protocol number AMREF P424 
2018). The questionnaire was developed based on the World Health Organization STEPS Instrument and 
Support Materials (106) and piloted in Makueni County, Kenya.  
7.1.2 
Self-perceived food literacy questionnaire 
The self-perceived food literacy questionnaire is based on the tool used to assess the food literacy among 
people with chronic diseases in Netherlands (107). This tool was developed through an expert-based and 
theory-driven process and shall be piloted and adjusted before being used in the Kenyan settings. The 
responses options are a 5-point Likert scale where 1= ‘not at all/never’ to 5 = ‘yes/always’ (Appendix 4).  
 
7.1.3 
Anthropometric measurements 
Anthropometric measurements will be taken during the filling of the socio-demographic and Health history 
questionnaire. These measurements will include height, weight waist and hip circumference. Height and 
weight shall be used to calculate the body mass index (BMI).  
 
7.1.4 
Body composition  
Body composition of all participants shall be taken at baseline and at the end of the intervention. The 
measurements shall be conducted by trained research assistants using the Bodystat 500® Body 
Composition Monitor.  
 
7.1.5 
Blood samples 
Two trained phlebotomists, each serving one hospital, will draw 5 ml venous blood using the closed vacuum 
extraction tubes with single-use needle and needle holder and following the WHO and Kenya Medical and 
Research Institute (KEMRI) guidelines(108). Laboratory requisition forms indicating the participant 
identification code shall be written for all the collected samples. The samples will be immediately stored in 
insulated coolers containing ice/cold packs at around 4◦C. At the end of sample collection, the 
phlebotomists will centrifuge the blood samples and serum transferred into sterile cryo-vials in the two 
level 4 hospital laboratories. Two centrifuges shall be provided by the study, assigned to the two study 
phlebotomists. Thereafter the samples will be frozen at -20 degrees centigrade in study nitrogen tanks and 
transported to Lancet Laboratories® in Nairobi for analysis.  
 
Phlebotomists will ensure hand hygiene by using pair of well-fitting clean disposable latex-free gloves, 
alcohol rubs, water and soap before after each blood draw to reduce risks of cross-contamination. Sufficient 
single-use disposable needless and sampling tubes will also be ensured for each blood sampling.  

19 
 
 
The study shall provide all required laboratory disposal equipment and materials.  
 
Disposal of all lab waste will adhere to Laboratory Biosafety and Bisecurity Policy Guidelines (109). In brief 
the following measures shall be ensured in disposal of infectious wastes: 
 
i. 
Red infectious/biohazard waste disposal containers shall be located in each area of the laboratory 
where infectious waste may accumulate. 
ii. 
Containers shall be lined with disposable bright orange/red biohazard bags before placing 
infectious waste into them to prevent leakage. 
iii. 
Infectious waste containers shall not be filled more than three-quarters full. 
iv. 
Biohazard bags shall be removed from the work area after each day's use. 
v. 
Bags and containers shall be transport to the biohazard holding room as per the facility procedures. 
 
7.1.6 
Interactive text messaging  
At the end of every 30 days of the study, participants will be asked to evaluate the usability of the text 
messages in past previous month using Likert scale rating. The response will determine the type of 
messages the participant will receive subsequent month.  
 
7.2 
Training of research assistants and piloting  
Training of research assistants and enumerators will take 3 days. On day 1, the research assistants will be 
introduced to the research methods in a step-by-step approach as shown below. This phase of training will 
be conducted either online or face-to-face to allow for flexibility during the COVID crisis. 
Step 1. Informed consent procedure, research ethics and regulatory requirements and documentation.  
Step 2. Participant recruitment and retention strategies  
Step 3. Review of the data collection tools, including the socio-demographic and health history 
questionnaire, food frequency questionnaire and the self-perceived food literacy questionnaire. This step 
is meant to give the research assistants and enumerators a broad understanding of the expected each tool. 
All questions in the three tools shall be read and discussed to provide an opportunity for clarification on 
possible responses.   
Step 4. Video illustrations of study-related anthropometric assessments: height, weight, waist and hip 
circumferences and body composition.  
On day 2, the research assistants will be provided with hands-on training on procedures that shall be applied 
in this study. This phase shall apply didactic approach, face-face demonstrations, and role plays. The trainers 

20 
 
will use actual data collection tools, PowerPoint slides and videos during these structured sessions. The 
following steps shall be followed in this phase of training: 
Steps 1: Role playing of the interviewer-administered data collection tools. 
Step 2: Demonstration and breakout sessions for role playing of anthropometric assessments.  
On day 3, the socio-demographic and health history questionnaire and the self-perceived food literacy scale 
will be piloted in hospitals that will not be included in the study. The pilot will include a sample size of 6 
respondents, representing 10% of the of the sample projected for the trial, as suggested by Connelly et al., 
(110) 
7.3 
Management of data quality during fieldwork  
To ensure accurate and reliable data collection, the following measures shall be applied: 
i. 
Timely provision of data collection tools and equipment to the enumerators and research assistant  
ii. 
Early logistical arrangements, coordinated by the PI and Co-PI in collaboration with the hospital in-
charges 
iii. 
Coordinating with hospital in-charges regarding arrival and data collection points of enumerators   
iv. 
Identifying sampled respondents, coordinated by the hospital in-charges  
v. 
Preparation for collection, with brief overview of steps by the Co-PI and research assistant.  
 
Additionally, data quality during field work shall be ensured by the following activities planned by the 
Principal Investigator (PI) MM, in collaboration with the Co-Principal Investigators (CO-PIs): 
i. 
Prepare, conduct, and administer the research budget, and trainings in compliance with applicable 
laws, regulations and institutional policy governing the conduct of the study.  
ii. 
Ensure that procedures in the study are consistent with sound research design and do not 
unnecessarily expose participants to risk or harm. 
iii. 
Define and communicate roles and responsibilities for each research team member. 
iv. 
Regularly meet with the CO-PIs and research team to keep them informed of the status of project 
activities. 
v. 
Ensure the integrity and safeguarding of research data records and scientific data. 
vi. 
Ensure the completion, accuracy and timeliness of research data and reports. 
 
JKUAT shall provide permission to conduct the study and provide overall supervision of the study through 
the Project Lead (FK) Legume Centre of Excellence for Food and Nutrition Security (LCEFONS).  
 
KU Leuven shall provide supervision and administration of the study’s research budget, and trainings in 
compliance with applicable laws, regulations and institutional policy governing the conduct of the study of 
the study through the Co-PIs (CM and RV).  

21 
 
 
7.4 
Ethical issues 
This study will be conducted in respect to the principles contained in the Declaration of Helsinki (111). A 
written informed consent will be obtained from all participants prior to their enrolment into the study 
(Appendix 1). The informed consent will allow the participant enough time to decide whether to be in the 
research study and to make that decision without any pressure from the researchers. Participants will also 
have the right to refuse to be in the study at all, and to stop participating at any time after study begins. 
 
Study personnel shall ensure strategies to protect privacy interests relating to contact with potential 
participants, and access to private information at all times during the study. All study personnel shall sign 
and adhere to the Data Confidentiality Agreement for Study Staff (Appendix 6).  
To ensure confidentiality, that an information disclosed by the participants shall not be divulged to others 
without permission in ways that are inconsistent with the understanding of the informed consent form. 
During consenting, subjects shall be informed of the precautions that will be taken to protect the 
confidentiality of the data and be informed of the parties who will or may have access.  
 
The community engagement strategy shall ensure that the study will be conducted in a way that is 
respectful to individuals and communities to maximize social value. Additionally,  internationally recognized 
standards of good practice with responsiveness to the local context (112) shall be adhered to.  
The data from the study will be stored in a secure server where only authorized individuals will have access 
to the data. The parties will retain the data for 10 years after study completion, according to the General 
Data Protection Regulation (GDPR) (113). However, neither party will destroy information without first 
informing the other parties. In case of future testing, permission to conduct further studies shall be sort 
from the participants.  
 
This study will seek the following approvals, permissions, and registration: 
• 
Letter of support from Jomo Kenyatta University of Agriculture and Technology; 
• 
Ethical approval from the African Medical Research Foundation-Ethics & Scientific Review 
Committee (AMREF-ESRC); 
• 
Research permit from the National Council for Science Technology and Innovation (NACOSTI); 
• 
Registration of clinical studies with human subjects that assess biomedical and/or health outcomes 
at clinicaltrial.gov (114).  
• 
Study permit for permission to conduct the study through the Department of Health in Nakuru 
County.  
 

22 
 
 
8 
Data Processing and Analysis  
8.1 
Data coding, entry, and editing; transcription of qualitative data generated  
The data will be collected by use of electronic forms.  Data shall be collected and stored in a secure cloud 
server, hosted at the Jomo Kenyatta University of Agriculture and Technology (JKUAT).  
8.2 
Plan for analysis of quantitative data  
Quantitative data will be analyzed by the intention to treat principle (115). Various patient characteristics 
and primary outcome measures, including anthropometric and biochemical measurements (HbA1c, FBG, 
lipid profiles) at baseline will be summarized using descriptive statistics. The descriptive statistics will 
include means and standard deviations for continuous variables and proportions for categorical variables. 
HbA1c levels will be compared at 3-months between the two arms using an ANCOVA which will control for 
baseline HbA1c levels. The intervention and the control groups will be followed-up for six months. One-way 
and interactive text messaging data will be analyzed descriptively. 
A subgroup analyses per hospital and participant socio-demographics including age, sex, education, and 
income levels will be conducted. All statistical analyses will be performed using R version 4.0.3 (116).  
9 
Plan for communicating findings of the study  
9.1 
Dissemination strategy  
Findings from the study shall be disseminated through print and electronic media to relevant stakeholders. 
Foreseen stakeholders include the Kenyan Ministry of Health, the county governments, NACOSTI and 
AMREF Ethics & Scientific Review Committee (ESRC) and the Jomo Kenyatta University of Agriculture and 
Technology website. The research findings will also be disseminated through a peer reviewed research 
publication. 
9.2 
Outline for research report  
The research report that shall be disseminated to various stakeholders will be composed of five sections:  
introduction, key findings, conclusion, and recommendations for future actions.  The findings from this 
study shall also be published in peer reviewed scientific paper, and shall follow the CONSORT 
guidelines(117).  
9.3 
Involvement of stakeholders in the study  
The county government has been made aware of the study in earlier contacts and correspondences in our 
earlier study (AMREF-ESRC P752/2020). Further, findings from this study will be provided to participants 
through online and physical meetings where applicable. The Ministry of Health national technical working 
group on nutrition and the County Government of Nakuru will be provided with a research report. A 

23 
 
dissemination meeting shall be held in collaboration with the county government and other relevant 
stakeholders such as community leaders, hospital staff and other organizations supporting diabetes care.  
9.4 
Likely policy implications that might arise from the study  
This being a pilot, the study seeks to generate information on the feasibility of using mHealth to optimize 
glycemic control and dietary behavior. The findings of the study may also be used by researchers to design 
larger studies on mHealth in LMICs. The findings may be of value to the county governments and the Kenyan 
Ministry of Health in development of policies and guidelines on type 2 diabetes and the patient 
organizations, including the Kenya Defeat Diabetes Association.  Study Limitations and Risks  
 
9.5 
Limitations of the study design and methods of data analysis  
This is a proof-of-concept study, which is therefore limited by the sample size and restricted 
generalizability.  
9.6 
Major assumptions in the study  
The main assumption in this study is that participants will be willing to take actions aimed at improving their 
glycemic control. Secondly, it is assumed that the participants will be willing to receive, read and apply the 
messages disseminated through their mobile phones.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

24 
 
10 Management and Organization of the Study  
The management and organization of this study is a collaborative organization between JKUAT and KU 
Leuven.  
10.1 Team members, their roles, and management procedures in the study  
The team members and roles in this study are listed in the table below: 
 
Table 3. Study Team Members and Roles 
Name  
Institution  
Role  
Moses Mokaya 
JKUAT and KU Leuven 
Principal Investigator 
Study coordinator, correspondence with 
MOH and hospital in-charges 
Oversight of text message delivery 
Data analysis and reporting 
Dr. Florence Kyallo 
JKUAT 
Co- Principal Investigator 
Prof. Christophe Matthys 
KU Leuven  
Co- Principal Investigator 
Prof. Roman Vangoitsenhoven 
KU Leuven  
Co- Principal Investigator 
Dr. Janai Ondieki 
JKUAT 
Co- Principal Investigator 
Study physician and Co-PI 
Research  (To be determined) 
JKUAT 
Support in research coordination, data 
collection and logistics management  
Enumerators (Trained Nutritionists 
o)-Two per hospital  
JKUAT 
Recruitment, Consenting, Questionnaire 
administration, measurement of 
anthropometrics  
 
10.2 Other resources and facilities that will be availed for the study  
The resources that will be availed for the study have been listed in the budget in Table 3. below. 
Additionally, a vehicle will be availed during the study for transportation of study personnel and samples.  
10.3 Schedule of activities  
The study timelines are listed in Table 3 below  
 
It is planned that the study will begin on 15 July 2021 to   
 
Table 4. Schedule of Activities 
 
 
 
 
Wk 0 
Wk 1
Wk 2
Wk 3
Wk 4
Wk 5
Wk 6
Wk 7
Wk 8
Wk 9
Wk 10 Wk 11 Wk 12
Wk 25
Planned Activity
23-Aug 30-Aug 06-Sep 13-Sep 20-Sep 27-Sep 04-Oct 11-Oct 18-Oct
25-Oct 01-Nov 08-Nov 15-Nov
14-Feb
Recruitment and allocation 
Baseline data collection
Introdiction call and text messages
Intervention month 1
Intervention month 2
Intervention month 3
Post-Intervention follow-up

25 
 
10.4 Budget  
The total budget for the entire study is estimated to cost Kes 2,550,320 as tabulated below 
Table 5. Budget 
Ethics Review Fees and Research Permit 
Item  
Units  
Unit Cost  Frequency  
Total Cost (Ksh)  
AMREF Ethics review 
1 
5000 
1 
5,000 
NACOSTI Research Permit 
1 
2000 
1 
2,000 
 Sub total 
  
  
  
7,000 
Mobilization and planning  
Item  
Units  
Unit Cost  
Days 
Total Cost  
Community Mobilizer 
6 
2,540 
1 
15,240 
Airtime for mobilization  
6 
500 
4 
12,000 
 Sub total 
  
  
  
27,240 
Lab test Equipment 
Item  
Units  
Unit Cost  Frequency  
Total Cost  
Plain Tubes for Serum Zinc Collection 
2 
1,200 
1 
2,400 
Vacutainer needles (100pcs) Gauge 21 
2 
1,400 
2 
5,600 
Alcohol swabs (100pcs) 
1 
420 
2 
800 
Micro pore Tape 
1 
400 
1 
400 
Disposable Rubber Gloves (Dust free 100pcs) 
1 
1,000 
2 
2,000 
Test Strips for Cholesterol Metre (25pcs) 
5 
2,500 
2 
25,000 
Test Strips for Glucometer (50pcs) 
3 
1,600 
2 
9,600 
Biohazard Safety Box 
1 
300 
1 
300 
Red Disposable bags (Big) 
5 
50 
1 
250 
Red Disposable bags (small)) 
10 
30 
1 
300 
Hand Sanitizers (500ml) 
5 
500 
1 
2,500 
Mask (50pcs) 
5 
800 
1 
4,000 
Cryol Vial (100pcs) 
3 
1,000 
1 
3,000 
 Sub total 
  
  
  
56,150 
Equipment for Handling, Transfer and Storage of Blood Samples 
Item  
Units  
Unit Cost  Frequency  
Cost  
Refill of Nitrogen Tank with liquid nitrogen 
47lit 
47 
480 
1 
22,560 
Sub total 
  
  
  
22,560 
Stationery Costs 
Item  
Units  
Unit Cost 
Frequency  
Cost  
Printing paper 
5 
500 
2 
5,000 
Pens 
15 
15 
2 
450 
 Sub total 
  
5,450 
Lab test costs  
Item  
Pts  
Unit Cost 
Frequency  
Cost  
HbA1C 
60 
2949 
3 
530,820 
Lipid Profile  
60 
2949 
3 
530,820 
Total Cholesterol, Serum 
60 
949 
3 
170,820 
 Sub total 
  
  
  
1,232,460 
 
 
mHealth Costs   

26 
 
Item  
Pts  
Unit Cost 
Frequency  
Cost  
Setting up Charges 
 - 
20,000 
1 
20,000 
Maintenance Costs  
 - 
20,000 
1 
20,000 
Bulk SMS Services: Intervention Arm 
30 
5 
48 
7,200 
Bulk SMS Services: Control Arm 
30 
5 
4 
600 
Audio Calls: Intervention  
30 
5 
12 
18,000 
 Sub total 
  
65,800 
Study monitoring  
Item  
Pax 
Unit Cost 
Frequency  
Cost  
Per Diem  (Principal Investigator) 
1 
7,640 
20 
152,800 
Per Diem  (PhD researcher) 
1 
7,640 
30 
229,200 
Per Diem (Driver) 
1 
5,135 
30 
154,050 
 Sub total 
  
536,050 
Personnel 
Item  
Pax 
Stipend 
Days  
Cost  
Phlebotomist 
2 
7,640 
14 
213,920 
Enumerators 
4 
2,540 
14 
142,240 
Enumerator’s transport 
6 
1,000 
2 
12,000 
Research Assistant 
1 
795 
90 
71,550 
Community Mobilization 
2 
2,540 
14 
71,120 
 Sub total 
  
  
  
510,830 
Transport 
Item  
Cars 
Unit Cost 
Frequency  
Cost  
Fuel Costs 
1 
10,000 
2 
20,000 
 Sub total 
  
  
  
20,000 
Grand Total  
2,483,540 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

27 
 
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34 
 
 
Appendix 2 Food Literacy Questionnaire 
1. Planning and management   
What is your opinion on the following?   
Assessment question  
Likert scale  
1 
What I eat has an impact on my health 
and wellbeing 
1: 
Strongly 
Disagree  
2: 
Somewhat 
disagree  
3:  Somewhat 
agree   
4: 
Strongly 
Agree  
2 
 How often do you think about health 
when deciding on what to eat  
1: Never  
2: Rarely  
3: Sometimes 
 
4: Always 
3 
Which of following food groups do you 
consider as a typical balanced meal  
1:  
Matooke,  
Rice,  
Chicken,  
One banana 
2:  
Matooke, 
Rice,  
Beans,  
One banana 
3:  
Matooke,  
Rice,  
Greens 
(amaranth/ 
managu),  
One banana 
4:  
Matooke, 
Beans 
or 
chicken, 
Greens 
(amaranth/ 
managu),  
One banana 
5:  
Not sure 
4 
How often do you plan meals ahead of time?   1: Never  
2: Rarely  
3: Sometimes  
4: Always 
5 
Do you normally have plan a weekly menu? 
1: Never  
2: Rarely  
3: Sometimes  
4: Always  
6 
How often do you plan the meals to include 
all food groups? 
1: Never  
2: Rarely  
3: Sometimes  
4: Always 
7 
How easy is it for you to plan a meal 
including at least one food from each of the 
food groups on a limited budget 
1: Very difficult  
2: Somehow difficult  
3: 
Somehow 
easy  
4: Always 
easy  
8 
How often do you think about vegetables 
when deciding what to eat?  
1: Never  
2: Rarely  
3: Sometimes  
4: Always  
9 
How often do you think about fruits when 
deciding what to eat? 
1: Never  
2: Rarely  
3: Sometimes  
4: Always  
2. Questions about selection  
10 
How often do you make a food shopping list before 
going to shop?  
1: Never  
2: Rarely  
3: Sometimes  
4: Always  
11 
How often do you purchase vegetables even if you 
have limited money? 
1: Never  
2: Rarely  
3: Sometimes  
4: Always  
12 
How often do you purchase fruits, even if you have 
limited money?  
1: Never  
2: Rarely  
3: Sometimes  
4: Always  
13 
 On average how long do you stock up on the following food items  
13a 
Leafy vegetables 
1: Do not stock 
(buy 
for 
immediate 
consumption) 
2: Daily 
3: two days 
4: three days 
5: four to 
five days 
6: 
weekly 
13b 
Other vegetables (carrots, 
cucumbers, 
avocado, 
tomatoes, eggplants etc) 
1: Do not stock 
(buy 
for 
immediate 
consumption) 
2: Daily 
3: two days 
4: three days 
5: 
four- 
five days 
6: 
weekly 
13c 
Fruits  
1: Do not stock 
(buy 
for 
immediate 
consumption)  
2: Daily 
3: two days 
4: three days 
5: 
four– 
five days 
6: 
weekly 
 
3. Questions about preparation 
14 
How do you normally store your fruits and vegetables (multiple choices are possible) 
 
1: In a fridge  
2: On a floor in the 
house 
3: 
In 
a 
basket 
4: on the 
shelves  
5: Others specify  
…………………………………………… 

35 
 
15 
How often do you cook meals at 
home?  
1: Never  
2: Rarely  
3: Sometimes  
4: Always  
16 
How often do you prepare vegetables 
at each main meal (e.g. pasted 
vegetables? a side dish)  
1: Never  
2: Rarely  
3: Sometimes  
4: Always  
17 
Vegetable preparation is too much 
work? 
1: Strongly 
agree 
2: Somehow 
agree 
3.Somehow 
disagree   
4: 
Strongly 
disagree   
18 
How confident do you feel about 
cooking a variety of healthy and tasty 
vegetables?  
1: Not confident  2: Low  
3: Moderate 
4: High  
 
19 
How would you rate your ability to 
cook vegetables in at least three 
different ways? e.g.  steaming, stir 
frying, pasting or in different dishes  
1: Not confident 
l  
2: Low  
3: Moderate 
4: High  
 
20 
How often do you try out new 
vegetable recipes?  
1: Never  
2: Rarely  
3: Sometimes  
4: Always  
21 
Rate your confidence in changing 
recipes (written or unwritten) to make 
them healthier.  
1: Not confident   2: Low  
3: Moderate 
4: High  
 
22 
How confident are you about the 
hygiene 
of 
home 
prepared 
vegetables? 
1: Not confident   2: Low  
3: Moderate 
4: High  
 
23 
How confident are you that vegetables 
prepared at home don’t contain 
pesticide residues 
1: Not confident   2: Low  
3: Moderate 
4: High  
 
24 
How confident are you about the 
hygiene of home prepared fruits? 
1: Not confident   2: Low  
3: Moderate 
4: High  
 
25 
How confident are you that fruits 
prepared at home don’t contain 
pesticide residues 
1: Not confident   2: Low  
3: Moderate 
4: High  
 
4. Eating behaviours  
26 
How many portions of vegetables is 
ministry of health and world health 
organisation is recommending people 
to eat? (a portion = 3 heaped table 
spoons or 1 handful) 
1: 
two 
or more 
portions 
a day  
2: 
one 
portion 
a 
day  
3: 
five 
portions 
a week  
4: three 
portions 
a week  
5: 
one 
portion 
a week 
6: 
Not 
sure 
27 
How many portions of fruits ministry of 
health and world health organisation is 
recommending people to eat? (1 
portion of fruit is equal to 1 medium 
piece of banana, orange, mango or a 
slice of watermelon or pineapple) 
1: 
two 
or more 
portions 
a day 
2: 
one 
portion 
a 
day  
3: 
five 
portions 
a week  
4: three 
portions 
a week  
5: 
one 
portion 
a week 
6: 
Not 
sure 
 
 
 
 
 

36 
 
 
 
 
28: Please indicate how often you consume at least one portion of fruits  
1 portion of fruit is equal to 1 banana , orange, mango or a 
slice of watermelon or pineapple   
 
 
What is a portion – 1 banana  mango 
1: Once in 
a month  
2: 
one 
time 
a 
week  
3: 
two 
times 
a 
week 
4: three 
times a 
week  
5: 
four 
times a 
week  
6: 
five 
times a 
week  
7: 
six 
times a 
week 
8: 
one 
time 
a 
day  
9: 
two 
or more 
times a 
day  
 
29: Please indicate how often you consume at least one portion of leafy vegetables   
 
 
Four heaped tablespoons (one handful) of cooked green 
leafy veggies like cabbage, Sukuma wiki,, sagaa, managu, 
spinach,  
 
What is a portion – 4 heaped table spoons or 1 
handful 
1: Once in 
a month  
2: 
one 
time 
a 
week  
3: 
two 
times 
a 
week 
4: three 
times a 
week  
5: 
four 
times a 
week  
6: 
five 
times a 
week  
7: 
six 
times a 
week 
8: 
one 
time 
a 
day  
9: two or 
more 
times a 
day  
 
 
30: Please indicate how often you consume at least one portion of vegetables other than leafy vegetables    
 
 
Three heaped tablespoons (one handful) of vegetables 
like sliced carrots, cucumber, green pepper, eggplant, 
mixed vegetables  
 
 
What is a portion – 3 heaped table spoons or 1 
handful 
1: Once in 
a month  
2: 
one 
time 
a 
week  
3: 
two 
times 
a 
week 
4: three 
times a 
week  
5: 
four 
times a 
week  
6: 
five 
times a 
week  
7: 
six 
times a 
week 
8: 
one 
time 
a 
day  
9: 
two 
or more 
times a 
day  
 
 
 
 
 
 
 
 
 
 
 

37 
 
 
 
31 
How easy is it for you to eat fruits and vegetables when you find yourself in the following situations  
31a When at work  
1: Very difficult  
2: 
Somewhat 
difficult  
3: 
Somewhat 
easy  
4: Always easy  
31b When traveling 
1: Very difficult  
2: 
Somewhat 
difficult  
3: 
Somewhat 
easy  
4: Always easy  
31c When you experience time 
pressure  
1: Very difficult  
2: 
Somewhat 
difficult  
3: 
Somewhat 
easy  
4: Always easy  
32 
How often do you pack fruits 
when going to work? 
1: Never  
2: Rarely  
3: Sometimes  
4: Always  
33 
How often do you pack 
vegetables when going to 
work? 
1: Never  
2: Rarely  
3: Sometimes  
4: Always  
34 
How often do you eat 
vegetables 
as 
snacks 
(between 
meals)? 
e.g. 
avocado, carrots, tomatoes, 
cucumbers 
1: Never  
2: Rarely  
3: Sometimes  
4: Always  
35 
How often do you eat fruits 
as a snack (in between 
meals)? 
1: Never  
2: Rarely  
3: Sometimes  
4: Always  
 
5. Nutrition information  
36 
When you have questions on what food to eat for better 
health, do you know where to ﬁnd this information? 
1: Never  
2: Rarely  
3: 
Sometimes  
4: Always  
37 
There is a lot of information available on healthy eating today. 
How well do you manage to choose the information relevant 
to you?  
1: Very 
difficult  
2: Somewhat 
difficult  
3: Somewhat 
easy  
4: Always easy  
38 
In general, how often do you use (listen and value) the sources of nutritional information below? 
38a 
Nutrition advice from family members  
1: Never  
2: Rarely  
3: 
Sometimes  
4: Always  
38b 
Nutrition advice from friends and peers   
1: Never  
2: Rarely  
3: 
Sometimes  
4: Always  
38c 
TV or radio program on nutrition 
1: Never  
2: Rarely  
3: 
Sometimes  
4: Always  
38d 
Self -proclaimed nutrition experts on streets  
1: Never  
2: Rarely  
3: 
Sometimes  
4: Always  
38e 
Health workers (doctors)  
1: Never  
2: Rarely  
3: 
Sometimes  
4: Always  
38f 
Nutritionists  
1: Never  
2: Rarely  
3: 
Sometimes  
4: Always  
38g 
Social media (WhatsApp, face book, you tube)  
1: Never  
2: Rarely  
3: 
Sometimes  
4: Always  
39 
How easy is it for you to judge if healthy eating information 
shared on various platforms can be trusted?  
1: 
Very 
difficult  
2: Somewhat 
difficult  
3: Somewhat 
easy  
4: Always easy  
 
 
 
 
 
 

38 
 
Appendix 3: Informed Consent Form  
  
Study Title  
Using mHealth to Optimize Glycemic Control in Adults with Type 2 
Diabetes in Nakuru County: A Proof-of-Concept Randomized 
Controlled Trial 
Investigator(s)  
Moses Mokaya  
Jomo Kenyatta University of Agriculture and Technology (JKUAT) 
+254 721 299 189  
 
Dr. Florence Kyallo   
Legume Center of Excellence for Food and Nutrition Security  
Jomo Kenyatta University of Agriculture and Technology (JKUAT) 
+254 722 693 523  
  
 
Prof. Christophe Matthys  
Katholieke Universiteit Leuven    
3000 Leuven, Belgium  
+32 16 34 2655  
 
Prof. Dr. Roman Vangoitsenhoven 
Katholieke Universiteit Leuven   
+32 16193235  
 
Dr. Janai Ondieki 
Jomo Kenyatta University of Agriculture and Technology 
+254 724 925 705 
  
Study Sponsor(s)  
VLIR UOS  
Collaborators  
County Government of Nakuru  
  
Part 1. Information Sheet   
You are being invited to participate in a study being conducted as a collaboration between 
JKUAT and KU Leuven, Belgium. This study is funded by VLIR-UOS and executed in 
collaboration with the County Government of Nakuru through the Ministry of Health.   
As part of the study, to implement an mhealth intervention to enhance dietary behavior and 
food literacy for people living with Type 2 Diabetes Mellitus. You are one of the many people 
being asked to participate in this intervention.    
 
What shall the study entail? 
 
• 
Participants in all groups will receive text messages with different content to support 
their diabetes care but sent at varying frequencies.   
• 
At the beginning and the end of 12 weeks, 3 electronic questionnaires (in a tablet), 
each lasting between 10-30 minutes shall be administered to you.  
• 
Various measurements shall be taken at the beginning of the study, and at the end of 
12 weeks. They include weight, height, waist and hip circumference and body 

39 
 
composition analysis. A government approved laboratory specialist (phlebotomist) 
shall draw 5ml of blood from your arm. This will be used to compare how the study 
affect your glycated hemoglobin (long term measure of blood glucose control) your 
fasting blood glucose and blood cholesterol, at the beginning and at the end of the 
study.    
• 
At the end of 6 months, you will be contacted and asked questions on your progress.   
Why is this Study important?  
You may personally benefit from participating in this research because its findings will be 
used to improve the management of type 2 diabetes mellitus in adults.   
  
Participation is your choice  
Your participation in this study is entirely voluntary and it is not an expectation of your 
doctors, the study staff or the Ministry of Health that you must participate in this study. Your 
decision on whether to participate will not affect the care you receive from your doctors and 
will not affect your participation in any other studies by Jomo Kenyatta University of 
Agriculture and technology and KU Leuven.   
Whether or not you decide to join the study, you will receive the best available health 
Education information on ways to better manage Type 2 Diabetes Mellitus in adults.   
  
What are the risks?  
You will be receiving 3 one-way text messages per week, one message in which you will be 
asked to respond, and one 1 voice call per month. The messages will give you practical 
information on dietary behavior and food literacy for people with type 2 diabetes. There is 
no foreseen risk of being involved in this study are always free to not answer a question if 
you do not want to.  
How will you be protected from the risk to contracting COVID 19 during interaction with the 
research team?  
Considering that the COVID-19 disease has now been classified as a pandemic we are taking 
the following precautionary measures during research activities:  
 
1. The study shall provide personal protective equipment (PPE) for all study participants and 
researchers.  
2. Regular and thorough washing of hands with soap and water, or alcohol-based hand 
sanitizer provided by the research.  
3. Maintaining a distance of at least 1 meter (5 feet) between yourself and anyone (who is 
coughing or sneezing), avoiding handshakes or hugging.  
4. Persons with a cough or sneezing should stay home or keep a social distance but avoid 
mixing with others in a crowd.  
5. Maintain good respiratory hygiene by covering your mouth and nose while coughing and 
sneezing with a handkerchief, tissue, or into flexed elbow.  
6. Stay at home if you feel unwell with symptoms like fever, cough and difficulty in breathing.  

40 
 
7. All study participants should at all times wear a face mask to reduce the chances of 
transmission of the virus.  
8. Any cases regarding the disease will be reported using the call line facility number 719. 
Correct messages to be relayed to the participants (if need be) will be received from *719#  
9. Surfaces used during the research activities (e.g. desks, tables) and objects will be wiped 
with disinfectant regularly.  
What are the Benefits?  
There will be no direct benefit to you, but your participation is likely to help us find out more 
about how to improve the management of type 2 diabetes.   
What procedures shall the study involve?  
If you choose to take part in this study, you will continue receiving care and treatment in 
your hospital as usual.   
How will we protect your Information and Confidentiality?  
All information shared during the study will be confidential to the extent permitted by law. 
The session will be tape recorded and converted into written format. Your participation 
means that you agree to allow the information to be used for scientific purposes, but your 
name will not be identified in any way in reports or publications.   
 
 
Can I Refuse to Participate or Withdraw from the Study?  
You are free to withdraw your consent and to discontinue your participation in this study at 
any time without prejudice against future medical care or study participation at JKUAT and 
KU Leuven. Participating in this study will have not affect your participation to the current or 
future studies at JKUAT and KU Leuven or at MOH facilities. If you wish to withdraw for the 
study, your records will not be used in any part of the study and shall be destroyed.   
  
What will happen with the results?  
The knowledge that we get from this research will be shared with you and your community 
before it is made widely available to the public. Each participant will receive a summary of 
the results. There will also be small meetings in the community, and these will be 
announced. Following the meetings, we will publish the results so that other interested 
people may learn from the research.  
What is the costs for Participation in Research?  
There are no costs to you for taking part in this discussion group.   
Who can I contact? 
If you have any questions, you can ask anyone from our team now or later. If you have 
questions later, you may contact [Dr. Florence Kyallo,  P.O. Box 62000 – 00200, Nairobi 
+254 722 693 523 E-mail:   fkyallo@jkuat.ac.ke]. If you have questions about your rights as 
a study subject, you may contact: 
The Research Officer 
AMREF Health Africa in Kenya, Wilson Airport, Lang’ata Road 
Office Tel:  +254 20 6994000 
Mobile No: 0795746777, Fax: +254 20 606340 
P.O Box 30125-00100 
Nairobi, Kenya 

41 
 
 
Legal Rights  
By signing this consent form, you are not waiving any legal rights.  
Do you have any questions at this time?  
 
Part II: Certificate of Consent   
I have read this information, or it has been read to me in a language that you can speak, and 
its contents explained to you. All my questions have been satisfactorily answered.   
Print Name of 
Participant  
[at least forename and surname]  
Signature or thumb 
of Participant  
  
  
DD/MM/YYYY  
  
  
If visually impaired, physically impaired, mentally impaired or illiterate  
I have witnessed the accurate reading of the consent form to the potential participant, and the 
individual has had the opportunity to ask questions. I confirm that the individual has given 
consent freely.   
  
Print Name of 
Participant  
[at least forename and surname]  
Thumb/Foot print of 
Participant  
  
 
  
  
Signature of Witness  [A literate witness must sign and should be selected by the 
participant and MUST have no connection to the research team.   
DD/MM/YYYY  
  
  
  
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

42 
 
Appendix 4. Socio-demographic and Disease History Questionnaire for Type 2 Diabetes Patients   
Identification   
Sub-county:   
Questionnaire number:   
Name of Interviewer:   
Respondent Code Identifier:                                                                                  Sex: M__/F__   
Respondent’s date of birth:   
Date of Interview:   
  Section 1: Demographic and Socio-Economic Characteristics   
1   Where do you live?    
Location:________________________   
Village: _________________________   
   
2   Highest level of education? l=Not attended school; 2=Completed primary; 3= Completed 
secondary; 4= Completed tertiary level education    
   
3   Current employment status? l= 
Employed 
Doing housework at home 
Student 
Retired/long-term disabled 
Unemployed  
   
4   Marital status   
1=Married; 2=Divorced/Separated; 3= Widowed; 4= Living   
together/Traditional marriage; 5=Other, specify: ______________________   
   
5   Household income per month in Ksh. (Including wages, rent, sales of vegetable, etc.)   
1=Less than 10,000; 2= 10,000-40,000; 3=40,001-70,000; 4=70,001-100,000; 5=More than 
100,000   
   
6   How many persons, including yourself, live in your household? ______   
   
Section 2: Disease History and Management   
1   
 How long have you had diabetes? ____Years ____Months   
   
2   
Have any member of your family (first relatives) being diagnosed of diabetes (Type-1 or Type  
-2)?    
1=Yes; 2=No   
   
3   
How often do you visit the hospital?    
1=Weekly; 2=Once in two weeks; 3=Once a month; 4= Other, specify: _______   
   
4   
Are you hypertensive? 1=Yes; 2=No    
   
5   
Have you taken medication for high blood pressure on a regular basis? 1=Yes; 2= No   
   
6   
On average how often do you check your blood sugar?    
1= Once a month; 2=At least once a week; 3=1 time per day; 4=Other (specify)   
   
7   
Which of the following describes your treatment regimen   
1= insulin and oral medication only; 2= diet only; 3= insulin and diet; 4= insulin, oral 
medication and diet   
   
8   
How well do you think you manage your diabetes with your eating habits?  1=Poor; 2=Fair; 
3=Good; 4=Very good; 5=Excellent   
   
   
 
 

43 
 
 Section 3: Personal Habits and Physical Activity (Based on the STEPS Instrument (106) 
Physical Activity  
I am going to ask you about the time you spend doing different types of physical activity in a typical week. Please answer these 
questions even if you do not consider yourself to be a physically active person.   
 
Think first about the time you spend doing work.  Think of work as the things that you have to do such as paid or unpaid work, 
study/training, household chores, harvesting food/crops, fishing or hunting for food, seeking employment. [Insert other examples 
if needed].  
 
In answering the following questions 'vigorous-intensity activities' are activities that require hard physical effort and cause large 
increases in breathing or heart rate, 'moderate-intensity activities' are activities that require moderate physical effort and cause 
small increases in breathing or heart rate.  
Question  
 
Response  
 Code  
Work  
Does your work involve vigorous-intensity activity that 
causes large increases in breathing or heart rate like 
[carrying or lifting heavy loads, digging or construction 
work]  for at least 10 minutes continuously?   
[INSERT EXAMPLES]  (USE SHOWCARD)  
Yes  
No  
1  
2     If No, 
go to P 4  
P1  
In a typical week, on how many days do you do vigorous 
intensity activities as part of your work?  
Number of days  └─┘  
P2  
How much time do you spend doing vigorous-intensity 
activities at work on a typical day?  
Hours : minutes  
└─┴─┘: 
└─┴─┘  
   hrs             
mins  
P3 (a-
b)  
Does your work involve moderate-intensity activity, that 
causes small increases in breathing or heart rate such as 
brisk walking [or carrying light loads]  for at least 10 
minutes continuously?    
 [INSERT EXAMPLES]   (USE SHOWCARD)  
Yes  
No  
1  
2      If No, 
go to P 7  
P4  
In a typical week, on how many days do you do moderate 
intensity activities as part of your work?   
Number of days  
└─┘  
P5  
How much time do you spend doing moderate-intensity 
activities at work on a typical day? 
 
 
 
 
 
  
Hours : minutes  
└─┴─┘: 
└─┴─┘  
   hrs             
mins  
P6  
(a-b)  
Travel to and from places  
 
The next questions exclude the physical activities at work that you have already mentioned 
Now I would like to ask you about the usual way you travel to and from places.  For example to work, for shopping, to 
market, to places of worship. [Insert other examples if needed]  
Do you walk or use a bicycle (pedal cycle) for at least 10 
minutes continuously to get to and from places?  
Yes  1  
No 2      If No, go to P 10  
P7  
In a typical week, on how many days do you walk or 
bicycle for at least 10 minutes continuously to get to and 
from places?  
Number of days  
└─┘  
P8  

44 
 
How much time do you spend walking or bicycling for 
travel on a typical day?   
Hours : minutes  
└─┴─┘: 
└─┴─┘      hrs               
mins  
P9  
(a-b)  
Question  
 
Response  
 
Code  
Recreational activities  
The next questions exclude the work and transport activities that you have already mentioned.  
Now I would like to ask you about sports, fitness and recreational activities (leisure), [Insert relevant terms].  
Do you do any vigorous-intensity sports, fitness or 
recreational (leisure) activities that cause large increases 
in breathing or heart rate like [running or football]  for at 
least 10 minutes continuously?   
[INSERT EXAMPLES]   (USE SHOWCARD)  
Yes    
No  
1  
2      If No, 
go  to P 13  
P10  
In a typical week, on how many days do you do vigorous 
intensity sports, fitness or recreational (leisure) activities?  
Number of days  └─┘  
P11  
How much time do you spend doing  vigorous-intensity 
sports, fitness or recreational activities on a typical day?  
Hours : minutes  
└─┴─┘: 
└─┴─┘  
   hrs             
mins  
P12 (a-
b)  
Do you do any moderate-intensity sports, fitness or 
recreational (leisure) activities that cause a small increase 
in breathing or heart rate such as brisk walking, [cycling, 
swimming, volleyball] for at least 10 minutes 
continuously?  
 [INSERT EXAMPLES]   (USE SHOWCARD)  
Yes    
No  
1  
2      If No, 
go to P16  
P13  
In a typical week, on how many days do you do moderate 
intensity sports, fitness or recreational (leisure) activities?  
Number of days  
 
└─┘  
P14  
How much time do you spend doing moderate-intensity 
sports, fitness or recreational (leisure) activities on a 
typical day?  
Hours : minutes  
└─┴─┘: 
└─┴─┘  
   hrs             
mins  
P15 (a-
b)  
Sedentary behaviour  
The following question is about sitting or reclining at work, 
a 
t home, getting to and from places, or with friends including 
time spen 
t sitting at a 
desk, sitting with friends, traveling in car, bus, train, reading 
[INSERT EXAMPLES]   (USE SHOWCARD)  
, playing cards or watching television, but do not include 
time spent sl 
eeping.  
How much time do you usually spend sitting or reclining 
on a typical day?  
Hours : minutes  
└─┴─┘: 
└─┴─┘     hrs                
mins  
P16  (a-
b)  
 
  
 
 
 
 
 
 
 

45 
 
Section 4: Food Consumption   
24-Hour Recall Questionnaire   
Please write down all foods and beverages consumed for the previous 24-hour time (one day) period starting at 12:00 
am and ending at 11:59 pm.    
List the approximate Time the meal was consumed, Place where it was consumed (home, work, name of restaurant, 
church, etc.), and the type of eating occasion or Meal (breakfast, lunch, dinner, snack, or other). List each 
Food/Beverage Item you consumed, including foods eaten between meals and all drinks, even if it is a non-caloric 
item like water, coffee, or tea. Specify Details/Ingredients/Preparation of each food or beverage consumed. Record 
the Amount of each food or beverage consumed using weight (grams, kilograms) and volume (millilitres, litres). Cups, 
tablespoons, and teaspoons measures can also be used.  Size (small, medium, large, length, width, height) measures 
the physical dimensions or proportion of a food.   
Date of interview:   
Date of Record:   
   
   
   
   
   
Meal & Time   Place   
Food/Beverage Item   
Details/Ingredients/Preparation   
Amount   
Breakfast   
   
   
   
   
   
   
Midmorning  
snack   
   
   
   
   
   
   
Lunch   
   
   
   
   
   
   
Afternoon   
snack   
   
   
   
   
   
   
Dinner   
   
   
   
   
   
Night snack   
  
   
   
   
   
   
 
 Would you consider the above two intake records of foods and beverages today a typical day’s eating pattern?    
1= Yes; 2=No   
If no, explain why not typical?   
Section 5: Anthropometric Measurements     
S/N   
Measure   
1st reading   
2nd reading   
Average   
1   
Weight (kg)   
   
   
   
2   
Height (m)   
   
   
   
3   
Triceps skin fold thickness (mm)   
   
   
   
4  
Waist circumference (cm)   
   
   
   
5  
Hip circumference (cm)   
   
   
   
6  
Body composition measurement