Better Dairy For All Evaluation in Ethiopia

• ClinicalTrials.gov Identifier: NCT05971888
• Recruitment Status: Suspended
• First Posted: August 2, 2023
• Sponsor: RTI International
• Collaborators: Bahir Dar University; Frontieri Consult
• Information provided by (Responsible Party): Valerie Flax, RTI International

Study Description

Brief Summary:

Global Alliance for Improved Nutrition (GAIN)'s "Better Dairy for All" program in Ethiopia seeks to improve children's and workers' consumption of healthy foods by improving access, increasing demand, and improving the enabling environment for dairy products by operating at multiple levels - individuals, households, markets, producers, and policies. RTI and local partners propose to conduct impact and process evaluations of GAIN's program tailored to the theory of change. The evaluation will include a mix of quantitative and qualitative methods and will be guided by the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) evaluation framework.

Condition or disease	Intervention/treatment	Phase
Dairy Consumption	Behavioral: Food system and demand generation	Not Applicable

Detailed Description:

Background: Dairy products are excellent sources of calcium, vitamin A, and vitamin B12, and good sources of zinc, but are not widely consumed in Ethiopia. GAIN's Better Dairy for All program has two main components. One component is focused on increasing dairy consumption among children 6 months up to 7 years in bottom of the pyramid (BoP) households in Amhara Region through a demand generation campaign and support to milk houses, cooperatives, and processors. The other component is focused on increasing consumption of dairy and other nutritious foods by BoP workers in industries and large-scale farms by making dairy and other nutritious foods, such as fortified oil and fortified wheat flour and fruits/vegetables, available at their workplaces accompanied by demand generation activities.

Objective: The objective of this study is to conduct an impact and process evaluation of GAIN's Better Dairy for All program.

Methods: In Amhara, the evaluation will use a parallel group mixed-methods quasi-experimental before-after design to assess the effectiveness of the intervention on dairy consumption of children. The evaluation will be carried out in 64 enumeration areas (EAs) in intervention woredas matched on demographic characteristics with 64 EAs in control woredas. Data will be collected through household surveys, semi-structured interviews with dairy value chain actors, and focus group discussions (FGDs) with caregivers of young children. Cross-sectional population-based household surveys with caregivers of young children will be conducted at baseline (N=1,144) and endline (N=1,144) to assess intervention impact on dairy consumption frequency and quantity using difference-in-differences analysis. In the intervention woredas, evaluators will conduct semi-structured interviews to evaluate program outcomes with milk houses, milk processors, and cooperatives (N=30) at baseline, midline, and endline. Evaluators will also conduct FGDs with caregivers of young children (N=8 FGDs) at midline and endline in the intervention woredas. This data will be used for the process evaluation.

In industries and large-scale farms, the evaluation of GAIN's program will use a cross-sectional pre-post design. The evaluation will be carried out in 5 purposefully selected industries/farms that start the intervention around the same time. Data will be collected through worker surveys, in-depth interviews (IDIs), and FGDs. Surveys with workers (N=524) will be conducted before and after the intervention to measure impacts of the program on workers' dairy consumption frequency and quantity. IDIs with industry/farm owners or managers and suppliers of dairy and other nutritious foods (N=5-10) and IDIs with workers (N=15) will be conducted at midline and endline. This data will be used for process evaluation.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 3576 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Data will be collected through household surveys, worker surveys, dairy value chain actor surveys, in-depth interviews (IDIs), and focus group discussions (FGDs). In Amhara Region, the protocol team has selected a subset of the intervention districts for the evaluation and identified an equal number of districts outside the program coverage area with similar characteristics to serve as the control.
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Impact and Process Evaluation of the Better Dairy for All Program in Ethiopia
• Estimated Study Start Date: August 1, 2024
• Estimated Primary Completion Date: September 15, 2026
• Estimated Study Completion Date: September 15, 2026

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Intervention	Behavioral: Food system and demand generation; GAIN's program to increase dairy consumption among BoP children and workers will include components to increase demand, improve access, and support the enabling environment. In Amhara, the demand generation component will share messages through radio, community influencers, and community conversations led by health extension workers targeting rural BoP households with children 6 months up to 7 years. GAIN will train milk houses and cooperatives on dairy safety and quality assurance and better business practices and will assist with cold chain and milk dispensing technology to improve milk availability and access. In industries and large-scale farms, GAIN will use a demand generation strategy to inform workers about the importance of dairy products and other nutritious foods and to encourage them to purchase them at their workplaces. GAIN will work with local businesses to launch and maintain dairy dispensers and arrange provision of other nutritious foods at work sites.
No Intervention: Control; In Amhara, an equal number of districts outside the program coverage area with characteristics similar to the intervention districts will serve as the control.

Outcome Measures

Primary Outcome Measures :

1. Frequency of dairy consumption [ Time Frame: Baseline (August 2023), Endline (July 2026) (3 years) ]
   Description (limit 999 characters) Change in the mean frequency of dairy consumption during the last 7 days by children 6 months to 7 years and workers
2. Frequency of nutritious food consumption [ Time Frame: Baseline (August 2023), Endline (July 2026) (3 years) ]
   Change in the mean frequency of consumption of promoted nutritious foods (fortified oil, wheat flour, and fruits/vegetables) during the last 7 days by workers

Secondary Outcome Measures :

1. Number of available dairy and nutritious foods [ Time Frame: Baseline (August 2023), Endline (July 2026) (3 years) ]
   Change in number of available dairy and target nutritious foods

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Household surveys

Inclusion Criteria:

• Reside in the enumeration areas;
• Be a caregiver of at least one child 6 months to 7 years old residing in the enumeration area;
• Be over 18 years old;
• The household is classified as BoP on Poverty Probability Index;
• Be able to speak Amharic;
• Provide informed consent to participate in the study.

Dairy value chain semi-structured interviews

Inclusion Criteria:

• Be a manager or owner of small and medium enterprises (milk houses, milk processors, or cooperatives) in the districts selected for the evaluation;
• Be over 18 years old;
• Be able to speak Amharic;
• Provide informed consent to participate in the study.

FGDs with caregivers

Inclusion criteria:

• Be a caregiver of a child 6 months up to 7 years old living in the intervention districts selected for the evaluation;
• Be over 18 years old;
• Be able to speak Amharic;
• Provide informed consent to participate in the study.

Worker surveys

Inclusion criteria:

• Be a worker at an industry or large-scale farm where the owner/manager has agreed to participate in GAIN's program;
• Be over 18 years old;
• Be able to speak one of the main local languages and/or Amharic;
• Provide informed consent to participate in the study.

In-depth interviews with workers

Inclusion criteria:

• Be an owner, worker, or food supplier connected to industries or large-scale farms involved in GAIN's program in the intervention districts selected for the evaluation;
• Be over 18 years old;
• Be able to speak one of the main local languages and/or Amharic;
• Provide informed consent to participate in the study.

Contacts and Locations

Locations

Ethiopia

Frontieri

Addis Ababa, Ethiopia

Sponsors and Collaborators

RTI International

Bahir Dar University

Frontieri Consult

Investigators

• Principal Investigator: Netsanet Fentahun, PhD; Bahir Dar University

More Information

• Responsible Party: Valerie Flax, Senior Research Public Health Analyst, RTI International
• ClinicalTrials.gov Identifier: NCT05971888
• Other Study ID Numbers: 424603
• First Posted: August 2, 2023
• Last Update Posted: April 22, 2024
• Last Verified: April 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Dataset will be shared through Nesstar.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Valerie Flax, RTI International:

diet; dairy; market intervention; social and behavior change communication intervention; children; workers; Ethiopia