NCT05971888

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
3mo left

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Feb 2025Sep 2026

First Submitted

Initial submission to the registry

July 20, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 2, 2023

Completed
1.5 years until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2026

Last Updated

February 17, 2025

Status Verified

January 1, 2025

Enrollment Period

1.6 years

First QC Date

July 20, 2023

Last Update Submit

February 13, 2025

Conditions

Keywords

dietdairymarket interventionsocial and behavior change communication interventionchildrenworkersEthiopia

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    Baseline (August 2023), Endline (July 2026) (3 years)

Secondary Outcomes (1)

  • Number of available dairy and nutritious foods

    Baseline (August 2023), Endline (July 2026) (3 years)

Study Arms (2)

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.

Interventions

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.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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;
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Frontieri

Addis Ababa, Ethiopia

Location

Study Officials

  • Netsanet Fentahun, PhD

    Bahir Dar University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Public Health Analyst

Study Record Dates

First Submitted

July 20, 2023

First Posted

August 2, 2023

Study Start

February 1, 2025

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

September 15, 2026

Last Updated

February 17, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

Dataset will be shared through Nesstar.

Locations