Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03558464 |
| Other study ID # |
GW_1AF_KenEff_1000d |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 8, 2018 |
| Est. completion date |
August 31, 2021 |
Study information
| Verified date |
October 2022 |
| Source |
GroundWork |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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).
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.
