ASF ConsumptionNCT05858151
Transforming Food System Evaluation in Mozambique
A study testing Food system and demand generation in people with ASF Consumption, run by RTI International at 1 site in Mozambique.
Trial summary
Global Alliance for Improved Nutrition (GAIN)'s "Transforming Food Systems to Improve Diet Quality and Resilience for the Most Vulnerable" program seeks to improve consumption of healthy foods by improving supply, increasing demand, and improving the enabling environment for different targeted foods in 4 countries by… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- ASF 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
- 5,216 participants
- Where
- 1 siteMozambique
- Study dates
- 15 May 2023to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 man ≥ 18 years or a woman 18-49 years;
- The household earns <$3.20 per person per day;
- Be able to speak one of the main local languages and/or Portuguese;
- Provide informed consent to participate in the study.
- Be a retailer of fish, chicken or eggs in one of the markets in the districts selected for the evaluation;
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- Be over 18 years old;
- Be able to speak one of the main local languages and/or Portuguese;
- Provide informed consent to participate in the study.
- Be a food transporter, trader, large-scale retailer, government official or other stakeholder involved in market-related activities in the fish, chicken or egg value chains 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 Portuguese;
- Provide informed consent to participate in the study.
- Be a small-scale retailer of fish, chicken, or eggs in intervention districts selected for the evaluation;
- Be over 18 years old;
- Be able to speak one of the main local languages and/or Portuguese;
- Provide informed consent to participate in the study.
- Belong to a BoP household living in a community 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 Portuguese;
- Provide informed consent to participate in the study.
Who cannot join
- Have a mental or psychological illness that prevents them from understanding the study;
- Have any physical illness that prevents them from being safely and constructively involved in the investigation;
- Be under the age of 18 years at the time of the study.
- Market Actor Surveys
- Have a mental or psychological illness that prevents them from understanding the study;
- Have any physical illness that prevents them from being safely and constructively involved in the investigation;
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- Be under the age of 18 years at the time of the study.
- In-depth interviews with market actors:
- Have any mental or psychological illness that prevents them from understanding the study
- Have any physical illness that prevents them from being safely and constructively involved in an investigation;
- Be under the age of 18 at the time of the study.
- Focus group discussion (FGD) participants will be selected from lists of participants in the market actor and household surveys and will be consented again for the FGDs if they meet the following criteria:
- FGDs) with market actors:
- Have any mental or psychological illness that prevents them from understanding the study;
- Have any physical illness that prevents them from being safely and constructively involved in an investigation;
- Be under the age of 18 at the time of the study.
- FGDsocus group discussions with households:
- Have any mental or psychological illness that prevents them from understanding the study
- Have any physical illness that prevents them from being safely and constructively involved in an investigation;
- Be under the age of 18 at the time of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Transforming Food Systems to Improve Diet Quality and Resilience for the Most Vulnerable Program in Mozambique
Global Alliance for Improved Nutrition (GAIN)'s "Transforming Food Systems to Improve Diet Quality and Resilience for the Most Vulnerable" program seeks to improve consumption of healthy foods by improving supply, increasing demand, and improving the enabling environment for different targeted foods in 4 countries 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 and the target foods for Mozambique. The evaluation in Mozambique will include a mix of quantitative and qualitative methods and will be guided by the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) implementation research framework.
Read the detailed description
To increase consumption of animal source foods (ASFs) by Bottom of Pyramid (BoP) consumers, the Global Alliance for Improved Nutrition (GAIN) will implement the Transforming Food Systems to Improve Diet Quality and Resilience for the Most Vulnerable program, which will use a market-based approach to improving diets through food systems. The set of interventions proposed is based on characteristics and challenges of the food environments of bottom of BoP consumers in Mozambique. GAIN will focus on elements of the food environment related to accessibility, affordability, and desirability of animal source foods (ASFs) in Mozambique.
GAIN's program will improve accessibility (physical distance that consumers travel to procure food) by developing sustainable last mile ASF delivery systems. This will involve developing an efficient and integrated private sector-led delivery system of fish (fresh and dry), chicken cuts (tails, heads, feet, necks, guts), and eggs from consolidation points/aggregators to last-mile retailers by facilitating logistics services (including on-demand backhaul trucks) and strengthening the linkages along the ASF supply chain. Accessibility will also be increased through improvement of fish drying technology and practices using solar tent dryers to enhance the quality and shelf life of dried fish, improve food safety, and decrease salt content.
GAIN intends to improve affordability of ASF by focusing on improving the value chains of the most affordable ASF options (fish, chicken cuts, and eggs) and will support accessibility by investing in enhanced cold chain systems and stronger distribution channels to underserved areas.
GAIN's program will improve desirability through a demand generation campaign to increase the frequency of ASF consumption among BoP consumers by focusing on key messages that are expected to drive behavior change. The campaign will focus on promoting ASFs as a food group for the whole family, using a short and catchy slogan. Messages will be disseminated through provincial and community radio via drama-based radio messages with new spots every 2 weeks, a musical jingle, and interactive call-in shows. Complementary channels will include television (cooking shows showing preparation of promoted foods), radio messages, social media campaigns, and illustrative point of sale materials (e.g., posters, danglers).
This evaluation of GAIN's Transforming Food Systems to Improve Diet Quality and Resilience for the Most Vulnerable program in Mozambique will use a mixed-methods quasi-experimental parallel group before-after cross-sectional design to assess effectiveness on increasing frequency of animal source food (ASF) consumption by bottom of the pyramid (BoP) consumers. The evaluation will be carried out in 4 intervention and 4 comparison districts, purposefully selected. It will include both impact and process evaluation components. Data will be collected through household surveys, market actor surveys and observations, in-depth interviews (IDIs), and focus group discussions (FGDs). Cross-sectional population-based household surveys with men and women in BoP households will be conducted at baseline (N=1,472) and endline (N=1,472) to assess the impact of the intervention on their ASF consumption frequency and dietary diversity using difference-in-differences analysis. Market actor surveys and observations will be conducted with retailers of fish, chicken, and eggs in both study arms at baseline and endline (N=800 at each time point). The baseline-endline market actor data will be analyzed using difference-in-difference analysis to assess improvements in availability, food safety, and prices of fish, chicken, and eggs. Process evaluation data will include IDIs with food transporters, traders, large-scale retailers, and other stakeholders (N=16 at each timepoint); FGDs with retailers of the target foods (N=16 FGDs at each time point); and FGDs with BoP households (N=16 FGDs at each time point). These will be conducted at midline and endline in the intervention districts only. Qualitative data will be analyzed using thematic content analysis methods. We will link the process and impact data through a program impact pathway analysis to document the pathways through which the program achieved its effects.
- Conditions
- ASF Consumption
- Being tested
- Food system and demand generation
- Keywords
- diet, animal source foods, market intervention, social and behavior change communication intervention, men, women, Mozambique
- Medical subject headings
- Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food system and demand generationBehavioural
The Global Alliance for Improved Nutrition (GAIN) will implement the Transforming Food Systems to Improve Diet Quality and Resilience for the Most Vulnerable program, which will use a market-based approach to improving diets through food systems. The set of interventions proposed is based on characteristics and challenges of the food environments of bottom of pyramid consumers in Mozambique. GAIN will focus on elements of the food environment related to accessibility, affordability, and desirability of animal source foods (ASFs) in Mozambique.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Not described Receives: Behavioral: Food system and demand generation |
| Control/No Intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
ASF frequency of consumption
Change in the mean frequency of fish, chicken, and egg consumption during the last 7 days by men and women in BoP households
Measured: Baseline (May 2023), endline (May 2026 (3 years))
Secondary outcomes (1)
Percent of household members with increased knowledge of target ASFs
Percent of household members
Measured: Baseline (May 2023), endline (May 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 posted15 May 2023
- Study start15 May 2023
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ASF 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, market actor surveys and observations, in-depth interviews (IDIs), and focus group discussions (FGDs). The protocol team has selected a subset of the intervention districts for the evaluation and identify an equal number of districts outside the program coverage area with similar characteristics to serve as the control.
- Masking
- None (open label)
- Enrolment
- 5,216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- Numbers Whizzy, Universidade de Lúrio, ANSA
- Responsible party
- Principal investigator, Valerie Flax, RTI International
- Investigators
- Sofia Costa, Principal investigator, Universidade Lúrio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05858151
- Sponsor's protocol ID
- 424601
- Status last verified
- Apr 2026
- First submitted
- 19 Apr 2023
- Last updated
- 23 Apr 2026
- 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 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Transforming Food Systems to Improve Diet Quality and Resilience for the Most Vulnerable Program in Mozambique
- ClinicalTrials.gov ID
- NCT05858151
- Acronym / sponsor ID
- 424601
- Conditions
- ASF Consumption
- Keywords
- diet, animal source foods, market intervention, social and behavior change communication intervention, men, women, Mozambique
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 5,216 participants (estimated)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- Numbers Whizzy, Universidade de Lúrio, ANSA
- Study start
- 15 May 2023 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 15 May 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 "Transforming Food Systems to Improve Diet Quality and Resilience for the Most Vulnerable" program seeks to improve consumption of healthy foods by improving supply, increasing demand, and improving the enabling environment for different targeted foods in 4 countries 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 and the target foods for Mozambique. The evaluation in Mozambique will include a mix of quantitative and qualitative methods and will be guided by the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) implementation research framework.
Detailed description
To increase consumption of animal source foods (ASFs) by Bottom of Pyramid (BoP) consumers, the Global Alliance for Improved Nutrition (GAIN) will implement the Transforming Food Systems to Improve Diet Quality and Resilience for the Most Vulnerable program, which will use a market-based approach to improving diets through food systems. The set of interventions proposed is based on characteristics and challenges of the food environments of bottom of BoP consumers in Mozambique. GAIN will focus on elements of the food environment related to accessibility, affordability, and desirability of animal source foods (ASFs) in Mozambique.
GAIN's program will improve accessibility (physical distance that consumers travel to procure food) by developing sustainable last mile ASF delivery systems. This will involve developing an efficient and integrated private sector-led delivery system of fish (fresh and dry), chicken cuts (tails, heads, feet, necks, guts), and eggs from consolidation points/aggregators to last-mile retailers by facilitating logistics services (including on-demand backhaul trucks) and strengthening the linkages along the ASF supply chain. Accessibility will also be increased through improvement of fish drying technology and practices using solar tent dryers to enhance the quality and shelf life of dried fish, improve food safety, and decrease salt content.
GAIN intends to improve affordability of ASF by focusing on improving the value chains of the most affordable ASF options (fish, chicken cuts, and eggs) and will support accessibility by investing in enhanced cold chain systems and stronger distribution channels to underserved areas.
GAIN's program will improve desirability through a demand generation campaign to increase the frequency of ASF consumption among BoP consumers by focusing on key messages that are expected to drive behavior change. The campaign will focus on promoting ASFs as a food group for the whole family, using a short and catchy slogan. Messages will be disseminated through provincial and community radio via drama-based radio messages with new spots every 2 weeks, a musical jingle, and interactive call-in shows. Complementary channels will include television (cooking shows showing preparation of promoted foods), radio messages, social media campaigns, and illustrative point of sale materials (e.g., posters, danglers).
This evaluation of GAIN's Transforming Food Systems to Improve Diet Quality and Resilience for the Most Vulnerable program in Mozambique will use a mixed-methods quasi-experimental parallel group before-after cross-sectional design to assess effectiveness on increasing frequency of animal source food (ASF) consumption by bottom of the pyramid (BoP) consumers. The evaluation will be carried out in 4 intervention and 4 comparison districts, purposefully selected. It will include both impact and process evaluation components. Data will be collected through household surveys, market actor surveys and observations, in-depth interviews (IDIs), and focus group discussions (FGDs). Cross-sectional population-based household surveys with men and women in BoP households will be conducted at baseline (N=1,472) and endline (N=1,472) to assess the impact of the intervention on their ASF consumption frequency and dietary diversity using difference-in-differences analysis. Market actor surveys and observations will be conducted with retailers of fish, chicken, and eggs in both study arms at baseline and endline (N=800 at each time point). The baseline-endline market actor data will be analyzed using difference-in-difference analysis to assess improvements in availability, food safety, and prices of fish, chicken, and eggs. Process evaluation data will include IDIs with food transporters, traders, large-scale retailers, and other stakeholders (N=16 at each timepoint); FGDs with retailers of the target foods (N=16 FGDs at each time point); and FGDs with BoP households (N=16 FGDs at each time point). These will be conducted at midline and endline in the intervention districts only. Qualitative data will be analyzed using thematic content analysis methods. We will link the process and impact data through a program impact pathway analysis to document the pathways through which the program achieved its effects.
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, market actor surveys and observations, in-depth interviews (IDIs), and focus group discussions (FGDs). The protocol team has selected a subset of the intervention districts for the evaluation and identify 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 | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Reside in the enumeration areas;
- Be a man ≥ 18 years or a woman 18-49 years;
- The household earns <$3.20 per person per day;
- Be able to speak one of the main local languages and/or Portuguese;
- Provide informed consent to participate in the study.
Key exclusion criteria (20 listed)
- Have a mental or psychological illness that prevents them from understanding the study;
- Have any physical illness that prevents them from being safely and constructively involved in the investigation;
- Be under the age of 18 years at the time of the study.
- Market Actor Surveys
- Have a mental or psychological illness that prevents them from understanding the study;
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 generationThe Global Alliance for Improved Nutrition (GAIN) will implement the Transforming Food Systems to Improve Diet Quality and Resilience for the Most Vulnerable program, which will use a market-based approach to improving diets through food systems. The set of interventions proposed is based on characteristics and challenges of the food environments of bottom of pyramid consumers in Mozambique. GAIN will focus on elements of the food environment related to accessibility, affordability, and desirability of animal source foods (ASFs) in Mozambique. | Behavioural | Intervention |
Primary outcome
ASF frequency of consumption
Time frame: Baseline (May 2023), endline (May 2026 (3 years))
Change in the mean frequency of fish, chicken, and egg consumption during the last 7 days by men and women in BoP households
1 secondary outcome
Percent of household members with increased knowledge of target ASFs
Time frame: Baseline (May 2023), endline (May 2026 (3 years))
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: Yes. Dataset will be shared through Nesstar
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.
Sofia Costa principal investigator
Universidade Lúrio
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 ASF Consumption, run by RTI International at 1 site in Mozambique.
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 21 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 23 Apr 2026. 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 Mozambique. 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?
This study is still under way. Results are not available in the source record yet.
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?
ASF frequency of consumption (time frame: Baseline (May 2023), endline (May 2026 (3 years))). 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 23 Apr 2026.