Clinical trial NCT05971888: Better Dairy for All Evaluation in Ethiopia
Official title: Impact and Process Evaluation of the Better Dairy for All Program in Ethiopia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dairy Consumption
Keywords: diet
dairy
market intervention
social and behavior change communication intervention
children
workers
Ethiopia
Lead sponsor: RTI International
Sponsor class: OTHER
Collaborators: name: Bahir Dar University
name: Frontieri Consult
First posted: 2023-08-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

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.

Eligibility 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.

Primary outcomes:
measure: Frequency of dairy consumption
timeFrame: Baseline (August 2023), Endline (July 2026) (3 years)
measure: Frequency of nutritious food consumption
timeFrame: Baseline (August 2023), Endline (July 2026) (3 years)
Secondary outcomes:
measure: Number of available dairy and nutritious foods
timeFrame: Baseline (August 2023), Endline (July 2026) (3 years)
Other outcomes:
Locations:
city: Addis Ababa
country: Ethiopia
facility: Frontieri
Study officials:
affiliation: Bahir Dar University
name: Netsanet Fentahun, PhD
role: PRINCIPAL_INVESTIGATOR
References: