Cluster Randomized, Parallel-group, Prospective, Follow-up Effectiveness Study in Kenyan Children 6-35 Months
Condition: Stunting
MeSH terms: Growth Disorders
Study type: Interventional

Summary: 
      Malnutrition is a public health problem in Kenya, with 26% of children under-five years of
      age stunted, and 26% of pre-school children, 26% of women of reproductive age and 42% of
      pregnant women being anaemic, respectively. Agriculture is the main source of income, food
      and nutrients for the majority of rural families in Sub-Saharan Africa including Kenya. Most
      farmers are smallholders and are vulnerable to poor nutrition. Thus far, programmes have
      mostly focused on increasing yields and household income, but not on improving nutritional
      status. One Acre Fund (1AF) has over the past 10 years successfully introduced an agriculture
      programme to smallholder farmers in Western Kenya focusing on improving harvest. 1AF is
      therefore well placed to transform an existing and successful agriculture programme into the
      world's largest 'nutrition network' for farmers, and it is the hope that a partnership
      between Children's Investment Fund Foundation (CIFF) and 1AF will create a strong voice for
      nutrition within the agriculture sector. The project aims to use an integrated programme by
      introducing nutrition-sensitive (improved water, sanitation and hygiene (WASH): e.g. soap for
      hand washing) and nutrition-specific (e.g. micronutrient supplements) components to 1AF's
      agricultural programme.

      The impact of such an integrated programme will be assessed in a cluster-randomized
      intervention study in children 6-35 months at recruitment comparing one group receiving the
      integrated intervention to another group receiving the agricultural intervention (already in
      place).
    

Detailed description: 
      Background/introduction:

      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.

      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
      [4]. 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 [5]. Since 2006, One Acre Fund (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 [6].

      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 MNPs
      (Micronutrient Powders) to children 6-59 months of age. These nutritional supplements are
      recommended by WHO in areas where micronutrient deficiencies and malnutrition are prevalent
      [7,8]. In order to increase protein consumption, chicken birds will be provided to
      households. Households will also be provided with seeds for red onion and indigenous greens.
      Further, children will be provided with oral rehydration salts (ORS) and zinc supplements as
      recommended by WHO and UNICEF for the treatment of acute diarrhoea [9]. 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. 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, a cluster-randomized, parallel-group,
      prospective, follow-up effectiveness study in children 6-35 months of age at recruitment that
      spans over 2 years will be conducted in the Western Province of Kenya.

      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.

      Objective/hypothesis:

      While the primary purpose is to longitudinally compare the changes of growth 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.

      As such, the research hypothesis is as follows: 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.

      Study design:

      The general study design 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:

        1. 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.

        2. 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 2,000 (1,000 in each group) children 6-35 months of age into the
      study. 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.

      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. 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.

        5. 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.

        6. 1AF (2016) One Acre Fund- Annual Report 2016.
           https://www.oneacrefund.org/uploads/all-files/2016_AnnualReport_r1.pdf: One Acre Fund.

        7. 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

        8. 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.

        9. 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.
    

Intervention name(s): Intervention (integrated package); Control
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Provided to all intervention households:
Soap (for daily hand washing)
Chlorine solution (for daily drinking water treatment)
8 birds of chicken (child consumes 1 egg/day)
Vegetable seeds (red onion, indigenous managu and sukuma)
Monthly trainings to all farmers on nutrition and WASH
Micronutrient powder (MixMe, 1g sachet every third day)
Oral rehydration solution (ORS) + zinc (to be used to treat acute diarrhoea: 20 mg zinc tablets; ORS sachets (10.3 g/sachet))
All families in the intervention group will receive the same agriculture-focused package (see section 'control intervention' below) as those in the control group.; Active control: The families living in the control clusters will receive the agriculture-focused package that is already in place in all participating clusters through the 1AF programme. The control intervention is the same for study 1 and study 2. This agriculture-focused package consists of:
Agricultural training (every 2 weeks on average) for all
Free to 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
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cluster Randomized, Parallel-group, Prospective, Follow-up Effectiveness Study
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention