MoreMilk Project: Milk Safety and Child Nutrition Impacts of a Training Scheme for Dairy Vendors in Nairobi, Kenya

NCT04109521 | Terminated DMC

• 1 other identifier: OPP1156625
• Study Type: interventional
• Target: 889
• Locations: 1 country
• Sites: 1

Brief 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 discussed with 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 the intervention in the same vendors and households. The vendor baseline and endline surveys will include questionnaire modules on operations, milk handling practices, and business performance. In addition, it will include a women's empowerment module to be administered to all vendors and their spouses (pro-WEAI tool). 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, as well as length/height and weight of the index child and his/her mother .

Conditions

Food Safety; Child Nutrition

Keywords

milk safety; child; nutrition; informal sector; dairy

Outcome Measures

Primary Outcomes (2)

• Health outcome: total bacterial count (TBC) per mL of milk sold by vendors

  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.

  12 months after baseline

• Nutrition outcome: mean dietary adequacy of protein, Ca, and vitamin B12 in children 12-48 months at 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

  12 months after baseline

Secondary Outcomes (10)

• Differential treatment effect on total bacterial count in milk

  4, 8 and 12 months after baseline

• Enterobacteriaceae count in milk

  12 months after baseline

• Coagulase positive staphylococci (CPS) in milk

  12 months after baseline

• Business profitability

  12 months after baseline

• Mean women's empowerment index-score of vendors and their spouses

  12 months after baseline

Other Outcomes (3)

• Dairy vendors milk handling and business practices

  12 months after baseline

• Household's milk handling knowledge and practices

  12 months after baseline

• Mean dimension-specific women's empowerment index-score of vendors and their spouses

  12 months after baseline

Study Arms (2)

Trained vendors

EXPERIMENTAL

The intervention consists of a Training, Certification and Marketing scheme for dairy vendors operating in the informal sector. This scheme includes a 12hr training offered at the beginning of the study, followed by 2 quarterly visits where milk will be tested for microbiological quality and results will be discussed with participants. The training will include three main components: (i) milk hygiene and quality; (ii) business skills; (iii) milk marketing. Trainings will be offered free of charge. The trainings will be given by business development service (BDS) providers, who will be trained through a "training of trainers" ahead of the intervention. Quarterly visits will involve the collection of a milk sample from each participant in the experimental arm in an unannounced visit and results on the microbiological quality of the milk reported back individually and explained to each vendor.

Other: Training, certification and marketing

Untrained vendors

NO INTERVENTION

Participants in the no-intervention arm will receive the same unannounced quarterly visits, where milk will be sampled and tested for microbiological quality, but results will not be shared with the participants. The participants in this arm will only receive the training upon completion of the endline survey (i.e. when the study is finished).

Interventions

Training, certification and marketing OTHER

The 12hr training will address the vendors (i) knowledge on hygienic handling of milk, preservation and low-cost methods for testing milk safety; (ii) business skills in record keeping, access and management of credit; (iii) milk marketing. On completion of the training and successfully passing an evaluation, vendors will be given a written certificate using a format suitable to be displayed in their premises (i.e. A4 poster, a hat or badge) indicating they have completed the training. The certification will not have legal value. Two quarterly unannounced visits will be conducted to collect a milk sample from the vendors and report back the results of microbiological quality. Vendors will have access to various milk marketing and communication items to be used in their daily operations. The materials will promote milk consumption through marketing focused on messages to consumers related to (i) good milk hygiene practices, (ii) good child nutrition practices, and (iii) household diets

Trained vendors

Eligibility Criteria

• Age: 12 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Operate in the informal dairy sector (i.e. selling unpacked milk, not-formally processed milk) at least 5 days per week and indicates (at baseline) an intention to remain in the business at least for the next 12 months.
• Operate a milkbar (i.e. business exclusively selling dairy products and eggs), a shop/kiosk (i.e. licensed for selling other products) or be a street vendor (i.e. not selling in a fixed building structure but in a specific location along the street).
• Sell milk directly to individual consumers/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.
• to 48 months of age at baseline

Sponsors & Collaborators

• The International Livestock Research Institute (ILRI): lead
• International Food Policy Research Institute: collaborator
• Bill and Melinda Gates Foundation: collaborator
• Department for International Development, United Kingdom: collaborator

Study Sites (1)

International Livestock Research Institute

Nairobi, 00100, Kenya

Location

MeSH Terms

Interventions

Certification; Marketing

Intervention Hierarchy (Ancestors)

Credentialing; Social Control, Formal; Health Care Economics and Organizations; Quality Assurance, Health Care; Health Care Quality, Access, and Evaluation; Commerce; Technology, Industry, and Agriculture

Study Officials

• Silvia Alonso, PhD

  The International Livestock Research Institute (ILRI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A two-arm cluster-randomized, non-masked, community-based trial will be used to estimate the effectiveness of the MoreMilk intervention. A baseline and an endline survey will be done for each arm with 12 months in between; the same vendors and households will be surveyed at baseline and endline. The unit of randomization is a cluster of 1 to 5 vendors and the households consuming milk from those vendors. 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 Record Dates

• First Submitted: September 27, 2019
• First Posted: September 30, 2019
• Study Start: October 28, 2019
• Primary Completion: January 31, 2020
• Study Completion: April 20, 2020
• Last Updated: October 19, 2021

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)