Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05117892 |
| Other study ID # |
OPP1156625_ELD |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 23, 2021 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
January 2023 |
| Source |
The International Livestock Research Institute (ILRI) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The objective of the MoreMilk trial is to assess the effect of a Training, Certification and
Marketing intervention for milk vendors in the informal sector on the safety of the milk sold
in the markets and on the nutrition of children in peri-urban areas of Kenya. The
intervention is a training scheme for dairy vendors designed to improve the vendors' business
skills and increase their capacity to handle milk hygienically and recognize good quality
milk. It will also support vendors to adopt marketing strategies and pass on messages to
their customers on the role of milk for nutrition and good food handling practices. The
intervention consists of a 12hr face-to-face training, followed by quarterly visits where
milk safety is tested and results are reported back to the participants. To assess the effect
of this intervention on milk safety, and selected health and nutrition outcomes, the study
will work with two groups of participants: dairy retailers, referred to as dairy vendors,
operating in the informal sector and consumer households that purchase milk from recruited
vendors. Dairy vendors will be randomly allocated to receiving the training at the beginning
of the study (treatment group) or at the end of the study (control group). A baseline survey
will be administered to participating vendors and households, and an endline survey will be
conducted 12 months after baseline in the same vendors and households. The vendor baseline
and endline surveys will include questionnaire modules on operations, milk handling
practices, and business performance. A sample of milk will also be collected to test the
microbiological quality and composition of the milk. Vendors will be visited 2 additional
times during the 12 months between intervention and endline, to monitor practices and
business performance and to collect a milk sample to be tested for microbiological quality
and milk composition. The baseline and endline surveys in households will assess milk and
food expenditure, milk handling and consumption practices, and a 24hr dietary recall for the
index child.
Description:
The International Livestock Research Institute (ILRI), together with partners, has pioneered
an approach to improving the safety of food sold in informal markets by professionalizing
informal traders who operate in these markets in low- and middle-income countries. The
approach involves training vendors in hygiene and business skills and improving their ability
to market products through brand creation, building skills in sales and milk promotion,
and/or social marketing. The approach appears sustainable and scalable, but the nutrition and
health impacts, though potentially important, have not been evaluated. The objective of the
study is to assess the impact of a Training, Certification and Marketing intervention for
milk vendors in the informal sector on milk safety and nutrition outcomes in children in
urban and peri-urban areas of Kenya.
The study will be conducted in peri-urban Eldoret, Kenya. The study area was selected for its
peri-urban status, ongoing urbanization, and high presence of milk markets. The target wards
are characterized by neighborhoods with adequate infrastructure and multi-storey buildings
and areas with tin-roofed houses and limited access to piped water, sanitation and
electricity. Importantly, it is estimated that about 70% (Kenya Market Trust, 2016) of the
milk consumed in the study area is sold through the informal dairy vendors-vendors that sell
unpackaged or not-formally processed milk-who are the focus of this study.
A two-arm cluster-randomized, non-masked, community-based trial will be used to estimate the
effectiveness of the MoreMilk intervention. The RCT aims at answering the following two
research questions:
- Does a "training, certification and marketing" intervention for dairy vendors operating
in the informal dairy markets in peri-urban Eldoret improves the microbiological quality
(i.e. safety) of the unpacked milk sold in informal markets?
- Does a "training, certification and marketing" intervention for dairy vendors operating
in the informal dairy markets in peri-urban Eldoret increase the natural log of mean
dietary adequacy of protein, Ca, and vitamin B12 for children 12-48 months (at baseline)
in consumer households?
The study population will include dairy vendors operating in the informal sector (businesses
selling unpackaged or not-formally processed milk to individual consumers; this includes raw,
boiled and unpacked pasteurized milk) in the study areas and consumer households that
purchase most of their weekly milk from those vendors. The unit of randomization is a cluster
of at least one vendor and the households consuming milk from those vendors. Clusters are
identified using a hybrid approach based on a computer-based algorithm informed by the GPS
locations of the informal milk vendors in the target areas. The resulting clusters ensure
that vendors in one cluster are located no more than 100 meters from each other and are
located at least 200m away from any vendor in a different cluster. Study clusters will be
randomly assigned to one of two arms:
1. Treatment arm: Training, certification, and marketing scheme for milk vendors.
2. Control arm: Delayed intervention (implemented after endline survey).
Study vendors in the intervention (treatment) clusters will be offered the possibility to
participate in a 12-15hr training. Trainings will be offered free of charge. Upon completion
of the endline survey, vendors in the control clusters will also be offered the training,
which will follow the same format as the one used in the intervention clusters. The training
will be offered a few hours per day over 5-days distributed across 3 weeks to accommodate
vendors' time constraints, which the investigators expect to be more severe for female
vendors. The trainings will be given by business development service (BDS) providers. BDS
correspond to a "wide range of non-financial services provided by public and private
suppliers (BDS providers) to entrepreneurs to help them operate efficiently and to grow their
business with the broader purpose of contributing to economic growth, employment generation
and poverty alleviation" (Kimando, 2012). The Kenyan register of BDS providers will be used
to identify available BDS providers. The selected BDS will receive a full training course,
covering the intervention content and specific teaching methods to be used during the
training of vendors.
The study will include 234 vendor clusters (with a minimum number of vendors per cluster of
one and a maximum of five), 291 vendors and 932 households at baseline. For the health
outcome, the study will be powered to detect a 0.4 standard deviation difference between the
natural log of TBC in the treatment and control groups. This equates roughly to a 20
percentage point increase in the proportion of vendors selling milk meeting EAS one year
after the intervention, off of a proportion of 37% (based on data collected in peri-urban
Nairobi in 2017). For the nutrition outcomes, the study will be powered to detect a change in
the natural log of mean dietary adequacy of Ca, protein, and vitamin B12 that corresponds to
a daily increase of 75gr of milk (0.5 cups) consumed per child. This is one-third of the
median daily milk consumption for children 24-48 months of age in the MilkMarkets data
collected in Dagoretti (peri-urban Nairobi) in 2017.
Randomization of vendor cluster to treatment or control arm will be conducted immediately
after completion of the baseline surveys for vendors and consumer households, and hence
post-consent. After randomization, vendors in clusters allocated to the intervention will be
contacted, informed of the training schedules available in their ward, and offered the
possibility to attend 1 of up to 3 scheduled training options. Vendors in the control
clusters will be informed that they will be given the option to participate in the trainings
one year later.
Selection and recruitment of vendors - From the full list of identified clusters, the
investigators will randomly select the 234 to meet the study sample size requirements. In
each cluster, a minimum of 1 vendor will be recruited.
Selection and recruitment of households - For each participating cluster, the investigators
will recruit up to 5 consumer households that meet our inclusion criteria. Each recruited
vendor will be given a small advertisement to display in their business/premise advertising
the study and inviting interested consumers to register interest to participate in the study
by providing their name and telephone number in a registration form. Vendors will be
encouraged to bring the study to the attention of their customers. The information will be
kept at the vendor's premise for at least 10 days and then collected by field workers.
Registered consumers will be contacted and information collected to check their eligibility
(see criteria above). If not enough eligible households were identified, a second approach to
recruitment will be used. A field worker will spend 2-3 hours in the morning or the evening
of a given day at the recruited vendor's premise and approach customers that purchase liquid
unprocessed milk during this time period. A brief set of questions will be asked to confirm
whether the consumer household meets our inclusion criteria. If it does, the study will be
presented and interest to participate in the study will be recorded. Basic contact details
will be obtained to facilitate follow up. After identification of all eligible households in
the cluster, 5 households will be randomly selected to participate in the study aiming at
achieving equal number of household per vendor(whenever there is more than 1 vendor in a
cluster) and ensuring there is at least one household per vendor in each cluster.
Selection of the index child - In each recruited household one child 12 months to 48 months
of age will be selected. If only one child falls into this age window at the time of
baseline, this child will be the index child. In case there are multiple children in the
household meeting the age criterion, the index child will be randomly selected manually or by
the computer-assisted personal interview software.
A baseline survey and an endline survey will be conducted in recruited vendors and households
prior to the intervention (baseline) and 12 months after baseline (endline). The
questionnaire to vendors will gather information on the following three elements: (i) milk
hygiene and handling practices of daily operations, including sourcing of milk, equipment
available and use of quality testing; (ii) business performance, recording milk volumes
purchased/sold, expenditures, revenues and cost of equipment; (iii) two domains of women
empowerment (based on the Women Empowerment in Agriculture Index) in their business and
related household gender dynamics. In addition, two un-announced visits to the participating
vendors will be conducted between the intervention and the enline survey, where observable
features on milk hygiene and handling will be recorded through a short questionnaire. These
two mid-term visits will allow for collection of information on business performance
indicators and any unexpected negative consequences from participation in the study. In
households, questionnaires will record the following information (i) household milk
expenditure; (b) milk consumption, handling and hygiene practices; (c) a 24hr dietary recall
for the selected child 12-48 months at baseline; (d) presence of diarrhea in the past 7 days
(diarrhea understood as one or more days having at least 3 loose stools/day).
At baseline, endline, and at the 2 unannounced visits, 50ml of milk sold by participating
vendors will be bought. Samples will be tested for total bacterial counts (TBC), and
enumeration of enterobacteriaceae. For vendors in the intervention clusters, results of the
laboratory analysis and feedback on milk hygiene practices will be communicated after each
testing (excluding at baseline).
For child dietary assessment, the "multiple-pass" 24hr recall method will be used. This
approach uses a special method to help the primary caretaker, usually the mother, of a child
remember what was consumed and ensure that enumerators do not miss important information.
Using the 24hr form, enumerators review the day's food and drink several times with the
primary caretaker of the child. Each time, or "pass" more detailed information is added to
the recall form, thus reducing the probability that foods are omitted. A detailed 24hr recall
protocol has been developed.
The process evaluation will examine the primary inputs, processes, outputs, and outcomes
along the program impact pathway to determine the "how" and "why" of program impact. The
scope of the process evaluation is limited to providing a qualitative assessment of issues
related to program implementation and delivery. A combination of random and purposive
sampling techniques will be used for the process evaluation. Quantitative data will be
collected through precoded questionnaires. Qualitative data will be collected through
semi-structured continuous observations of program activities, semi-structured individual
qualitative interviews with implementation staff and beneficiaries, and group free listing
with beneficiaries.
A scientific advisory committee has been set up, formed of 3 individuals external to the
research team and to the project partner institutions. The Committee will revise and provide
feedback on the study protocol and data analysis. The Committee will select a chair for the
duration of the study, who will convene meetings as required based on the outcomes of the
monitoring.
