A Family Centred Approach to Enhance Lifestyle Change and Behavioural Modification for Prevention of Cardiovascular Diseases Among Adolescents and Their Families in Uganda
Phase: NA
Conditions: Adolescent Behavior, Lifestyle Modification, Cardiovascular Disease Other
Sponsor: MRC/UVRI and LSHTM Uganda Research Unit

 
 
 
Title: A Family-Centred approach to enhance lifestyle 
change and behavioural modification for prevention 
of cardiovascular Diseases among adolescents and 
their families in Uganda  
 
Acronym: FaCe-D study  
 
version date 05 March 2025  
FaCe-D study Protocol version 4.0  
  
 
 
 
 
 
 
 
 
 
 
 
 
     
      
  

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Protocol version 4.0                                version dated 05 March 2025 
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                                                                           Acronym: FaCe-D study 
 
INVESTIGATING TEAM 
 
Name 
Affiliation 
Position/training 
Role 
Josephine Birungi  -MRC/UVRI and LSHTM 
-The AIDS Support Organisation 
(TASO) 
Independent 
researcher, Medical 
Doctor, 
Public 
health 
and 
implementation 
scientist 
Principal 
Investigator- 
Uganda 
David Moore 
University of British Columbia, 
Canada 
Independent 
researcher  
Professor, 
Department 
of 
Medicine,  
Principal 
Investigator- 
Canada 
Rachel King 
University of California – San 
Francisco 
USA 
Independent 
researcher 
and 
Social 
and 
Behavioural scientist  
Principal 
Investigator- 
USA 
Martin Muddu,  
IDRC, Uganda 
Independent 
researcher; 
Physician 
and 
implementation 
scientist   
Co-Investigator 
Levi Mugenyi 
MRC/UVRI and LSHTM 
Biostatistician  
Co-Investigator 
Costella 
M. 
Tindyebwa,  
Almond Initiatives Ltd 
Monitoring 
and 
evaluation specialist 
Co-Investigator 
Ivan Namakoola 
MRC/UVRI and LSHTM 
Clinical trials and 
implementation 
scientist 
Co-Investigator 
Flavia Zalwango 
MRC/UVRI and LSHTM 
Senior 
Social 
Scientist  
Co-Investigator 
Mathias Akuzibwe MRC/UVRI and LSHTM 
 Social scientist 
Co-Investigator 
Moreen 
Chaka 
Namulundu 
MRC/UVRI and LSHTM 
Social scientist  
Co-Investigator 
Faith 
Tumuhairwe  
TASO 
Public 
health 
specialist  
Co-Investigator 
Simple Ouma,  
 TASO 
Public health    
implementation 
scientist  
Co-Investigator 
Sumayiya 
Nalubega 
TASO 
Ethic and Research 
Compliance Officer 
Co-Investigator 

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Arthur 
Namara 
Araali 
MRC/UVRI & LSHTM 
Community 
engagement 
specialist 
Research Scientist 
Co-Investigator 
Perez 
Nicholas 
Ochanda 
Global Health Uganda 
Health Economist – 
PhDc 
Co-investigator 
Gerald Mutungi 
Ministry 
of 
Health 
(NCD 
Program) 
Policy Maker (Ass. 
Commissioner Non-
Communicable 
disease) 
Key Knowledge user 
Co-Investigator 
Mina Nakawuka 
Ministry of Health (AIDS Control 
Program) 
Policy 
Maker 
(Program Officer for 
Adult 
HIV 
care 
Uganda 
Knowledge User 
Co-Investigator 
Eleanor 
Namusoke 
Ministry of Health (AIDS Control 
Program) 
Policy 
Maker 
(Program Officer for 
Children 
and 
Adolescent HIV care 
Knowledge user 
Co-Investigator 
Moffat J Nyirenda 
MRC/UVRI and LSHTM 
Senior Advisor 
Prof 
of 
Global 
Health, NCDs 
Senior Advisor 
Co-Investigator 
 
 
 
 
 
By my signature below, I hereby confirm that the study will be conducted in accordance with this protocol 
and compliance with the tripartite harmonized ICH Guideline for Good Clinical Practice 1996 and the 
version of such protocol agreed to by the applicable regulatory authorities and approved by all Institutional 
Review Board and Ethical Committees. 
 
 
 
Principal Investigator:  
 
 
Name: Josephine Birungi  
Signature:               Date   13 March 2025 
 
 

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Table of Contents 
1.0 Introduction ................................................................................................................................................................ 6 
1.1 CVD and Mental health disorders among adolescents ........................................................................................... 6 
1.2 Economic Burden of CVDs: ..................................................................................................................................... 7 
1.3. Definition of cardiovascular Disease (CVD) and the risk factors ............................................................................ 7 
1.4 Evidence- based intervention ................................................................................................................................. 8 
1.5. Why adolescents are the target population: ......................................................................................................... 8 
2.0. Overall Study aims ..................................................................................................................................................... 8 
2.1. Hypothesis .............................................................................................................................................................. 9 
2.2 Study Objectives: .................................................................................................................................................... 9 
2.2.1 Primary Objective:............................................................................................................................................ 9 
2.2.2 Co-primary Objective: ...................................................................................................................................... 9 
2.2.3 Secondary Objectives: ...................................................................................................................................... 9 
2.3 Proposed intervention by study team before seeking views of stakeholders ........................................................ 9 
3.0 Theory of change: ....................................................................................................................................................... 9 
4.0 Methodology ............................................................................................................................................................. 10 
4.1. Study phases ........................................................................................................................................................ 10 
5.0 Formative Research phase ........................................................................................................................................ 10 
5.1 Aim and Objectives for the formative phase ........................................................................................................ 11 
5.2. Methods for formative phase .............................................................................................................................. 11 
5.2.1 Study design ................................................................................................................................................... 11 
5.2.2 Study population of the formative phase ...................................................................................................... 11 
5.2.3 Setting ............................................................................................................................................................ 11 
5.2.4 Recruitment Approach ................................................................................................................................... 12 
5.3 Data collection .................................................................................................................................................. 12 
5.4 Documents review ................................................................................................................................................ 12 
5.5 Data analysis ......................................................................................................................................................... 12 
5.6 Co-designing of the final version of the intervention (FCA) suitable to Ugandan setting .................................... 12 
6.0 Implementation and evaluation phases ................................................................................................................... 13 
6.1 Study Design for the evaluation of effectiveness of the intervention .................................................................. 13 
6.2. Randomisation of clusters.................................................................................................................................... 13 
6.3. Sample size ........................................................................................................................................................... 14 
6.4. Study setting ........................................................................................................................................................ 14 
6.5 Study population of the implementation and evaluation phase .......................................................................... 14 
6.5.1 Adolescent inclusion and exclusion criteria: .................................................................................................. 14 
6.5.2 Household head/ Parent/Caretaker/food preparers inclusion and Exclusion criteria .................................. 14 
6.6 Intervention after obtaining stakeholder views ................................................................................................... 15 
Table 1: Summary of the Intervention component and processes ........................................................................ 17 
6.7. Outcomes ............................................................................................................................................................. 18 
6.7.1 Primary effectiveness outcomes: ................................................................................................................... 18 
Table 2 Definition of Ideal Cardiovascular Health Metrics (<20 Years of Age) as Defined by the American Heart 
Association .............................................................................................................................................................. 18 
6.7.2. Overall Scoring and the Cardiovascular Health Categorization .................................................................... 18 

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6.7.3 Secondary effectiveness outcomes ................................................................................................................... 18 
6.7.4 Implementation science outcomes .................................................................................................................... 19 
6.8. Study Duration and Data Collection ..................................................................................................................... 20 
Table 1: FaCe-D Study schedule .............................................................................................................................. 20 
6.9. Training ................................................................................................................................................................ 20 
6.8.1. Training of study teams................................................................................................................................. 20 
6.9.2 Training of VHTs, peer champions and health facility workers ..................................................................... 20 
6.9.3 VHT Monitoring and Supervision: .................................................................................................................. 21 
6.9.4 VHT Facilitation and Support: ........................................................................................................................ 21 
7.0 Statistical Analysis ..................................................................................................................................................... 21 
8.0 Process evaluation of the FaCe-D study ................................................................................................................... 22 
8.1. The aim of the process evaluation ....................................................................................................................... 22 
8.2. Research questions guiding the process evaluation ............................................................................................ 22 
8.3. The specific objectives of the process evaluation ............................................................................................... 23 
8.4. The outcomes of process evaluation ................................................................................................................... 23 
8.5. Methods and design for the process evaluation ................................................................................................. 23 
8.5.1 study design ................................................................................................................................................... 23 
8.5.2 Study Population ............................................................................................................................................ 23 
8.5.3 Data Collection for the process evaluation .................................................................................................... 24 
Table 3: Process evaluation Objectives and outcomes ........................................................................................... 24 
8.5.4. Data Management and analysis ........................................................................................................................ 25 
8.6 Credibility and transferability ............................................................................................................................... 25 
9.0 Economic evaluation ................................................................................................................................................. 26 
9.1. Cost estimation and analysis ................................................................................................................................ 26 
9.2 Measurement of cost effectiveness ...................................................................................................................... 26 
9.3 Cost-effectiveness analysis ................................................................................................................................... 27 
10.0 IS Logic model ......................................................................................................................................................... 27 
10.1 Implementation strategies .................................................................................................................................. 28 
11.0 Governance and Ethics............................................................................................................................................ 28 
12.0 Safeguarding ........................................................................................................................................................... 28 
13.0. Dissemination plan ................................................................................................................................................. 28 
Figure 2: FaCe-D implementation districts ..................................................................................................................... 29 
References ...................................................................................................................................................................... 29 
14.0 Appendices .............................................................................................................................................................. 35 
Appendix 1: Summary of the data to be collected ..................................................................................................... 35 
Appendix 2: FaCe-D study Screening tool ................................................................................................................... 36 
Appendix 3: FaCe-D Enrolment (CVH and Mental Wellbeing) Tool ............................................................................ 37 
Appendix 5 MINI KID ................................................................................................................................................... 46 
Appendix 6: Modified VHT register ............................................................................................................................. 49 
Appendix 7: Cardiovascular Health Matrix ................................................................................................................. 49 
Appendix 8 Health Economics questionnaire ............................................................................................................. 49 
Appendix 9: VHT Monitoring and Supervision Checklist- FaCe-D ............................................................................... 51 
Appendix 10: Process evaluation Data collection tools .............................................................................................. 52 
Appendix 11: Participants’ education materials: Health plate and portion sizes ....................................................... 58 

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Appendix 12: Physical Activity diary ........................................................................................................................... 58 
Appendix 13: Food diary ............................................................................................................................................. 64 
 
 
 
 
 
 
 
 
 
 
 

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1.0 Introduction 
Uganda suffers a dual burden of non-communicable diseases (NCDs) and HIV/AIDS with an overall 
prevalence of pre-hypertension of 38.8% among its 42 million population (adolescents account for 23.6% of 
this) and 5.8% for HIV/AIDS. A nationwide study among persons ≥12 years in the country found the 
prevalence of hypertension (blood pressure ≥140/90) as high as 34.3% in urban areas, and 22% in rural areas3 
(Lunyera et al 2018). While another nationwide study found that only 7.7% of the adult population were 
aware of their high blood pressure (Guwatude et al, 2014). Furthermore, 24.3% of 15,000 adults living with 
HIV (PLHIV) screened at an urban clinic were found to be hypertensive (Muddu et al, 2021. The 2021 global 
nutrition report indicates Uganda has shown little progress towards achieving diet related NCD targets that 
include halting the rise in obesity and diabetes, 30% mean reduction in population intake of salt (<5 mg per 
day) and 25% relative reduction in raised blood pressure. According to this same report, 10.4% of the adult 
women (>18 years) and 2.3% of the adult men are obese (Global Nutrion report, 2021).  
In a study conducted in Uganda and Tanzania in 2015 by Nsanya and others, the prevalence of high 
(elevated) blood pressure defined as mean systolic and/or diastolic BP at ≥90th percentile among 
adolescents aged 12 to 19 years was 36% (Nsanya et al 2019).  Another study report showed that over 50% 
of adolescents in western Uganda had some knowledge of the risk factors for CVD (health diet and physical 
activity), but many engage in behaviours that put them at risk for CVD(Agaba and Muhumuza, 2021). In 
2020, only 36.3% of the school going children (10-12 years) in Kampala met the WHO recommended 
amount of physical activity defined as at least 60 minutes of moderate-to-vigorous physical activity per 
day. According to Akseer and others who conducted a systematic review on NCDs among adolescents in 
194 countries (Uganda Inclusive), physical activity was inadequate in over 80% of the adolescents aged 11 
to 17 years across all regions and both sexes (Akseer et al, 2020).  
In Kampala, Uganda, a concerning 63.7% of school-going children aged 10-12 years fail to meet World Health 
Organization (WHO) physical activity guidelines, with notable disparities: boys, children of normal weight, 
and those attending public schools exhibit higher activity levels (Nakabazzi et al., 2020). Encouragingly, 
school-based initiatives have shown considerable promise in mitigating NCD risk factors, with 80% of studies 
demonstrating positive outcomes, especially when incorporating family and community engagement (Saraf 
et al., 2012). Regular physical activity and aerobic exercise have proven beneficial in reducing cardiovascular 
issues and enhancing quality of life among adolescents living with HIV (Ndirangu-Mugo et al., n.d.). These 
findings underscore the critical need for tailored interventions promoting physical activity and NCD 
prevention among adolescents, particularly vulnerable populations. 
 
1.1 CVD and Mental health disorders among adolescents 
Furthermore, recent studies indicate a high prevalence of anxiety and depression among adolescents 
globally. In Jordan, 78.2% of adolescents reported severe anxiety symptoms, while 49.1% experienced severe 
depressive symptoms (Entisar Dwekat et al., 2021). A study in India found moderate to severe anxiety in 
9.9% and depression in 18.5% of adolescents, with depression more common in boys and increasing with 
age (D. Patel & D. Patel, 2020). Research in Colombia revealed anxiety symptoms in 37% of adolescents and 
depression symptoms in 12.3% (Ospina-Ospina et al., 2011). A study in Bangalore, India, during the COVID-
19 pandemic found even higher rates, with 62.74% of adolescents experiencing anxiety and 50.32% 
experiencing depression (Neha et al., 2022). Factors associated with these conditions include gender, age, 
socioeconomic status, and parental education levels.  
Research has also indicated a significant relationship between cardiovascular disease (CVD) risk factors and 
mental health issues among youth. A study of children and adolescents with major depressive disorder found 

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that 52% had at least two CVD risk factors, including hypertension and elevated cholesterol levels (Korczak 
et al., 2021). Another study revealed that depressed adolescents exhibited poorer vascular functioning and 
increased CVD risk compared to controls (Waloszek et al., 2015). Not meeting physical activity 
recommendations and having a depression diagnosis were significant predictors of obesity risk in 
adolescents (Kaar et al., 2022). The interconnection between cardiovascular and mental health underscores 
the need for a holistic approach to healthcare that integrates treatment of physical symptoms with 
interventions addressing mental health issues (Borkowski & Borkowska, 2024). These findings highlight the 
importance of considering mental health in CVD risk assessment and prevention strategies for youth, 
potentially warranting routine CVD risk factor screening among depressed youth regardless of BMI. 
Additionally, there is strong evidence showing that poor sleep quality, such as short sleep duration, insomnia, 
or sleep apnea, is associated with an increased risk of CVD such as hypertension, atherosclerosis, and 
myocardial infarction (Covassin & Singh, 2016). Sleep disturbances are thought to contribute to elevated 
stress hormones, systemic inflammation, and impaired vascular function, all of which play a crucial role in 
the pathogenesis of CVD (Raggi et al., 2021) 
1.2 Economic Burden of CVDs: 
The economic burden of cardiovascular diseases (CVDs) and mental health disorders in low- and middle-
income countries (LMICs) is substantial, affecting individuals, households, and communities. Households 
affected by these conditions face severe financial strain, including higher healthcare expenditures, reduced 
income, and increased use of detrimental financial coping strategies (Kazibwe et al., 2021; Lund et al., 2019). 
In Africa, CVDs alone result in billions of dollars in lost productivity and healthcare costs annually (Gaziano, 
2008). Comorbid depression in CVD patients further increases healthcare utilization and costs while reducing 
employment productivity (Rodwin et al., 2013). The chronic nature of these conditions can result in 
catastrophic health expenditure, pushing households deeper into poverty and entrenching inequality 
(Kazibwe et al., 2021). However, innovative care delivery models targeting depression in CVD patients have 
shown potential to reduce costs or be cost-neutral while improving quality of life (Rodwin et al., 2013). 
 
1.3. Definition of cardiovascular Disease (CVD) and the risk factors  
CVDs is a broad term that encompasses a range of conditions affecting the heart and blood vessels, including 
myocardial infarction, angina, coronary heart disease, stroke, transient ischemic attack, peripheral vascular 
disease, and congestive heart failure. The key risk factors for CVD include high blood pressure, high 
cholesterol, diabetes, smoking, obesity, physical inactivity, and family history. Identifying and addressing 
these modifiable risk factors is crucial for preventing the development and progression of cardiovascular 
disease. Lifestyle changes, such as a healthy diet, regular exercise, and smoking cessation, can significantly 
reduce an individual's risk of developing CVD, while medical interventions like medication and surgical 
procedures may be necessary in some cases to manage the condition.  
 
The "Life Simple 7" framework outlines seven essential components for achieving ideal cardiovascular 
health: (1) no smoking, (2) a BMI of less than 25 kg/m²(< 85th percentile those below 20 years, (3) at least 
150 minutes of moderate-intensity physical activity per week in adults and at least 60 minutes daily for 
children, (4) a heart-healthy diet rich in fruits, vegetables, and whole grains with at least 4-5 servings daily, 
(5) blood pressure below 120/80 mmHg or less than 90th percentile in children below 20 years, (6) total 
cholesterol levels under 200 mg/dL in adults and less than 170mg/dl in children , and (7) fasting blood glucose 
below 100 mg/dL. This matrix serves as a practical guide for individuals and communities to enhance 
cardiovascular health and reduce disease risk (American Heart Association, 2010). 
 

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1.4 Evidence- based intervention 
The iHealth-T2D study, a cluster randomized controlled trial (Kasturiratne et al., 2020, Muilwijk et al 2021), 
demonstrated the effectiveness of the Family Centred Approach (FCA) in preventing type 2 diabetes among 
high-risk South Asians. The intervention group showed significant reductions in weight and waist 
circumference compared to the control group (Muilwijk et al., 2021). The education sessions were delivered 
through 22 contact sessions over 12 months (Muilwijk et al., 2021). The FaCe-D study, will adapt and evaluate 
the iHealth-T2D intervention in Uganda, targeting improvement of cardiovascular health and reduction of 
cardiovascular disease risk among adolescents.  
 
1.5. Why adolescents are the target population: 
Adolescence is critical development stage characterised by significant physical, cognitive, emotional and 
social changes. Adolescence is often marked by the onset of puberty and development of sexual and 
reproductive maturity, and the pursuit of increasing independence and identity formation. During this 
period, individuals undergo profound psychological and behavioural transformations as they navigate their 
way from childhood to adulthood.  It is a stage when one establishes health behaviour that may affect one’s 
health and wellbeing later in life and it is also a time when we observe increase in risky behaviour which can 
lead to harmful outcomes. Furthermore, the clinical signs and symptoms of cardiovascular disease (CVD) may 
present in adulthood, but the atherosclerotic process often begins in adolescence 12-14. The progression of 
this atherosclerotic process in the young people is often influenced by modifiable CVD risk factors such as 
unhealthy diet, physical inactivity, overweight and obesity. For instance, it has been shown that 8 in 10 obese 
teenagers have gone on to become obese in adulthood 15.   
 
In Uganda, almost a quarter of the population are adolescents. As a country that has suffered the effects of 
HIV epidemic for over three decades, some of the adolescents have been living with HIV since birth.  Yet 
research among adult HIV positive persons in Uganda showed a prevalence of 18% subclinical 
atherosclerosis16. Additionally, some modifiable risk factors such as obesity and dyslipidaemia are more 
prevalent among HIV positive than negative individuals17. This puts People Living with HIV at increased risk 
of cardiovascular diseases.  Therefore, by intervening during adolescence, the adulthood phase is likely to 
have a lesser burden of morbidity and mortality due to CVD and the related complications.  
  
For example, a cluster-randomised controlled trial in United Kingdom and South Asia, known as iHealth-T2D 
study showed that an intensive family-based lifestyle intervention, referred to in this protocol as Family 
Centred Approach (FCA) leads to effective reduction in weight, waist circumference and blood pressure 
among adult persons at risk of type 2 diabetes 18. The iHealth-T2D intervention comprised of 22 contact 
session in 12 months; nine (9) being one to one visit and 13 telephone calls delivered by community health 
workers. The education sessions focused on health diet and increasing the physical activity among health 
persons at risk of type 2 diabetes. We propose to adapt, implement and evaluate this family- based 
intervention to determine its effectiveness in improving cardiovascular health of adolescents in Uganda, 
measured by the life’s simple 7 metrics19. 
2.0. Overall Study aims 
Our primary aim is to adapt and implement a modified version of FCA that was implemented in the iHealth-
T2D study18, and evaluate its effectiveness in reducing  cardiovascular disease risk among adolescents and 
their families in Uganda using the Life’s Simple 7 metrics. Furthermore, we wish to determine its effect on 
anxiety, depression, sleep quality and the uptake, implementation costs, barriers and facilitators.  
 

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2.1. Hypothesis 
We hypothesize that implementing the FCA will significantly improve cardiovascular health and reduce 
CVD risks among adolescents in Uganda and that the intervention will demonstrate favourable 
implementation science outcomes, supporting its scalability and sustainability. 
2.2 Study Objectives: 
2.2.1 Primary Objective: 
To evaluate the effectiveness of the FaCe-D intervention in enhancing cardiovascular health among 
adolescents.  
This will be measured by assessing the intervention's effect on the proportion of adolescents achieving Ideal 
Cardiovascular Health (ICH) score based on the Life simple 7 metrics after 12 months of follow -up. 
 
2.2.2 Co-primary Objective: 
To assess the acceptability, adoption, and fidelity of the FCA in the Ugandan context. 
 
2.2.3 Secondary Objectives: 
1. To establish the contextual factors, barriers, and facilitators that influence uptake, implementation 
and outcomes of the FCA in Uganda. 
2. To explore and evaluate the effects of the FaCe-D intervention on anxiety, depression and sleep 
quality among adolescents. 
4. To determine the costs and cost-effectiveness of implementing the adapted FaCe-D study, including 
estimation of incremental cost-effectiveness ratio. 
 
2.3 Proposed intervention by study team before seeking views of stakeholders 
The FaCe-D study team proposed to implement an intervention similar to that of iHealth T2D study (Muilwijk et al, 
2021) in Uganda where Village Health Team members would visit families residing in the study villages and educate 
them about health diet as well as physical activity. As part of first step in the adaption process, the study team 
proposed some changes to the iHealth T2D study intervention to make it easier for the participants and the 
stakeholders to understand and make meaningful input into the design. The adaptation of iHealth T2D intervention 
focused majorly on the context; changes in setting in which the intervention would be implemented, cadre of 
personnel to implement the intervention, and study population. In addition, the adaptation was to involve revisions 
to the content of education materials, frequency and length of some components of the intervention to suit the 
Ugandan setting. It is this modified design of the intervention that was presented to the stakeholders and study 
participants for their suggestions and perspectives. 
 
3.0 Theory of change: 
The adolescents are often guided and depend on their families for support in Uganda. We therefore assume that 
once the families are willing to participate, the adolescents will also be willing to participate. We will design 
adolescent friendly education materials, and work with both the VHTs and their peers to implement this 
intervention. By doing this, they will be motivated to change diet and engage in the recommended level of physical 
activity per day. The life style modification and behaviour change will result in increased knowledge and awareness 
about CVD in the short term, reduced CVD risk in the medium term, and delayed progression tot disease and 
complications. 

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4.0 Methodology 
 
4.1. Study phases 
The study will be conducted in three (3) phases listed below.  
a) Formative phase (data collection and analysis of this phase is completed)  
b) Implementation phase 
c) Evaluation (effectiveness and process evaluation) phase 
Following the completion of the formative phase (UVRI REC approval number GC/127/991), we present the 
additional two phases of the study as explained in detail to indicate the data collection and the frameworks 
to be used. 
a) The Implementation phase during which we will roll out the intervention to the participating 
households and  
b) The Evaluation phase (checking the effect of the intervention on the clinical outcomes, including 
mental health outcomes, implementation science outcomes). We will also conduct the process and 
health economic evaluation.  
 
5.0 Formative Research phase 
This first phase of the project was completed successfully, and the findings were used to design the FCA 
study intervention. In this phase we focused on adapting the intervention, guided by the Consolidated 
Framework for Implementation Research (CIFR) (Damschroder et al 2009, Damschroder et al 2015). This 
framework guided the research team to adapt the intervention based on the identified barriers and 

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facilitators to delivering the FCA. We established the process of negotiating access to and mobilizing 
adolescents, families and communities. We also learnt how best to approach and engage stakeholders at 
village, parish, division and district levels, identification and recruitment of the community health workers 
(in this case the Village Health Teams also know n as VHTs) to implement the intervention.  
 
5.1 Aim and Objectives for the formative phase  
 The aim was to explore the knowledge on cardiovascular health including CVD risk, perceptions and 
attitudes of participants, providers and other stakeholders towards the ihealth-T2D FCA intervention, obtain 
their input in the modification and design of the intervention to make it appropriate for Ugandan context.  
Specifically, we hoped to achieve the following objectives in this phase. 
1) To explore the knowledge on cardiovascular health, perceptions, preferences and recommendations 
of potential participants on the FCA as an intervention for reducing and controlling common CVD risk 
factors among adolescents and their families.  We set out to identify the preferences for the 
frequency and duration of visits, and phone calls, attitudes towards healthy eating, physical activity, 
and taking records of the food consumed and time spent on physical activities and any anticipated 
challenges to adopting healthy behaviours. 
2) To identify potential facilitators and barriers to adapting and implementing the FCA intervention in 
Uganda. We sought to understand the likely feasibility of engaging adolescents and their families in 
a longitudinal intervention and the optimal timing during the day and week for home visits by the 
village health teams.  
3) To use the data generated to design implementation strategies to promote the delivery, and uptake 
of the adapted FCA.  
 
5.2. Methods for formative phase   
 
5.2.1 Study design 
The formative phase employed a cross sectional study design to collect qualitative data. We conducted focus 
group discussion (FGDs) to collect data from adolescents, household heads and members in charge of 
preparing food and VHTs. The key informant Interviews (KIIs) were conducted to collect data from the policy 
makers and other experts in this field.  
 
5.2.2 Study population of the formative phase 
The primary target population for this phase of the study included adolescents and their families residing 
either in Jinja or Kampala. Among household members, we targeted the household head and the member 
in charge of food preparation. The participants were selected using the purposive sampling technique22 in 
consultation with the VHT and LCs (local leaders).  
 
Inclusion and exclusion criteria for adolescents: 
Adolescents aged 10-19 years and able to provide consent /ascent, emancipated minors were included and 
exclude adolescents in boarding school and those without parental consent.  
 
5.2.3 Setting 
The formative study was conducted in Nakawa division of Kampala district (urban) and Mafubira- Namulesa 
divisions of Jinja district (rural) – refer to figure 2. 
 

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5.2.4 Recruitment Approach 
Working with the local council (LCs) leaders and village health team members (VHTs), we identified potential 
participants in the formative phase. The VHTs in each of the two participating districts then identified a 
minimum of 20 families with at least one adolescent aged 10-19 (in or out-of-school). The VHT member also 
visited the identified family to provide some information regarding the study, seek consent and provide an 
invitation letter to the venue where the FGD was to be held. The FGD comprised of 8-12 members from 
different household. 
 
5.3 Data collection 
Data collection was stratified by rural and urban residence, as we anticipated that preferences and potential 
barriers and facilitators may differ between these settings.  
We set out to conduct four to six (4-6) focus group discussions (FGDs) that involved adolescents, two -four 
(2-4) FGDs with household members/food preparers, and one to two (2-4) FGDs with VHTs. The adolescent 
FGDs were grouped according to their gender and age categories; 10-14 years, and 15-19 years while the 
household member and food preparers were grouped according to gender (male or female). Each FGD 
comprised of 8-12 members from each participant category and the key informant interview recruited 20-
30 participants. The interviews were recorded in addition to the note-taking by the research assistants. Audio 
recordings of all interviews and FGDs were transcribed verbatim by competent and experienced social 
scientists.  
 
All participants in the FGD received transport reimbursement of 10,000 shillings and either a bar of soap or 
scholastic materials (books/pens/set). We provided refreshments during FGDs. We also interviewed policy 
makers from the ministries of; Health (NCD and AIDS control programme), education and sports, gender, 
labour and social development, district/parish officials, VHT coordinators and Local leaders, 
dietitians/nutritionists with good understanding of the local community context (Jinja and Kampala) and 
health researchers in areas of CVDs. The participants for the individual key informant interviews (KII) 
received 50,000 Uganda shillings. 
 
5.4 Documents review  
A review of literature about healthy diet and appropriate physical exercises was conducted to identify 
relevant literature, curricula and education material on diet/nutrition, recommended healthy lifestyles, 
community health, and role of community health workers/VHTs) in Uganda. This was done in order to ensure 
that the adapted FCA intervention conforms to current policies and health education materials in Uganda. 
 
5.5 Data analysis 
The data collected from FGDs and KIIs were analysed using two approaches; deductive and inductive. 
The deductive approach was guided by Consolidate Framework for Implementation Research (CFIR) 
Framework application and the inductive approach (this was open coding to find new emerging themes). 
Using the CFIR framework that has five domains and 39 constructs (https://cfirguide.org/constructs/), we 
explored the barriers and facilitators of adapting and implementing FCA in the Ugandan context.  Then, the 
themes were mapped onto the CFIR constructs. The inductive approach involved open coding to find other 
new emerging themes. An electronic data management package (NVivo 14) was used to code the data under 
identified themes and subthemes. 
 
5.6 Co-designing of the final version of the intervention (FCA) suitable to Ugandan setting 
Following the documents review, data collection and analysis, the study team developed a draft of an FCA 
fit for the Ugandan context and the required tools. These were presented at a validation workshop involving 
investigators and experts for review. A dissemination workshop for stakeholders including; policy makers, 

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civil society organizations members, development and implementing partners, youth and adolescents, 
advocate, health officials and municipal officers and community members was organised to share the near 
final FCA. The final version of the FCA was developed after this workshop taking into account the feedback 
from the different stakeholders.  
 
6.0 Implementation and evaluation phases 
These two phases will be implemented concurrently. The study will evaluate the following; effect of the 
intervention on health and implementation science outcome, the process and the economics/cost and cost 
effectiveness. 
 
6.1 Study Design for the evaluation of effectiveness of the intervention 
The evaluation phase, the study will use a hybrid type II cluster randomized controlled trial design (Curran 
et al., 2012, Clemson et al., 2017, Cully et al.,2012) to evaluate the clinical effectiveness and the 
implementation outcomes. The clinical effectiveness of the FaCe-D study will be determined at 12 months 
while the implementation outcome will be assessed through to 18 months (Figure 1). The cluster will be the 
village and the adolescents in a household will be the main study participant. This study will involve 32 
villages, stratified into 16 urban and 16 rural clusters, with each cluster consisting of 40 adolescents. The 
clusters within each stratum will be randomly assigned to either treatment group or wait-list control group. 
Each cohort will be followed for 18 months, with the clinical effectiveness of the intervention assessed during 
the first 12 months (Figure 1). 
 
a) First 12 Months (Effectiveness Phase): 
• The immediate (treatment) arm will receive the FaCe-D intervention, comprising dietary and 
exercise interventions delivered by Village Health Teams (VHTs) – details in section 4.6 
 
b) The wait-list control arm will receive the standard of care, with VHTs performing their usual roles) of 
health promotion in both communicable and non-communicable diseases as outlined by the Ministry 
of Health guidelines. In brief, the standard of care involves visit by the VHT at least once a quarter to 
check home hygiene and environment, children immunisation status and other health promotion 
activities. The VHT may or may not involve the entire family/household. 
 
c) Last 6 Months (maintenance Phase): 
• In the immediate (treatment) arm, the FaCe-D intervention will continue under the 
supervision of public health facilities. During this phase, VHTs in the intervention clusters will 
scale up the intervention to include all households within the village. This stage will focus on 
evaluating implementation science outcomes, particularly adoption, fidelity and 
maintenance. 
• In the wait-list control arm, all clusters will begin implementing the FaCe-D intervention, 
ensuring that every participant benefit from the program. 
 
6.2. Randomisation of clusters 
At a meeting organised by the study team, VHTs and LC1 representing each village will draw a piece of paper 
written on the arm of the study the study their village will belong to. Each paper piece will be unfolded and 
read to all members in the room and recorded as the final arm. We will use systematic random sampling to 
select households to participant in the study. The LC1 working with the VHT will present a list of the 
households with adolescents aged 10 -19 years to the study team. Using the list, we will select every nth 
participant to obtain the 40 households. If the village has less than 40 eligible households, we will include all 
consenting households. If a household is found to have more than one adolescent, all those consenting will 

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be selected to participate. This event will be attended by other key stakeholders, including community 
advisory boards, youth councillors, health center in-charges, the district health officer, and the city health 
officer, all contributing to the collaborative effort to promote transparency  
 6.3. Sample size  
A minimum sample size of 1280 adolescents was determined using STATA “clustersampsi” package for 
cluster randomized controlled trials. This calculation considered a baseline proportion of adolescents with 
ideal cardiovascular health of 53% based on a South African study among the rural population (Nsanya et al., 
2019). With this sample size, the intervention will have 90% power to detect an improvement of at least 10% 
absolute difference in proportion of adolescents with ideal cardiovascular health considering 32 clusters of 
average size 40, an intra-class correlation coefficient of 0.005 and a significance level of 0.05. 
 
6.4. Study setting  
We will undertake this implementation research in two sub-counties located within Kampala and Jinja 
districts in Ugandan, which reflects some diverse environments where adolescent populations live. The 
urban site is in Nakawa division, Kampala district, Central Uganda. It comprises of Bugolobi and Kiswa 
parishes and Mbuya parishes. The rural sites are in Budondo and Mafubira sub-countries in Jinja district, 
Eastern Uganda, covering Buwenda and Namulesa parishes. Mafubira has both peri-urban and rural 
parishes. We have chosen Buwenda and Namulesa rural parishes, characterized by lower population density, 
agricultural livelihoods, and limited infrastructure, typical of rural areas. The study settings offer a 
contrasting representation of urban and rural environments. Nakawa division, Kampala, has a population of 
318,447 and 248,583 households, characterized by a predominantly middle-income earning population 
engaged in formal employment and living an urban lifestyle. We will aim to enroll adolescents from both the 
affluent and less-affluent households. In contrast, Jinja district has a population of 584,119, primarily 
comprising rural subsistence farmers with few formal sector wage earners and an estimated annual 
household income of US$100. 
 
6.5 Study population of the implementation and evaluation phase 
The target population is adolescents aged 10-19 years. In our study. if a household has more than one 
adolescent, we will include all of them, provided they meet the inclusion criteria and consent to participate. 
This component of the study that involves quantitative data collection will focus mainly on the adolescents 
aged 10-19 years however the household head/parent/caretaker and food preparer will be required to 
consent and also participate in completing the food diaries and health economics questionaires.  
 
6.5.1 Adolescent inclusion and exclusion criteria:  
The participant will be enrolled in the cluster randomized control trial only if they meet the following 
- 
Aged 10 -19 years 
- 
Household head/Parent have provided consent/permission 
- 
Planning to continue staying in the study village for the next 12 months 
The participant will be excluded from the study if they are; 
- 
In boarding school or planning to join boarding school 
- 
Pregnant or lactating 
- 
Known to have a chronic condition such as CVD, diabetes, asthma, cancer or mental illness 
- 
Not able to assent or consent. 
 
6.5.2 Household head/ Parent/Caretaker/food preparers inclusion and Exclusion criteria 
The participant will be included in the study if they are; 

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- 
Stay in the household for at least 2 weeks in a month 
- 
Planning to continue staying in the study village for the next 12 months 
 
The participant will be excluded from the study if they are; 
 
 
- have a mental illness impairing their ability to consent 
- very ill requiring admission 
 
6.6 Intervention after obtaining stakeholder views 
FCA was adapted from the effective iHealth-T2D intervention for prevention of type 2 diabetes (T2D) among 
high-risk South Asians (Kasturiratne et al., 2020). We co-designed the FaCe-D intervention together with 
stakeholders during the formative phase of this study, detailed elsewhere (UVRI REC approval number 
GC/127/991). FaCe-D intervention will be delivered collaboratively by the Village Health Team (VHTs) and 
adolescent peer champions. Our intervention leverages the existing VHT network and taps into the 
influential role of peer champions among adolescents. VHTs provide vital link between households and the 
formal healthcare system, while peer champions offer a unique opportunity to harness social influence and 
promote behavioural change among adolescents.  
 
The selection of VHTs and peer champions as intervention deliverers was justified by our findings from the 
formative phase, which revealed that adolescents primarily seek health information from their peers, and 
VHTs require reinforcement to effectively engage adolescents. This collaborative approach addresses these 
gaps, and will enhance the intervention's acceptability, effectiveness, and sustainability within the Ugandan 
context. 
 
The study intervention comprises four components; three of which will be implemented by VHT members 
and peer champions at family level, and these include: a) monthly home visits, b) health diet education and 
food preparation demonstration to the family by VHTs, and c) health education, peer mentorship and 
monitoring of physical activity by adolescent peer. The fourth component that will be implemented by the 
study team is short messages (text, audio and video) to study participants to reinforce lifestyle modification 
and behavioural change (Table 1). Each component is explained in detail below; 
 
Monthly Home Visits: Under the home visit component, VHT members and peer champions will conduct 
regular visits to 10-12 households per month, approximately 3-4 homes per week. The frequency of visits 
will be twice a month for the first month, followed by monthly visits for the subsequent 11 months. Each 
home visit, lasting 45-90 minutes, will involve VHT and peer champion-led, interactive training sessions to 
educate adolescents and their families on healthy diet modification strategies. These sessions will emphasize 
balanced eating principles, including increasing fruit and vegetable intake, whole grains, lean protein 
sources, and healthy fats and the benefits of physical activity. They will take basic measurements of weight, 
height and blood pressure, reviewing previous diet and physical activity plans, and support the family in 
developing a healthy menu. Additionally, VHT members will conduct food demonstrations and utilize 
education materials, VHT registers, weighing scales, blood pressure machines, and portable stadiometers. In 
the first three months after enrolment, before the introduction of the intervention, home visits will engage 
the entire family and preferably take place on Saturdays and Sundays when most family members are 
present, with the VHT member discussing and determining the most convenient day of the week for each 
family. Following each visit, VHT members will complete the modified VHT register; a Ministry of Health tool 
that includes NCCD variables. 
  

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Physical activity: During the study, adolescents will be required to incorporate a daily 60-minute exercise 
routine. The study participants will be encouraged to begin with at least 15 minutes of daily exercise and 
gradually increase the duration to reach the recommended level. While findings from the formative phase 
showed a preference for jumping rope for girls and football for boys. The VHTs and peer champions will be 
encouraged to work with each family to identify and make the local play materials, such as ropes and 
dodgeballs, “blada” game, “Ssonko” game etc. using readily available materials. Additionally, information 
materials and physical activity videos will be shared with all families. These activities will be documented in 
the physical activity (PA) diary and the level of activity recorded in the VHT register. Each adolescent will be 
provided with a Physical Activity diary that will be completed every seven days starting on the day when the 
VHT/Peer champion visits their home. The PA diary will be carbonated so that a copy is picked by the VHT 
and one retained with the participant. To support physical activity, at community level, each village will 
receive two balls (football and netball). To promote participation and team spirit, jersey shirts will be 
provided to best performing adolescents in each village, that is those who successfully meet the WHO 
recommended physical activity level for three consecutive months. Parents will also have the option to 
purchase full jerseys for their children if they wish. Existing village facilities, such as playgrounds, schools, 
mosques and churches, will be utilized to minimize costs and maximize community engagement. The VHT 
and peer champion will work with Community members to organise village/ group physical activities on a 
quarterly basis.  In addition to promoting and studying physical activity adoption in the individuals 
(adolescents), the study will encourage regular exercise among families and community members through 
quarterly community physical activities organised by the VHT and peer champion. For the first three months, 
these activities will be held monthly to establish momentum. VHTs, Local Council 1 (LC1) members, and other 
local resourceful persons will lead and report on these activities. These community-led physical activities will 
be conducted without any budget allocation from the study team. Instead, the team will be invited as guests 
to participate and provide support. To motivate participation, a Physical Activity Day will be held to recognize 
and reward outstanding performance. 
 
Diet modification: VHTs shall have a list with structured health education topics for delivery during every 
home visit. Health education topics shall cover information related to a heart healthy diet and preventing 
NCD risk. Using available food in the home, dry rations or charts, the VHT member and peer champion will 
then carry out demonstrations on healthy foods and their preparation. Documentation of details of meal 
consumption will be done by the household head or a member delegated by the household head. Families 
will be encouraged to set up kitchen gardens using the available space. A community-based demonstration 
garden will be identified as (these already exist within the study communities) to showcase locally 
available, dietary diverse foods. The Health Kitchen initiative will utilize traditional local foods in the 
locality to demonstrate healthy meals catering to various dietary needs. These sessions will occur at LC1, 
VHT, or public community spaces, showcasing balanced eating principles at least once in 6 months. To 
support diet modification, the study will provide food charts to each family and VHT, along with food 
diaries for training. Demonstration foods will be provided during VHT training, accompanied by video clips 
sharing healthy cooking practices. 
 
Phone reminders: To re-enforce the health lifestyle education and health literacy, the study will utilize phone 
reminders through short, informative, and engaging SMS messages sent twice weekly - midweek and 
weekend. These messages will be drawn from the health education topic for that month. We will purchase 
two phones, one for Jinja and another for Kampala Research Assistants for monitoring and clarifying any 
queries related to the messages. To ensure accessibility, messages will be sent to participants’ preferred 

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contacts, including household members, adolescents, or neighbours, accommodating those with limited 
technology access. Additionally, participants can call the designated study line as needed. To foster 
community interaction, participating villages will be encouraged to create WhatsApp groups for sharing 
experiences, information, and coordinating study activities, although this is not a mandatory intervention 
component. This multifaceted approach will ensure consistent communication, promote health awareness, 
and re-enforce the education by VHTs. 
 
Table 1: Summary of the Intervention component and processes 
Component 
Description 
Frequency 
Duration 
Person 
Responsible 
Materials/Tools 
Goals 
1. Monthly 
Home Visits 
VHT & peer 
champion 
visits for 
education, 
Anthropomet
ric 
measurement
s and 
planning/goal 
setting 
Twice 
monthly 
(first 
month), 
then 
monthly 
(2nd Month 
to 11th 
Month) 
45-90 
minutes 
VHT Members, 
Peer Champions 
VHT Registers, 
Education 
Materials, 
Weighing 
Scales, Blood 
Pressure 
Machines, 
review diet and 
physical activity 
plans 
Promote 
healthy 
lifestyles 
Develop 
healthy 
menu 
2. Physical 
Activity 
Participation 
in physical 
activities of 
their choice 
Adolescents: 
60-minute 
daily exercise; 
Adults: 30-60 
minutes, 3-5 
times/week 
recommen
ded daily 
Between 
30 -60 
minutes  
Peer Champions, 
VHT Members to 
support 
participants 
identify 
enjoyable 
physical activity 
(PA) activity and 
develop a PA 
plan 
Physical Activity 
Diaries and 
education 
materials 
Reduce 
NCD risk 
factors 
3. Diet 
Modification 
Health Diet 
education,  
food 
demonstratio
ns, kitchen 
garden setup 
Monthly 
education 
Quarterly 
demonstra
tions 
45-90 
minutes 
VHT Members, 
Peer Champions 
Nutrition 
Charts/Posters, 
Food dairies and 
food 
Demonstration 
Kits, Kitchen 
Garden Guides, 
Reduce 
NCD risk 
factors 
4. Phone 
Reminders 
SMS 
(twice/week: 
Wed, Sat) and 
WhatsApp 
(once/week: 
Sun) for 
engagement, 
health literacy 
Twice a 
week 
-- 
Study Team 
Mobile phones, 
SMS/WhatsApp 
software 
Leverag
e 
existing 
VHT 
network 
 

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6.7. Outcomes 
The outcomes include; the effectiveness and implementation science outcomes. 
6.7.1 Primary effectiveness outcomes: 
 The primary effectiveness outcome of the study is the Ideal Cardiovascular Health (ICH) using the American 
Heart Association (AHA) Life’s Simple 7 metrics smoking status, body mass index (BMI), physical activity, 
Blood pressure, fasting blood glucose, cholesterol, and diet. The study seeks to establish the proportion of 
adolescents and their family members meeting at least five ICH metrics, to enhance the overall ICH score, 
and to reduce the proportion of individuals exhibiting poor cardiovascular health metrics after 12 months of 
study intervention. These metrics will be classified into three categories: ideal (5-7 metrics met), 
intermediate (3-4 metrics met), and poor (0-2 metrics met). This classification will provide a clear 
understanding of the FaCe-D intervention's impact on cardiovascular health, based on seven key 
components: Each of these metrics will be assessed and scored based on a previous study by Pahkala-et-al-
2013 as shown in table 2: 
 
Table 2 Definition of Ideal Cardiovascular Health Metrics (<20 Years of Age) as Defined by the American 
Heart Association  
 
6.7.2. Overall Scoring and the Cardiovascular Health Categorization 
To create the Life Simple 7 score, a value of 1 will be assigned for each metric if the criterion was met as per 
table. The total score for an individual can range from 0 to 7 points. A score of 5-7 points will be considered 
ideal cardiovascular health, and a score of <5 points will be considered not Ideal health. With moderate 
cardiovascular health (3-4 points) and poor cardiovascular health (0-2 points). Therefore, the main outcome 
(ideal cardiovascular health) will be a binary variable coded 1 for a score of 5-7 points representing ideal 
health, and 0 for a score of less than 5 points representing non-ideal health.  
 
6.7.3 Secondary effectiveness outcomes 
These will include anxiety scores, depression scores and sleep quality among adolescents. Screening for 
anxiety and depression among adolescents aged 10-17 years will be conducted using the Mini International 
Neuropsychiatric Interview for Children and Adolescents version 7.0.2 (MINI-KID 7.0.2). The MINI-KID 7.0.2 
is a structured diagnostic interview designed to assess the presence of 24 DSM-V child and adolescent 
psychiatric disorders as well as the risk of suicide. The MINI-KID is proven to generate reliable and valid 

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psychiatric diagnoses for children and adolescents. For this study, we will utilize the anxiety and depression 
modules. Sleep quality will be measured using the single item sleep quality scale (SQS) by Snyder et al (2018). 
The SQS has favorable measurement characteristics compared to lengthier more frequently administered 
sleep questionnaires like the Pittsburg Sleep Quality Index (PSQI) The single items SQS is very easy to 
administer and has been validated and widely used in different population. Participants will be asked to 
report on their sleep quality over a 7-day recall period, taking into consideration core components of sleep 
quality such as number of hours slept, the ease of falling asleep, and frequency of waking up during the night 
(except to go to the bathroom). The SQS is assessed on a 10-point visual analog scale (0 = terrible and 
10 = excellent), with higher scores indicating better sleep quality. The total score will be interpreted as 
follows: 0 = terrible, 1–3 = poor, 4–6 = fair, 7–9 = good, and 10 = excellent. 
6.7.4 Implementation science outcomes  
The data collection and analysis for these outcomes will be guided by the Reach, Effectiveness, 
Implementation, Adoption and Maintenance (RE-AIM) framework (Glasgow et al., 2019). Reach is the 
proportion of persons who participate in the intervention, effectiveness is about the effect of the 
intervention. Adoption refers to what extent the participants and other stakeholders take up the 
intervention, implementation refers to what extent the intervention is delivered as planned, and 
maintenance is about sustainability. 
 
1. Reach: How many family members attended the health education talk provided by the VHT? How many 
family members increased their engagement in physical activity? How many households changed diet – 
reduced salt consumption?   
2. Effectiveness: Did CVD risk behaviours decrease among adolescents and their families, and which 
components accounted for reduced risk? Did the intervention reduce BMI among adolescents and family 
members with abnormal BMI? Did the intervention reduce BMI among adolescents and family members 
with abnormal BMI? Did BP among adolescents and family members with elevated BP or hypertension 
improve? 
3.  Adoption: How many family members participated in FCA activities? How many family members 
attended the health education talk provided by the VHT? How many family members participated in our 
recommended level of exercise? How many family members followed our dietary recommendation?  Did 
the number of household members reach FCA expectations? How many of the VHTs and peer champions 
participated implemented the intervention.  
4. Implementation: Was the intervention implemented with fidelity? Were appropriate intervention 
components offered to adolescents and families?  How many of the 13 VHT visits were conducted? 
How many of the recommended topics for discussion were done by the VHT. What are the reasons 
to explain why intervention components was or was not implemented according to plan? 
5. Maintenance: How well was the intervention absorbed into the routine practices of adolescents 
and families? What are the barriers and facilitators to maintaining the intervention after the study? 
What are the barriers and facilitators for scaling the intervention up to the national level? What 
systems have been put in place to ensure maintenance. 
The data for evaluating implementation science outcomes will be collected both quantitatively and 
qualitatively from all participating adolescents in the household who will have been reached by the 
intervention, household heads and food preparers. We will purposively sample boys and girls, and women 
and men of different ages. The participants will have participated in the intervention for at least 6 months. 
Recruitment of adolescents and their families will be supported by the VHTs (trained on the intervention) 
and local leaders. Representatives from policy makers and local government district level in health 
departments, non-government organisations, community leaders will be identified and invited to participate 
as key informants. 

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6.8. Study Duration and Data Collection 
The overall duration of the study is five years, with the implementation and evaluation phase lasting 
approximately two years. The demographic data will be collected at baseline (month 0), while the rest of the 
data on Life’s simple 7 metrics will be collected at baseline, month 6, month 12 (end of effectiveness phase) 
and month 18 (end of maintenance phase). In this phase, study field workers (with a medical background 
supported by a social science research scientist) will collect data using the study tools while the VHTs will 
continue to use a modified Ministry of Health (MoH) register (see VHT modified register appendix 5) to 
collect data during the monthly visits to the families/households. The data from the modified VHT register 
will be extracted using the data abstraction tool. The data on anxiety, depression and sleep quality among 
adolescents will be collected at baseline, 6 and12 months.  
 
The study timeline is illustrated in Table 1. 
Table 1: FaCe-D Study schedule 
 
6.9. Training   
Training of study teams, Village Health Teams (VHTs), peer champions, and other healthcare providers is 
crucial for effective implementation. 
 
6.8.1. Training of study teams  
All study staff will undergo a five-day protocol training, covering data collection tools and research ethics. 
They will also be training on how to carry out the testing for blood sugar and cholesterol using the point of 
care machines. 
 
6.9.2 Training of VHTs, peer champions and health facility workers   
All VHTs will receive refresher training using the current VHT training curriculum provided by the MoH, as 
well as training on completing the modified MoH village register, which includes measurement of weight, 
physical activities, and blood pressure. Training sessions will utilize visual aids and local language to ensure 
effective communication and sharing culturally adapted examples, making healthy eating more relatable and 
achievable.  
 
-3 
Implementation and evaluation phase 
TIMEPOINT (Month) 
0 
3 
6 
9 
12 
15 
18 
21 
24 
 
 
Effectiveness phase 
Maintenance 
Closure 
Protocol training, VHT training, SOP 
development and household mapping 
X 
 
 
 
Inform consent 
 
X 
 
 
INTERVENTION 
 
 
 
 
 
 
 
 
 
 
16 clusters (Intervention) 
 
 
 
 
 
 
 
 
 
 
16 clusters (Wait list)  
 
 
 
 
 
 
 
 
 
 
DATA type/tool: 
 
 
 
 
 
 
 
 
 
 
Screening tool 
 
X 
 
 
 
 
 
 
 
 
Demographic and Medical History 
 
X 
 
 
 
 
 
 
 
 
FaCe-D CVH (Life Simple 7) 
 
X 
 
X 
 
X 
 
X 
 
 
Anxiety, depression screen (MINI KID) 
and sleep quality (SQS tool)  
 
X 
 
X 
 
X 
 
 
 
 
Food diary data abstraction 
 
X 
X 
X 
X 
X 
X 
X 
 
 
Physical activity diary data abstraction 
 
X 
X 
X 
X 
X 
X 
X 
 
 
FFQ 
 
X 
X 
X 
X 
X 
X 
X 
 
 
PROCESS EVALUATION (KIIs and FGDs) 
 
 
 
X 
 
X 
 
X 
 
 
Costing data/Health economics data 
 
X 
 
X 
 
X 
 
X 
 
 

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Peer champions, selected from among the adolescents in the participating households will undergo training 
similar to VHTs. However, their role will be distinct, serving as bridges between fellow adolescents and VHTs, 
complementing but not duplicating VHT responsibilities. This targeted training will enable peer champions 
to effectively support their peers. 
 
Health facility staff will receive refresher training on NCD prevention, management, and CVD risk 
assessment. By equipping study teams, VHTs, peer champions, and healthcare providers with the necessary 
skills and knowledge, this comprehensive training will facilitate effective implementation and ensure the 
success of the study. 
 
6.9.3 VHT Monitoring and Supervision: 
 Effective monitoring and supervision will ensure VHT motivation, standardization, and accountability. 
Activities will occur at multiple levels: Peer-to-peer, VHT Coordinators, Community Advisory Board (CAB) 
members, designated health workers, district or ministry representatives, and study team representatives. 
VHTs will present a report to the study staff at the health facility every two weeks and during this visit she/he 
will meet with both the study staff and designated health worker in-charge of VHTs to review performance 
and completeness of data.  A monitoring and supervision checklist (Appendix 6) and data quality framework 
will aid these activities. The study team will conduct direct observation using checklists, monthly review 
meetings, random checks, field incident and referral tracking, and GIS location and timestamps (where 
possible). 
 
6.9.4 VHT Facilitation and Support: 
 Each VHT will receive a monthly facilitation of 80,000 Uganda Shillings, issued in two instalments (40,000 
Uganda Shillings) upon presentation of the VHT register with records/evidence of visits conducted and 
signing an accountability form. Additionally, VHTs will receive: An Umbrella, Bag, T-shirt for identification, 
Equipment and tools, including Food charts, Handbook, VHT register, Notebooks and pens, weighing scale, 
Stadiometer and Blood pressure machine, these provisions will support VHTs in their critical role in the FaCe-
D study and will be left with the VHTs after the study end after discussion with the ministry of health team.  
The peer champions will receive a total facilitation and transport of 40,000 Uganda shillings issued in one 
instalment upon presentation of a Home visit report to the health facility once a month. 
 
7.0 Statistical Analysis 
Data on baseline characteristics of the study participants will be analysed using descriptive summary 
statistics including mean (standard deviation) and median (interquartile range) for the continuous variables, 
and frequencies and percentages for the categorical variables. The intervention effect on cardiovascular 
disease risk outcomes among the study adolescents will be determined using mixed-effects regression 
model. The model will be used to account for within cluster variations. The model is illustrated below. 
 
𝐸(𝜃𝑗𝑘) = 𝛼+ 𝛽𝑋𝑗𝑘+ 𝜇𝑗 
 
Where j is a cluster (1 to 32), k is an individual, θ is the expected outcome (e.g., ideal cardiovascular health), 
α is the outcome in the control group, β is the intervention effect, X_jk is an indicator for whether individual 
k is the in cluster j receiving the intervention, μ_j is a random effect for cluster j. The above model can be 
naturally extended to accommodate all types of outcomes by replacing the expected outcome E(θ_jk) with 
E(μ_jk ) for a mean (continuous) outcome, log(λ_jk) for rate (count) outcome, and logit(π_jk) for proportion 
(binary) outcome (e.g., ideal cardiovascular health).  The baseline measures of the outcomes will be included 
a priori in the model to adjust for their effects. Additional covariates (potential confounders) will include 
participants individual level factors (like age, sex, education and others) and household level factors (like 
head of household age, sex, educations and others). Intervention effect will be measured using Odds ratio 

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(OR) for binary outcomes (the main outcome, ideal cardiovascular health), mean difference (MD) for 
continuous outcomes, and incidence rate ratio (IRR) for count outcomes. All these measures of the 
intervention effect will be presented with 95 % confidence interval (CI). Wald test p-value will also be 
reported to indicate the strength of evidence for the intervention effect. In addition, intra-cluster correlation 
(ICC) will be estimated. 
 
8.0 Process evaluation of the FaCe-D study   
Our team will evaluate the process of implementing the FaCe-D study intervention based on the grounds of 
a broad social behavioral approach to support adolescents and their families’ engagements and capacity 
building for healthy lifestyles and diet literacy. We will place the needs, experiences, attitudes and 
perspectives of the adolescents and their families at the center of the implementation and process 
evaluation of the intervention as well as investigate participants’ motivations and decision-making processes 
related to preferences and needs of adolescents and their families to engage in health literacy, lifestyle and 
behavioral change.   
 
The findings from the process evaluation will enhance the social construction and acceptability of the FaCe-
D intervention, link outcomes to policy and advocacy, and impact on sustainability of CVD health (Amuyunzu-
Nyamongo, 2010). The process evaluation will also provide an opportunity to document the implementation 
process and make recommendations to refine the delivery procedures and the FCA intervention(Moore et 
al., 2015). 
 
 A qualitative approach will underpin the collection of social behavioral information in two chosen districts 
(Kampala and Jinja) in Uganda. We seek to understand the importance of context, especially when 
comparing rural (Jinja) and urban (Kampala) areas in Uganda.  We will yield an in-depth socio-cultural 
understanding of adolescents and their families on reported outcomes, their motivations, preferences, 
needs, beliefs, expectations, identities, hopes, views on feeding habits, physical activities, and decision-
making processes in order to better understand stakeholder (adolescents and their families, 
VHTs/healthcare provider, policy maker, community leader) positioning during implementation of the FaCe-
D intervention; so as to inform policy and practice, ensure effective service user education, position service 
users and their families to understand the intervention, and interpret study outcomes, and facilitate its 
further implementation(Maher & Sekajugo, 2011).   
 
8.1. The aim of the process evaluation 
The aim is to investigate the contextual and process factors that influence the reach, adoption, 
appropriateness, effectiveness, fidelity, acceptability, scalability (uptake) and sustainability of FaCe-D 
intervention for improving the cardiovascular health among adolescents and their families in Uganda.  
 
8.2. Research questions guiding the process evaluation 
1. What are the perceptions and experiences of participants (adolescents, parents and community 
members), health care providers and policy makers on the FaCe-D intervention for improvement 
of CVD health among adolescents and their families? 
2. What are the barriers and facilitators to implementation of the FaCe-D intervention?  
3. What are the barriers and facilitators to acceptability and sustainability of the FaCe-D intervention 
for improvement of CVD health among adolescents and their families? 
4. What are the factors that can potentially influence the scaling up of the FaCe-D intervention for 
improvement of CVD health among adolescents and their families in Uganda? 

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5. how has the FaCe-D intervention helped improve the literacy, lifestyle and behavioural change 
among adolescents and their families and communities in Uganda? 
6. What can be done to enable acceptability/uptake of the FCA intervention by adolescents and their 
families in Uganda? 
 
8.3. The specific objectives of the process evaluation  
1. To explore the perceptions and experiences of participants (adolescents, household members and 
community members), health care providers and policymakers on the FaCe-D intervention for 
improvement of CVD health among adolescents and their families.  
2. To explore the contextual and process factors (barriers and facilitators) for acceptability and scale-
up of the FaCe-D intervention at the family and community level.  
3. To evaluate and appraise the procedures followed during implementation of the FaCe-D intervention 
to improve CVD health among adolescents in their communities.  
4. To determine the feasibility for the adoption of FaCe-D intervention and its scale-up.  
5. To recommend healthy lifestyles, behaviours, feeding practices and physical activities preferred and 
adopted by adolescents and their families in context of cultural beliefs, values, attitudes and practices 
of the community.  
 
8.4. The outcomes of process evaluation  
Widely, process evaluations are used to assess fidelity and quality of implementation, clarify causal 
mechanisms and identify contextual factors associated with variation in outcomes (Van Hout et al., 2020). 
The process evaluation in FaCe-D study is therefore focused on identifying the contextual factors that affect, 
adoption, fidelity, maintenance and effectiveness of the FaCe-D as an intervention. This synergistic approach 
to evaluate, understand and respond will support the FaCe-D intervention to inform surveillance, policy and 
practice development, and efforts to involve and educate family members and communities on matters that 
reduce the risks of CVD among the children in Uganda. 
 
8.5. Methods and design for the process evaluation 
8.5.1 study design  
This study will adopt a behavioral social science-qualitative research design (Djamba & Neuman, 2002). We 
will understand  how and why our efforts to implement FCA  may succeed or fail, and how patients and 
providers experience and make decisions to participate or not, in our intervention (Bokhour et al., 2018). 
Therefore, key questions on attitudes, how our intervention can be implemented, its effectiveness, and 
adoption at different sites will be explored using this design. Therefore, at the end, we will be able to  reveal 
organizational and interpersonal dynamics affecting the intervention; explaining practice change; discerning 
barriers and facilitators to uptake of the intervention; identifying what strategies are being used to foster 
organizational change, how successful they are perceived to be, and how they make a difference; and in 
identifying 
contextual 
factors 
and 
provider 
perceptions 
that 
affect 
implementation 
and 
sustainability(Morgan & Harmon, 2001). 
 
8.5.2 Study Population 
 The study population for the process evaluation will include adolescents, household heads, parents/care 
takers), food preparers community members and leaders, policy makers, local government and VHT/ peer 
champions. The primary food preparer will be determined through discussion with the members who will 
identify the person who prepares most meals. Only one primary food preparer per household will be 
included in the study, provided they meet the inclusion criteria and can consent to participate 
 

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8.5.3 Data Collection for the process evaluation 
Data collection will explore the experiences, perceptions, attitudes, and practices of a wide variety of 
stakeholders during the process of FaCe-D intervention implementation to develop an understanding of the 
impact of broader structural and contextual factors on the implementation process.  Data shall be collected 
using focus group discussions among adolescents and their families (care takers)/community members, key 
informant interviews with community leaders, policy makers, ministerial/local government and VHTs. These 
will be selected using the purposive sampling methods.  
 
Observations shall be made on the procedures followed and activities done before, during and after health 
education sessions. Daily activities including preferred physical activities and feeding practices will be 
recorded by adolescents and these shall be retrieved and reviewed by the VHT every week. This will help to 
assess fidelity and self-efficacy in the context of the intervention, assess the barriers and facilitators and 
recommendations to improve the intervention adaptation process (Lessard et al., 2016). Socio-behavioural 
qualitative data will be collected by a team of trained Social Scientist Researchers. The data 
collection/interviews will continue until data saturation is reached. The intervention will take into 
consideration the age, gender and other socio-demographic characteristics of the participants before 
engaging them in physical activities.  We will collect data at three time-points. That is; at baseline within the 
first month of joining the intervention to collect data on the perceptions and attitude of the participants, at 
midline (6 months) in the intervention in order to collect data of the experiences including challenges and 
achievements/benefits that are attributable to our intervention, and to learn from their experiences to 
improve the delivery of the intervention. Also, we shall conduct exit interviews with patients as end line data 
collection with the aim of gathering information for scalability of our intervention. 
Table 3 below summarises the data collection techniques that will be used for the study.  
 
Table 3: Process evaluation Objectives and outcomes 
 
Factors affecting Fidelity as key evaluation outcome at baseline  (within 3 month of implementing the 
intervention), (12 months and 18 months 
Objective  
Key questions  
Methods to be used  
Population and sampling  
-To evaluate and appraise 
the procedures followed 
during the implementation 
of the FaCe-D intervention 
to improve CVD health 
among adolescents in their 
communities.  
-What are the barriers and 
facilitators 
to 
implementation fidelity of 
the FaCe-D intervention? 
 
8 Field observations  
 
 
4-10 Key informant 
interviews (KIIs) 
6-12 
Focus 
group 
discussions (FGDs) 
VHT home visits  and education 
sessions on physical activities, 
food preparation. Family and 
community 
members’ 
involvement 
in 
FaCe-D 
intervention.  
Health 
care 
providers, 
Local/community 
leaders, 
VHTs 
and 
District 
Health 
Teams.  
Adolescents, family members 
and community members 
Factors affecting adoption as a key evaluation outcome at baseline (3 months of joining the intervention) and end 
line (12 months) 
-To explore the barriers and 
facilitators 
for 
acceptability/uptake of the 
- 
What 
enables 
acceptability/ uptake of the 
FCA 
intervention 
by 
4-10 Key informant 
interviews (KIIs) 
With health care providers, 
Local/community 
leaders, 

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FCA intervention at the 
family, 
community 
and 
health provider level.  
 
adolescents 
and 
their 
families ? 
 
6-12 
Focus 
Group 
Discussions 
VHTs 
and 
District 
Health 
Teams.  
Adolescents, family members, 
community 
members 
and 
VHTs and peer champions 
Maintenance as a key evaluation outcome at (12 months ad 18 months 
-To explore the contextual 
and 
process 
factors 
(barriers and facilitators) 
for scaling-up of the FaCe-D 
intervention 
at 
the 
adolescent.family, 
community, 
health 
provider 
and 
national 
levels?  
- What are the barriers and 
facilitators to maintaining 
the intervention in families 
and communities?  
-What are the barriers and 
facilitators to scaling the 
intervention up to the 
community and national 
levels? 
4-10 Key informant 
interviews  
 
6-12 
Focus 
Group 
Discussions (FGDs) 
With health care providers, 
Local/community 
leaders, 
VHTs 
and 
District 
Health 
Teams.  
 
Adolescents, family members 
and community members 
Effectiveness as a key evaluation outcome at midline (6 months) and end line (12 months) 
-To establish if there has 
been improvement in the 
the diet and health lifestyle 
literacy among adolescents 
and their families  
- 
Can 
the 
FaCe-D 
intervention help improve 
the diet and health lifestyle 
literacy, among adolescents 
and their families 
4-10 Key informant 
interviews (KIIs) 
6-12 
Focus 
group 
discussions (FGDs) 
Local, Ministerial policy makers 
and District Health Teams  
Adolescents, family members 
and community members 
-To explore the perceptions 
and 
experiences 
of 
participants on the FCA 
intervention improvement 
of 
CVD 
health 
among 
adolescents 
and 
their 
families.  
-What are the perceptions 
and 
experiences 
of 
participants on the FCA 
intervention for the CVD 
health among adolescents 
and their families? 
6-12 
Focus 
group 
discussions (FGDs) 
 
4-10 Key informant 
interviews (KIIs) 
Adolescents, family members 
and community members 
with Local, Ministerial policy 
makers and District Health 
Teams  
 
8.5.4. Data Management and analysis  
Field notes from study procedure observations will be analysed thematically to provide a description of 
process and content involved in adapting and delivering the intervention. Recordings from the dairies will 
be interpreted and discussed with the participants and these shall be used to inform other steps to improve 
the uptake of the intervention. Audio recordings of interviews and FGDs will be transcribed verbatim by 
competent and experienced social scientists. Translation from the local language into English and back 
translation will be done in cases where interviews are conducted in local languages. An electronic data 
management package (NVivo 14) will be used to manage the data and a thematic approach shall be used to 
analyze the data (Zamawe, 2015). The research team will take time to read the texts several times to identify 
the themes and emergent subthemes. The data shall be coded under respective themes and subthemes. The 
RE-AIM Framework will, therefore, guide the evaluation of the process basing on the identified barriers and 
facilitators to the adoption, acceptability, feasibility, fidelity effectiveness and sustainability of the FCA 
intervention at individual, interpersonal, community and structural levels.  
 
8.6 Credibility and transferability 
Our proposal to conduct the process evaluation considers research ethics. The credibility and reliability of 
our data will be anchored in the ability to triangulate our data. Triangulation will occur across methods (focus 
group discussions, key informant and in-depth interviews, observations and activity dairies). In addition, our 

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process evaluation data will be analysed in comparison with clinical/effectiveness outcomes data and health 
economics analysis which will collectively inform scalability and transferability to other community settings.  
 
9.0 Economic evaluation  
A trial-based cost-effectiveness analysis will be conducted to establish the incremental costs, incremental 
benefit and the incremental cost-effectiveness ratio (ICER) for using the FaCe-D intervention for prevention 
of cardiovascular diseases among adolescents and their families. A societal perspective which includes costs 
to healthcare payer, patients and their household will be adopted to capture the broader impact of the 
intervention. The purpose of this evaluation is to assist decision-makers in determining whether the 
implementation of FaCe-D intervention, as demonstrated in this trial would be cost-effective if implemented 
on a routine basis. The analysis will follow the Consolidated Health Evaluation Reporting Standards (CHEERS) 
statement, for reporting economic evaluation studies to inform health policy. 
 
9.1. Cost estimation and analysis 
A three-stage approach will be followed to determine the total and unit cost estimates, based on the study 
trial design. The first stage will include identification of incremental resources used during the study 
implementation. Relevant cost categories and cost centres such as start-up versus recurrent costs, direct 
versus indirect costs, personnel, training and travel costs will be used to classify resources used during study 
implementation. Costs will further be identified and categorised by perspective. The next stages will involve 
quantification and valuation of incremental resources used during the study implementation. In order to 
capture the full value of the alternatives, we shall further categorize costs into financial and economic costs. 
Financial costs are monetary outlays paid out for acquisition or implementation of the alternatives, while 
economic costs will comprise the value of services and inputs regardless of the sources of funding and take 
into account the value of donated goods. For fixed costs such as building equipment.  A top-down approach 
will be employed to allocate shared costs to the intervention using allocation proxies.  
 
To determine the resources associated with the healthcare payer for implementing the intervention, 
information will be gathered from project financial records and through interviews with the program 
financial managers and project team. The data collection will be conducted prospectively throughout the 
study implementation period. Intervention costs will be carefully assessed and separated cost related 
research. Given a broader perspective, participant and household related costs will be collected separately 
in this study. A household level economic questionnaire will be used prospectively alongside other study 
case report forms. The questionnaire will focus on the direct and indirect costs associated with three 
components of the study intervention such as health diet, physical activity and regular screening. Direct costs 
include direct expenditure on food items, physical activities and regular screening for CVD following the 
intervention. Indirect costs will be determining the amount of time caregivers or parents spending in 
supporting their adolescents in the three main intervention areas. The valuation of time used will assume 
that national minimum wage rates represent the alternative cost of the caregivers’ time. 
 
9.2 Measurement of cost effectiveness 
The outcome evaluation will be based on estimable primary outcomes of the main trial as approved by the 
research team. We shall consider additional generic effectiveness measures applied in economic evaluation 
such as Disability adjusted life years (DALYs) averted due to prevention of CVD. DALY is a generic 
effectiveness measure that would allow as compare our economic evaluation results with other 
interventions within the health sector. As much as possible, we shall use the main-trial parameters and 
available global burden of disease studies to compute the DALYs averted.  
 

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9.3 Cost-effectiveness analysis  
The final outcome of this evaluation will be incremental cost, incremental effectiveness and the incremental 
cost-effectiveness ratio (ICER) of the intervention. The estimated ICER will be compared against a 
recommended cost-effectiveness threshold by World Health Organization for in the low-middle income 
countries. For instance, the intervention will be deemed highly cost-effective if the ICER is less than one time 
the gross domestic product (GDP) per capita or, deemed cost-effective if the ICER is between one and three 
times the GDP per capita of Uganda.  All costs will be adjusted to a stable year dollar price. A selected 
discount rate will be used to value the present value of future resources to be used in the implementation 
of the intervention. Sensitivity analyses will be conducted to check the impact of parameter uncertainty on 
the results. Parameters will be varied based on selected ranges. One-way sensitivity analysis will be 
performed on all parameter inputs to generate Tornado plots representing the most influencing parameters. 
While probabilistic sensitivity analyses will be performed using monte Carlo simulation to generate cost-
effectiveness acceptability curves and portray the robustness of the model.  All modelling will be performed 
using a Microsoft-excel based decision analytical model and were possible TreeAge software will be used for 
probabilistic sensitivity analyses.   
 
10.0 IS Logic model 
 
Willingness of families & 
adolescents to integrate 
physical activity and diet 
modification into their 
daily lives and record 

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10.1 Implementation strategies 
With reference to the logic model of implementation of FaCe-D study, the implementation strategies will 
include the stakeholder engagement, training of the village health teams and peer champions, development 
and distribution of health education materials, participants’ handbooks, food and physical activity dairies. 
We will also work with the ministry of health teams in the department of community and non-communicable 
disease to monitor and supervise the VHTs through fostering communication and improved coordination 
and strengthening referral and linkages while drawing on the resources within the community. 
 
11.0 Governance and Ethics 
Compliance: The study will be subject to research ethics oversight from the Uganda Virus Research Institute 
Research Ethics Committee. Uganda National Council of Science and Technology (UNCST) and the University 
of British Columbia Behavioural Research Ethics Board. Ethical considerations: We will conduct the research 
by the principles of Good Clinical Practice and LSHTM research governance and integrity guidelines. 
(https://www.lshtm.ac.uk/research/research-governance-integrity). The study will be conducted with a 
team of qualified professionals who possess the necessary knowledge and skills including training in Human 
subject’s protection.  
 
Informed Consent: All study participants including adolescents and their family members will be provided 
with adequate information to fully understand the purpose, procedures, potential benefits, and risks 
associated with participating in the study. Written informed consent /assent will be obtained from both the 
adolescents and their parents or legal guardians, while respecting their autonomy and ensuring their 
comprehension of the intervention. Participants will be free to decline to join the study or to withdraw at 
any time.  Parental/guardian consent will be obtained from all adolescents aged 10-17 years followed by 
their individual assent. Adolescents for whom parental/guardian consent cannot be obtained will be 
excluded for the study. All interviews and informed consent procedures will be conducted in the local 
languages understood by the participants to ensue comprehension of the study. 
 
Privacy and confidentiality:  All data collected will be treated with confidentially. Data including identifying 
information such as the consent and assent forms will be stored in secure cabins under lock and key. 
Computer databases will be encrypted, and data will be anonymized and stored without participant 
identifiers in accordance with Good Clinical Practice. Data will be stored at MRC/UVR & LSHTM – Uganda 
research unit but will be accessible to all partners. There will be no need to transfer data so no need for data 
transfer agreement. 
 
12.0 Safeguarding 
We are committed to safeguarding the welfare of minors and vulnerable adults during project 
implementation. Our protocol will follow key principles: empowerment, prevention, proportionality, 
protection, partnership, and accountability, ensuring the safety of beneficiaries, stakeholders, and staff. 
The project management team, led by Dr. Ivan Namakoola as the safeguarding officer, will oversee 
compliance. A trained safeguarding focal person will be appointed at each project site. 
All staff will be informed about the protocol, and copies will be shared with relevant stakeholders. Personal 
and sensitive data will be securely collected and stored, with an annual review to ensure compliance with 
any operational developments. 
13.0. Dissemination plan  
We will disseminate the results at parish (group of villages that were involved in the study), at the district 
level and to the technical working groups at the ministry of health through their routine meetings. We will 
however arrange a meeting bringing together different stakeholders to share the results and hear their 

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feedback and next steps. Dr. Birungi, Dr. Muddu and Dr. Ouma have organized several meetings to 
disseminate results to policymakers at the Ministry of Health and other relevant Ministries, and some of this 
effort has resulted into policy shift. In recent years, study team members have disseminated research 
findings in top journals (e.g., Lancet, Lancet Global Health, AIDS and Behavior, JAIDS, and PLOS Medicine). 
Study team members have collectively published over 100 peer-reviewed journal articles in the past five 
years, and have given presentations at universities, research conferences such as at the meetings of the 
International AIDS Society, and research seminars and workshops. The team have experience disseminating 
research findings through academic publications. Lastly, our primary dissemination strategy will be to 
produce multiple peer-reviewed publications (which will also be posted and freely available on institutions’ 
websites) and conference presentations. 
 
Figure 2: FaCe-D implementation districts 
 
 
References 
AGABA D, & MUHUMUZA, A. Knowledge and Practices of Adolescents about risk factors for Non-Communicable       
Diseases at Kabwohe Health Centre IV. Student’s Journal of Health Research Africa 2021; 2 (6). 
 
AKSEER N, MEHTA S, WIGLE J, et al. Non-communicable diseases among adolescents: current status, determinants, 
interventions and policies. BMC public health 2020; 20(1): 1908. 
AJAYI, I. O., ADEBAMOWO, C., ADAMI, H. O., DALAL, S., DIAMOND, M. B., BAJUNIRWE, F., GUWATUDDE, D., 
NJELEKELA, M., NANKYA-MUTYOBA, J., CHIWANGA, F. S., VOLMINK, J., KALYESUBULA, R., LAURENCE, C., 
REID, T. G., DOCKERY, D., HEMENWAY, D., SPIEGELMAN, D. & HOLMES, M. D. 2016. Urban-rural and 
geographic differences in overweight and obesity in four sub-Saharan African adult populations: a multi-
country cross-sectional study. BMC Public Health, 16, 1126. 
ALBERGA AS, SIGAL RJ, GOLDFIELD G, PRUD'HOMME D, KENNY GP. Overweight and obese teenagers: why is 
adolescence a critical period? Pediatr Obes. 2012 Aug;7(4):261-73. doi: 10.1111/j.2047-6310.2011.00046.x. 
Epub 2012 Mar 28. PMID: 22461384.  
AMUYUNZU-NYAMONGO M. Need for a multi-factorial, multi-sectorial and multi-disciplinary approach to NCD 
prevention and control in Africa. Global Health Promotion. 2010;17(2_suppl):31-32. 
doi:10.1177/1757975910363928 
ASSUNÇÃO AR, BOTTARO M, FERREIRA-JUNIOR JB, IZQUIERDO M, CADORE EL, GENTIL P (2016) The Chronic Effects of 
Low- and High-Intensity Resistance Training on Muscular Fitness in Adolescents. PLoS ONE 11(8): e0160650. 
doi:10.1371/journal.pone.0160650 
ARGYRIADIS Health promotion strategies for cardiovascular disease in the community of Uganda: Policies, 
challenges, and pathways to a healthier future  10.30574/ijsra.2023.10.1.0759 BAALWA, J., BYARUGABA, B. B., 

FaCe-D study  
Protocol version 4.0                                version dated 05 March 2025 
30 
 
KABAGAMBE, E. K., KABAGAMBE, K. E. & OTIM, A. M. 2010. Prevalence of overweight and obesity in young adults in 
Uganda. Afr Health Sci, 10, 367-73. 
BERENSON GS, SRINIVASAN SR, BAO W, NEWMAN WP, 3RD, TRACY RE, WATTIGNEY WA. Association between 
multiple cardiovascular risk factors and atherosclerosis in children and young adults. The Bogalusa Heart Study. N 
Engl J Med 1998; 338(23): 1650-6. 
 
BOATENG, D., WEKESAH, F., BROWNE, J. L., AGYEMANG, C., AGYEI-BAFFOUR, P., AIKINS, A. D., SMIT, H. A., GROBBEE, 
D. E. & KLIPSTEIN-GROBUSCH, K. 2017. Knowledge and awareness of and perception towards cardiovascular 
disease risk in sub-Saharan Africa: A systematic review. PLoS One, 12, e0189264. 
BOKHOUR BG, FIX GM, MUELLER NM, BARKER AM, LAVELA SL, HILL JN, SOLOMON JL, LUKAS CV. How can healthcare 
organizations implement patient-centered care? Examining a large-scale cultural transformation. BMC health 
services research. 2018 Dec;18:1-1. 
BORKOWSKI P, BORKOWSKA N (February 18, 2024) Understanding Mental Health Challenges in Cardiovascular Care. 
Cureus 16(2): e54402. doi:10.7759/cureus.54402  
BOTSFORD, C., BRELLENTHIN, A. G., CISLER, J. M., HILLARD, C. J., KOLTYN, K. F., & CROMBIE, K. M. (2023). Circulating 
endocannabinoids and psychological outcomes in women with PTSD. Journal of anxiety disorders, 93, 102656. 
https://doi.org/10.1016/j.janxdis.2022.102656 
CAMPBELL S, GREENWOOD M, PRIOR S, SHEARER T, WALKEM K, YOUNG S, BYWATERS D, WALKER K. Purposive 
sampling: complex or simple? Research case examples. J Res Nurs. 2020 Dec;25(8):652-661. doi: 
10.1177/1744987120927206. Epub 2020 Jun 18. PMID: 34394687; PMCID: PMC7932468. 
CASPERSEN, C. J., POWELL, K. E., & CHRISTENSON, G. M. (1985). Physical activity, exercise, and physical fitness: 
definitions and distinctions for health-related research. Public health reports (Washington, D.C. : 
1974), 100(2), 126–131. 
CLEMSON L, MACKENZIE L, ROBERTS C, POULOS R, TAN A, LOVARINI M, SHERRINGTON C, SIMPSON JM, WILLIS K, LAM 
M, TIEDEMANN A, POND D, PEIRIS D, HILMER S, PIT SW, HOWARD K, LOVITT L, WHITE F. Integrated solutions 
for sustainable fall prevention in primary care, the iSOLVE project: a type 2 hybrid effectiveness-
implementation design. Implement Sci. 2017 Feb 7;12(1):12. doi: 10.1186/s13012-016-0529-9. PMID: 
28173827; PMCID: PMC5296956. 
CROMBIE, K.M., SARTIN-TARM, A., SELLNOW, K., AHRENHOLTZ, R., LEE, S. MATALAMAKI, M., ADAMS, T.G., CISLER, 
J.M., Aerobic Exercise and Consolidation of Fear Extinction Learning among Women with Posttraumatic Stress 
Disorder, Behaviour Research and Therapy, https:// doi.org/10.1016/j.brat.2021.103867. 
CUENCA-GARCÍA M, ORTEGA FB, RUIZ JR, GONZÁLEZ-GROSS M, LABAYEN I, JAGO R, MARTÍNEZ-GÓMEZ D, 
DALLONGEVILLE J, BEL-SERRAT S, MARCOS A, MANIOS Y, BREIDENASSEL C, WIDHALM K, GOTTRAND F, 
FERRARI M, KAFATOS A, MOLNÁR D, MORENO LA, DE HENAUW S, CASTILLO MJ, SJÖSTRÖM M; HELENA Study 
Group. Combined influence of healthy diet and active lifestyle on cardiovascular disease risk factors in 
adolescents. Scand J Med Sci Sports. 2014 Jun;24(3):553-62. doi: 10.1111/sms.12022. Epub 2012 Dec 12. 
PMID: 23237548. 
CULLY JA, ARMENTO ME, MOTT J, NADORFF MR, NAIK AD, STANLEY MA, SOROCCO KH, KUNIK ME, PETERSEN NJ, 
KAUTH MR. Brief cognitive behavioral therapy in primary care: a hybrid type 2 patient-randomized 
effectiveness-implementation design. Implement Sci. 2012 Jul 11;7:64. doi: 10.1186/1748-5908-7-64. PMID: 
22784436; PMCID: PMC3503767. 
CURRAN, G. M., BAUER, M., MITTMAN, B., PYNE, J. M. & STETLER, C. 2012. Effectiveness-implementation hybrid 
designs: combining elements of clinical effectiveness and implementation research to enhance public health 
impact. Med Care, 50, 217-26. 
DAMSCHRODER LJ, ARON DC, KEITH RE, KIRSH SR, ALEXANDER JA, LOWERY JC. Fostering implementation of health 
services research findings into practice: a consolidated framework for advancing implementation science. Implement 
Sci 2009; 4: 50. 
DAMSCHRODER LJ, LOWERY JC. Evaluation of a large-scale weight management program using the consolidated 
framework for implementation research (CFIR). Implement Sci 2013; 8: 51. 
 
DJAMBA Y. K., & NEUMAN, WL (2002). Social Research Methods: Qualitative and Quantitative Approaches.;30. 

FaCe-D study  
Protocol version 4.0                                version dated 05 March 2025 
31 
 
DWEKAT, E., AL-AMER, R. M., AL-DARAAWI, H., & SALEH, M. Y. N. (2023). Prevalence and Correlates of Depression 
and Anxiety Among Jordanian Adolescents: A Cross-Sectional Study. Youth & Society, 55(1), 103-
121. https://doi.org/10.1177/0044118X211041383 
FIRTH, J., ROSENBAUM, S., STUBBS, B., GORCZYNSKI, P., YUNG, A. R., & VANCAMPFORT, D. (2016). Motivating factors 
and barriers towards exercise in severe mental illness: a systematic review and meta-analysis. Psychological 
medicine, 46(14), 2869–2881. https://doi.org/10.1017/S0033291716001732 
GAZIANO TA. Economic burden and the cost-effectiveness of treatment of cardiovascular diseases in Africa. Heart. 
2008 Feb;94(2):140-4. doi: 10.1136/hrt.2007.128785. PMID: 18195120.  
GLASGOW, R. E. & ESTABROOKS, P. E. 2018. Pragmatic Applications of RE-AIM for Health Care Initiatives in 
Community and Clinical Settings. Prev Chronic Dis, 15, E02. 
GLASGOW, R. E., HARDEN, S. M., GAGLIO, B., RABIN, B., SMITH, M. L., PORTER, G. C., ORY, M. G., & ESTABROOKS, P. 
A. (2019). RE-AIM Planning and Evaluation Framework: Adapting to New Science and Practice With a 20-Year 
Review. Frontiers in public health, 7, 64. https://doi.org/10.3389/fpubh.2019.00064 
GLOBAL NUTRITION REPORT, N.D. UGANDA: NUTRITION PROFILE. [online] Available at: 
<https://globalnutritionreport.org/resources/nutrition-profiles/africa/eastern-africa/uganda/> [Accessed 25 
Nov. 2024]. 
GRAJEK, M., KRUPA-KOTARA, K., BIAŁEK-DRATWA, A., SOBCZYK, K., GROT, M., KOWALSKI, O., & STAŚKIEWICZ, W. 
(2022). Nutrition and mental health: A review of current knowledge about the impact of diet on mental 
health. Frontiers in nutrition, 9, 943998. https://doi.org/10.3389/fnut.2022.943998 
GUWATUDDE, D., MUTUNGI, G., WESONGA, R., KAJJURA, R., KASULE, H., MUWONGE, J., SSENONO, V. & 
BAHENDEKA, S. K. 2015. The Epidemiology of Hypertension in Uganda: Findings from the National Non-
Communicable Diseases Risk Factor Survey. PLoS One, 10, e0138991. 
HONG YM. Atherosclerotic cardiovascular disease beginning in childhood. Korean Circ J 2010; 40(1): 1-9. 
 
 
KAAR, J.L., BOWEN, A.E., PANGELINAN, M.M., STUDTS, C.R., SHOMAKER, L.B., & SIMON, S.L. (2022). Abstract P097: 
The Missing Link In Current Prevention Strategies Focused On Reducing CVD Risk Among Youth: Youth's 
Mental Health. Circulation.  
KABWAMA SN, KIRUNDA B, MUTUNGI G, WESONGA R, BAHENDEKA SK, GUWATUDDE D. Prevalence and correlates 
of abdominal obesity among adults in Uganda: findings from a national cross-sectional, population based 
survey 2014. BMC Obes. 2018 Dec 3;5:40. doi: 10.1186/s40608-018-0217-1. PMID: 30524745; PMCID: 
PMC6276139.  
KANSIIME, S., MWESIGIRE, D. & MUGERWA, H. 2019. Prevalence of non-communicable diseases among HIV positive 
patients on antiretroviral therapy at joint clinical research centre, Lubowa, Uganda. PLoS One, 14, e0221022. 
KASTURIRATNE, A., KHAWAJA, K.I., AHMAD, S. et al. The iHealth-T2D study, prevention of type 2 diabetes amongst 
South Asians with central obesity and prediabetes: study protocol for a randomised controlled trial. Trials 22, 
928 (2021). https://doi.org/10.1186/s13063-021-05803-7  
KAVISHE, B., BIRARO, S., BAISLEY, K., VANOBBERGHEN, F., KAPIGA, S., MUNDERI, P., SMEETH, L., PECK, R., 
MGHAMBA, J., MUTUNGI, G., IKOONA, E., LEVIN, J., BOU MONCLUS, M. A., KATENDE, D., KISANGA, E., 
HAYES, R. & GROSSKURTH, H. 2015. High prevalence of hypertension and of risk factors for non-
communicable diseases (NCDs): a population based cross-sectional survey of NCDS and HIV infection in 
Northwestern Tanzania and Southern Uganda. BMC Med, 13, 126. 
KAZIBWE J, TRAN PB, ANNERSTEDT KS. The household financial burden of non-communicable diseases in low- and 
middle-income countries: a systematic review. Health Research Policy and Systems. 2021 Jun;19(1):96. DOI: 
10.1186/s12961-021-00732-y. PMID: 34154609; PMCID: PMC8215836. 
KIRUNDA, B. E., FADNES, L. T., WAMANI, H., VAN DEN BROECK, J. & TYLLESKAR, T. 2015. Population-based survey of 
overweight and obesity and the associated factors in peri-urban and rural Eastern Uganda. BMC Public 
Health, 15, 1168. 
KORCZAK DJ, CLEVERLEY K, BIRKEN CS, PIGNATIELLO T, MAHMUD FH, MCCRINDLE BW. Cardiovascular Disease Risk 
Factors Among Children and Adolescents With Depression. Front Psychiatry. 2021 Aug 13;12:702737. doi: 
10.3389/fpsyt.2021.702737. PMID: 34489758; PMCID: PMC8418089.  
KWARISIIMA, D., BALZER, L., HELLER, D., KOTWANI, P., CHAMIE, G., CLARK, T., AYIEKO, J., MWANGWA, F., JAIN, V., 
BYONANEBYE, D., PETERSEN, M., HAVLIR, D. & KAMYA, M. R. 2016. Population-Based Assessment of 

FaCe-D study  
Protocol version 4.0                                version dated 05 March 2025 
32 
 
Hypertension Epidemiology and Risk Factors among HIV-Positive and General Populations in Rural Uganda. 
PLoS One, 11, e0156309. 
LACHANCE L, RAMSEY D. Food, mood, and brain health: implications for the modern clinician. Mo Med. 2015 Mar-
Apr;112(2):111-5. PMID: 25958655; PMCID: PMC6170050. 
LESSARD L, RECHT B, PACKARD A. Analysis and design of optimization algorithms via integral quadratic constraints. 
SIAM Journal on Optimization. 2016;26(1):57-95. 
LLOYD-JONES DM, HONG Y, LABARTHE D, et al. Defining and setting national goals for cardiovascular health 
promotion and disease reduction: the American Heart Association's strategic Impact Goal through 2020 and beyond. 
Circulation 2010; 121(4): 586-613. 
 
LUND C, DOCRAT S, ABDULMALIK J, ALEM A, FEKADU A, GUREJE O, GURUNG D, HAILEMARIAM D, HAILEMICHAEL Y, 
HANLON C, JORDANS MJD, KIZZA D, NANDA S, OLAYIWOLA S, SHIDHAYE R, UPADHAYA N, THORNICROFT G, 
CHISHOLM D. Household economic costs associated with mental, neurological and substance use disorders: 
a cross-sectional survey in six low- and middle-income countries. BJPsych Open. 2019 Apr 8;5(3):e34. doi: 
10.1192/bjo.2019.20. PMID: 31530317; PMCID: PMC6469228 
LUNYERA, J., KIRENGA, B., STANIFER, J. W., KASOZI, S., VAN DER MOLEN, T., KATAGIRA, W., KAMYA, M. R. & 
KALYESUBULA, R. 2018. Geographic differences in the prevalence of hypertension in Uganda: Results of a 
national epidemiological study. PLoS One, 13, e0201001. 
MAHER, D., & SEKAJUGO, J. (2011). Research on health transition in Africa: time for action. Health research policy 
and systems, 9, 5. https://doi.org/10.1186/1478-4505-9-5 
MCCRINDLE. (2001). Cardiovascular risk factors in adolescents: relevance, detection, and intervention. Adolescent 
medicine, 12 1, 147-62 .  
MDEGE, N. D., MAN, M. S., TAYLOR NEE BROWN, C. A. & TORGERSON, D. J. 2011. Systematic review of stepped 
wedge cluster randomized trials shows that design is particularly used to evaluate interventions during 
routine implementation. J Clin Epidemiol, 64, 936-48 
MINISTRY OF HEALTH. Uganda Population-based HIV Impact Assessment (UPHIA) 2020. Kampala, Uganda; 2022 
 
MOORE, G. F., AUDREY, S., BARKER, M., BOND, L., BONELL, C., HARDEMAN, W., MOORE, L., O'CATHAIN, A., TINATI, 
T., WIGHT, D., & BAIRD, J. (2015). Process evaluation of complex interventions: Medical Research Council 
guidance. BMJ (Clinical research ed.), 350, h1258. https://doi.org/10.1136/bmj.h1258  
MORGAN GA, HARMON RJ. Data collection techniques. Journal-american academy of child and adolescent 
psychiatry. 2001 Aug 1;40(8):973-6. 
MORRIS ZS, WOODING S, GRANT J. The answer is 17 years, what is the question: understanding time lags in 
translational research. J R Soc Med 2011; 104(12): 510-20 
MUDDU M, SSINABULYA I, KIGOZI SP, et al. Hypertension care cascade at a large urban HIV clinic in Uganda: a mixed 
methods study using the Capability, Opportunity, Motivation for Behavior change (COM-B) model. 
Implement Sci Commun 2021; 2(1): 121. 
MUILWIJK M, LOH M, SIDDIQUI S, MAHMOOD S et al. Effects of a lifestyle intervention programme after 1 year of 
follow-up among South Asians at high risk of type 2 diabetes: a cluster randomised controlled trial. BMJ Glob 
Health. 2021 Nov;6(11):e006479. doi: 10.1136/bmjgh-2021-006479. PMID: 34725039; PMCID: PMC8562508. 
MUSESENGWA, R., CHIMBARI, M.J. & MUKARATIRWA, S. Initiating community engagement in an ecohealth research 
project in Southern Africa. Infect Dis Poverty 6, 22 (2017). https://doi.org/10.1186/s40249-016-0231-9. 
MUSINGUZI, G. & NUWAHA, F. 2013. Prevalence, awareness and control of hypertension in Uganda. PLoS One, 8, 
e62236.  
NAKABAZZI B, WACHIRA LM, OYEYEMI AL, SSENYONGA R, ONYWERA VO. Prevalence and socio-demographic 
correlates of accelerometer measured physical activity levels of school-going children in Kampala city, 
Uganda. PLoS One. 2020 Jul 9;15(7):e0235211. doi: 10.1371/journal.pone.0235211. PMID: 32645010; 
PMCID: PMC7347200. 
NATIONAL POPULATION COUNCIL. Population growth in Uganda: Challenges and Oppportunities. Kampala, Uganda; 
2021.  
 NEHA., JANAKIRAM, P. C. AND YENKANAIK, Y. B. . (2022) “Prevalence of Depression, Anxiety during Covid-19 
Pandemic among adolescents of Bangalore North- A Cross-Sectional Study”, International Journal of Medical 
Science and Clinical Research Studies , 2(12), pp. 1526–1534. doi: 10.47191/ijmscrs/v2-i12-30. 

FaCe-D study  
Protocol version 4.0                                version dated 05 March 2025 
33 
 
NDEJJO R, NUWAHA F, BASTIAENS H, WANYENZE RK, MUSINGUZI G. Cardiovascular disease prevention knowledge 
and associated factors among adults in Mukono and Buikwe districts in Uganda. BMC Public Health. 2020 Jul 
22;20(1):1151. doi: 10.1186/s12889-020-09264-6. PMID: 32698818; PMCID: PMC7374818.  
NDIRANGU-MUGO, E., SHUMBA, C.S., GATITI, P. ET AL. Interventions for Prevention of Non-Communicable Diseases 
among Adolescents Living with HIV: A Systematic Review. SN Compr. Clin. Med. 4, 118 (2022). 
https://doi.org/10.1007/s42399-022-01186-1  
NGARUIYA C, HAYWARD A, POST L, MOWAFI H. Obesity as a form of malnutrition: over-nutrition on the Uganda 
"malnutrition" agenda. Pan Afr Med J. 2017 Sep 20;28:49. doi: 10.11604/pamj.2017.28.49.11176. PMID: 
29184601; PMCID: PMC5697987. 
NSANYA, M. K., KAVISHE, B. B., KATENDE, D., MOSHA, N., HANSEN, C., NSUBUGA, R. N., MUNDERI, P., GROSSKURTH, 
H. & KAPIGA, S. 2019. Prevalence of high blood pressure and associated factors among adolescents and 
young people in Tanzania and Uganda. J Clin Hypertens (Greenwich), 21, 470-478. 
O'NEIL, A., QUIRK, S. E., HOUSDEN, S., BRENNAN, S. L., WILLIAMS, L. J., PASCO, J. A., BERK, M., & JACKA, F. N. (2014). 
Relationship between diet and mental health in children and adolescents: a systematic review. American 
journal of public health, 104(10), e31–e42. https://doi.org/10.2105/AJPH.2014.302110 
OSPINA-OSPINA, F.DELC., HINESTROSA-UPEGUI, M. F., PAREDES, M. C., GUZMÁN, Y., & GRANADOS, C. (2011). 
Síntomas de ansiedad y depresión en adolescentes escolarizados de 10 a 17 años en Chía, Colombia 
[Symptoms of anxiety and depression in adolescents between 10 to 17 year-old attending schools in Chía, 
Colombia]. Revista de salud publica (Bogota, Colombia), 13(6), 908–920. https://doi.org/10.1590/s0124-
00642011000600004 
PALINKAS LA, HORWITZ SM, GREEN CA, WISDOM JP, DUAN N, HOAGWOOD K. Purposeful Sampling for Qualitative 
Data Collection and Analysis in Mixed Method Implementation Research. Adm Policy Ment Health 2015; 42(5): 533-
44. 
 
PAHKALA, K., HIETALAMPI, et al (2013). Ideal cardiovascular health in adolescence: effect of lifestyle intervention 
and association with vascular intima-media thickness and elasticity (the Special Turku Coronary Risk Factor 
Intervention Project for Children [STRIP] study). Circulation, 127(21), 2088–2096. 
https://doi.org/10.1161/CIRCULATIONAHA.112.000761  
 
PERIARD D, TELENTI A, SUDRE P, ET AL. Atherogenic dyslipidemia in HIV-infected individuals treated with protease 
inhibitors. The Swiss HIV Cohort Study. Circulation 1999; 100(7): 700-5. 
RAESIDE R, PARTRIDGE SR, SINGLETON A, REDFERN J. Cardiovascular Disease Prevention in Adolescents: eHealth, Co-
Creation, and Advocacy. Med Sci (Basel). 2019 Feb 24;7(2):34. doi: 10.3390/medsci7020034. PMID: 
30813490; PMCID: PMC6410225.  
RODWIN BA, SPRUILL TM, LADAPO JA. Economics of psychosocial factors in patients with cardiovascular disease. 
Prog Cardiovasc Dis. 2013 May-Jun;55(6):563-73. doi: 10.1016/j.pcad.2013.03.006. Epub 2013 Apr 9. PMID: 
23621966. 
SARAF DS, NONGKYNRIH B, PANDAV CS, GUPTA SK, SHAH B, KAPOOR SK, KRISHNAN A. A systematic review of 
school-based interventions to prevent risk factors associated with noncommunicable diseases. Asia Pac J 
Public Health. 2012 Sep;24(5):733-52. doi: 10.1177/1010539512445053. Epub 2012 May 16. PMID: 
22593222. 
SSINABULYA I, KAYIMA J, LONGENECKER C, et al. Subclinical atherosclerosis among HIV-infected adults attending 
HIV/AIDS care at two large ambulatory HIV clinics in Uganda. PLoS One 2014; 9(2): e89537. 
  
SOMMER A, TWIG G. The Impact of Childhood and Adolescent Obesity on Cardiovascular Risk in Adulthood: a 
Systematic Review. Curr Diab Rep. 2018 Aug 30;18(10):91. doi: 10.1007/s11892-018-1062-9. PMID: 
30167798.  
STARY HC. Evolution and progression of atherosclerotic lesions in coronary arteries of children and young adults. 
Arteriosclerosis 1989; 9(1 Suppl): I19-32 
VAN HOUT M, BACHMANN M, LAZARUS JV, et al Strengthening integration of chronic care in Africa: protocol for the 
qualitative process evaluation of integrated HIV, diabetes and hypertension care in a cluster randomised 
controlled trial in Tanzania and Uganda BMJ Open 2020;10:e039237. doi: 10.1136/bmjopen-2020-039237 

FaCe-D study  
Protocol version 4.0                                version dated 05 March 2025 
34 
 
VECCHIO, L. M., MENG, Y., XHIMA, K., LIPSMAN, N., HAMANI, C., & AUBERT, I. (2018). The Neuroprotective Effects of 
Exercise: Maintaining a Healthy Brain Throughout Aging. Brain plasticity (Amsterdam, Netherlands), 4(1), 17–
52. https://doi.org/10.3233/BPL-180069 
WALOSZEK JM, BYRNE ML, WOODS MJ, NICHOLAS CL, BEI B, MURRAY G, RANITI M, ALLEN NB, TRINDER J. Early 
physiological markers of cardiovascular risk in community based adolescents with a depressive disorder. J 
Affect Disord. 2015 Apr 1;175:403-10. doi: 10.1016/j.jad.2015.01.008. Epub 2015 Jan 19. PMID: 25678173.  
WRITING GROUP MEMBERS, LLOYD-JONES, D., ADAMS, R. J., BROWN, T. M., CARNETHON, M., DAI, S., DE SIMONE, 
G., FERGUSON, T. B., FORD, E., FURIE, K., GILLESPIE, C., GO, A., GREENLUND, K., HAASE, N., HAILPERN, S., HO, 
P. M., HOWARD, V., KISSELA, B., KITTNER, S., LACKLAND, D., … American Heart Association Statistics 
Committee and Stroke Statistics Subcommittee (2010). Heart disease and stroke statistics--2010 update: a 
report from the American Heart Association. Circulation, 121(7), e46–e215. 
https://doi.org/10.1161/CIRCULATIONAHA.109.192667 
ZAMAWE FC. The Implication of Using NVivo Software in Qualitative Data Analysis: Evidence-Based Reflections. 
Malawi Med J. 2015 Mar;27(1):13-5. doi: 10.4314/mmj.v27i1.4. PMID: 26137192; PMCID: PMC4478399. 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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14.0 Appendices 
 
Appendix 1: Summary of the data to be collected 
Time/ Activity 
Data to be collected 
tool 
Frequency 
By 
whom 
Identification of 
participants for 
implementation 
phase 
Households with adolescents 
VHT registers  
Local/Village 
leaders registers 
once 
Study 
team 
At enrollment  
Demographic data including 
family and treatment history 
diabetes or hypertension, or 
chronic conditions, number of 
family members present blood 
pressure, height & weight, BMI 
and Cardiovascular Health matrix 
will be calculated based on seven 
simple risk factors (Life’s Simple 
7) Any chronic illness 
Enrollment and 
Biomedical 
indicators tool 
Cardiovascular 
health matrix 
BMI wheel 
GPAQ 
 
At baseline 
Study 
field 
worker 
 
During VHT visit  Weight and blood pressure  
Lifestyle data: physical activity, 7 
–days food diary data (self-
carbonating)  
Materials given out to the family 
Village registers 
Adolescent physical 
Activity diary 
7-day food diary 
Every home 
visit 
VHT 
At 12 months 
and 18 months)  
blood pressure, & weight, height  
BMI and CVD health and risk to be 
calculated 
Do a point of care Cholesterol 
measurement and a fasting Blood 
Glucose 
Any new chronic illness illnesses 
present 
Lifestyle data (physical activity, 7 
–days food diary data & 24-hour 
recall food recall 
Anxiety, depression and sleep 
quality 
End of study tool 
end of the 
study 
Study 
field 
worker 
Costing data 
Costing tool 
Questionnaire 
0, 6, 12,18 
 
Process 
evaluation 
Implementation science 
outcomes listed below 
 
6, 12,18  
Social 
scientist 
team 
 

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Appendix 2: FaCe-D study Screening tool 
 
Screening Date:                                                     Partic  
 
 
Participant’s Initials:                                                                    Screening ID:  
Participants must meet ALL of the inclusion criteria and NONE of the 
exclusion before filling the enrolment form 
 
Screening (Inclusion) Criteria - tick Yes or No 
1. Is the participant aged ≥10 and 19 years of age?               Yes,                            No 
 
2. Has the participants parent/caretaker provided consent?           Yes,         No 
 
3. Has the participants Household head provided consent?           Yes,         No 
 
4. Is the participant planning to stay in this village for the next 12 months      Yes        No 
 
Screening (Exclusion) Criteria - tick Yes or No 
 
5. Is the participant in boarding school?                                   Yes,                            No  
 
6. Is the participant know to have any chronic conditions?                  Yes,              No  
 
7. Is the participant pregnant or lactating?                 Yes,               No                  NA 
 
8. Is the participant Very sick, requiring immediate hospital care/admission? Yes,       No 
 
Proceed to next steps only if yes to question 9 
 
9. Has the patient met all of the inclusion criteria and none of the Exclusion criteria? Yes,          No 
 
If Yes to question 9 proceed to consent process and thereafter for Baseline clinical measurements and if possible 
point of care Tests form before completing the enrolment form 
 
I am confident that the information supplied in this tool/ form is complete and accurate data. 
Data collector’s Initials: 
 
 
 
 
Date of signature: 
 
 
 
 
 
 
 
 
 
 
 
 
D 
d 
m 
m 
m 
y 
y 
y 
y 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix 3: FaCe-D Enrolment (CVH and Mental Wellbeing) Tool 
FaCe-D ICH and Mental Wellbeing Tool 
Location Data 
Question 
Response  
Code  
Village 
 
 
District  
 
 
Interviewer name/ ID  
 
 
Date of completion of tool (Day, month, and year) 
 
 
Time of interview 
 
 
 
Demographics 
Question 
Response  
Code  
Participant name 
 
 
Sex 
 
 
Age  
 
 
Study step 
 
 
Contact phone number 
 
 
Phone ownership  
 
 
Highest level of education  
 
 
Ethnic group  
 
 
Marital status  
 
 
Work status  
 
 
Average household income 
 
 
Number of people who live in household including respondent 
 
 
Medication for any chronic illness apart from diabetes, 
hypertension, cardiovascular disorder, or mental disorder 
Yes 1 
No 2 if yes, please specify 
 
 
Step 1 Behavioral measurements 
Tobacco use 
Now I’m going to ask you some questions about smoking/tobacco use. 
Question 
Response  
Code  
Do you currently smoke any tobacco products, such as cigarettes, cigars or 
pipes? 
Yes 1 
No 2 if no, go to code xx 
 
Do you currently smoke tobacco products daily?  
Yes 1 
No 2 if no, go to code xx 
 
In Years. If known go to code xx 
 

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Do you remember how long ago it was that you started smoking? If they 
know age please list 
Don’t know 77 
 
In Months. If known go to code xx 
 
In Weeks. If known go to code xx 
 
Age in years: 
 
On average, how many of the following products do you smoke/use each 
day/week? 
 
 
Don’t Know 99 
Manufactured cigarettes 
 
Hand-rolled cigarettes 
 
Pipes full of tobacco 
 
Cigars 
 
Number of Shisha sessions 
 
Other 
 
Other (please specify): 
 
During the past 12 months, have you tried to stop smoking? 
Yes 1 
No 2 
 
In the past, did you ever smoke any tobacco products?   
Yes 1 
No 2 
 
In the past, did you ever smoke daily? 
 
Yes 1 
No 2 
 
How old were you when you stopped smoking? 
Age (years) 
If not known 99 
If known go to code xxx 
 
How long ago did you stop smoking? 
Don’t Know 99 
 
In Years. If known go to code xx 
 
In Months. If known go to code xx 
 
In Weeks. If known go to code xx 
 
Do you currently use any smokeless tobacco products such as (snuff, 
chewing tobacco)? 
Yes 1 
No 2 if no, go to code xx 
 
Do you currently use smokeless tobacco products daily?  
Yes 1 
No 2 if no, go to code xx 
 
On average, how many times a day/week do you use …. 
 
Don’t Know 99. 
 
Snuff by mouth: Daily. Weekly 
 
Snuff by nose: Daily. Weekly 
 
Chewing tobacco: Daily. Weekly 
 
Other  
 
Other (please specify): 
 
In the past, did you ever use smokeless tobacco products such as chewing 
tobacco, etc.? 
Yes 1 
No 2 if no, go to code xx 
 
During the past 30 days, did someone smoke in your home? Smokers 
should exclude themselves.   
Yes 1 
No 2 
 

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During the past 30 days, did someone smoke in closed areas in your 
workplace (in the building, in a work area or a specific office)? 
Yes 1 
No 2 
Don’t work in closed area 
 
 
Alcohol Consumption  
The next questions ask about the consumption of alcohol  
Question 
Response  
Code  
Have you ever consumed any alcohol such as beer, wine, spirits or local 
brew? 
Yes 1 
No 2  
 
In the past, have you stopped drinking due to health reasons, such as a 
negative impact on your health or on the advice of your doctor or other 
health worker? 
Yes 1 if yes, go to code xx 
No 2 if no, go to code xx 
 
During the past month, how frequently have you had at least one 
standard alcoholic drink? For a few sips of alcohol during the past 12 
months, the answer should be “Never”. 
Daily 1 
5-6 days per week 2 
3-4 days per week 3 
1-2 days per week 4 
1-3 days per month 5 
Less than once a month 6 
Never 7 
 
During the past month, what was the largest number of standard alcoholic 
drinks you had on a single occasion? 
Largest number 
Don’t know 99 
 
During the past month, how frequently have you had at least one locally 
brewed drink? For a few sips of local brew during the past 12 months, the 
answer should be “Never”. 
Daily 1 
5-6 days per week 2 
3-4 days per week 3 
1-2 days per week 4 
1-3 days per month 5 
Less than once a month 6 
Never 7 
 
During the past month, what was the largest number of locally brewed 
drinks you had on a single occasion? 
Largest number 
Don’t know 99 
 
During the past month, how often have you failed to do what was 
normally expected from you because of drinking? 
Daily or almost daily 
Weekly 
Never  
 
 
 
 
 

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Diet 
The next questions ask about the fruits and vegetables that you usually eat. A serving is approximately the size of your fist. 
Question 
Response  
Code  
In a typical week, on how many days do you eat fruit? 
Number of days 
Don’t know 99. If zero days go to code xx 
 
How many servings of fruit do you eat on one of those days?    
Number of servings 
Don’t know 99 
 
In a typical week, on how many days do you eat vegetables?  
 
Number of days. If zero days go to code xx 
Don’t know 99 
 
How many servings of vegetables do you eat on one of those 
days?   
Number of servings 
Don’t know 99 
 
Dietary salt, oil, and sugar 
With the next questions, we would like to learn more about salt, oil, and sugar in your diet. Dietary salt includes ordinary table 
salt, unrefined salt such as sea salt, iodized salt, salty stock cubes and powders, and salty sauces such as soy sauce. Oil includes 
vegetable oil, olive oil, ghee, butter, nut oils, and blue band. Sugar includes refined and unrefined sugar, honey, and other 
sweeteners. 
How often do you add salt or a salty sauce such as soy sauce or 
additive like aromat to your food right before you eat it or as 
you are eating it? 
Always  
Often  
Sometimes 
Rarely  
Never 
Don’t know 99 
 
How often is salt, salty seasoning or a salty sauce added in 
cooking or preparing foods in your household? 
 
Always  
Often  
Sometimes 
Rarely  
Never 
Don’t know 99 
 
How often do you eat processed food high in salt?  These are 
foods that have been altered from their natural state, such as 
packaged salty snacks, canned salty food, fast food, sausages, 
cheese, bacon and processed meat 
Always  
Often  
Sometimes 
Rarely  
Never 
Don’t know 99 
 
How much salt or salty sauce do you think you consume? 
 
Far too much 
Too much  
 

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Just the right amount 
Too little  
Far too little  
Don’t know 99  
Do you do any of the following on a regular basis to control your salt intake?  
Limit consumption of processed foods 
Yes 1 
No 2 
 
Look at the salt or sodium content on food labels 
Yes 1 
No 2 
 
Buy low salt/sodium alternatives 
Yes 1 
No 2 
 
Use spices other than salt when cooking 
Yes 1 
No 2 
 
Avoid eating foods prepared outside of a home 
Yes 1 
No 2 
 
Do other things specifically to control your salt intake 
Yes 1. If yes go to code xx 
No 2 
 
Other (please specify) 
 
 
How often do you add oil or fat such as blue band, ghee, pork 
fat, and olive oil  to your food right before you eat it or as you 
are eating it? 
Always  
Often  
Sometimes 
Rarely  
Never 
Don’t know 99 
 
How often is oil or any other fat like ghee and butter added in 
cooking or preparing foods in your household? 
Always  
Often  
Sometimes 
Rarely  
Never 
Don’t know 99 
 
Do you do any of the following on a regular basis to control your oil intake?  
Limit consumption of processed foods 
Yes 1 
No 2 
 
Look at the fat or hydrogenated oil content on food labels 
Yes 1 
No 2 
 
Buy low fat alternatives 
Yes 1 
 

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No 2 
Cook without oil or oil-based additives 
Yes 1 
No 2 
 
Avoid eating foods prepared outside of a home 
Yes 1 
No 2 
 
Do other things specifically to control your oil/ fat intake 
Yes 1. If yes go to code xx 
No 2 
 
Other (please specify) 
 
 
How often do you add sugar or other sweeteners like honey   to 
your drinks right before you drink them or as you are drinking 
them? 
Always  
Often  
Sometimes 
Rarely  
Never 
Don’t know 99 
 
How often is sugar or other sweeteners like honey added in 
cooking or preparing foods in your household? 
Always  
Often  
Sometimes 
Rarely  
Never 
Don’t know 99 
 
Do you do any of the following on a regular basis to control your sugar intake?  
Limit consumption of processed foods 
Yes 1 
No 2 
 
Look at the sugar content on food labels 
Yes 1 
No 2 
 
Buy low sugar alternatives 
Yes 1 
No 2 
 
Prepare drinks or food without sugar or honey 
Yes 1 
No 2 
 
Avoid eating foods prepared outside of a home 
Yes 1 
No 2 
 
Do other things specifically to control your sugar intake 
Yes 1. If yes go to code xx 
No 2 
 
Other (please specify) 
 
 
 
 

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Physical activity 
Next, I am going to ask you about the time you spend doing different types of physical activity in a typical week. 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. 
Question 
Response  
Code  
Do you do any vigorous-intensity sports, fitness or leisure activities that 
cause large increases in breathing or heart rate like running or football?  
Yes 1 
No 2 if no, go to code xx 
 
In a typical week, on how many days do you do vigorous-intensity sports, 
fitness or leisure activities? 
Number of days  
 
How much time do you spend doing vigorous-intensity sports, fitness or 
leisure activities on a typical day? 
Hours: minutes  
 
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, or volleyball? 
Yes 1 
No 2 if no, go to code xx 
 
In a typical week, on how many days do you do moderate-intensity sports, 
fitness or leisure activities?  
Number of days  
 
How much time do you spend doing moderate-intensity sports, fitness or 
leisure activities on a typical day? 
Hours: minutes  
 
Sedentary behaviour 
The following question is about sitting or reclining at work, at home, getting to and from places, or with friends including time 
spent sitting at a desk, sitting with friends, traveling in car, bus, train, reading, playing cards or watching television, but do not 
include time spent sleeping. 
How much time do you usually spend sitting or reclining on a typical day? 
Hours: minutes 
 
 
Blood pressure history 
Have you ever had your blood pressure measured by a doctor or other 
health worker? 
Yes 1 
No 2 if no, go to code xx 
 
Have you ever been told by a doctor or other health worker that you 
have raised blood pressure or hypertension? 
Yes 1 
No 2 if no, go to code xx 
 
Were you first told in the past 12 months? 
Yes 1 
No 2 
 
In the past month, have you taken any drugs (medication) for raised 
blood pressure prescribed by a doctor or other health worker? 
Yes 1 
No 2 
 
Have you ever seen a traditional healer for raised blood pressure or 
hypertension? 
Yes 1 
No 2 
 
Are you currently taking any herbal or traditional remedy for your raised 
blood pressure? 
Yes 1 
No 2 
 
 
 

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Diabetes history  
Have you ever had your blood sugar measured by a doctor or 
other health worker? 
Yes 1 
No 2 if no, go to code xx 
 
Have you ever been told by a doctor or other health worker that 
you have raised blood sugar or diabetes? 
Yes 1 
No 2 if no, go to code xx 
 
Were you first told in the past 12 months? 
Yes 1 
No 2 
 
In the past month, have you taken any drugs (medication) for 
diabetes prescribed by a doctor or other health worker? 
Yes 1 
No 2 
 
Are you currently taking insulin for diabetes prescribed by a 
doctor or other health worker? 
Yes 1 
No 2 
 
Have you ever seen a traditional healer for diabetes or raised 
blood sugar? 
Yes 1 
No 2 
 
Are you currently taking any herbal or traditional remedy for 
your diabetes? 
Yes 1 
No 2 
 
 
Cholesterol history  
Have you ever had your cholesterol (fat levels in your blood) 
measured by a doctor or other health worker? 
Yes 1 
No 2 if no, go to code xx 
 
Have you ever been told by a doctor or other health worker that 
you have raised cholesterol? 
Yes 1 
No 2 if no, go to code xx 
 
Were you first told in the past 12 months? 
Yes 1 
No 2 
 
In the past month, have you taken any oral treatment 
(medication) for raised total cholesterol prescribed by a doctor 
or other health worker? 
Yes 1 
No 2 
 
Have you ever seen a traditional healer for raised cholesterol? 
Yes 1 
No 2 
 
Are you currently taking any herbal or traditional remedy for 
your raised cholesterol? 
Yes 1 
No 2 
 
 
Cardiovascular disease history  
Have you ever had a heart attack or chest pain from heart 
disease (angina) or a stroke (cerebrovascular accident or 
incident)? 
Yes 1 
No 2 
 
Are you currently taking aspirin daily or almost daily to prevent 
or treat heart disease? 
Yes 1 
No 2 
 
Have you ever seen a traditional healer for raised cholesterol? 
Yes 1 
 

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No 2 
Are you currently taking any herbal or traditional remedy for 
your raised cholesterol? 
Yes 1 
No 2 
 
Are you currently taking statins (medicines to lower cholesterol) 
daily or almost daily regularly to prevent or treat heart disease? 
Yes 1 
No 2 
 
 
Mental health history 
Have you ever seen a doctor, counselor, psychologist, 
psychiatrist or other health worker for a mental health disorder 
like depression or anxiety? 
Yes 1 
No 2 if no, go to code xx 
 
Have you ever been told by a doctor or other health worker that 
you have a mental health disorder? 
Yes 1 
No 2 if no, go to code xx 
 
Were you first told in the past 12 months? 
Yes 1 
No 2 
 
In the past month, have you taken any drugs (medication) for a 
mental health disorder prescribed by a doctor or other health 
worker? 
Yes 1 
No 2 
 
Have you ever seen a traditional healer for a mental health 
disorder? 
Yes 1 
No 2 
 
Are you currently taking any herbal or traditional remedy for a 
mental health disorder? 
Yes 1 
No 2 
 
 
Step 2 Physical Measurements  
Blood pressure  
Reading 1 
Record first measurement after the participant has rested for 15 
minutes. Wait 3 minutes before taking second measurement. 
Systolic (mmHg) 
 
Diastolic (mmHg) 
 
Reading 2 
Record second measurement. Record third measurement after 
participant has rested 3 minutes. 
Systolic (mmHg) 
 
Diastolic (mmHg) 
 
Reading 3 
Record third measurement 
Systolic (mmHg) 
 
Diastolic (mmHg) 
 
During the past month, have you been treated for raised blood 
pressure with drugs (medication) prescribed by a doctor or 
other health worker? 
Yes 1 
No 2 
 
Height and weight  
For women: Are you pregnant? If pregnant, skip height, 
measurements  
Yes 1 
No 2 
 
Height in centimeters with one decimal point  
 
 
Weight in kgs with one decimal point 
 
 

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Step 3 Biochemistry  
Blood glucose  
Time of last meal (24-hour clock). It is essential that participant 
has not had anything to drink or eat apart from water in the last 
8 hours immediately before the blood test. 
 
 
Fasting blood glucose in MMOL/L or MG/DL  
 
 
Today, have you taken insulin or other drugs (medication) that 
have been prescribed by a doctor or other health worker for 
raised blood glucose? 
Yes 1 
No 2 
 
Blood lipids 
Total cholesterol in MMOL/L or MG/DL) 
 
 
During the past month, have you been treated for raised 
cholesterol with drugs (medication) prescribed by a doctor or 
other health worker? 
Yes 1 
No 2 
 
Triglycerides in MMOL/L OR MG/DL) 
 
 
HDL Cholesterol in MMOL/L OR MG/DL) 
 
 
 
Appendix 5 MINI KID 
MAJOR DEPRESSIVE EPISODE (MINI KID, pages 6-7) 
No 
Question 
No 
Yes 
A1 
a. 
At any time in your life, did you feel sad or depressed? Felt down or empty or 
hopeless? Felt grouchy or annoyed? Did you feel this way most of the time, for 
at least 2 weeks? 
 
 
b. 
For the past 2 weeks, did you feel this way, most of the day, nearly every day? 
 
 
A2 
a. 
At any time in your life, were you bored a lot or much less interested in things 
(like playing your favourite games)? Have you felt that you couldn't enjoy 
things? Did you feel this way most of the time, for at least 2 weeks?  
 
 
b. 
For the past 2 weeks, did you feel this way, most of the day, nearly every day? 
 
 
A3 
 Over the two weeks, when you felt depressed/grouchy/ uninterested: 
Past two 
weeks 
Past 
Episode 
No 
Yes 
No 
Yes 
a. 
Were you less hungry or hungrier most days? Did you lose or gain weight 
without trying? 
 
 
 
 
b. 
Did you have trouble sleeping almost every night (“trouble sleeping” means 
trouble falling asleep, waking up in the middle of the night, waking up too early 
or sleeping too much)? 
 
 
 
 
c. 
Did you talk or move slower than usual? Were you fidgety, restless or couldn’t 
sit still almost every day? Did anyone notice this? 
 
 
 
 
d. 
Did you feel tired most of the time? 
 
 
 
 

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e. 
Did you feel bad about yourself most of the time? Did you feel guilty most of 
the time? 
 
 
 
 
f. 
Did you have trouble concentrating or thinking or did you have trouble making 
up your mind almost every day? 
 
 
 
 
g. 
Did you feel so bad that you wished that you were dead? Did you think about 
hurting yourself? Did you have thoughts of death? Did you think about killing 
yourself? 
 
 
 
 
A4. 
Did these sad, depressed feelings cause a lot of problems at home? At school? 
With friends? With other people? Or in some other important way? 
 
 
 
 
A5. 
In between your times of depression, were you free of depression or sadness 
for of at least 2 months? 
NA 
NA 
 
 
W. Rule out medical, organic or drug causes for all disorders 
No 
Yes 
Uncertain 
W1 
a. 
Were you taking any drugs or medicines or in withdrawal from any of these? 
 
 
 
 b. 
Did you have any medical illness? 
 
 
 
W2 
IF W1a OR W1b IS CODED YES, in the clinician’s judgment, is likely to be a 
direct cause of the patient’s disorder?  
 
 
 
W2 
su
m 
Has an “organic”/ medical/drug related cause been ruled out? 
 
 
 
 
How many episodes of depression did you have in your lifetime? (Between 
each episode there must be at least 2 months without any significant 
depression) 
 
 
GENERALIZED ANXIETY DISORDER 
No 
Question 
No 
Yes 
U1 
a 
For the past six months, have you worried a lot or been nervous?  
Have you been worried or nervous about several things, 
(like school, your health, or something bad happening)? 
Have you been more worried than other kids your age? 
 
 
b 
Do you worry most days? 
 
 
IS THE PATIENT’S ANXIETY RESTRICTED EXCLUSIVELY TO, OR BETTER EXPLAINED 
BY, ANY DISORDER PRIOR TO THIS POINT? 
 
 
U2 
Do you find it hard to stop worrying? Do the worries make it hard for you to pay 
attention to what you are doing? 
 
 
U3 
When you are worried, do you, most of the time: 
a 
Feel like you can't sit still? 
 
 
b 
Feel tense in your muscles? 
 
 
c 
Feel tired, weak or exhausted easily? 
 
 

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d 
Have a hard time paying attention to what you are doing? Does your mind go 
blank? 
 
 
e 
Feel grouchy or annoyed? 
 
 
f 
Have trouble sleeping ("trouble sleeping" means trouble falling asleep, waking 
up in the middle of the night, wakening up too early or sleeping too much)? 
 
 
 
ARE 1 OR MORE U3 ANSWERS CODED, YES? 
 
 
U4 
Do these worries or anxieties cause a lot of problems at school or with your 
friends or at home or at work or with other people? 
 
 
W. 
Rule out medical, organic or drug causes for all disorders 
No 
Yes 
uncertain 
W1 
a 
Were you taking any drugs or medicines or in withdrawal from any of these? 
 
 
 
b 
Did you have any medical illness? 
 
 
 
W2 
IF W1a OR W1b IS CODED YES, in the clinician’s judgment, is either likely to be a 
direct cause of the patient's disorder? 
 
 
 
W2 
sum 
Has an “organic”/ medical/drug related cause been ruled out? 
 
 
 
 
 
Sleep quality 
 
 
 
 
 
 

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Appendix 6: Modified VHT register 
 
 
Appendix 7: Cardiovascular Health Matrix 
 
 
 
Appendix 8 Health Economics questionnaire 
Participant/household description 
The interviewer should gather basic information about the characteristics of the participants and their 
household before and during implementation of the Face-D study. This information will enable us to 
uniquely identify the participant.  
Non-ideal Cardiovascular Health (metric score here = 0 
Ideal Cardiovascular Health (any score = 

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Participant/household details 
Participant/respondent’s ID: 
 
Household ID: 
 
Participant name: 
 
Participant gender; 
 
District:  
 
Setting (Rural/Urban): 
 
Household income 
 
Data collector’s name: 
 
Date contacted: 
 
Household/participant information on food expenditure. 
This section will be used to record information on each participant and their household involved in the 
FaCe-D study implementation over 12months. The interviewer will ask for monthly information about 
household expenditure associated with food or healthy diet  
In the last one month, has your household expenditure on food changed due to participation in this study? 
(Yes/No) 
How did the expenditure change? (Increased, decreased, unchanged) 
In the table below, identify the major food items, quantity and number of meals your household spent 
money on as a result of participating in this study within the last month.  
Food item 
Unit 
Quantity 
Unit costs 
Total cost 
 
 
 
 
 
 
In the table below, identify the major food items and indicate the number of meals based on the food 
items identified as a result of participating in this study within the last month. Indicate the amount of 
money your household spent.  
Food item 
Number of meals per 
week 
Number of meals 
per week 
Unit costs per 
meal 
 
 
 
 
 
 
 
 
In the past month, did your household reduce or discontinue consumption of unhealth food items? 
(Yes/no). If yes, indicate the food items, quantity and number of meals consumed compared to previous 
months 

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Food item 
No. of meals in past 
month after the study 
No. of meals per 
month before the 
study 
Unit costs per 
meal 
 
 
 
 
Household/participant information on physical activity. 
In the last month, did you participate in any paid or non-paid physical activity due to participation in this 
study (Yes/no) 
If yes, please indicate in the table below the type of physical activity or items/sessions, quantities and costs 
that you or your household spent on.  
Physical activity items or 
session 
Unit 
Quantity/number 
of sessions 
Unit cost 
Total cost 
 
 
 
 
 
 
In the last month, indicate the time you spent doing physical activity both paid or non-paid physical activity 
as a result of participating in this research study. 
Name of Physical activity 
Period of Physical 
activity 
(Daily/weekly) 
How many 
days/weeks  
How many 
hours per 
day/week  
Total hours 
spent per month 
 
 
 
 
 
Household/participant information on regular screening. 
In the last month, did you go for regular screening (paid or non-paid) for any cardiovascular disease? 
(Yes/No) 
If yes, please indicate the type of screening and frequency in the table below. 
Name of screening/test 
 Number of tests  
Unit cost per 
test/screen  
Total cost 
 
 
 
 
 
Appendix 9: VHT Monitoring and Supervision Checklist- FaCe-D 
Supervisor Name  
 
Designation  
 
VHT name  
 
VHT Contact 
 
Village 
 
Subcounty  
 
District  
 
Date  
 
 
Supervision Task 
Yes 
No  
N/A 
Notes 

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One on one mentoring sessions (30-60 minutes) at 
participating health facility in the community or 
virtual; these allow all critical issues to be addressed. 
Review past performance, provide feedback, set 
goals, motivate and develop capacity. 
Every month 
 
Peer to peer accountability to reinforce work goals 
and methods, ethics, safeguarding issues and share 
learnings and best practice. This increases the VHT’s 
self-confidence and self-awareness. 
Every month 
 
Observation of practice.  This helps to evaluate the 
quality, style, personal presentation, and technical 
skills of the VHT, and feedback should be provided 
immediately. However, be mindful that the VHT may 
feel nervous. These may be sampled. 
Every quarter 
 
VHT group meetings to share experiences, learnings, 
and best practice. High performing VHTs may also be 
recognized at the health facility when they are 
bringing back the reports 
Every Quarter 
 
Community Participatory Data Analysis/ dissemination Every 6 Months 
 
 
 
National Participatory Data Analysis/ dissemination 
Annually 
 
 
 
 
Emergency support supervision as the need may arise. As and when 
required 
 
GIS and time stamps where possible 
Depending on 
availability of funds 
 
 
Appendix 10: Process evaluation Data collection tools  
Adolescent including peer champions_ DATA COLLECTION 
Capture demographics (religion, highest level of education, livelihood, age, marital status, children) 
Knowledge, perceptions and attitudes about FCA (REACH) 
What do you know about CVDs? Probe for common CVDs, risk factors, prevention etc 
Tell me about the FCA intervention/what do you know about FCA/FaCe-D study? Probe for; awareness 
about FCA, purpose of the study/FCA, source of information, adequacy of information, intervention 
components etc 

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Perceptions about FaCe-D study/FCA 
What are your views/perceptions about FaCe-D study/FCA? Probe for.  
-If it’s the right strategy to prevent CVDs 
-What are your expectations/hopes (the positives or negatives)? 
-What are your views about doing physical activities daily, for 6o minutes?  -What are the barriers and 
facilitators?   
-What are your views about changing/improving your diet as recommended by the health workers 
(reducing sugar and salt intake, less oils and fried foods, fast and packed foods? -What are the barriers and 
facilitators?   
-What are your views about VHTs home visits and health education? -What are the barriers and 
facilitators?   
-What are your views on receiving health information about FCA intervention via text messages?  -What are 
the barriers and facilitators?   
Acceptability (REACH & Adoption)  
What factors influenced the decision to participate in the FaCe-D study? Barriers and facilitators to 
acceptability  
What can be done to improve participation?  
Full or partial participation (adoption)  
 
Do you think you will be able to fully or partially participate in the FCA intervention? Probe for willingness, 
what would be the barriers and facilitators for your choice?  
What can be done to enhance full participation in the intervention?  
Any comments  
 
 
Family members_ DATA COLLECTION  
Capture demographics (religion, highest level of education, livelihood, age, marital status, children) 
Knowledge, perceptions and attitudes about FCA (REACH) 
What do you know about CVDs? Probe for common CVDs, risk factors, prevention etc 
Tell me about the FCA intervention/what do you know about FCA/FaCe-D study? Probe for; awareness 
about FCA, purpose of the study/FCA, source of information, adequacy of information, intervention 
components etc 

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Perceptions about FaCe-D study/FCA 
What are your views/perceptions about FaCe-D study/FCA? Probe for;  
-If it’s the right strategy to prevent CVDs 
-What are your expectations/hopes (the positives or negatives)? 
-What are your views about doing physical activities daily, for 6o minutes?  -What are the barriers and 
facilitators?   
-What are your views about changing/improving your diet as recommended by the health workers 
(reducing sugar and salt intake, less oils and fried foods, fast and packed foods? -What are the barriers and 
facilitators?   
-What are your views about VHTs home visits and health education? -What are the barriers and 
facilitators?   
-What are your views on receiving health information about FCA intervention via text messages?  -What are 
the barriers and facilitators?   
Acceptability (REACH & Adoption)  
What factors influenced the decision to participate in the FaCe-D study? Barriers and facilitators to 
acceptability  
What can be done to improve participation?  
Full or partial participation (adoption)  
 
Do you think you will be able to fully or partially participate in the FCA intervention? Probe for willingness, 
what would be the barriers and facilitators for your choice?  
What can be done to enhance full participation in the intervention?  
Any comments  
 
 
VHTs_ DATA COLLECTION  
Capture demographics (religion, highest level of education, livelihood, age, marital status, children) 
Knowledge, perceptions and attitudes about FCA (REACH) 
What do you know about CVDs? Probe for common CVDs, risk factors, prevention etc 
Tell me about the FCA intervention/what do you know about FCA/FaCe-D study? Probe for; awareness 
about FCA, purpose of the study/FCA, source of information, adequacy of information, intervention 
components etc 

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Perceptions about FaCe-D study/FCA 
What are your views/perceptions about FaCe-D study/FCA? Probe for;  
-If it’s the right strategy to prevent CVDs 
-What are your expectations/hopes (the positives or negatives)? 
What are your views about having community members including your family doing physical activities 
daily, for 6o minutes for adolescents and 3 days for 30 minutes for adults?  -What are the barriers and 
facilitators?   
What are your views about your community members including your family changing/improving your diet 
as recommended by the health workers (reducing sugar and salt intake, less oils and fried foods, fast and 
packed foods? -What are the barriers and facilitators?   
What are your views about visiting peoples’ homes to offer health education on living a healthy lifestyle? -
What are the barriers and facilitators?   
What are your views on receiving health information about FCA intervention via text messages?  -What are 
the barriers and facilitators?   
Acceptability (REACH & Adoption)  
For the participants recruited, what are the t factors that influenced the decision to participate in the FaCe-
D study? facilitators to acceptability  
For the participants that declined participaing, what are the that factors that influenced the decision to not 
to participate in the FaCe-D study? Barriers to acceptability  
What can be done to improve participation?  
Any comments  
 
 
Policymakers_ DATA COLLECTION  
Capture demographics (religion, highest level of education, livelihood, age, marital status, children) 
Knowledge, perceptions, and attitudes about FCA (REACH) 
What do you know about CVDs? Probe for common CVDs, risk factors, prevention, etc 
Perceptions about FaCe-D study/FCA (first explain the FCA intervention) 
What are your views about having adolescents and their families doing physical activities daily, for 6o 
minutes for adolescents and 3 days for 30 minutes for adults?  -What are the barriers and facilitators?   

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What are your views about having adolescents and their families change/improve their diet as 
recommended by the health workers (reducing sugar and salt intake, less oils and fried foods, fast and 
packed foods? -What are the barriers and facilitators?   
What are your views about VHTs visiting peoples’ homes to offer health education on living a healthy 
lifestyle? -What are the barriers and facilitators?   
What training or support is required to ensure the VHTs deliver the FCA intervention effectively? 
What are your views on having adolescents and their families receive additional health information via text 
messages?  -What are the barriers and facilitators?   
For each of the barriers mentioned earlier, what can be done to address them?   
Acceptability  
What can be done to have more families embrace doing physical exercises and changing their diet as 
recommended by the health workers? 
What specific resources/policies could support the implementation of the FCA intervention?  
What specific policies could support the sustainability of the FCA intervention?  
What specific resources could support the sustainability of the FCA intervention? (probe for; whom to 
provide the resources) 
Any comments  
 
 
FGDs_Community members_ DATA COLLECTION  
Capture demographics (religion, highest level of education, livelihood, age, marital status, children) 
Knowledge, perceptions, and attitudes about FCA (REACH) 
What do you know about CVDs? Probe for common CVDs, risk factors, prevention, etc What do you know 
about CVDs? Probe for common CVDs, risk factors, prevention etc 
Perceptions about FaCe-D study/FCA (first explain the FCA intervention) 
What are your views about having adolescents and their families doing physical activities daily, for 6o 
minutes for adolescents and 3 days for 30 minutes for adults?  -What are the barriers and facilitators?   
What are your views about having adolescents and their families change/improve their diet as 
recommended by the health workers (reducing sugar and salt intake, less oils and fried foods, fast and 
packed foods? -What are the barriers and facilitators?   
What are your views about VHTs visiting peoples’ homes to offer health education on living a healthy 
lifestyle? -What are the barriers and facilitators?   

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What training or support is required to ensure the VHTs deliver the FCA intervention effectively? 
What are your views on having adolescents and their families receive additional health information via text 
messages?  -What are the barriers and facilitators?   
For each of the barriers mentioned earlier, what can be done to address them?   
Acceptability  
What can be done to have more families embrace doing physical exercises in your community? 
 What can be done to have more families embrace changing their diet as recommended by the health 
workers? 
Any comments  
 
 

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Appendix 11: Participants’ education materials: Health plate and portion sizes 
         
   
pen
 
 

 
 
Appendix 12: Physical Activity diary 
 
NO 
Types of physical 
activity 
PICTURES 
 
Time 
(mins) 
1st 
2nd 
3rd 
4th 
5th 
6th 
7th  to 
30/31st of 
the 
month 
1 
Skipping a rope 
 
0-10 
 
11-30 
 
>30 <60 
 
=/>60 
 
 
 
 
 
 
 
2 
Football 
 
 
 
 
 
 
 
 
 
3 
Cycling  
 
 
 
 
 
 
 
 
 

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59 
 
 
4 
Washing dishes 
 
 
 
 
 
 
 
 
 
5 
Jumping  
 
 
 
 
 
 
 
 
 
6 
Making the bed 
 
 
 
 
 
 
 
 
 
7 
Dancing 
 
 
 
 
 
 
 
 
 

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60 
 
 
8 
Running 
 
 
 
 
 
 
 
 
 
 
 
9 
Ridding a tire  
 
 
 
 
 
 
 
 
 
10 
Pushups 
 
 
 
 
 
 
 
 
 
11 
Climbing a tree 
 
 
 
 
 
 
 
 
 

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61 
 
 
12 
Cleaning  
 
 
 
 
 
 
 
 
 
13 
Walking  
 
 
 
 
 
 
 
 
 
14 
Climbing steps 
 
 
 
 
 
 
 
 
 
15 
Gardening  
 
 
 
 
 
 
 
 
 
 

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62 
 
 
16 
Okwepena( 
dodge ball) 
 
 
 
 
 
 
 
 
 
17 
Cleaning the car 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
19 
Preparation of 
food 
 
 
 
 
 
 
 
 
 
 
 
 
 

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63 
 
 
 
 
         
 
 
 
 
 
 
 
20 
Pushing the 
wheelbarrow 
 
 
 
 
 
 
 
 
 
21 
Volleyball  
 
 
 
 
 
 
 
 
 
21 
Others e.g. swimming, gymnastics, netball, basketball, boxing, 
rugby, karate, table  tennis, Golf etc. 
 
 
 
 
 
 
 
 

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64 
 
 
Appendix 13: Food diary 
Food diary for Jan 2025… participants study ID…… 
No  Food 
groups  
 
 
 
Please write the foods you have consumed today 
and response for  7 days 
Name  
Types  
PICTURES  
 
1st 
2nd 3rd 
4th 
5th 
6th 
7th to 30th 
/31st of the 
month  
1 
Energy 
giving 
foods 
 Whole grains 
e.g.  unprocessed 
maize, millet, 
wheat, brown 
rice, whole 
wheat bread, 
sorghum 
 
 
Adolescent 
 
 
 
 
 
 
 
 
Household 
 
 
 
 
 
 
2 
 
Refined grains 
and bakery 
products e.g. 
Processed maize, 
rice, bread, 
 
 
Adolescent 
 
 
 
 
 
 
 
 
Household 
 
 
 
 
 
 
3 
 
starchy tubers or 
roots such as 
potatoes, yams, 
karo or cassava, 
 
Adolescent 
 
 
 
 
 
 
 

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matooke, Irish 
potatoes 
 
 
 
Household 
 
 
 
 
 
 
4 
 
Healthy oils e.g. 
sunflower, 
sesame, corn, 
olive oil, shea 
butter, ground 
nut oil, vegetable 
oil, avocado oil 
 
 
Adolescent 
 
 
 
 
 
 
 
 
Household 
 
 
 
 
 
 
5 
 
Un healthy oils 
e.g., Ghee 
 
Adolescent 
 
 
 
 
 
 
 

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,butter, 
margarine 
 
 
Household 
 
 
 
 
 
 
6 
Body 
building 
foods  
Plant proteins 
Pulses e.g. Dry 
beans, broad 
beans, dry peas, 
chickpeas, cow 
peas, lentils, 
soya beans 
 
 
 
 
 
 
 
 
 

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7 
 
Plant proteins 
Nuts and seeds 
e.g. Ground nuts, 
almonds, awusa 
nut, peanut, 
cashew nuts, 
sweet acacia, 
sesame seeds 
 
 
 
 
 
 
 
 
 
 
8 
 
Animal proteins 
Meat  e.g. white 
meat, red meat 
poultry ( chicken, 
turkey ) 
processed meat, 
organ meat 
(kidney, liver 
mixed offal’s, 
intestines) 
animal 
skin/ear/feet/he
 
 
 
 
 
 
.  
 
 

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ad , insects, 
tinned meats 
 
9 
 
Fish and sea 
foods e.g. whole 
fish , fish meat, 
silver fish and 
shell fish  
`
 
 
Adolescent 
 
 
 
 
 
 
 
 
Household 
 
 
 
 
 
 
10 
 
Milk and dairy 
e.g. fresh milk, 
sour milk, milk 
powder, cheese, 
yogurt and 
cream 
 
 
 
 
 
 
 
 
 

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11 
 
Eggs e.g. whole 
(boiled egg) or  
separated eggs( 
fried egg, 
scrambled eggs 
 
 
 
 
 
 
 
 
 
12 
Vegeta
bles 
Dark Green leafy 
Vegetables e.g. 
dodo, bugga, 
spinach, 
cabbage, nakatti, 
sukuma wiki, 
ejobyo, pumpkin 
leaves. 
 
 
 
 
 
 
 
 
 
 
 
 

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13 
Other 
vegetab
les  
Ginger, turmeric 
root, garlic, 
onions, tomatoes 
and broccoli, 
cucumber, 
asparagus and 
okra, carrots, 
green/yellow/re
d pepper, egg 
plants freach 
beans, 
mushrooms, 
tomatoes, 
avocado, 
pumpkin, bitter 
berries(entulla). 
 
 
 
 
 
 
 
 
 
14 
Fruits  
Mangoes, 
pumpkin, starchy 
fruits(bananas) , 
watermelon, 
pineapple, 
pawpaw, 
tangerines’, 
oranges, passion 
fruits, jack fruits, 
apples, lemons, 
black plum, 
mapela, 
grapefruits, 
apples, tamarind. 
 
 
 
 
 
 
 
 
 
 

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15 
Sugars 
and 
sweets 
Sugar, honey, 
syrups, candies, 
sweets, 
chocolates, 
sweet cakes 
 
 
 
 
 
 
 
 
Adolescent 
 
 
 
 
 
 
 
 
Household 
 
 
 
 
 
 
16 
Beverag
es  
  Non-alcoholic 
e.g. Black tea, 
coffee, soda, 
 
Adolescent 
 
 
 
 
 
 
 

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powdered drink 
mixes, artificial 
diluted or 
sweetened 
juices, non-dairy 
fermented juices. 
 
 
 
 
 
 
 
 
 
 
18 
 
 Alcoholic 
beverages e.g. 
beers, wine, 
whiskeys  
 
Adolescent 
 
 
 
 
 
 
 
 
Household 
 
 
 
 
 
 
19 
Others 
Condiments, 
spices, soup 
stocks, broths, 
baking 
powder/soda 
ash, salt 
 
 
 
 
 
Adolescent 
 
 
 
 
 
 
 
 
Household