Clinical trial NCT03558464: Effectiveness Study During the First 1,000 Days in Kenya
Official title: Effectiveness of an Integrated Programme to Reduce Maternal and Child Malnutrition in Kenya: a Study in Pregnant Women and Their Offspring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stunting
Anemia
Micronutrient Deficiency
Lead sponsor: GroundWork
Sponsor class: OTHER
Collaborators: name: One Acre Fund
name: Children's Investment Fund Foundation
First posted: 2018-06-15
Enrollment: 1199
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster Randomized, Parallel-group, Prospective, Follow-up Effectiveness Study
Primary purpose: PREVENTION

Brief summary: Malnutrition is a public health problem in Kenya, with 26% of children underfive 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 nutritionspecific (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 pregnant women and - after delivery - their offspring until they reach two years of age comparing one group receiving the integrated intervention to another group receiving the agricultural intervention (already in place).

Detailed description: Background/Introduction

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 LNS to pregnant women up to 6 months after delivery and LNS to their offspring from 6-24 months of age. These nutritional supplements are recommended by WHO in areas where micronutrient deficiencies and malnutrition are prevalent. As a nutrition-sensitive intervention, pregnant women will receive mebendazole as preventive anthelminthic treatment after the first trimester.

In order to increase protein consumption, chicken birds will be provided to households. 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 \[9\]. 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.

In order to monitor and evaluate 1AF's programmes, 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 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 biological indicators such as growth, anemia and micronutrient status between the intervention and control group, the programmatic aspects such as adherence to and coverage of the intervention package and trying to link this 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 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 design:

The general study design is a cluster-randomized, parallel-group, prospective, follow-up effectiveness study over a period of 1000 days comparing 2 groups:

1. Intervention group: Pregnant women will be given LNS (1 sachet/day) and an anthelminthic drug (mebendazole) 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 anthelmintic drugs for mothers will be discontinued and instead, the child will receive MNP (1 sachet every three days), 1 egg per 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 provided free of charge. The households in the intervention group will also have the same agricultural intervention as 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.

It is anticipated to enroll 1200 (600 in each group) pregnant women into the study; this is expected to yield a sufficiently large sample of children later in the study. Women will be recruited from 140 clusters (randomly assigned to intervention or control) that will be drawn from from Kimilili, Webuye, Bumula, Sirisia and Kabuchai 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. 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 below:

Round 1 (Enrolment, ≤20 wk of gestation):

On the day of enrollment 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 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 1AF health field officers will also collect data on intervention adherence and recent morbidity.

Eligibility criteria: Inclusion Criteria:

* Pregnant women (≥ 18 years of age) with gestational age ≤20 weeks
* Written Informed Consent as documented by signature

Exclusion Criteria:

* 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

Primary outcomes:
measure: Stunting and length/height-for-age z-score
timeFrame: 2 years
Secondary outcomes:
measure: Maternal hemoglobin
timeFrame: 8 months
measure: Birth weight
timeFrame: 7 months
measure: Birth length
timeFrame: 7 months
measure: Head circumference at birth
timeFrame: 7 months
measure: Child hemoglobin
timeFrame: 2 years
measure: Child iron deficiency
timeFrame: 18 months
measure: Child vitamin A deficiency
timeFrame: 18 months
measure: Child diarrhea
timeFrame: 18 months
Other outcomes:
Locations:
city: Kakamega
country: Kenya
facility: One Acre Fund
Study officials:
affiliation: GroundWork
name: Rita Wegmüller, PhD
role: PRINCIPAL_INVESTIGATOR
References: