MoreMilk: Making the Most of Milk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,297
- 试验地点
- 2
- 主要终点
- Health outcome: total bacterial count (TBC) per mL of milk sold by vendors
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Due to the nature of the intervention, it will not be possible to mask allocation to the researchers and the participants. Masking will only be done at analysis stage, meaning that analysis will be done without revealing group allocation (A/B) and by someone who is not knowledgeable about the allocation of clusters to treatment or control. Masking will only be broken after the primary analyses have been completed
入排标准
- 年龄范围
- 12 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(households):
- •Buying unpacked milk
- •Meet at least 50% of its weekly milk needs with unpacked milk from a recruited vendor.
- •Have at least one child 12 to 48 months of age at the time of recruitment.
- •Inclusion Criteria (children):
- •12 to 48 months of age at baseline
排除标准
- 未提供
结局指标
主要结局
Health outcome: total bacterial count (TBC) per mL of milk sold by vendors
时间窗: 12 months after baseline
Total bacterial count represents the number of viable aerobic bacteria present in one mL of milk and reflects the hygienic handling of milk from production to the point of testing. It is a well-established food hygiene indicator and the primary milk safety indicator in the East African Standards for Raw Milk. While it is a good indicator of the sanitary quality of the milk, it does not directly correlate to the presence of pathogens or toxins in a food product. However, food products with high TBC can be reasonably assumed to carry health hazards. Given that the distributions of TBC in food products are highly skew, we will analyze this outcome with an appropriate log transformation, which is likely to be the natural log (which is the most commonly used log transformation when analyzing TBC and the one considered for power calculations in this study) or a stronger fractional power of root.
Nutrition outcome: mean dietary adequacy of protein, Ca, and vitamin B12 in children 12-48 months at baseline
时间窗: 12 months after baseline
Milk contains protein and calcium and is a good source of vitamin B12. The promotion of milk by vendors in the treatment arm is expected to increase milk consumption in children, but it may also lead to reduced intake of other nutrient-dense foods. We will assess the dietary adequacy of these three nutrients in the overall diet. The outcome will be constructed by first calculating the dietary adequacy for each key nutrient (i.e. protein, calcium, and vitamin B12). Nutrient adequacy is defined as the observed nutrient intake divided by the age-specific nutrient requirement. We will then calculate the mean adequacy across all three nutrients for each individual. We expect the distribution of mean dietary adequacy to be positively skew and we will therefore use the natural log of mean dietary adequacy in the analysis or a stronger fractional power of root, if required
次要结局
- Child milk intake(12 months after baseline)
- Child acute diarrhea(12 months after baseline)
- Enterobacteriaceae count in milk(12 months after baseline)
- Mean dimension-specific women's empowerment index-score of vendors(12 months after baseline)
- Child dietary adequacy(12 months after baseline)
- Differential treatment effect on total bacterial count in milk(4, 8 and 12 months after baseline)
- Business profitability(12 months after baseline)