Dairy ConsumptionNCT05971888
Better Dairy for All Evaluation in Ethiopia
A study testing Food system and demand generation in people with Dairy Consumption, run by RTI International at 1 site in Ethiopia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dairy Consumption
- What is being tested?
- Food system and demand generation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteEthiopia
- Study dates
- 1 Feb 2025to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 26Show fewer
- Dairy value chain semi-structured interviews
- 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
- 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
- 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
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact and Process Evaluation of the Better Dairy for All Program in Ethiopia
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.
Read the 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.
- Conditions
- Dairy Consumption
- Being tested
- Food system and demand generation
- Keywords
- diet, dairy, market intervention, social and behavior change communication intervention, children, workers, Ethiopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food system and demand generationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Not described Receives: Behavioral: Food system and demand generation |
| Control | No intervention | In Amhara, an equal number of districts outside the program coverage area with characteristics similar to the intervention districts will serve as the control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of dairy consumption
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
Measured: Baseline (August 2023), Endline (July 2026) (3 years)
Frequency of nutritious food consumption
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
Measured: Baseline (August 2023), Endline (July 2026) (3 years)
Secondary outcomes (1)
Number of available dairy and nutritious foods
Change in number of available dairy and target nutritious foods
Measured: Baseline (August 2023), Endline (July 2026) (3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start1 Feb 2025 (estimated)
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Why it stopped: The program, Better Dairy for All, funded by the Global Alliance for Improved Nutrition (GAIN) will no longer continue because of state of emergency imposed in Amhara Region, making it infeasible to implement programmatic activities.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dairy ConsumptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- Bahir Dar University, Frontieri Consult
- Responsible party
- Principal investigator, Valerie Flax, RTI International
- Investigators
- Netsanet Fentahun, PhD, Principal investigator, Bahir Dar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971888
- Sponsor's protocol ID
- 424603
- Status last verified
- Jan 2025
- First submitted
- 20 Jul 2023
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Dataset will be shared through Nesstar.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact and Process Evaluation of the Better Dairy for All Program in Ethiopia
- ClinicalTrials.gov ID
- NCT05971888
- Acronym / sponsor ID
- 424603
- Conditions
- Dairy Consumption
- Keywords
- diet, dairy, market intervention, social and behavior change communication intervention, children, workers, Ethiopia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The program, Better Dairy for All, funded by the Global Alliance for Improved Nutrition (GAIN) will no longer continue because of state of emergency imposed in Amhara Region, making it infeasible to implement programmatic activities.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- Bahir Dar University, Frontieri Consult
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: Food system and demand generation |
| Control | No intervention | –In Amhara, an equal number of districts outside the program coverage area with characteristics similar to the intervention districts will serve as the control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- 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;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food system and demand generationGAIN'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. | Behavioural | Intervention |
Primary outcome
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
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
1 secondary outcome
Number of available dairy and nutritious foods
Time frame: Baseline (August 2023), Endline (July 2026) (3 years)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Individual participant dataSharing planned: Yes. Dataset will be shared through Nesstar.
Related trials for Dairy Consumption
Recruiting
Fermented Dairy Product and Bifidobacterium Diversity
A03 - Digestive System, B03 - Bacteria
Recruiting
The Effect of Dairy Intake on Body Weight and Composition and Metabolic Health in Adolescents and Seniors
Dairy Consumption, Metabolic Health
Active, not recruitingObservational study
Plant-based Diets and Risk of Cancer in the Adventist Health Study-2
Cancer, Breast, Cancer, Colorectal
Active, not recruiting
Determine How Consumption of Dairy Fat Fractions Rich in Phospholipids and Proteins Influence Inflammation in the Fed State-Phase 1
Metabolic Syndrome, Obesity
Active, not recruiting
Determine How Consumption of Dairy Fat as Cheese Influences Inflammation-Phase 2
Metabolic Syndrome, Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Netsanet Fentahun, PhD principal investigator
Bahir Dar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food system and demand generation in people with Dairy Consumption, run by RTI International at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of dairy consumption (time frame: Baseline (August 2023), Endline (July 2026) (3 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.