Programme Effectiveness of an Integrated Programme to Reduce Maternal and Child Malnutrition in Kenya: Cluster Randomized, Parallel-group, Prospective, Follow-up Effectiveness Study in Children 6-35 Months of Age at Recruitment
Phase: NA
Conditions: Stunting
Sponsor: Fabian Rohner

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 1 of 43 
 
 
 
Clinical Study Protocol 
 
Effectiveness of an integrated programme to reduce maternal and child malnutrition in Kenya  
 
 
 
Study Identifier: GW_1AF_KenEff 
 
 
Investigators: 
 
Sponsor-Investigator: Dr. Fabian Rohner, GroundWork, Switzerland  
 
Principal Investigator: Dr. Rita Wegmüller, GroundWork, Switzerland  
 
Local Principal Investigator: Mr. Kelvin Musau, One Acre Fund, Kenya 
 
Co-Principal Investigator: Ms Haley Kawaja, One Acre Fund, Kenya 
 
Co-Principal Investigator: Ms Marion Kiprotich, One Acre Fund Kenya 
 
Study Clinician: Dr. med. Tim Chindia, General Public Health Practitioner, Kenya 
 
Co-Investigator: Ms. Emily Lloyd, One Acre Fund, Kenya 
 
Co-Investigator: Dr. Maya Duru, One Acre Fund, Kenya 
 
Co-Investigator: Dr. med. Bradley A. Woodruff, GroundWork, Switzerland 
 
Co-Investigator: Dr. Nicolai Petry, GroundWork, Switzerland 
 
Co-Investigator: Mr. James Wirth, GroundWork, Switzerland 
 
 
 

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 2 of 43 
Table of contents 
 
ABSTRACT 
4 
ABBREVIATIONS 
5 
1. BACKGROUND 
6 
2. PROBLEM STATEMENT 
8 
3. REVIEW OF LITERATURE 
8 
4. RESEARCH OBJECTIVES 
9 
4.1 
Overall Objective 
9 
4.2 
Primary Objective 
10 
4.3 
Secondary Objectives 
10 
4.4 
‘Safety’ Objectives 
10 
5. CONCEPTUAL FRAMEWORK AND OPERATIONALIZATION 
10 
6. HYPOTHESIS/RESEARCH QUESTIONS 
14 
7. STUDY DESIGN AND SAMPLING STRATEGY 
14 
7.1 
Study design and sampling procedures 
14 
7.2 
Sample size and randomization 
19 
7.3 
Study population 
21 
7.3.1 
Eligibility criteria 
21 
7.3.2 
Recruitment and screening 
22 
7.3.3 
Criteria for withdrawal/discontinuation of participants 
22 
7.4 
Interventions 
23 
8. DATA COLLECTION 
29 
8.1 
Training and management of data quality 
29 
8.2 
Quantitative data collection 
30 
8.2.1 
Data collection instruments 
31 
8.3 
Qualitative data collection 
31 
8.4 
Ethical issues 
31 
9. DATA PROCESSING AND ANALYSIS 
33 
9.1 
Data processing 
33 
9.2 
Data analysis 
33 
9.2.1 
Primary analysis 
33 
9.2.2 
Secondary analyses 
33 
9.2.3 
Interim analyses 
34 
9.2.4 
Handling of missing data and drop-outs 
34 
10. PLAN FOR COMMUNICATING FINDINGS OF THE STUDY 
34 
10.1 
Dissemination strategy 
34 
10.2 
Involvement of stakeholders 
35 
10.3 
Potential policy implications 
35 
11. STUDY LIMITATIONS AND RISKS 
35 
11.1 
Limitations of study design 
35 
11.2 
Major assumptions 
35 
12. MANAGEMENT AND ORGANIZATION OF THE STUDY 
36 
12.1 
Team members and roles 
36 
12.2 
Other resources and facilities 
37 
12.3 
Timelines 
38 
12.4 
Budget 
39 
13. REFERENCES 
40 
14. APPENDICES 
42 
14.1 
Participant information and consent forms 
42 
Study 1 English (version 2) 
42 
Study 1 Swahili (version 2) 
42 
Study 1 Luhya (version 2) 
42 
Study 2 English (version 2) 
42 

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 3 of 43 
Study 2 Swahili (version 2) 
42 
Study 2 Luhya (version 2) 
42 
14.2 
Questionnaires/assessment forms 
43 
Enrolment form study 1 
43 
Round 1 form study 1 (version 2) 
43 
Round 2 form study 1 (version 2) 
43 
Round 3 form study 1 (version 2) 
43 
Round 4 form study 1 (version 2) 
43 
Round 5 form study 1 (version 2) 
43 
Monthly adherence and morbidity questionnaires study 1 
43 
Referral form study 1 
43 
Enrolment form study 2 
43 
Round 1 form study 2 
43 
Round 2 form study 2 
43 
Round 3 form study 2 
43 
Quarterly adherence and morbidity monitoring questionnaire study 2 
43 
Referral form study 2 
43 
Adverse event reporting form study 1 & 2 
43 
Serious adverse event reporting form study 1 & 2 
43 
14.3 
Curriculum vitae of investigators and certificates 
43 
14.4 
IRB approval letter from PI’s country 
43 
14.5 
Signed government approval letter 
43 
14.6 
Pharmacy and Poisons Board retention certificate & Import Permit for LNS 
43 
 
 

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 4 of 43 
ABSTRACT 
 
 
Background: In Kenya, 26% of children under-five years of age are malnourished, and 26% of pre-
school children, 26% of women of reproductive age and 42% of pregnant women are anaemic, 
respectively. Agriculture is the main source of income and food for the majority of rural families in Sub-
Saharan Africa including Kenya. Agricultural programmes have led to increased yield and household 
income but had limited success in improving nutritional status. 
Objectives: To assess the impact on growth and micronutrient status of an integrated programme by 
introducing nutrition-specific (e.g. micronutrient supplements) and nutrition-sensitive (improved water, 
sanitation and hygiene, e.g. chlorine, soap) components to an existing agricultural programme. 
Methods: The impact of the integrated programme will be assessed in two cluster-randomized 
intervention studies comparing one group receiving the integrated intervention to another group 
receiving the agricultural intervention alone (control arm):  
Study 1: cluster-randomized, parallel-group, prospective, follow-up effectiveness study in pregnant 
women and their offspring 
Study 2: cluster-randomized, parallel-group, prospective, follow-up effectiveness study in children 6-
59 months old 
 
Study duration: The fieldwork of study 1 will take place over approximately 2.5 years (April 2018-
December 2020), while the duration for study 2 will be approximately 2 years (February to 2018-
March 2020). 
 
Budget: The budget for conducting the two studies is $ 2,055,458. 
 

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 5 of 43 
ABBREVIATIONS 
 
1AF 
One Acre Fund 
AE 
Adverse Event  
AGP 
Alpha 1- acid glycoprotein 
AMREF 
African Medical & Research Foundation 
BMI 
Body mass index 
CHV 
Community Health Volunteer 
CIFF 
Children´s Investment Fund Foundation 
CRP 
C-reactive protein 
ESRC 
Ethics & Scientific Review Committee 
FANTA 
Food and Nutrition Technical Assistance 
FAO 
Food and Agriculture Organization 
GA 
Gestational age 
HAZ 
Height for age z- score 
Hb 
Haemoglobin 
HC 
Head circumference 
IYCF 
Infant and Young Child Feeding 
KAP 
Knowledge, attitude and practices 
KEK 
Kantonale Ethikkommission (Cantonal Ethics Committee) 
LAZ 
Length for age z-score 
LNS 
Lipid-based Nutrient Supplement 
MNP 
Micronutrient Powder 
MUAC 
Mid-upper arm circumference 
ORS 
Oral rehydration solution 
PI 
Principal Investigator  
RAE 
Retinol activity equivalent 
RBP 
Retinol binding protein 
RDA 
Recommended daily allowance 
SAE 
Serious adverse event 
SDG 
Sustainable development goal 
SF 
Serum ferritin 
SOP 
Standard Operating Procedure 
TfR 
Transferrin Receptor 
UNICEF 
United Nations Children’s Fund 
WASH 
Water, Sanitation and Hygiene 
WFP 
World Food Programme 
WHO 
World Health Organization 
WHZ 
Weight for height z-score 
 
 

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 6 of 43 
1. BACKGROUND 
 
Malnutrition, and particularly malnutrition in children under 5 years of age, remains a public health 
problem in many areas of the world [1]. A diet low in diversity and micronutrient density is one 
contributing factor while a second factor is poor water, sanitation and hygiene (WASH) practices often 
leading to diseases such as persistent diarrhoea and resulting in morbidity and mortality in children 
under 5 years of age. According to the WHO World Health Statistics 2017 that are monitoring health 
in order to reach the Sustainable Development Goals (SDGs) [2] including data from between 2006 
and 2015, the global under 5 mortality rate per 1000 live birth is 42.5 and is clearly highest in the 
African Region with 81.3 while in Kenya it is lower than the African average with 49.4. The picture is 
similar for maternal mortality with 216 per 100,000 live births globally but with the highest in the 
African region with 542 and 510 in Kenya.  
The statistics also look at several WASH indicators. The mortality rate attributed to exposure to 
unsafe WASH services per 100,000 populations is clearly highest in the African region with a burden 
of 43.1, while the global burden is at 12.4, and with Kenya slightly below the African burden with 32.5. 
In line with this, two additional WASH indicators demonstrate the poor status in the African region. 
The use of improved drinking water source is lowest in the African region with 68%, while globally 
91% use an improved source and in all the other WHO regions it is over 90%. Kenya is slightly below 
the African average with 63% using an improved drinking water source. Looking at sanitation the use 
of improved sanitation is lowest in the African region with only 32% and is similar at the Kenyan level 
with 30% while globally 68% use improved sanitation. The most recent Kenya Demographic and 
Health Survey in 2014 estimates that only about a third of households in Kenya have washing places 
at their homes [3]. Also, nationally, three out of four households share toilets with other households or 
have unimproved toilets (open defecation, open latrines, etc.). Malnutrition is specifically covered in 
SDG Target 2.2 (By end 2030, end all forms of malnutrition, including achieving, by 2025, the 
internationally agreed targets on stunting and wasting in children under 5 years of age, and address 
the nutritional needs of adolescent girls, pregnant and lactating women and older persons). The WHO 
statistics indicate a worldwide problem with 22.9% of children under 5 years of age stunted and 7.7% 
wasted. While the Africa Region (33.5% and 7.4%)) together with the South-East-Asia Region (33.8% 
and 15.3)) have the highest stunting and wasting prevalence, respectively, the prevalence in Kenya is 
below the Africa average with 26.0% stunted and only 4% wasted.  
 
Anaemia, resulting from an inadequate intake of iron and/or low iron bioavailability from the diet as 
well as from other causes like diseases such as malaria and other micronutrient deficiencies, has 
been shown to be of public health significance worldwide, particularly in preschool children and 
women of reproductive age. The Global Burden of Disease study in 2015 estimated that anaemia was 
the impairment that affected the greatest number of people in 2015 with 2.36 billion individuals 
affected [4]. Looking at years lost due to disabilities worldwide, iron deficiency anaemia ranks fourth. 
The 2013 Global Burden of Disease study estimates that 27% of the world’s population was anaemic 
with low-income countries accounting for more than 89% of the burden [5]. Iron deficiency is 
estimated to be the dominant cause of anaemia worldwide with > 60%. The Kenya National 
Micronutrient Survey of 2011 [6] and the most recent Demographic and Health Survey in 2014 [3] 
show that 26% of pre-school children, 26% of women of reproductive age and 42% of pregnant 
women were anaemic. The prevalence of iron deficiency in children was 21.8% (serum ferritin 
<12µg/L after being adjusted for inflammation), and that of iron deficiency anaemia was 13.3%. In 
non-pregnant women of reproductive age, 21.3% were iron deficient (serum ferritin <15µg/L after 
inflammation adjustment) and 14.0% suffered from iron deficiency anaemia. These values were 
higher in pregnant women with 36.1% and 26.0%, respectively. The prevalence of vitamin A 
deficiency based on retinol-binding protein was highest in pre-school age children with 9.2%.  
Anaemia can result in several health consequences, starting in very early live such as impaired 
development of the brain in the foetus and early infancy, impaired immune system and increased 
infant mortality as well as reduced physical capacity and work performance in adults [7]. Anaemia is in 
general much more amenable to prevention and treatment than many other conditions such as 
diabetes or cardiovascular disease but supplementation strategies have failed in many countries. 
Using a integrated approach delivering micronutrients to pregnant women and young children through 
a platform that already exists together with other interventions such as WASH that contribute to the 
prevention of childhood malnutrition might be a promising way forward.  
The present project will use the One Acre Fund (1AF) agriculture platform to add nutrition-specific and 
nutrition-sensitive interventions to the agricultural intervention already in place in western Kenya. 

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 7 of 43 
Agriculture is the main source of income, food and nutrients for the majority of rural families in Sub-
Saharan Africa including Kenya. Most rural families in Sub-Saharan Africa are smallholder farmers, 
and rely on agricultural produce for income and direct consumption. Despite the fact that these 
households are food producers, research has shown that rural farming households are typically net 
food consumers and are more vulnerable to malnutrition [8]. Decades of investments in the agriculture 
sector have focused on improving yields and income but have notably failed to improve the nutrition 
status of farming families and their children [9]. Since 2006, 1AF has been providing a bundle of 
services and agricultural inputs to smallholder farmers using a model where farmers take loans to pay 
for inputs and services received. The core service bundle includes environmentally appropriate seed 
and fertilizer, physical delivery of inputs, training, and small loans. 1AF currently reaches 445,000 
farming households in Kenya, Burundi, Rwanda, Tanzania, Malawi, and Uganda. Kenya was 1AF’s 
first country of operation and their activities will soon cover all of Western and Nyanza Provinces, 
which are the primary food-producing regions and hold one third of Kenya’s population. The most 
recent 1AF report impressively shows the increasing number of farm families served, the Dollar gain 
in farmer impact and the close to 100% farmer repayment rate of credits for seeds and fertilizers [10]. 
In partnership with the Children's Investment Fund Foundation (CIFF), 1AF aims to introduce 
nutrition-sensitive and nutrition-specific components into the services offered to smallholder farmer 
households. The nutrition-specific interventions consist of providing lipid-based nutrient supplements 
(LNS) to pregnant women up to 6 months after delivery and LNS to their offspring from 6-24 months 
of age in one study and providing MNPs (Micronutrient Powders) to children 6-59 months of age in a 
second study. These nutritional supplements are recommended by WHO in areas where micronutrient 
deficiencies and malnutrition are prevalent [11,12]. In order to increase protein consumption, raw eggs 
(to be used for cooking) will be provided to pregnant women and up to 6 months post partum and to 
their offspring from 6-24 months of age in study 1 and chicken birds to households in study 2. Study 2 
households will also be provided with seeds for red onion and indigenous greens. Further, children 
older than 6 months will be provided with oral rehydration salts (ORS) and zinc supplements as 
recommended by WHO and UNICEF for the treatment of acute diarrhoea [13]. As a nutrition-sensitive 
intervention, pregnant women will receive albendazole as preventive anthelminthic treatment after the 
first trimester as recommended by WHO in endemic areas [7,14]. Lastly, some WASH related 
interventions will also be provided, such as training sessions, soap for hand washing and chlorine for 
drinking water treatment.  
 
To test the incorporation of nutrition services in 1AF's agricultural programme, pilot projects in western 
Kenya will be conducted between 2017 and 2020. These interventions are relevant to western Kenya 
where anaemia, micronutrient deficiencies, and under-nutrition are public health concerns [3,15]. The 
dietary diversity, food frequency and subsequently, a minimum acceptably dietary quality for young 
children are lower in the Western Province than for the national average. Further, the number of 
households with washing places is lower and diarrhoea prevalence is slightly higher compared to the 
national average [3]. 
In order to monitor and evaluate 1AF's programmes, two studies were designed to be conducted in 
the Western Province of Kenya and are presented here as study 1 and study 2:  
 
Study 1: a cluster-randomized, parallel-group, prospective, follow-up effectiveness study that 
will span over the "1,000 days window", the period from conception until the child’s second 
birthday 
 
Study 2: a cluster-randomized, parallel-group, prospective, follow-up effectiveness study in 
children 6-35 months of age at recruitment that spans over 2 years 
In both studies, clusters will be randomly assigned to either have the regular 1AF agricultural 
intervention package (already in place in all clusters participating in the study and therefore called 
control) or the integrated intervention package that on top of the agricultural package consists of 
nutrition-specific (such as providing additional micronutrients) and nutrition-sensitive (such as 
providing soap for hand washing) interventions. The impact on malnutrition and programmatic 
‘success’ will be evaluated. 
While in both studies the primary purpose is to longitudinally compare the changes of biological 
indicators such as growth and anaemia between the intervention and control group, the 
programmatic aspects such as adherence to and coverage of the intervention package and 
possible links to changes in dietary patterns and ultimately linear growth will also be evaluated. 

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 8 of 43 
2. PROBLEM STATEMENT 
 
Agriculture is the main source of income, food and nutrients for the majority of rural families in Sub-
Saharan Africa including Kenya. Most rural families in Sub-Saharan Africa are smallholder farmers, 
and rely on agricultural produce for income and direct consumption. Despite the fact that these 
households are food producers, research has shown that rural farming households are typically net 
food consumers and are more vulnerable to malnutrition [8]. Decades of investments in the agriculture 
sector have focused on improving yields and income but have notably failed to improve the nutrition 
status of farming families and their children [9]. 
Young children < 5 years of age and pregnant women are the most vulnerable groups when it comes 
to malnutrition as both population groups have an additional need for macro- as well as micronutrients 
to ensure proper development and growth of the child or foetus, respectively [16,17]. Single nutrition-
based, health-based or agriculture-based strategies have so far not resulted in reducing malnutrition 
and micronutrient deficiencies significantly. In the present project, we will use an integrated approach 
combining agriculture with nutrition-specific and nutrition-sensitive interventions and compare it to an 
agriculture intervention alone. Most of the planned interventions are targeted to the pregnant women 
and/or children < 5 years of age directly while some interventions are targeted to the household (e.g. 
soap for hand washing).  
The project will be conducted in the Western Province of Kenya, which is, together with the Nyanza 
Province, the primary food-producing region and they together hold one third of Kenya’s population. 
The planned interventions are relevant to western Kenya where anaemia, micronutrient deficiencies, 
and under-nutrition are public health concerns [3,15]. If the integrated approach proves to be efficient 
in reducing malnutrition and micronutrient deficiencies in young children in a farming population, it 
could be replicated in the other regions of Kenya or countries where 1AF is active with their 
agricultural programme (Burundi, Rwanda, Tanzania, Malawi and Uganda). Further, the programme 
could potentially be expanded to other subsistence farming areas in Africa and on other continents 
with similar climatic conditions. By reducing malnutrition, young children will be less susceptible to 
infectious diseases and therefore develop better both, physically but also mentally, as they will miss 
fewer classes at school. By reducing micronutrient deficiencies and anaemia, children will be more 
active and perform better at school, which will result in an adult population with a higher level of 
education and likely a higher level of work productivity as practices learned during the training 
sessions in the intervention on safe WASH and nutrition might be integrated into daily live into 
adulthood. 
3. REVIEW OF LITERATURE 
Several agricultural programmes have tried to decrease the prevalence of undernourishment (inability 
to acquire enough food to meet dietary energy requirements) in the past decades. Such programmes 
are likely to have contributed to the reduction in undernutrition from 18.6 to 10.8% worldwide and the 
reduction from 27.6 to 19.8 in Africa between 1990 and 2016 [14]. The recent data indicate that Kenya 
has the fourth highest number of undernourished people in Africa. However, decreasing the 
prevalence of undernourishment doesn’t necessarily mean an improvement in the malnutrition 
situation. Numerous studies have been undertaken to document knowledge of the effects of 
agricultural development projects on human nutrition. A recent publication taking into account 9 
reviews published between 2001 and 2012 comes to the conclusion that evidence of agricultural 
interventions for impacts on nutrition is weak and mixed at best [18]. Although there is clear evidence 
that investment in agricultural technologies has, on average, improved yields, increased caloric 
consumption, and/or increased incomes, there is still confusion about the mechanisms through which 
agriculture can enhance nutritional status. It might be that agriculture alone is not sufficient as the 
topic of malnutrition is too complex and involves many other areas such as the consumption of a 
nutritionally diverse diet and adequate WASH practices and health care systems that are accessible 
and affordable for all.  
Many studies have looked into the effect of nutrition-specific interventions such as providing multiple 
micronutrients to vulnerable population groups. Such nutritional supplements are recommended by 
WHO in areas where micronutrient deficiencies and malnutrition are prevalent [11,12]. Two recent 
trials conducted in Ghana and Malawi have demonstrated the positive effect of LNS given during 

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 9 of 43 
pregnancy resulting in increased weight, length and head circumference at birth as compared to 
women receiving iron and folic acid supplements [19,20]. One study, conducted in Bangladesh, has 
demonstrated the positive effect of LNS provided during pregnancy and infancy on child linear growth 
and head circumference [21]. There is clear evidence on the efficacy and effectiveness of the use of 
MNPs with respect to increased micronutrient status, reduction of anaemia prevalence and improved 
growth in most settings [22,23]. However, in some settings simultaneous prevention of common 
diseases (e.g. malaria, other infectious diseases) might be needed to see an effect as some studies in 
malaria-endemic areas using fortified products have demonstrated limited efficacy [24-26].  
Nutrition-sensitive interventions such as providing oral rehydration salts (ORS) and zinc supplements 
for the treatment of acute diarrhoea in young children and preventive anthelminthic treatment to 
pregnant women in endemic areas are recommended by WHO [7,13,14]. A recent Cochrane review 
concludes that in areas where the prevalence of zinc deficiency and malnutrition is high, children 
older than 6 months are likely to benefit from zinc supplementation by shortening the duration of acute 
diarrhoea [27]. Although a recently published Cochrane review including 4 RCTs did not show an 
effect of albendazole on maternal anaemia or preterm birth or perinatal mortality (not reporting on any 
other antenatal care outcomes) [28], the 2017 WHO Guidelines on preventive chemotherapy to 
control soil-transmitted helminth infections in high-risk groups [29], keep the recommendation of 
preventive treatment as it helps lessen the burden of other infections and contributes to a sustained 
reduction of transmission. Other nutrition-sensitive interventions include WASH related interventions, 
such as providing soap and chlorine to households. A recent meta-analysis has found that soap use 
or availability or the use of treated water was significantly associated with lower infection with any soil-
transmitted helminths [30]. Further, a systematic review [31], multi-country reviews [32], and a pooled 
analysis of several studies [33] as well as a recent analysis in Ethiopia [34] show a decreased risk of 
diarrhea following hand washing promotion interventions. The effect of nutrition-sensitive interventions 
alone on malnutrition (stunting or wasting) has not been demonstrated with clear evidence yet, but 
such interventions might be the key for success in an integrated programme that additionally includes 
nutrition-specific and agricultural interventions. 
In the past, mainly studies either focusing on agriculture interventions alone, nutrition-specific 
interventions alone (supplementation and food fortification), and nutrition-sensitive interventions alone 
(improvement of WASH conditions or treatment of infectious diseases) have been conducted and 
some of them have shown limited effects. Combining the three types of interventions is promising and 
may result in a larger success rate, as different areas that influence growth are included. 
Thus, the research questions for the two suggested studies are:  
 
Study 1: Can linear growth in children during their first 24 months of life be enhanced after the 
provision of agricultural services, nutritionally enhanced and WASH products as well as nutrition and 
WASH training over the period of the 1000 days window of opportunity (from conception until the 
child’s 2nd birthday) when compared to the control group provided only with agricultural services? 
 
Study 2: Can the rate of linear growth in children between 6-59 months of age be enhanced after the 
provision of agricultural services, nutritionally enhanced and WASH products, diversified crops as well 
as nutrition and WASH training over the period of 2 years when compared to the control group 
provided only with agricultural services? 
 
4. RESEARCH OBJECTIVES 
 
4.1 Overall Objective 
The purpose of the studies is to assess the programme effectiveness of an integrated approach 
(agriculture, nutrition-specific and nutrition-sensitive) compared to an agricultural approach alone and 
its impact on nutritional outcomes for mothers and young children as well as to identify and assess 
the conceptual and operational factors at the different stages of the intervention package that may 
have affected these outcomes. 
 

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 10 of 43 
4.2 Primary Objective 
Study 1 seeks to assess the effect of the integrated intervention package on growth, birth outcomes, 
anaemia, micronutrient deficiencies, and morbidity in mothers and their offspring in comparison to the 
control arm; thereby attributing changes in dietary and hygiene patterns to such effects. 
 
Study 2 seeks to determine the effect of the integrated intervention on growth, anaemia, dietary 
diversity, young child feeding and WASH patterns in comparison to the control group and access to 
and coverage of diversified crops and nutrition products.   
 
4.3 Secondary Objectives 
Secondary objectives of study 1 and study 2 are to identify and assess the conceptual and 
operational factors at the different stages of the intervention package that may have affected the 
outcome and to determine unintended consequences of the interventions. 
 
4.4 ‘Safety’ Objectives 
Studies 1 and 2 seek to assess the inappropriate use of nutritionally adequate products in the 
intervention groups. Specifically, the studies investigate if in the intervention group as compared to the 
control group: 
- 
a lower proportion of the children less than 6 months of age are exclusively breastfed  
- 
complementary food is introduced too early 
- 
dietary diversity is lower in pregnant/lactating women and children 
- 
there is an increase of overweight and obesity in pregnant/lactating women and children 
- 
there is an increase of morbidity incidences such as diarrhoea in the children (this is 
monitored monthly in study 1 and quarterly in study 2) 
 
 
5. CONCEPTUAL FRAMEWORK AND OPERATIONALIZATION 
 
Figure 1 shows how project activities (inputs) will lead to outputs and result in outcomes as well as the 
potential impact of the planned activities. The model shows the combined activities planned within 
study 1 and study 2. 

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 11 of 43 
 
Figure 1: Logic model for the CIFF/1AF programme that includes the two studies presented in this protocol 

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 12 of 43 
The objectives of the programme intervention and the indicators to assess achievement of these 
objectives are shown in Table 1. 
 
Table 1: Objectives and corresponding key indicators 
Level of 
data 
Hypothesis 
Indicators  
Proposed 
studies 
Purpose 1: To assess the effect of the 1AF intervention package on birth outcomes, anemia, 
micronutrient deficiencies, stunting, and morbidity in mothers and their young children 
Impact 
Decreased stunting in 
children receiving the 
intervention package (or 
parts thereof) 
 Change in length-for-age z scores (LAZ)  
 Percentage of children whose LAZ is below -2 
standard deviations from the median of the WHO 
Child Growth Standard 
 Studiy 1&2 
 
Impact 
Reduced prevalence of 
anemia and micronutrient 
deficiencies in children 
receiving the intervention 
package 
 Change in proportion with anaemia 
 Change in haemoglobin concentration 
 Change in retinol binding protein concentration 
(i.e. vitamin A status) 
 Change in concentration of serum ferritin and 
soluble transferrin receptor (i.e. iron status) 
 Study 1 
 
Impact 
Increased birth weight of 
children from mothers 
having received the 
intervention package 
during the pregnancy 
 Change in birth weight 
 
 Study 1 
 
Outcome Reduced prevalence (or 
incidence) in diarrheal 
disease in infants and 
young children receiving 
the intervention package 
 Age- and sex-specific morbidity rates with a focus 
on diarrhoea 
 Study 1 
 
Purpose 2: To identify and assess the conceptual and operational factors at the different stages of the 
intervention package that may have affected the outcome 
Outcome Increased intake of 
nutritional products 
among pregnant and 
lactating women and 
children 
 Consumption of adequately formulated nutritional 
products in the period preceding data collection 
 Monitoring of type, frequency and quantity of 
adequate nutritional products 
 Study 1&2 
Outcome Increased dietary diversity 
among pregnant and 
lactating women  
 FANTA/FAO minimum Dietary Diversity-Women  
 
 Study 1 
 
Outcome Increased adherence to 
adequate child feeding 
practices 
 Prevalence of early initiation of breastfeeding 
 Prevalence of exclusive breastfeeding 
 Duration of exclusive breastfeeding 
 WHO suite of IYCF (Infant and Young Child 
Feeding) indicators of dietary diversity, frequency, 
and adequacy 
 Study 1 
 
 
 Study 1&2 
Outcome Improved WASH practices  Ability to identify five critical times for 
handwashing 
 Proportion of households with soap and water 
available  
 Study 1&2 
Outcome Improved access to and 
availability of nutritionally 
adequate products for 
pregnant and lactating 
women and children  
 Access to nutritionally adequate foods 
 Affordability of such products as a function of the 
socio-economic status of the respondent 
 Study 1&2 

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 13 of 43 
Output 
Increased knowledge and 
awareness of the 
importance of adequate 
antenatal and child 
feeding practices and care 
 Ability to differentiate between facts and myths on 
antenatal and child feeding practices and care 
 Knowledge of new information gathered on child 
feeding practices and formulated nutritional 
products for pregnant and lactating women and 
children 
 Knowledge of the risks for not having adequate 
antenatal and child feeding practices and care 
 Awareness of sources of information for antenatal 
and child feeding practices 
 Study 1&2 
Purpose 3: To determine unintended consequences of the interventions 
Outcome Inappropriate use of 
nutritionally adequate 
products 
 Percentage of children less than 6 months of age 
not exclusively breastfed due to provision of 
complementary foods before 6 months of age 
 Study 1&2 
Impact 
Increase in the prevalence 
of overweight and obesity 
 Percentage increase in the proportion of children 
whose WHZ (weight for height z-score) is above 
+2 and +3 standard deviations from the median of 
the WHO Child Growth Standard 
 Study 1&2 
 
Several factors may influence our results, which we will take into account during data analysis. The 
following parameters assessed at baseline have been defined as independent variables to potentially 
influence the outcome at delivery and study end of study 1: 
- 
maternal height 
- 
maternal BMI (body mass index) 
- 
maternal age 
- 
maternal education 
- 
gestational age at enrolment 
- 
parity 
- 
time interval from prior birth 
- 
household socio-economic status 
- 
household food insecurity 
- 
site 
 
The following additional parameters assessed at round 3 (delivery) have been defined as independent 
variables for study endpoint outcomes: 
- 
child sex 
- 
mode of delivery 
 
 
The following parameters assessed at baseline have been defined as independent variables to 
potentially influence the outcome at round 2 and 3 of study 2: 
 
- 
maternal age 
- 
maternal education 
- 
parity 
- 
time interval from prior birth 
- 
child sex 
- 
household socio-economic status 
- 
household food insecurity 
- 
whether cluster received health insurance (other study taking place in the same district) 
- 
site 
 
 
 

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 14 of 43 
6. HYPOTHESIS/RESEARCH QUESTIONS 
 
Study 1 hypothesis: Linear growth in children during their first 24 months of life will improve after the 
provision of agricultural services, nutritionally enhanced and WASH products as well as nutrition and 
WASH training over the period of the 1,000 days window of opportunity when compared to the control 
group provided only with agricultural services. 
 
Study 2 hypothesis: Linear growth in children between 6-59 months of age will improve after the 
provision of agricultural services, nutritionally enhanced and WASH products and diversified crops as 
well as nutrition and WASH training over the period of 2 years when compared to the control group 
provided only with agricultural services. 
 
Table 2 below indicates the expected direction of relationship between the independent variables and 
the primary outcome (length at 24 mo of age in study 1 and length after 2 years of intervention in 
study 2). 
 
Table 2: Expected direction of relationship between independent variables and primary 
outcome (linear growth) 
Independent variable 
Direction of relationship 
Study 
Maternal height 
Positive 
1 
Maternal BMI 
Positive unless overweight/obese 
1 
Maternal age 
Negative 
in 
youngest 
as 
rather 
inexperienced 
and 
physiologically 
less 
ready  
1&2 
Maternal education 
Positive 
1&2 
Gestational age at enrolment 
Younger gestational age is positive as 
duration of intervention is longer 
1 
Parity 
Negative 
(multiparous 
higher 
risk 
of 
stunting) 
1&2 
Time interval from prior birth 
Longer interval is positive 
1&2 
Household socio-economic status 
Positive 
1&2 
Household food insecurity 
Negative 
1&2 
Health insurance intervention 
Positive if people go more often to health 
centres 
2 
Site 
Direction is not clear 
1&2 
Child sex 
Positive with female sex 
1&2 
Mode of delivery 
Caesarean section negative 
1 
 
 
7. STUDY DESIGN AND SAMPLING STRATEGY 
7.1 Study design and sampling procedures 
 
Study 1: 
General study design: Study 1 is a cluster-randomized, parallel-group, prospective, follow-up 
effectiveness study over a period of 1000 days comparing 2 groups: 
a) Intervention group: Pregnant women will be given LNS (1 sachet/day), raw eggs (2/day), and 
an anthelminthic drug (albendazole) in the second trimester of pregnancy, as well as soap 
and chlorine solution for the woman and the household. After delivery these products will be 
continued until the child reaches 6 months of age. Thereafter, LNS and eggs for mothers and 
anthelmintic drugs will be discontinued and instead, the child will receive LNS (1 sachet/day), 
one egg/day and Oral Rehydration Salts (ORS) along with zinc tablets (20 mg/day) for 
treatment in case of acute diarrhoea. These products will be given until the child reaches 2 
years of age. The products will be accompanied by life stage-appropriate nutrition and WASH 
trainings (pregnancy, lactation, infant and young child feeding), as well as SMS reminders to 
highlight certain messages on antenatal care and nutrition. All products and trainings will be 

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 15 of 43 
provided free of charge. The households in the intervention group will also have the same 
agricultural intervention as the control group. 
b) Control group: All households will be provided with agricultural training (every 2 weeks on 
average) for free. In addition, households can also enrol for the following products on credit: 
compost booster, cook stoves, seeds (onions, maize, indigenous greens, beans), maize 
storage bags, drying tarps, trees, solar lights, fertilizer, actellic dust (insecticide), re-usable 
sanitary pads. 
 
We anticipate recruiting 1200 (600 in each group) pregnant women into the study (see section 7.2 for 
sample size calculation); this is expected to yield a sufficiently large sample of children later in the 
study. Women will be recruited from 120 clusters (randomly assigned to intervention or control) that 
will be drawn from from Kimilili and Webuye districts in Bungoma County in Western Province of 
Kenya.  
We anticipate recruiting 1,200 (600 in each group) pregnant women into the study (see section 11.2 
for sample size calculation); this is expected to yield a sufficiently large sample of children later in the 
study. Women will be recruited from 120 clusters (randomly assigned to intervention or control) that 
will be drawn from from Kimilili and Webuye districts in Bungoma County in Western Province of 
Kenya.  
The communities will be informed about the study in village meetings by CHVs and by conducting 
outreach within their catchment area to identify pregnant women. Pregnant women will then be 
screened by 1AF enumerators. During screening, a few questions on health status and pregnancy 
will be asked. If the woman is prior or equal to 20 weeks of gestation (according to last menstrual 
period), has no visible severe disease and no allergy to peanuts or milk products, and confirms 
anticipated residence in the area for the coming 30 months, written informed consent for her and her 
offspring will be sought from her. She will then be asked to provide a urine sample to confirm 
pregnancy and she will be enrolled if pregnancy is confirmed. Following the screening, 5 assessment 
rounds (baseline and 4 follow-up assessments during the intervention) will be conducted at the 
participant’s homes (rounds 1-3) or at a central place (rounds 4 and 5) within walking distance from 
their homes (Figure 2). Assessment round 3 (immediately) after delivery will be conducted as home 
visits or clinic visits in case of delivery at a clinic. Details of assessment procedures for each round 
are illustrated in (Figure 3). 
 
Round 1 (Enrolment, ≤20 wk of gestation): 
On the day of enrolment the round 1 assessment will be done. As part of this, the following 
information will be collected: household demographics and characteristics, maternal education; 
knowledge, attitude and practices (KAP) of specific dietary and nutrition practices during pregnancy; 
individual dietary diversity; antenatal care; WASH practices; height, weight and mid-upper arm 
circumference; maternal haemoglobin concentration and malaria parasitaemia from a capillary blood 
sample. After round 1, participants randomly allocated to the intervention group will start receiving the 
intervention package. 
 
Round 2 (Gestational age of 34±1 wk): 
In round 2, interview questions related to diet and nutrition KAP during pregnancy, dietary diversity, 
antenatal care, and WASH will be asked. Additionally, MUAC (mid-upper arm circumference) will be 
measured and a capillary blood sample for measurement of haemoglobin concentration, malaria 
parasitaemia and micronutrient status will be provided.   
 
Round 3 (Within 24-48 hours after delivery): 
The mother-child pair will be visited within 24-48 hours after delivery. The following information will be 
recorded: delivery date and time, delivery method, recent antenatal care, and early initiation of 
breastfeeding. The mother will be assessed for MUAC but no blood sampling will be conducted. For 
the newborn, head circumference, birth weight and birth length, and haemoglobin concentration (from 
a heelprick) will be measured.  
 
Round 4 (At 6.5 mo ± 1 mo of age of offspring): 
This assessment will be conducted when the child turns 6.5 months old. Breastfeeding and other 
infant and young child feeding indicators, child morbidity, maternal dietary diversity, postnatal care, 
and WASH information will be gathered. In mothers, MUAC and weight will be measured and 
haemoglobin concentration and malaria parasitaemia from a capillary sample will be assessed. In 

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 16 of 43 
children, length, weight and head circumference will be measured and a capillary blood sample for 
haemoglobin concentration, malaria parasitaemia and micronutrient status will be provided. 
 
Round 5 (At 24 ± 1mo of age of offspring): 
This assessment will be conducted when the child turns 24 months old. Questionnaire-based 
information on child feeding, child dietary diversity, child morbidity and WASH will be collected. As in 
round 4, child length, weight and head circumference will be measured and a fingerprick blood 
sample will be provided for the measurement of haemoglobin concentration, malaria parasitaemia, 
and micronutrient status. No maternal biomarkers will be collected at this point. 
 
As part of the monthly visits to the participants’ households, the CHV will also collect data on 
intervention adherence and recent morbidity. 
 
 
 
Figure 2: Timing of assessment rounds for study 1. 
 
 
 

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 17 of 43 
     
 
Figure 3: Detailed procedures for each assessment round in study 1  
(LMP: last menstrual period; GA: gestational age; ICD: informed consent document; MUAC: mid-upper arm circumference; Hb: 
haemoglobin; RDT: rapid diagnostic test (for malaria); HH: household; SES: socioeconomic status; KAP: knowledge, attitude 
and practice; ANC: antenatal care; WASH: water, sanitation and hygiene; MN: micronutrients; HC: head circumference; IYCF: 
infant and young child feeding) 

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 18 of 43 
The detailed procedures of study 1 are summarized in Table 3 below. 
 
Table 3: Study 1 summary table of procedures and assessments 
Study Periods 
Screening 
Intervention Period 
Visit/Round 
0 
1 
2 
3 
4 
5 
Time (hour, day, week) 
≤20 
wk 
GA 
≤20 wk 
GA 
34±1wk 
GA 
Delivery 
+48h 
Infant 
6.5±1 mo 
old 
Infant 
24±1 
mo old  
Randomisation of clusters 
(done prior to recruitment) 
Oral consent for screening 
questions 
x 
 
 
 
 
 
Pregnancy and health status 
questions 
x 
 
 
 
 
 
In- /exclusion criteria 
x 
 
 
 
 
 
Written participant information 
and informed consent 
 
x 
 
 
 
 
Pregnancy test 
 
x 
 
 
 
 
Re-assessment of in- 
/exclusion criteria 
 
x 
 
 
 
 
Household 
demographics/characteristics 
 
x 
 
 
 
 
Maternal education 
 
x 
 
 
 
 
Maternal anthropometry 
 
x 
x 
x 
x 
 
Child anthropometry 
 
 
 
x 
x 
x 
Capillary blood sampling in 
women 
 
x 
x 
 
x 
 
Capillary blood sampling in 
children 
 
 
 
x 
x 
x 
Ante-/postnatal care 
 
x 
x 
x 
x 
 
Dietary and nutrition practices 
KAP, dietary diversity 
(pregnancy, lactation) 
 
x 
x 
 
x 
 
WASH practices 
 
x 
x 
 
x 
x 
Delivery information (incl. 
breastfeeding, birth weight 
and length) 
 
 
 
x 
 
 
Breastfeeding and other IYCF 
indicators 
 
 
 
 
x 
x 
Child dietary diversity 
 
 
 
 
x 
x 
Child morbidity 
 
 
 
 
x 
x 
Intervention adherence 
 
 
x 
x 
x 
x 
 
 
Study 2: 
General study design: Study 2 is a cluster-randomized, parallel-group, prospective, follow-up 
effectiveness study over a period of 2 years comparing 2 groups of children 6-35 months of age at 
recruitment: 
 
a) Intervention group: All selected households with children 6-35 months of age at recruitment 
will receive MNP (1 sachet every three days per child) and ORS along with zinc (20 mg/day) 
for treatment of acute diarrhoea. The households will also be provided with soap, chlorine 
solution, poultry (8 chickens at start of intervention), and seeds for red onion and indigenous 
greens (March 2018 and March 2019). The products will be accompanied by monthly nutrition 
and WASH trainings. The products and trainings will be provided free of charge. Additionally, 
all households will receive the agricultural package as in the control group. 
b) Control group: All households will be provided with agricultural training (every 2 weeks on 

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 19 of 43 
average) for free. In addition, households can also enrol for the following products on credit: 
compost booster, cook stoves, seeds (onions, maize, indigenous greens, beans), maize 
storage bags, drying tarps, trees, solar lights, fertilizer, actellic dust (insecticide), re-usable 
sanitary pads. 
We anticipate recruiting 2,000 (1,000 in each group) children 6-35 months of age into the study (see 
section 7.2 for sample size calculation). Children will be recruited from 100 clusters (randomly 
assigned to intervention or control) that will be drawn from Lugari district in Kakamega County located 
in the Western Province of Kenya.  
Questionnaire based and anthropometric data will be collected in 3 rounds at a central place in 
walking distance from participant’s homes one year apart from each other (Table 4). The following 
information will be collected in round 1 (baseline assessment prior to the actual start of intervention 
distribution): 
- 
Age 
- 
Height and weight 
- 
Household demographics/characteristics and caregiver’s education 
- 
Dietary diversity, breastfeeding and infant and young children feeding (IYCF) practices 
- 
WASH practices 
- 
Child morbidity 
In rounds 2 and 3, information on dietary diversity, breastfeeding and IYCF practices, WASH 
practices and child morbidity will be collected again. Additionally, changes in adherence and coverage 
of the intervention package as well as unintended outcomes (e.g. reduction of exclusive breastfeeding 
due to premature introduction of complementary foods) will be assessed. 
 
Table 4: Study 2 summary table of procedures and assessments 
Study Periods 
 
Intervention Period 
Visit/Round 
1 
2 
3 
Time (hour, day, week) 
Prior to start of 
intervention 
1 year after start 
of intervention 
2 years after start 
of intervention 
Age (Date of birth) 
x 
 
 
Anthropometry 
x 
x 
x 
Household 
demographics/characteristics 
x 
 
 
Mother’s/caregiver’s education 
x 
 
 
Dietary diversity, 
breastfeeding and child 
feeding practices 
x 
x 
x 
WASH practices 
x 
x 
x 
Child morbidity 
x 
x 
x 
Adherence to and coverage of 
intervention package 
 
x 
x 
 
 
7.2 Sample size and randomization 
 
Study 1 and 2: 
Some indicators included in study 1, such as maternal haemoglobin, child haemoglobin, and child 
length-for-age z score (LAZ), are measured more than once in the same study subject over time. This 
is also the case for haemoglobin and height-for-age z score (HAZ) in the children in study 2. For these 
indicators, the average change in outcomes in study subjects in the intervention group will be 
compared to the average change in study subjects in the control group. Other indicators in study 1, 
such as birth weight and length, are measured only once in each study subject. For these indicators, 
the average value in the intervention group will be compared to the average value in the control 
group.   
The sample size depends on the size of the desired minimum difference between the intervention 
group and the control group, which can be detectable with statistical significance. This minimum 

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 20 of 43 
difference is expressed as the effect size, which is the difference in the value of the indicator between 
the two groups to be compared divided by the standard deviation of the indicator. For those outcomes 
measured more than once, the indicator is the change over time in study subjects. This effect size can 
be written as follows: 
 
 
Where Cx and Cy stand for the two measurements of those indicators which are measured twice. 
The sample size calculations make the following assumptions: 1) a two-tailed comparison (that is, 
there is no a priori conclusion about which group is higher and which is lower), 2) statistical 
significance is defined as a p value less than 0.05, 3) the power of the study is at least 0.8, and 4) that 
the standard deviation of the indicator in both study groups is the same.  
Although it is difficult to find highly comparable interventions and their effect sizes for key outcomes 
put forth, Table 5 below provides an overview of observed effect sizes for somewhat similar 
interventions and outcomes.  
Table 5: Effect sizes in children for similar outcomes and interventions reported in the 
literature 
Description of intervention 
Reported outcome 
Effect size (95%CI) 
Reference 
Maternal education on 
complementary feeding and 
provision of complementary foods 
Weight gain 
0.34 (0.11, 0.56) 
[35] 
 
Linear growth 
0.26 (0.08, 0.43) 
Maternal education on 
complementary feeding alone 
Weight gain 
0.30 (0.05, 0.54) 
Linear growth 
0.21 (0.01, 0.41) 
Micronutrient powders 
Haemoglobin 
0.98 (0.55, 1.40) 
0.69 (0.07, 1.32) 
0.33 (0.87, 1.53) 
0.20 (-1.24, 1.64) 
[36-40]  
LAZ 
0.04 (-0.13, 0.22) 
Serum retinol 
1.66 (-1.60, 4.92) 
Serum ferritin 
1.78 (-0.31, 3.88) 
Lipid-based nutrient supplements 
(children) 
Haemoglobin 
0.63 (-0.48, 1.73) 
0.52 (1.84, 2.88) 
[41-43] 
 
Linear growth 
0.22 (0.05, 0.39) 
Weight gain 
0.25 (0.19, 0.31) 
Lipid-based nutrient supplements 
(pregnancy&infancy) 
Linear growth 
0.28 (0.07, 0.50) 
 [44] 
Weight gain 
0.24 (0.15, 0.33) 
Education on IYCF (programmes) 
Linear growth 
0.12 to 0.64 
[45] 
Weight gain 
-0.06 to 0.96 
Complementary foods and 
education on IYCF (programmes) 
Linear growth 
0.0 to 0.14 
Weight gain 
0.18 to 0.24 
Iron fortification (infants, pre-school 
and school-children) 
Haemoglobin 
0.55 (0.34, 0.76) 
[37,46] 
Serum ferritin 
0.91 (0.38, 1.44) 
Vitamin A fortification 
Serum retinol 
0.61 (0.39, 0.83) 
 
For study 1, considering field logistics (number of pregnant women that can be recruited within 3 
months in a manageable area) the number of pregnant women that is estimated to be available for 
recruitment into the study is 1,200. The primary outcome is change in length-for-age z-score (LAZ) in 
the children of enrolled women between birth and the end of follow up at 24 months of age. The effect 
size that is detectable takes into account the design effect of cluster randomization (design effect = 
1.3) which is based on the design effect found in other studies and study subject refusal and loss to 
follow up. For the latter, it was assumed that 95% of eligible pregnant women would consent to 
participation and that 80% of enrolled women would complete follow-up at delivery. Of children born to 
women completing follow-up, 95% would be recruited for continued follow-up, and 75% of enrolled 








1 
Group
2 
Group
1 
Group
 
deviation
 
Standard
 
Mean
 
Mean
Cy
Cx
Cy
Cx
Cy
Cx
LAZ
LAZ
LAZ
LAZ
LAZ
LAZ





 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 21 of 43 
children would still be enrolled at final data collection at 24 months of age. Taking into account all 
these assumptions for the recruitment of a total of 1,200 pregnant women (600 women in the control 
and 600 women in the intervention group) in 120 clusters this will allow detecting an effect size of 0.26 
in LAZ in children between 6-24 months of age, which is a reasonable effect size when compared to 
another study in which LNS was used during pregnancy and infancy (Table 5). Effect sizes for 
changes in haemoglobin concentration in children, one of the secondary outcomes in our study, are 
higher than for linear growth and thus our sample size will allow detecting changes in this indicator 
(Table 5). 
Sample size was also calculated for birth weight. From prior studies of birth weight in less-developed 
countries, an average birth weight in the study population of 3,000 g, a standard deviation of 500 g, 
and a birth weight 85 g larger in the intervention population was assumed. Furthermore, it was 
assumed that the study drop out will be at 20%.  A sample size of about 1,090 women is needed, or 
545 per study arm which is covered with the calculation for the primary outcome with 600 women per 
arm. 
For study 2, considering logistical challenges we estimated that a maximum of 2,000 children 6-35 
months of age could be recruited. The primary outcome is change in length-for-age z-score (LAZ) 
between enrolment and after 2 years of follow up. The effect size that is detectable takes into account 
the design effect of cluster randomization (design effect = 1.3) as in study 1 and assumes that 
caregivers of 95% of eligible children would consent to participation and that 80% of enrolled children 
would complete the 2 years follow-up. Taking into account all these assumptions for the recruitment of 
a total of 2,000 children (1,000 children in the control and 1,000 children in the intervention group) in 
100 clusters this will allow detecting an effect size of 0.17 in LAZ or HAZ in children between baseline 
and 2 years follow up, which is a reasonable effect size and has been shown in other studies before 
(Table 5). As in study 1, our sample size will allow detection of changes in haemoglobin concentration 
as effect sizes are higher than for linear growth (Table 5). 
 
As these are cluster-randomized studies, no individual randomization will take place. Clusters will be 
created according to village size and location with the aim to create clusters that correspond with 
village(s) boundaries and are big enough to likely have 10 pregnant women to be recruited in study 1, 
and 20 children in study 2. The clusters will be comprised of villages that are geographically close to 
one another and separate from other clusters. Once the clusters are determined, they will be 
randomly assigned to control or treatment in both studies.  
 
7.3 Study population 
 
7.3.1 
Eligibility criteria 
 
Participants fulfilling all of the following inclusion criteria are eligible for the study: 
Study 1: 
- 
Pregnant women (≥ 18 years of age) with gestational age ≤20 weeks 
- 
Written Informed Consent as documented by signature 
 
Study 2: 
- 
Children 6-35 months of age at recruitment 
- 
Written Informed Consent as documented by signature 
 
The presence of any one of the following exclusion criteria will lead to exclusion of the participant 
Study 1: 
- 
Family does not intend to stay within the study area for at least the following 30 months 
- 
Known history of allergy towards peanut or milk products 
- 
Visible severe disease 
 
Study 2: 
- 
Family does not intend to stay within the study area for at least the following 24 months 

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 22 of 43 
- 
Visible severe disease 
 
7.3.2 
Recruitment and screening 
 
Study 1: 
During community meetings and outreach CHVs will inform and 1AF field officers will screen potential 
participants. In case a woman declares to be pregnant, oral consent for a screening assessment 
including providing the date of last menstrual period and checking for inclusion/exclusion criteria will 
be taken. If woman is eligible written informed consent will be sought and the woman will be asked to 
provide a urine sample for a pregnancy test. Women will be enrolled in case pregnancy is confirmed. 
All pregnant women meeting all the inclusion/exclusion criteria will be included in the study until the 
anticipated sample size in each selected cluster is reached.  
 
Study 2: 
Household lists of farmers participating in the 1AF programme will be used to determine whether a 
household has at least one eligible child between 6-35 months of age. A child will be included once 
inclusion and exclusion criteria have been checked and written informed consent is obtained from the 
caregiver. The baseline assessment will then be conducted. 1AF field officers will be responsible for 
recruiting the selected children. 
 
7.3.3 
Criteria for withdrawal/discontinuation of participants 
 
Study 1: 
Pregnant women are free to withdraw themselves or their children from participation in the study at 
any time. If the pregnant woman is being diagnosed with severe anaemia (haemoglobin (Hb)<70g/L) 
or severe acute malnutrition (MUAC < 23 cm) at round 1, she will be excluded from participation and 
will be referred for treatment according to national guidelines to the nearest health centre. If the 
pregnant woman is being diagnosed with malaria parasitaemia and has an axillary temperature of 
>37.5°C in round 1, she will be referred for treatment but will continue participating in the study after 
temporary suspension from interventions if required as assessed by the study physician. If the 
pregnant woman has an Hb between 70 and 109 g/L in rounds 1 or 2, she will be advised by the 
study team to go to the hospital for further management. This will be facilitated by CHVs. If the 
mother, infant or child is being diagnosed with malaria parasitaemia and an axillary temperature of 
>37.5°C, or severe anaemia (Hb<70g/L), or they suffer from severe acute malnutrition (WHZ<-3 
and/or bilateral oedema for child, MUAC < 23 cm for mother) in rounds 2 to 5, affected participants 
will be referred for treatment according to national guidelines but will continue in the study after 
temporary suspension from interventions if required as assessed by the study physician. If a child is 
born with low birth weight (<2500 g) and/or has a Hb < 135 g/L, he/she will be referred for a medical 
check. Further, study participants will be discontinued from participation in the study in case of any 
clinical significant adverse event (AE), or any other medical condition or situation that prevents 
continued participation in the study. If a participant is discontinued no specific follow-up assessments 
will be conducted other than the follow up until resolution in case of exclusion due to a serious 
adverse event (SAE). Participants will not be replaced, as a non-consent and dropout rate of 46% 
prior to reaching 24 months of age is included in the sample size calculation.  
 
Study 2: 
Caregivers are free to withdraw their children from participation in the study at any time. If a child is 
being diagnosed with severe acute malnutrition (WHZ<-3 and/or bilateral oedema) at round 1, he/she 
will be excluded from participation and will be referred for treatment according to national guidelines 
to the nearest health centre. If a child suffers from severe acute malnutrition (WHZ<-3 and/or bilateral 
oedema) in rounds 2 and 3, affected participants will be referred for treatment according to national 
guidelines but will continue in the study after temporary suspension from interventions if required as 
assessed by the study physician. Further, study participants will be discontinued from participation in 
the study in case of any clinical significant adverse event (AE), or any other medical condition or 
situation that prevents continued participation in the study. If a participant is discontinued no specific 
follow-up assessments will be conducted other than the follow up until resolution in case of exclusion 
due to a serious adverse event. Participants will not be replaced, as a non-consent and dropout rate 
of 24% prior to the final assessment after 2 years is included in the sample size calculation.  

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 23 of 43 
7.4 Interventions 
LNS (Enov’ Mum) (to be provided to pregnant women and up to 6 months after delivery in 
intervention group in study 1) 
Enov` Mum has been designed based on recommendations of WHO, World Food Programme (WFP) 
and UNICEF [11] and is produced by Nutriset. This lipid-based Ready-to-Use Food supplement for 
home fortification aims at improving the nutrition and health status of pregnant and lactating women 
by filling micronutrients gaps in a non-emergency context thereby improving the development of the 
foetus and the infant. Enov’Mum is composed of the following ingredients: vegetable oils (rapeseed, 
palm, soy) skimmed milk powder, sugar, whey powder, peanuts, soy isolate, maltodextrin (corn), 
stabilizer (fully hydrogenated vegetable fat, mono- and diglycerides), vitamin and mineral complex, 
and aroma. This product does not contain any genetically modified organism and does not contain 
any ingredients of animal origin, except dairy products.  Enov’Mum will be provided in individual 20 g 
sachets (Figure 4) and pregnant and lactating women will consume one sachet per day containing 
essential fatty acids and one to two recommended daily allowances (RDA) of vitamins and minerals 
(Table 6). 
As adherence to antenatal iron/folic acid supplementation in Kenya is low (with 30.1% receiving no 
iron at all during pregnancy, 65% receiving any, but of those 53% receiving it for less than 60 days) [3] 
supplementing the women with LNS additionally is not expected to have any negative effects, and 
WHO guidelines during emergencies even state that iron/folic acid supplementation does not need to 
be discontinued while multiple micronutrient supplements are provided [11]. The participating 
pregnant women will remain under the national antenatal care services and will be encouraged to 
attend those in the same way as non-study participants are. 
 
Table 6: Composition of Enov’Mum per 20 g sachet 
Nutrient 
Unit 
20 g LNS portion 
Energy 
kcal 
120 
Protein 
g 
2.6 
Lipids 
g 
9.2 
Linoleic acid 
g 
1.58 
α-Linolenic acid 
g 
0.65 
Vitamin A, RAE 
mg 
800 
Thiamin (B1) 
mg 
1.4 
Riboflavin (B2) 
mg 
1.4 
Pyridoxine (B6) 
mg 
1.9 
Cobalamine (B12) 
μg 
2.6 
Folate, DFE 
μg 
600 
Vitamin C 
mg 
55 
Vitamin D 
μg 
15 
Vitamin E 
mg 
15 
Calcium 
mg 
60 
Copper 
mg 
1.15 
Iodine 
μg 
250 
Iron 
mg 
20 
Magnesium 
mg 
9 
Phosphorus 
mg 
57 
Potassium 
mg 
104 
Selenium 
μg 
30 
Zinc 
mg 
10 
 
 
 

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 24 of 43 
 
Figure 4: LNS Enov’Mum (daily portion) 
Anthelminthic treatment (to be provided to pregnant women in intervention group once during the 
second trimester) 
A single dose of 400 mg albendazole will be provided to all pregnant women in the intervention group 
during the second trimester (13-27 weeks of gestation).  
 
LNS (Enov’ Nutributter) (to be provided to children 6-24 months of age in intervention group in study 
1) 
Enov’Nutributter is a lipid based nutrient supplement produced by Nutriset and designed to promote 
infant growth, motor development and to prevent malnutrition in children 6-24 months of age. Its 
micronutrient content is especially calculated to meet the needs of a child in this age group (see Table 
7 for the composition). Enov’Nutributter is a paste based on peanuts, sugar, vegetable fat, skimmed 
milk powder, maltodextrin and whey, enriched with a vitamin and mineral complex and can either be 
consumed directly or added to the complementary food. Enov’Nutributter will be provided in individual 
20 g sachets (Figure 5) and caregivers will be instructed to feed one sachet per day..  
 
Table 7: Composition of Enov’Nutributter per 20 g sachet 
Nutrient 
Unit 
20 g LNS portion 
Energy 
kcal 
107 
Protein 
g 
2.6 
Lipids 
g 
6.9 
Linoleic acid 
g 
1.15 
α-Linolenic acid 
g 
0.27 
Calcium 
mg 
60 
Phosphorus 
mg 
86 
Potassium 
mg 
152 
Magnesium 
mg 
16 
Zinc 
mg 
4 
Copper 
mg 
0.2 
Iodine 
μg 
250 
Iron 
mg 
9 
Iodine 
μg 
90 
Selenium 
μg 
10 
Vitamin A, RAE 
mg 
400 
Vitamin C 
mg 
30 
Thiamin (B1) 
mg 
0.3 
Riboflavin (B2) 
mg 
0.4 
Pyridoxine (B6) 
mg 
0.3 
Cobalamine (B12) 
μg 
0.5 
Folic acid 
μg 
80 
Pantothenic acid 
mg 
1.8 
Niacin 
mg 
4 
Sodium 
mg 
<58 
 

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 25 of 43 
 
Figure 5: LNS Enov’Nutributter (daily portion) 
 
MNP (MixMe) (to be provided to children 6-59 months of age in intervention group in study 2) 
The MNP (MixMeTM) to be used is produced by the company DSM according to recommendations by 
WHO [12] and distributed by UNICEF and WFP with the aim to improve diet quality of nutritionally 
vulnerable groups, such as young children [47]. MNPs are dosed into sachets (Figure 6) containing 
the dry powder with micronutrients that can be added to any semi-solid or solid food that is ready for 
consumption.  
MNP will be provided in individual 1g sachets, which consist of the micronutrients as in Table 8. 
Children will consume 1 sachet every three days (120 days/year).  
 
Table 8: Vitamin and mineral content in a 1 g sachet of MNP 
Nutrient 
Unit 
MNP (1g portion) 
Vitamin A, RAE 
mg 
400 
Thiamin (B1) 
mg 
0.1 
Riboflavin (B2) 
mg 
0.5 
Niacin (B3) 
mg 
6 
Pyridoxine (B6) 
mg 
0.5 
Cobalamine (B12) 
μg 
0.9 
Folate, DFE 
μg 
150 
Vitamin C 
mg 
30 
Vitamin D 
μg 
5 
Vitamin E 
mg 
5 
Copper 
mg 
0.56 
Iodine 
μg 
90 
Iron 
mg 
10 
Selenium 
μg 
17 
Zinc 
mg 
4.1 
 

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 26 of 43 
 
Figure 6: 1g sachet of MNP (to be consumed every three days) 
 
Oral Rehydration Salts (ORS) and zinc (to be provided to offspring from 6 to 24 months of age in 
intervention group in study 1 and children 6-59 months of age in intervention group in study 2 in case 
of acute diarrhoea) 
Single dose packages of ORS and 20 mg zinc dispersible tablets will be provided to the mothers in 
the intervention group when the offspring turns 6 months old in study 1 and to all intervention 
households with recruited children in study 2. Mothers and caregivers will be taught on how to treat 
dehydration at home according to the recommendations of the Kenya National Formulary for Primary 
Care Level 2008 and of the WHO [48]. They will be instructed to contact their CHV if the child shows 
signs of dehydration or still symptomatic after 7 days. This will allow the CHV to refer the child to a 
clinic if needed. Mothers and caregivers will be given 14 zinc supplements (one 20 mg tablet daily for 
14 days) and 21 ORS sachets (10.3 g/sachet), which is enough ORS to treat the child for 
approximately 7 days.  Mothers will be instructed to give 50-100 mL of ORS after each loose stool for 
children 6-23 months of age (studies 1 and 2) and 100-200 mL after each loose stool for children > 23 
months of age (study 2). Additionally, the mothers and caregivers will be trained to administer one 
tablet of dispersible zinc daily for 14 days, which will shorten the current episode but will also prevent 
near future episodes. During regular visits by CHVs the used courses will be replaced. 
Individual sachets of DawaLyte ORS each containing 10.3 g and composed of anhydrous glucose, 
potassium chloride, sodium chloride and trisodium citrate) will be used in the study (Figure 7). 
JuniorZinc in the form of dispersible tablets (20 mg zinc as zinc sulphate per tablet) will be used in the 
study (Figure 8). Both products will be supplied by Dawa Ltd. 
 
 
Figure 7: ORS sachets to be distributed in study 1 and study 2 
 

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 27 of 43 
 
Figure 8: Zinc dispersible tablets to be used in study 1 and 2 
 
Chlorine solution (to all intervention households during the whole intervention period in both studies) 
Chlorine solutions will be distributed in 500 mL bottles (Aquaguard supplied by Supersleek Ltd.) once 
per year and mothers/caregivers will be trained on how to properly use it. 
 
Soap (to all intervention households during the whole intervention period in both studies) 
One 600 g bar of local soap will be provided per household per month.  
 
Raw eggs (to all intervention households in study 1) 
Raw eggs will be provided to the households during the whole duration of study 1. Pregnant and 
lactating women up to 6 months post-partum will receive 30 eggs every 2 weeks and will be 
encouraged to eat 2 eggs per day. Once the child turns 6 months, the families will receive 15 eggs 
every 2 weeks and the mothers will be encouraged to feed the child 1 egg per day. The eggs will be 
purchased regularly from carefully selected and monitored suppliers. All suppliers are approved by the 
County Public Health Officer and have food handling certificates. Additionally, all warehouse staff 
have food handling certificates. The warehouse where the eggs are stored has been assessed by the 
Public Health Officer and recommendations taken into account and modifications made. Approval has 
been  given to store eggs in the climate-controlled section of the warehouse. The eggs will be 
distributed to the women every other week. The eggs will be distributed every other week in order to 
make sure only fresh eggs are consumed which should not pose any risk to the participants. The 
participants will further be sensitized on the dangers of consuming raw eggs and advised to always 
boil/fry the egg before consumption and the need of hygiene when preparing dishes containing eggs. 
As the regular consumption of eggs is not common, the benefits of egg consumption will be explained 
to the mothers. Adherence to egg consumption will be monitored by interviewing the mothers monthly.  
 
Poultry (to all intervention households in study 2) 
All intervention households in study 2 will receive 8 birds of chicken when they receive their first 
bundle of products. Chickens that have died from disease or accident will be replaced the following 
year. 
 
Nutritionally enhanced seeds (to all intervention households in study 2) 
Seeds for red onion and indigenous greens (managu and sukuma), all traditionally bred, will be 
provided to enrolled households in study 2 in March 2018 and March 2019 to align with planting. Red 
Onions and Sukuma Wiki seeds will be supplied by East African Seed based in Nairobi and Managu 
seeds will be supplied by Kenya Seed Company based in Kitale, Kenya. 
 
Life stage appropriate nutrition and WASH trainings (to participating women in intervention group 
in study 1 and caregivers in intervention group in study 2) 
In study 1, CHVs will deliver monthly trainings to groups of mothers (according to their life cycle) and 
will additionally provide home counselling visits twice per month. In study 2, monthly training meetings 
(1 module per meeting) will be held by 1AF trainers. Training modules are currently being developed 
and may be adjusted for the study. The initial set of modules is presented in Table 9. 
 

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 28 of 43 
 
Table 9: Nutrition and WASH training modules that will be administered 
Module 
No. 
Life cycle 
Topic of training module 
1 
Pregnant women 
Nutrition for pregnant women – Diversity and frequency, caloric 
needs 
2 
Pregnant women 
Nutrition ANC care (folic acid, iron, deworming) 
3 
Pregnant women 
Impact of family planning on the nutritional status of a pregnant 
woman 
4 
Pregnant women 
Water treatment, storage, food sanitation and hygiene 
5 
Newborns (0 to 6 months) 
Immediate breastfeeding, colostrum and milk production 
6 
Newborns (0 to 6 months) 
Breastfeeding efficacy skills 
- Common problems 
- Positions 
7 
Newborns (0 to 6 months) 
Milk Supply 
- Biology 
- Extraction 
- Storage 
8 
Newborns (0 to 6 months) 
Breastfeeding on demand 
Feeding through illness 
9 
Newborns (0 to 6 months) 
Nutrition for the breastfeeding mother 
10 
Children under five 
Timely introduction to complementary foods  
11 
Children under five  
Routine health services and disease prevention 
- Growth Monitoring 
- Vitamin A 
- Deworming 
- Immunity and nutrition 
12 
Children under five 
Food diversity in child feeding 
- 6 months 
- 7 to 9 months 
- 9 to 11 months 
- 12 to 23 months 
- 24 to 59 months (study 2 only) 
13 
Children under five 
Food frequency in child feeding 
- 6 months 
- 7 to 9 months 
- 9 to 11 months 
- 12 to 23 months 
- 24 to 59 months (study 2 only) 
14 
Children under five 
Responsive feeding 
Feeding through illness 
15 
Children under five 
Sanitation and hygiene 
- Safe food handling 
- Handling of child faeces 
16 
Children under five 
Malnutrition 
17 
Children under five 
Water 
- Treatment, handling and storage 
18 
Children under five 
Hand washing 
19 
Children under five 
Micronutrient Powders 
 
 
SMS reminders on antenatal care and life stage appropriate nutrition (to pregnant women in 
intervention group in study 1) 
Messages will be sent using the mHealth (Mobile Health) technology Medic Mobile. Pregnant women 
will register their phones. CHVs will receive weekly messages on study activities and reminders to 
relay to pregnant women about routine antenatal care. Further, messages on key nutrition, hygiene 
and health topics will be sent regularly. These messages are currently being adapted from Mobile 
Alliance for Maternal Action (MAMA) content and field-tested and content will be finalised before study 
start. 

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 29 of 43 
 
Agriculture-focused package (to all households in intervention and control group in study 1 and 
study 2) 
The same agriculture intervention as in the control group will also be provided to the intervention 
group, as all the selected clusters are part of the 1AF agricultural programme. Agricultural training 
(every 2 weeks on average) will be provided to all households for free. Additionally, households can 
enrol for the following products on credit: compost boosters, cook stoves, seeds (onions, maize, 
indigenous greens, beans), maize storage bags, drying tarps, trees, solar lights, fertilizer, actellic dust 
(insecticide), re-usable sanitary pads. 
8. DATA COLLECTION 
8.1 Training and management of data quality 
 
Before field work starts, data collectors, CHV, and supervisors will undergo training which includes the 
data collection tools, interview techniques, anthropometry and blood sampling. The training will 
include both, theory and practice, as well as a field test to optimize and adjust the questionnaires and 
procedures. Pre- and post-tests will determine the most suitable candidates and only those who pass 
the tests will be eligible for recruitment, starting with those with the best results. Therefore, the 
number of training participants will be 30% higher than actually needed; this will allow selection of the 
best performing from a large pool and also yield a list of potential substitute candidates should some 
field staff no longer be available.  
 
Field staff interviewing participants will administer the questionnaires to each other and enter data into 
the tablets during the training. This will also help to revise the questionnaires based on any 
programming or survey wording errors. For anthropometry, a rigorous standardization practice will be 
conducted and the performance of each data collector (1AF enumerators) carefully evaluated so as to 
ensure highest quality of anthropometric measurements. The phlebotomists (lab technicians) will be 
specifically trained on capillary blood sampling by fingerprick and heelprick and on the use of the on-
site diagnostic tests (HemoCue analyser and RDTs for malaria) as well as on the blood processing 
steps and storage of serum samples for later analysis of micronutrient status. 
 
Prior to the start of the field work in the selected clusters, the teams will undergo a 2-day pilot test 
carried out in two clusters that are not part of the study. All steps of recruitment and data collection will 
be carried out as if it were for the study (including selection procedures, interviews, anthropometry, 
and blood sampling). Prior to each of the larger follow-up visits for study 1 (round 3, 4 and 5) and prior 
to each follow up round in study 2, a refresher training will be conducted on all team members. 
During the main rounds of assessment, international experts will be present during the initial data 
collection period to closely supervise fieldwork in order to ensure that procedures are being followed 
closely. 
 
To ensure a high quality of data collection, SOPs will be developed for the different persons involved 
in the study (SOPs for interviewers, phlebotomists, anthropometrists, team leaders and supervisors). 
Questionnaire-based data as well as anthropometric and blood-based data will be collected 
electronically in the field. That way real-time data monitoring will be conducted on an on-going basis 
in order to provide immediate feedback to the data collectors in case of sub-optimal data quality. In 
detail, all questionnaire-based data will be collected electronically using tablets and multiple forms for 
each study visit. They will be directly captured in a tablet. A paper form will be used for the collection 
of anthropometric and blood sampling results data as this will partly take place at a central place and 
will be recorded by other people than the questionnaire-based information. This also ensures source 
data to be available for the primary and main secondary indicators. Anthropometric and blood 
sampling data and results will be data entered into the tablet in the evening by the interviewer. All 
electronically captured data will be transferred to the appropriate password secured CommCare 
platform and will be available for data monitoring, cleaning and analysis for specific investigators. 
The CommCare interface enables to enter validation conditions for each question/parameter, which 
will be set in order to minimise the entry of wrong data (e.g. limiting the entry for gestational age to 2-
45). The data will also be checked in the CommCare database.  Additionally, regular back-checks will 
be conducted. For these, 10-15% of participants will be randomly re-surveyed on a selected subset of 

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 30 of 43 
questions to assess errors. Any enumerator with high error rates will be held back for retraining. 
Enumerators found falsifying data through the back-check process will be fired. 
 
Currently, a pilot study mimicking study 1 recruitment and distribution of interventions is being 
conducted and results will be taken into account in the final planning and training of field staff of study 
1.  
 
8.2 Quantitative data collection 
 
For the primary outcome, change in LAZ between birth and 24 months of age in study 1 and over 
the course of the 2 years programme activity in study 2, length will be measured at one or two central 
places in each selected cluster that are well accepted by the public (e.g. health post, house of village 
head or midwife). The length measurement will always be conducted by two trained people 
independently (duplicate). If the length differs by more than 7 mm, which was set as the maximum 
allowable difference for acceptable precision (to achieve a rate of re-measurement of around 5%) 
between the measurement of two observers in a big standardization session [49], the electronic data-
capturing device will prompt the anthropometrists to repeat both measurements. If a child is less than 
24 month, the child’s length will be measured lying down (recumbent) using a length board, which will 
be placed on a flat, stable surface such as a table. If the child is aged 24 month or older, standing 
height will be measured unless the child is unable to stand. A height board installed at a right angle 
between a level floor and against a straight, vertical surface such as a wall or pillar will be used.  
 
For the anthropometric secondary outcomes, proportion of stunted children (LAZ<-2SD), length 
will be measured as described for the primary outcome above in both studies. Additionally, child 
weight will be measured using a calibrated infant scale placed on a horizontal, stable and flat surface 
that will be checked with a test weight every day before starting the measurements and head 
circumference (HC, only in study 1) will be measured using a MUAC/HC tape. All assessments will be 
done in duplicate by two different anthropometrists. A maximum allowable difference between the two 
data collectors of 100 g will be allowed for weight and 5.0 mm for HC [49]. In study 1, the 
measurement of MUAC will be used to identify the proportion of malnourished women (MUAC < 23 
cm). MUAC will be measured on the left arm (hanging to the side of the body and relaxed) after 
having identified and marked the midpoint of the upper arm using a MUAC tape. All anthropometric 
measurements will be conducted by trained and standardized anthropometrists. Additionally, height 
and weight will be measured in women using the standard procedures as described above. 
 
Blood-based secondary outcomes measured in children in study 1 include: Haemoglobin 
concentration measured at birth and 6 and 24 months of age will be used to assess the change in 
haemoglobin concentration and proportion with anaemia (Hb< 11g/dL). SF (serum ferritin), CRP (C-
reactive protein) and AGP (alpha 1- acid glycoprotein) measured at 6 and 24 months of age will be 
used to assess the proportion with inflammation-adjusted iron deficiency (SF<12 μg/L) and the 
change in proportion with inflammation-adjusted iron deficiency. RBP (retinol binding protein), CRP 
and AGP measured at 6 and 24 months of age will be used to assess the proportion with 
inflammation-adjusted vitamin A deficiency (RBP<0.7 µmol/L) and the change of proportion with 
inflammation-adjusted vitamin A deficiency. 
 
Blood-based secondary outcomes measured in pregnant women include: Haemoglobin 
concentration measured at 34 weeks gestation and 6 months postpartum will be used to assess the 
change in haemoglobin concentration, the proportion with anaemia (Hb < 11 g/dL), and the change in 
the proportion with anaemia. SF, CRP and AGP measured at 34 weeks gestation will be used to 
assess the proportion with inflammation-adjusted iron deficiency (SF<15 μg/L). RBP, CRP and AGP 
measured at 34 weeks gestation will be used to assess the proportion with inflammation-adjusted 
vitamin A deficiency (RBP<0.7 µmol/L). 
The measurement of haemoglobin will be undertaken on-site using the HemoCue™ device and 
commercially available control blood. The control blood will be used every morning before measuring 
any participant’s blood sample. SF, RBP, CRP and AGP will be measured using the enzyme linked 
immunosorbent assay (ELISA) technique at the VitMin laboratory in Germany which is using control 
samples to assure high quality results. At the different time points, capillary blood will be collected 
from mothers and eligible children by experienced technicians trained for the techniques used in this 
evaluation. For children below 12 months of age, capillary blood will be collected by sticking the heel 

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 31 of 43 
using lancets appropriate for this age group. For women and children above 12 months old, capillary 
blood will be collected by sticking the middle or ring finger. The first blood drop will be swiped, the 
second and third drop collected (approximately 10 µl) will be used for the on-site analysis of anaemia 
and malaria (see section 9.2.3 for malaria as an outcome). This will be done in rounds 1, 2, and 4 in 
women, and in rounds 3, 4, and 5 for children. Additionally, micronutrient status will be assessed at 
round 2 in women and rounds 4 and 5 in children for which approximately 300µl of capillary blood will 
be collected in Microtainers™ (Sarstedt, Germany) and stored in portable cold boxes for the day and 
later aliquoting and freezing of the serum.  
 
Diarrhoea incidence rate between birth and 24 months of age will be assessed monthly between 
study rounds 3 and 5 using questionnaires by trained enumerators. 
 
8.2.1 
Data collection instruments 
In all assessment rounds in study 1 and 2, questionnaires will be administered to the participant or the 
participants’ mother/caregiver by previously trained study staff. The type of modules and in which 
study they are used are summarized in Table 10. 
 
Table 10: Summary of modules used to collect information through questionnaires. 
Module 
Study 1 
Study 2 
Household demographics 
x 
x 
Household characteristics 
x 
x 
Maternal education/occupation 
x 
x 
Maternal information on pregnancies and child birth 
x 
x 
Knowledge, attitude and practices (KAP) of dietary and nutrition 
practices during pregnancy and lactation 
x 
 
Woman dietary diversity 
x 
 
Antenatal care 
x 
 
Postnatal care 
x 
 
Knowledge and consumption of study specific intervention products 
x 
x 
Knowledge and practices on Water, sanitation and hygiene (WASH) 
x 
x 
Initiation of breastfeeding 
x 
x 
Infant and young child feeding indicators (IYCF) 
x 
x 
Child illness 
x 
x 
Adherence 
x 
x 
 
8.3 Qualitative data collection 
 
Not applicable 
 
8.4 Ethical issues 
The decision of the Ethics Committee of the Canton of Zurich (KEK Zurich) regarding a ‘no objection 
statement’ as well as the decision of the AMREF’s (African Medical & Research Foundation) Ethics & 
Scientific Review Committee (ESRC) in Kenya concerning the conduct of the study will be made in 
writing to the Sponsor-Investigator before commencement of this study. The clinical study will only 
begin once approval (or no objection statement) from both Ethics Committees has been received. Any 
additional requirements imposed by the ESRC will be implemented to the best possible. Substantial 
amendments are only implemented following prior approval of the ESRC. 
 
Previously trained 1AF enumerators will explain to each participant in study 1 or to caregivers of 
children participating in study 2 the nature of the study, its purpose, the procedures involved, the 
expected duration, the potential risks and benefits and any discomfort it may entail. The information 
will be provided in the language best understood by the participant/caregiver (Swahili and Luhya). 
Each participant or caregiver will be informed that the participation in the study is voluntary and that 
she may withdraw herself or her child from the study at any time and that withdrawal of consent will 
not affect her and/or her child’s subsequent medical assistance and treatment.  

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 32 of 43 
The participant will be informed that her and or/her child’s medical records may be examined by 
authorised individuals other than health care staff if need arises. 
All participants for the study or caregivers of participating children will be provided a participant 
information sheet (in Swahili or Luhya) and a consent form describing the study and providing 
sufficient information for the participant or the caregiver to make an informed decision about their own 
or their child’s participation in the study. In case of illiterate participants/caregivers, the study will be 
explained in the presence of an impartial witness or read out by the impartial witness that is chosen 
by the potential study participant. Enough time will be given to the participants/caregivers to decide 
whether to participate or not. This is particularly important as in some circumstances the 
caregiver/pregnant woman may need to await her husband’s/the head of household’s approval for 
participation.  
The participant information sheet and the consent form will be submitted to the KEK Zurich and to the 
local ESRC to be reviewed and approved. The formal consent of a participant, using the approved 
consent form, will be obtained before the participant is submitted to any study procedure.   
The participant/caregiver of participating children will read, or have read in case of illiterate 
participants in the presence of an impartial witness, and consider the statement before signing and 
dating the informed consent form, and will be given a copy of the signed document. The consent will 
also be signed and dated by the investigator (or his designee) and it will be retained as part of the 
study records. 
For study 1, consent will be taken from the pregnant woman for herself and her offspring. Participants 
will not receive any compensation for their participation but will receive baby clothing and blankets as 
a small incentive (both control and intervention group).  
For study 2, consent will be taken from the caregiver of the participating child. Participants will not 
receive any compensation for their participation but will receive blankets as a small incentive (both 
control and intervention group).  
 
The investigator affirms and upholds the principle of the participant's right to privacy and that they 
shall comply with applicable privacy laws. Especially, anonymity of the participants will be guaranteed 
when presenting the data at scientific meetings or publishing them in scientific journals.  
Individual subject medical information obtained as a result of this study is considered confidential and 
disclosure to third parties is prohibited, except in circumstances where medical follow-up is required 
pursuant to information obtained. Subject confidentiality will be further ensured by utilising subject 
identification code numbers to correspond to treatment data in the computer files. 
Direct access to source documents will only be permitted to the advisory board (see below) members 
if requested by them. Access to all study related documents (protocol, questionnaires, dataset, 
randomization code, etc.) during and after the study will be managed by the sponsor-investigator who 
will delegate access to the respective documents. 
 
Data from the two studies will be stored on CommCare’s secure cloud server. Only selected 1AF 
Kenya Monitoring & Evaluation staff and GroundWork investigators will have access to the password-
protected data on CommCare. They will be able to access the data as it is uploaded from the tablets. 
De-identified data will be downloaded regularly on password-protected servers for monitoring 
purposes, which will serve as a back-up. 
 
The serum samples collected for the analysis of micronutrient status will be stored until final lab 
results are received and validated from the VitMin Lab. Six months after the results are considered as 
final, the samples will be destroyed. The duplicate sample, which will be held as back-up samples in 
Kenya in case something happens to the samples during shipment to Germany, will also be destroyed 
six months after results are considered final. 
 
The investigators suggest having an advisory board that will review the protocol, tools and baseline 
reports, followed by moderated teleconferences to discuss course correction. They would also review 
the final reports. The following people have accepted to be on the advisory board: 
 
Prof. James Jay Berkley, KEMRI-Wellcome Trust, Kilifi, Kenya 
Dr. Sophie Moore, King’s College London, London, UK 
Dr. Seth Adu-Afarwuah, University of Ghana, Accra, Ghana 
 

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 33 of 43 
9. DATA PROCESSING AND ANALYSIS 
9.1 Data processing 
 
The CommCare platform will be used for this study. All forms will be programmed by Kelvin Musau 
(Monitoring  & Evaluation Nutrition Associate and local PI) and the CommCare coding will be verified 
by an experienced Monitoring & Evaluation Project Specialist. Most data will be collected 
electronically using tablets and once collected will automatically be transferred and stored on 1AF’s 
account on the CommCare server. All forms will be pretested in the field. Data captured on paper 
forms first (anthropometry and blood results) will be entered into the tablets in the evening of the 
same day and together with that days participant’s form uploaded to CommCare. Incoming data will 
be checked regularly, on a daily base initially, and edited according to query forms. 
 
9.2 Data analysis 
The intervention group will be compared to the control group in both studies using the intention to 
treat approach as this is not a strictly controlled clinical trial and adherence is one of the outcomes.  
Data analysis will be done researcher-blinded, meaning that the data analyst will not be provided with 
the keys to the group assignments before completion of data analysis. A data analysis plan will be 
elaborated once the study protocol is approved by the ethics committee and well in advance of the 
actual data analysis. 
 
9.2.1 
Primary analysis 
 
The intended primary analysis (primary outcome) will be conducted by Bradley Woodruff using SPSS 
once a clean dataset is available.  
 
Study 1 and 2: 
Anthropometric indices derived from measurements collected during study 1 and study 2 will be 
calculated using the WHO Child Growth Standard. Differences will be considered significant if p < 
0.05, and interactions will be considered significant if p < 0.1. Covariates will include at least 
household socio-economic status, sex, and age. Regression models will be applied to analyse the 
effect of programme adherence. 
Mean change in LAZ or HAZ measures will be compared between the two study arms in both studies 
using linear regression analysis. Details of the statistical methods will be outlined in the statistical 
analysis plan that will be elaborated once the protocol has been reviewed by the advisory board and 
approved by the ethics committees. 
 
9.2.2 
Secondary analyses 
 
The intended secondary analysis (secondary outcomes) will be conducted by Bradley Woodruff using 
SPSS once a clean dataset is available.  
 
Study 1 and 2 (main secondary analyses): 
For both studies, the values for continuous variables, including MUAC, birth weight, birth length, HC, 
Hb, SF, RBP, CRP, AGP, TfR (transferrin receptor), and anthropometric indices, will be checked for 
normality of distribution, and non-normally distributed variables will be either transformed to obtain 
normality or analysed using non-parametric methods. Mean change in outcome measures will be 
compared between the two study arms using simple paired t-tests or for multivariate analysis using 
linear regression analysis. All measures of precision and statistical significance will be adjusted for the 
complex sampling employed. Differences will be considered significant if p < 0.05, and interactions 
will be considered significant if p < 0.1. Covariates will include at least household socio-economic 
status, sex, and age. Regression models will be applied to analyse the effect of programme 
adherence. 
Details of the statistical methods will be outlined in the statistical analysis plan that will be elaborated 
once the protocol has been reviewed by the advisory board and approved by the ethics committees. 
 
Study 1 and 2 (additional secondary analyses): 

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 34 of 43 
We will look at potential negative effects of the intervention and will assess whether there is a 
difference between the intervention and control group with respect to: 
- 
a lower proportion of the children less than 6 months of age are exclusively breastfed 
- 
complementary food is introduced too early 
- 
dietary diversity is lower in pregnant/lactating women and children 
- 
there is an increase of overweight and obesity in pregnant/lactating women and children 
- 
there is an increase of morbidity incidences such as diarrhoea in the children (this is 
monitored monthly) 
Overweight and obesity will be defined as BMI > 25 and 30 for the women, respectively. For children, 
overweight will be defined as a weight-for-height z-score of greater than +2.0 but less than or equal to 
+3.0 and obesity as a weight-for-height z-score greater than +3.0.  
Details of the statistical methods will be outlined in the statistical analysis plan that will be elaborated 
once the protocol has been reviewed by the advisory board and approved by the ethics committees. 
 
9.2.3 
Interim analyses 
 
An interim analysis comparing birth length and weight between the intervention and control group as 
well as indicators collected during pregnancy (MUAC, weight, haemoglobin) will be conducted.  
Further, small basic interim analysis after each round of data collection will be conducted in order to 
use them for interim reports which will only contain the most highly-relevant information and will be 
sent to the advisory board members. 
These interim analyses will be performed by another statistician in order to make sure that Bradley 
Woodruff remains blinded for the main analysis.  
 
9.2.4 
Handling of missing data and drop-outs 
In both studies, subjects without one of a paired measurement will not be included in the final analysis 
of change over time.  In addition, in both studies, subjects missing the single outcome measurement 
will be included in the analysis of change over time.  As a result, we will assume that drop-outs of 
subjects missing a specific measurement will not differ substantially from those subjects for whom 
complete measurements are available.  
 
10. PLAN FOR COMMUNICATING FINDINGS OF THE STUDY 
10.1 
Dissemination strategy 
 
The dissemination of the evaluation will be conducted using four concurrent dissemination activities. 
   
1. Reporting of study results: The results from the various studies will be documented in multiple 
study reports, produced following each round of data collection for the two studies. Reports 
containing data from one data collection round will contain only the most highly-relevant 
information to make programmatic decisions. Following the completion of all data collection 
rounds for each evaluation activity, a comprehensive report will be produced containing all 
relevant information.  
2. Peer-reviewed publications: Following completion of the various reports, further analyses on 
the data will be conducted and manuscript(s) will be submitted to peer-reviewed journals.  
3. Presentation at national and international meetings and conferences: Following the 
completion of the study reports, results, in part or as a whole, will be presented to 
stakeholders. In addition, abstracts describing key results will be submitted for presentation at 
relevant meetings and conferences.  
4. At the end of the study, the participating communities will be informed about the results of the 
study. This will include findings on the main study outcomes but also findings on product 
adherence and acceptability of the participating women and children. Possible next steps 
depending on the findings will also be highlighted to the communities. 
 

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 35 of 43 
10.2 
Involvement of stakeholders 
 
After receiving all the necessary ethics and government approvals, One Acre Fund will conduct 
introductory meetings with County health management teams, government administration and any 
present partner working on nutrition in order to introduce the two studies to these stakeholders. 
Further, the aim and reason of the two studies will be introduced to all community members through 
sensitization meetings. A focus will be on the interventions being tested and the community’s equal 
chance of being selected into the intervention or control group. We also plan to provide process 
evaluation and reporting of indicators to relevant stakeholders as part of routine program updates and 
to strengthen working relations.  
 
10.3 
Potential policy implications 
 
The two studies compare a purely agricultural intervention with an integrated intervention including 
nutrition and hygiene interventions in addition to the agricultural approach. If the study results show 
improved growth and micronutrient status in children in the integrated approach group when 
compared to the agricultural group alone, this may result in changing some of the existing policies 
towards a more integrated approach rather than trying to improve agriculture alone, nutrition alone or 
hygiene (WASH) alone. Further, in case of positive results with respect to growth and anemia 
prevention in study 1, this may help to formulate guidelines for the use of LNS in a non-emergency 
context adding to the growing body of evidence that LNS may indeed help in improving growth and 
development in low-income countries. Similarly, study 2 may add to the existing evidence of the effect 
of micronutrient powders on micronutrient status. The results may also lead to a change of local 
nutrition guidelines.  
 
By referring study participants who are malnourished, anaemic or have a positive RDT result for 
malaria accompanied by fever (>37.5°C), using the existing referral system this may indicate where 
specific treatment centres for malnutrition and anaemia are most required and could help in improving 
the situation. 
 
In summary, children and pregnant women in other regions of Kenya and other parts of the world with 
similar climatic and environmental settings may benefit from the study results, which will hopefully 
help in formulating guidelines and policies. 
 
11. STUDY LIMITATIONS AND RISKS 
11.1 
Limitations of study design 
The longitudinal design in both studies is a strong design as within subject comparison is possible, 
particularly for anthropometry and blood-based data. This design however has its drawbacks, 
particularly when using questionnaires, as participants may remember questions and may be aware 
what the answers should be and thereby introducing bias. This is particularly a limitation for study 1 in 
which some questionnaires are administered in consecutive rounds that may only be apart from each 
other by a couple of months. This is less of an issue in study two in which the assessment rounds are 
2 years apart.  
 
For study 2, choosing a longitudinal design forces us to widen the age range at admission in order to 
keep the study size manageable. This may lead to a more heterogeneous study population and bears 
the potential to mask certain findings that are more probable to take place in a very narrow age range 
only.  
 
By conducting the studies in a rather narrow area of Western Kenya, the findings might not be directly 
extrapolated to the rest of the country or to other countries. However, results might be applicable to 
many countries in Africa where farming is the main source of income/occupation. 
 
11.2 
Major assumptions 
In both studies, subjects without one of a paired measurement will not be included in the final analysis 
of change over time. In addition, in both studies, subjects missing the single outcome measurement 

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 36 of 43 
will be included in the analysis of change over time. As a result, we will assume that drop-outs of 
subjects missing a specific measurement will not differ substantially from those subjects for whom 
complete measurements are available.  
 
 
12. MANAGEMENT AND ORGANIZATION OF THE STUDY 
12.1 
Team members and roles 
 
The studies will be mainly managed and led by the Sponsor-Investigator, Dr. Fabian Rohner, the 
Principal Investigator, Dr. Rita Wegmüller and the Local Principal Investigator Mr. Kelvin Musau. They 
will be supported in different areas by all the other investigators. Detailed responsibilities of each team 
member are illustrated in Table 11. 
 
 
Table 11: Responsibilities of team members 
Name 
Role in study 
Responsibilities 
Dr. Fabian Rohner 
Sponsor-Investigator 
- 
Overall management of the studies 
- 
Supervision of training of investigators 
- 
Monitoring of studies 
- 
Ensuring all the ethics approvals are obtained 
- 
Ensuring that the trial is conducted according to the 
protocol 
- 
Ensure that required infrastructure, equipment, 
expertise, and trained staff is available 
- 
Ensure SAEs are reported to the ethics committee 
Dr. Rita Wegmüller 
Principal Investigator 
- 
Ensure studies are conducted according to the 
protocol 
- 
Development of SOPs 
- 
Development, testing and revision of study forms 
- 
Conduct of study staff training 
- 
Regular data monitoring and data quality checks 
- 
Ensure AEs and SAEs are collected and reported 
- 
Coordinate lab analysis 
- 
Write up of final study report 
Mr. Kelvin Musau 
Local Principal 
Investigator 
- 
Assist in the development, testing and revision of 
study forms 
- 
Programming of study forms 
- 
Ensure studies are conducted according to the 
protocol 
- 
Manage the field teams (interviewers, nurses) 
- 
Conduct of study staff training 
- 
Daily data monitoring 
- 
Daily monitoring of field staff 
- 
Conduct and evaluate regular quality checks in the 
field 
- 
Ensure AEs and SAEs are collected and reported 
- 
Ensure participant information is explained 
accurately 
- 
Maintain accurate records including consent forms 
Ms. Haley Kawaja 
Co-Principal 
Investigator 
- 
Content creation for nutrition trainings and lessons 
- 
Lead the trial design from a process and logistical 
perspective 
- 
Support development and review of study protocols 
and implementation guides 
- 
Lead product vetting and product ordering through 

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 37 of 43 
local and global procurement means  
- 
Oversee the logistical coordination of storing 
products, packaging products in the warehouses, 
and delivering products to participants 
- 
Support in recruitment, interviewing and hiring of 
staff  
- 
Oversee printing and procurement of all study 
materials 
Ms Marion 
Kiprotich 
Co-Principal 
Investigator 
- 
Government relations and policy 
- 
Interpret and explain laws and policies applicable to 
this study. 
- 
Ensures study compliance with govt and regulators-
NACOSTI/AMREF/KNDI/PPB. 
- 
Training of nutrition staff on Anthropometry, 
standardization and quality checks. 
- 
Timely reporting of SAEs/AEs to IRB 
- 
Work closely with study doctor on referrals and 
follow ups 
- 
Periodic reports to government/stakeholders and 
regulators 
- 
Point person between One Acre Fund & AMREF 
ESRC 
Dr. med. Tim 
Chindia 
Co-Investigator 
(Study Clinician) 
- 
Provide for study-related medical care of study 
participants 
- 
Facilitate referrals 
- 
Ensure correct and complete adverse event and 
serious adverse event assessment and reporting 
Ms. Emily Lloyd 
Co-Investigator 
- 
Assist PIs in study implementation 
- 
Assist PIs in training of staff 
- 
Product procurement: ensure that sufficient supply 
of intervention products are available 
- 
Donor communications 
Dr. Maya Duru 
Co-Investigator 
- 
Advise on research design 
- 
Ensure data quality 
- 
Advise on final data analysis 
- 
Contribute to the final reporting 
Dr. med. Bradley 
A. Woodruff 
Co-Investigator 
(Statistician) 
- 
Develop statistical analysis plan 
- 
Conduct statistical analysis 
- 
Conduct second evaluation of SAEs 
Dr. Nicolai Petry 
Co-Investigator 
- 
Assist PI in the development of forms 
- 
Assist PI in staff training 
- 
Contribute to the final reporting 
Mr. James Wirth 
Co-Investigator 
- 
Assist PI in staff training 
- 
Contribute to the final reporting 
 
12.2 
Other resources and facilities 
 
Not applicable

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 38 of 43 
 
12.3 
Timelines 
 
The detailed schedule of the two studies is outlined below (Table 12). The training of study 2 staff is planned to start in late January while the training for study 
1 is planned for April. 
 
Table 12: Gant chart 
 

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 39 of 43 
 
12.4 
Budget 
 
The overall budget that is available to conduct the two studies is $ 2,055,458. An overview of the 
detailed budget categories by year is given in Table 13. 
 
Table 13: Budget summary by budget category and year 
Summary by budget category 
Cost 
  
Year 1 
Year 2 
Year 3 
Staff - research international 
 $74'820  
 $72'180  
 $134'880  
Staff - research national 
 $93'100  
 $93'100  
 $93'100  
Staff - program international 
 $59'850  
 $59'850  
 $59'850  
Staff - program national 
 $119'700  
 $119'700  
 $119'700  
International travel 
 $18'069  
 $16'999  
 $11'034  
National travels 
 $59'302  
 $54'452  
 $6'552  
Program supplies (product bundles) 
 $174'420  
 $171'420  
 $109'420  
Medical evaluations (referrals, clinician) 
 $23'500  
 $23'500  
 $23'500  
Data collection - equipment, commodities 
 $37'716  
 $26'016  
 $56'616  
Laboratory analysis and shipment 
 $14'620  
 $14'620  
 $48'620  
Program and govt staff training 
 $66'600  
 $21'600  
 $16'600  
Other costs (translation, enumerator 
training...) 
 $13'936  
 $6'436  
 $5'236  
Subtotal 
 $615'580  
 $492'820  
 $498'055  
Indirect cost 
 $7'874  
 $6'605  
 $14'368  
Total 
 $763'506  
 $639'477  
 $652'475  
 
 
 

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 40 of 43 
13. REFERENCES 
 
1. Development Initiatives (2017) Global Nutrition Report 2017: Nourishing the SDGs. Bristol, UK: 
Development Initiatives. 
2. WHO (2017) World Health Statistics 2017: Monitoring health for the SDGs, Sustainable 
Development 
Goals. 
http://apps.who.int/iris/bitstream/10665/255336/1/9789241565486-
eng.pdf?ua=1: Geneva: World Health Organization. 
3. 
DHS 
(2015) 
Kenya 
Demographic 
and 
Health 
Survey 
2014. 
http://dhsprogram.com/pubs/pdf/FR308/FR308.pdf: Kenya National Bureau of Statistics, 
Ministry of Health, Nationla AIDS Control Council, Kenya Medical Research Institute, National 
Council for Population and Development, The DHS Program, ICF International. 
4. Disease GBD, Injury I, Prevalence C (2016) Global, regional, and national incidence, prevalence, 
and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis 
for the Global Burden of Disease Study 2015. Lancet 388: 1545-1602. 
5. Kassebaum NJ, Collaborators GBDA (2016) The Global Burden of Anemia. Hematol Oncol Clin 
North Am 30: 247-308. 
6. MoH (unpublished (expected end 2016)) Kenya National Micronutrient Survey, KNMS 2011. 
Ministry of Health, UNICEF, GAIN, WHO, MI, WFP. 
7. UNICEF/UNU/WHO (2001) Iron Deficiency Anaemia: Assessment, prevention and control; A guide 
for 
programme 
managers. 
http://apps.who.int/iris/bitstream/10665/66914/1/WHO_NHD_01.3.pdf?ua=1: Geneva: World 
Health Organization. 
8. Senbanjo IO, Olayiwola IO, Afolabi WA, Senbanjo OC (2013) Maternal and child under-nutrition in 
rural and urban communities of Lagos state, Nigeria: the relationship and risk factors. BMC 
Res Notes 6: 286. 
9. Fanzo J (2014) Strengthening the engagement of food and health systems to improve nutrition 
security: Synthesis and overview of approaches to address malnutrition. Global Food Security 
3: 183-192. 
10. 1AF (2016) One Acre Fund- Annual Report 2016. https://www.oneacrefund.org/uploads/all-
files/2016_AnnualReport_r1.pdf: One Acre Fund. 
11. WHO (2007) Preventing and controlling micronutrient deficiencies in populations affected by an 
emergency. 
http://www.who.int/nutrition/publications/micronutrients/WHO_WFP_UNICEFstatement.pdf: 
World Health Organisation, World Food Programme, UNICEF  
12. WHO (2016) WHO guideline: Use of multiple micronutrient powders for point- of- use fortification 
of foods consumed by infants and young children aged 6- 23 months and children aged 2-12 
years. 
http://apps.who.int/iris/bitstream/10665/252540/1/9789241549943-eng.pdf?ua=1: 
Geneva: World Health Organization. 
13. 
WHO/UNICEF 
(2004) 
Clinical 
management 
of 
acute 
diarrhoea. 
http://apps.who.int/iris/bitstream/10665/68627/1/WHO_FCH_CAH_04.7.pdf: 
World 
Health 
Organization, UNICEF. 
14. FAO (2015) FAO Statistical Pocketbook 2015: World food and agriculture. http://www.fao.org/3/a-
i4691e.pdf: Rome: Food and Agriculture Organization of the United Nations. 
15. Suchdev PS, Ruth LJ, Woodruff BA, Mbakaya C, Mandava U, et al. (2012) Selling Sprinkles 
micronutrient powder reduces anemia, iron deficiency, and vitamin A deficiency in young 
children in Western Kenya: a cluster-randomized controlled trial. Am J Clin Nutr 95: 1223-
1230. 
16. Food and Nutrition Board, Institute of Medicine (2005) Dietary Reference Intakes for Energy, 
Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids: The National 
Academic Press, Washington, D.C. 
17. Food and Nutrition Board, Institute of Medicine (2001) Dietary Reference Intakes for Vitamin A, 
Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, 
Silicon, Vanadium, and Zinc: The National Academic Press, Washington, D.C. 
18. Webb P, Kennedy E (2014) Impacts of agriculture on nutrition: nature of the evidence and 
research gaps. Food Nutr Bull 35: 126-132. 
19. Adu-Afarwuah S, Lartey A, Okronipa H, Ashorn P, Zeilani M, et al. (2015) Lipid-based nutrient 
supplement increases the birth size of infants of primiparous women in Ghana. Am J Clin Nutr 
101: 835-846. 

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 41 of 43 
20. Ashorn P, Alho L, Ashorn U, Cheung YB, Dewey KG, et al. (2015) The impact of lipid-based 
nutrient supplement provision to pregnant women on newborn size in rural Malawi: a 
randomized controlled trial. Am J Clin Nutr 101: 387-397. 
21. Dewey KG, Mridha MK, Matias SL, Arnold CD, Cummins JR, et al. (2017) Lipid-based nutrient 
supplementation in the first 1000 d improves child growth in Bangladesh: a cluster-
randomized effectiveness trial. Am J Clin Nutr 105: 944-957. 
22. De-Regil LM, Suchdev PS, Vist GE, Walleser S, Pena-Rosas JP (2011) Home fortification of foods 
with multiple micronutrient powders for health and nutrition in children under two years of age. 
Cochrane Database of Systematic Reviews. 
23. Rah JH, dePee S, Kraemer K, Steiger G, Bloem MW, et al. (2012) Program experience with 
micronutrient powders and current evidence. J Nutr 142: 191S-196S. 
24. Rohner F, Zimmermann MB, Amon RJ, Vounatsou P, Tschannen AB, et al. (2010) In a randomized 
controlled trial of iron fortification, anthelmintic treatment, and intermittent preventive 
treatment of malaria for anemia control in Ivorian children, only anthelmintic treatment shows 
modest benefit. J Nutr 140: 635-641. 
25. Glinz D, Hurrell RF, Ouattara M, Zimmermann MB, Brittenham GM, et al. (2015) The effect of iron-
fortified complementary food and intermittent preventive treatment of malaria on anaemia in 
12- to 36-month-old children: a cluster-randomised controlled trial. Malar J 14: 347. 
26. Wegmuller R, Camara F, Zimmermann MB, Adou P, Hurrell RF (2006) Salt dual-fortified with 
iodine and micronized ground ferric pyrophosphate affects iron status but not hemoglobin in 
children in Cote d'Ivoire. J Nutr 136: 1814-1820. 
27. Lazzerini M, Wanzira H (2016) Oral zinc for treating diarrhoea in children. Cochrane Database 
Syst Rev 12: CD005436. 
28. Salam RA, Haider BA, Humayun Q, Bhutta ZA (2015) Effect of administration of antihelminthics 
for soil-transmitted helminths during pregnancy. Cochrane Database Syst Rev: CD005547. 
29. WHO (2017) Guideline: Preventive chemotherapy to control soil-transmitted helminth infections in 
at-risk population groups. http://apps.who.int/iris/bitstream/10665/258983/1/9789241550116-
eng.pdf?ua=1: Geneva: World Health Organization. 
30. Strunz EC, Addiss DG, Stocks ME, Ogden S, Utzinger J, et al. (2014) Water, sanitation, hygiene, 
and soil-transmitted helminth infection: a systematic review and meta-analysis. PLoS Med 11: 
e1001620. 
31. Curtis V, Cairncross S (2003) Effect of washing hands with soap on diarrhoea risk in the 
community: a systematic review. Lancet Infect Dis 3: 275-281. 
32. Dangour AD, Watson L, Cumming O, Boisson S, Che Y, et al. (2013) Interventions to improve 
water quality and supply, sanitation and hygiene practices, and their effects on the nutritional 
status of children. Cochrane Database Syst Rev: CD009382. 
33. Bhutta ZA, Nelson EA, Lee WS, Tarr PI, Zablah R, et al. (2008) Recent advances and evidence 
gaps in persistent diarrhea. J Pediatr Gastroenterol Nutr 47: 260-265. 
34. Woodruff BA, Wirth JP, Bailes A, Matji J, Timmer A, et al. (2017) Determinants of stunting 
reduction in Ethiopia 2000 - 2011. Matern Child Nutr 13. 
35. Imdad A, Yakoob MY, Bhutta ZA (2011) Impact of maternal education about complementary 
feeding and provision of complementary foods on child growth in developing countries. BMC 
Public Health 11 Suppl 3: S25. 
36. Salam RA, MacPhail C, Das JK, Bhutta ZA (2013) Effectiveness of micronutrient powders (MNP) 
in women and children. BMC Public Health 13: S22. 
37. Petry N, Olofin I, Boy E, Donahue Angel M, Rohner F (2016) The Effect of Low Dose Iron and Zinc 
Intake on Child Micronutrient Status and Development during the First 1000 Days of Life: A 
Systematic Review and Meta-Analysis. Nutrients 8. 
38. Locks LM, Reerink I, Tucker Brown A, Gnegne S, Ramalanjaona N, et al. (2017) The Impact of 
Integrated Infant and Young Child Feeding and Micronutrient Powder Intervention on Feeding 
Practices and Anemia in Children Aged 6-23 Months in Madagascar. Nutrients 9. 
39. Macharia-Mutie CW, Moretti D, Van den Briel N, Omusundi AM, Mwangi AM, et al. (2012) Maize 
porridge enriched with a micronutrient powder containing low-dose iron as NaFeEDTA but not 
amaranth grain flour reduces anemia and iron deficiency in Kenyan preschool children. J Nutr 
142: 1756-1763. 
40. Lundeen E, Schueth T, Toktobaev N, Zlotkin S, Hyder SM, et al. (2010) Daily use of Sprinkles 
micronutrient powder for 2 months reduces anemia among children 6 to 36 months of age in 
the Kyrgyz Republic: a cluster-randomized trial. Food Nutr Bull 31: 446-460. 

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 42 of 43 
41. Matias SL, Vargas-Vasquez A, Bado Perez R, Alcazar Valdivia L, Aquino Vivanco O, et al. (2017) 
Effects of lipid-based nutrient supplements v. micronutrient powders on nutritional and 
developmental outcomes among Peruvian infants. Public Health Nutr 20: 2998-3007. 
42. Abbeddou S, Yakes Jimenez E, Some JW, Ouedraogo JB, Brown KH, et al. (2017) Small-quantity 
lipid-based nutrient supplements containing different amounts of zinc along with diarrhea and 
malaria treatment increase iron and vitamin A status and reduce anemia prevalence, but do 
not affect zinc status in young Burkinabe children: a cluster-randomized trial. BMC Pediatr 17: 
46. 
43. Hess SY, Abbeddou S, Jimenez EY, Some JW, Vosti SA, et al. (2015) Small-quantity lipid-based 
nutrient supplements, regardless of their zinc content, increase growth and reduce the 
prevalence of stunting and wasting in young burkinabe children: a cluster-randomized trial. 
PLoS One 10: e0122242. 
44. Adu-Afarwuah S, Lartey A, Okronipa H, Ashorn P, Peerson JM, et al. (2016) Small-quantity, lipid-
based nutrient supplements provided to women during pregnancy and 6 mo postpartum and 
to their infants from 6 mo of age increase the mean attained length of 18-mo-old children in 
semi-urban Ghana: a randomized controlled trial. Am J Clin Nutr 104: 797-808. 
45. Dewey KG, Adu-Afarwuah S (2008) Systematic review of the efficacy and effectiveness of 
complementary feeding interventions in developing countries. Matern Child Nutr 4 Suppl 1: 
24-85. 
46. Das JK, Salam RA, Kumar R, Bhutta ZA (2013) Micronutrient fortification of food and its impact on 
woman and child health: a systematic review. Syst Rev 2: 67. 
47. 
UNICEF 
(2016) 
Multiple 
Micronutrient 
Powder 
Supply 
& 
Market 
Outlook. 
https://www.unicef.org/supply/files/Multiple_Micronutrient_Powder_Supply_and_Market_Upda
te.pdf: New York: United Nations Children's Fund. 
48. WHO (2005) The treatment of diarrhoea: a manual for physicians and other senior health workers. 
http://apps.who.int/iris/bitstream/10665/43209/1/9241593180.pdf: Word Health Organization. 
49. de Onis M, Onyango AW, Van den Broeck J, Chumlea WC, Martorell R (2004) Measurement and 
standardization protocols for anthropometry used in the construction of a new international 
growth reference. Food Nutr Bull 25: S27-36. 
14. APPENDICES 
14.1 
Participant information and consent forms 
Study 1 English (version 2) 
Study 1 Swahili (version 2) 
Study 1 Luhya (version 2) 
Study 2 English (version 2) 
Study 2 Swahili (version 2) 
Study 2 Luhya (version 2) 
 

 
GW_1AF_KenEff, Version 02 of 15/01/2018 
 
Page 43 of 43 
14.2 
Questionnaires/assessment forms 
Enrolment form study 1 
Round 1 form study 1 (version 2) 
Round 2 form study 1 (version 2) 
Round 3 form study 1 (version 2) 
Round 4 form study 1 (version 2) 
Round 5 form study 1 (version 2) 
Monthly adherence and morbidity questionnaires study 1 
Referral form study 1 
Enrolment form study 2 
Round 1 form study 2 
Round 2 form study 2 
Round 3 form study 2 
Quarterly adherence and morbidity monitoring questionnaire study 2 
Referral form study 2  
Adverse event reporting form study 1 & 2 
Serious adverse event reporting form study 1 & 2 
 
14.3 
Curriculum vitae of investigators and certificates (documents of 2 local Co-PIs 
added) 
 
14.4 
IRB approval letter from PI’s country 
 
14.5 
Signed government approval letter 
 
14.6 
Pharmacy and Poisons Board retention certificate & Import Permit for LNS 
14.7 
SOP on Blood collection and processing