Nutritional WastingNCT05825716
Ifaa Effectiveness Evaluation on Food Security and Nutrition
An observational study of Nutritional Wasting and Nutritional Stunting, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Ethiopia.
Trial summary
The Ifaa Project is a USAID-funded Resilience and Food Security Activity (RFSA) that is being implemented by Catholic Relief Services (CRS) and partners in the East Hararghe Zone of the Oromia Region in Ethiopia. Read more about this study
- Who is it for?
- Ages 15 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutritional Wasting, Nutritional Stunting
- What is being tested?
- Ifaa Basic, Ifaa Enhanced and Ifaa Enhanced + Livelihoods
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 3,317 participants
- Where
- 1 siteEthiopia
- Study dates
- 21 May 2023to 5 Jul 2025
- Phase
- Observational
- 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 15 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The overall goal of the Ifaa Project is to improve food security of vulnerable households in targeted PSNP communities, contributing to a sustained reduction in rural poverty. To achieve this goal, Ifaa will provide additional multi-sectoral interventions to benefit further 60,000 PSNP households in the Oromia region, which is Ethiopia's largest, most populous region and also one of its poorest. The study population is PSNP beneficiaries that are participating in the Ifaa Project.
Who may be able to join
- Households are PSNP clients
- Households are Ifaa Project beneficiaries that are planned participants in: 1) Savings and Internal Lending Communities (SILC) groups (Ifaa Basic); 2) SILC Groups AND Care Groups (Ifaa and Enhanced); or 3) SILC groups AND Care Groups AND a Livelihoods Pathway.
- Households have a pregnant woman OR at least one child <36 months of age
- Households have an adult member that is capable of giving informed consent and completing an interview
Who cannot join
- Child-headed households (all members age 17yrs or less)
- Individuals not mentally able to give informed consent and complete an interview
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ifaa Effectiveness Evaluation: A Comparison of Multisectoral Food Security and Resilience Interventions in the Oromia Region of Ethiopia
The Ifaa Project is a USAID-funded Resilience and Food Security Activity (RFSA) that is being implemented by Catholic Relief Services (CRS) and partners in the East Hararghe Zone of the Oromia Region in Ethiopia. Ifaa targets households that are participating in the Productive Safety Net Programme (PSNP) which is a social protection program administered by the Government of Ethiopia that provides food and cash assistance to vulnerable households. The Ifaa Project will deliver multi-sectoral programming in 241 kebeles (sub-districts) in nine woredas (districts) of East Hararghe Zone, however, intervention packages vary by location. The proposed effectiveness evaluation will quantify the impacts of three different intervention packages in terms of key project indicators in the areas of household food security, diet, and child nutrition.
Read the detailed description
The Ifaa Project will deliver multi-sectoral programming in 241 kebeles (sub-districts) in nine woredas (districts) of East Hararghe Zone, however, intervention packages vary by location. The three Ifaa intervention packages that will be delivered to PSNP beneficiaries based on the beneficiaries residence location include: 1) the Ifaa basic package; 2) enhanced package without livelihoods; and 3) enhanced package with livelihoods. The proposed effectiveness evaluation will quantify the impacts of three different intervention packages in terms of key project indicators in the areas of household food security, diet, and child nutrition. As the Ifaa consortium learning partner, Johns Hopkins School of Public Health (JHSPH) has been requested to design an effectiveness evaluation of the different intervention packages to compare their outcomes among beneficiary households.
To align the evaluation with project aims, key project indicators are used as study outcome measures. The specific objectives of the evaluation are to quantify the impact of Ifaa interventions as follows:
- At the household level, Poor or Borderline Food Consumption Score (FCS)
- at the individual level, change in minimum dietary diversity among children <5 years A secondary objective is to examine Ifaa impacts on child nutrition indicators, including measures of both acute and chronic malnutrition.
A longitudinal cohort design will be used to compare the effectiveness of three Ifaa intervention packages among PSNP beneficiaries in Eastern Hararghe: 1) the Ifaa basic package; 2) enhanced package without livelihoods; and 3) enhanced package with livelihoods. Under this approach, the enrolled households will have either a pregnant woman or children <24 months of age. Households will be followed over a two-year period, with the baseline and endline survey conducted at a similar time in the calendar year to avoid seasonal changes in food security. The magnitude of change in key indicators over time will be assessed for each group; if needed, adjusted models will be used to account for baseline differences between groups.
- Conditions
- Nutritional Wasting, Nutritional Stunting
- Being tested
- Ifaa Basic, Ifaa Enhanced, Ifaa Enhanced + Livelihoods
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ifaa BasicOther
- PSNP Systems: (1) Provision of food aid commodities (wheat, oil, and pulse) per the PSNP transfer schedule for 3-6 months; 2) Food System Taskforce (FSTF) capacity building, and 3) private sector engagement
- Health and Nutrition: 1) Government of Ethiopia (GoE) basic health extension program; 2) GoE supportive supervision coaching; 3) GoE-led community social behavior change (SBC) sessions; and 4) Community Management of Acute Malnutrition (CMAM) Programming.
- Water and Sanitation: 1) Water infrastructure development; 2) improved governance via water, sanitation and hygiene (WASH) committees; and 3) water source monitoring.
- Natural Resource Management: 1) Public works projects; 2) community training in planning and sustaining community assets; 3) Implementation of the environment and social management framework; 4) enhance participation of watershed committees
Ifaa EnhancedBehavioural
- PSNP Systems: 1) establishment and training of Community Technical Coordinating Forum; 2) Case management capacity building; and 3) private sector construction of infrastructure
- Health and Nutrition:1) the Care Group Model approach; 2) home garden promotion; 3) the nutrition budget calculator; and 4) labor and time-saving technologies.
- Community-level interventions are 1) adolescent nutrition school clubs; 2) religious leader mobilization and training vulnerable groups; 3) audio toolkit against harmful traditional practice; 4) enhanced SBC tools for health/nutrition promotion; 5) additional health extension programs
- Water and Sanitation: 1) Community Led Total Sanitation and Hygiene; 2) WASH systems assessments and strengthening; 3) Ensuring water quality and safety via routine monitoring; 4) Private sector engagement of WASH-related businesses;
Ifaa Enhanced + LivelihoodsOther
- Additional resources provided to the groups, including 1) Engagement of Private Service Providers to enable access to sustainable credit and larger loans; 2) Financial Education using an expanded 'Smart Skills' curriculum focusing on savings, smart borrowing and effective financial management; and 3) Life Skills Training for Youth.
- Additional supports include: 1) Seven Steps of Marketing Training; 2) Climate Smart Agriculture to reduce water needs and increase soil health and vegetation coverage; 3) Producers Groups and linkages to markets/suppliers/buyers; Selected financial institutions will be provided with a credit guarantee fund and capacity-building support to help facilitate loans. Private sector value chain assessment and financing. Additional private sector engagement and linkage facilitation.
| Study group | Role | What they receive |
|---|---|---|
| Ifaa Basic | comparison group Receives: Other: Ifaa Basic | |
| Ifaa Enhanced | intervention group 1 Receives: Behavioral: Ifaa Enhanced | |
| Ifaa Enhanced + Livelihoods | intervention group 2 Receives: Other: Ifaa Enhanced + Livelihoods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Poor or Borderline Food Consumption Score (%)
The food consumption score (FCS) reflects the diversity and frequency of household food and nutritional intake consumed in the seven days preceding the survey and is an indicator used globally. The consumption frequency of eight food groups is assessed in the preceding 7 days, and weighted scores for each food group are summed to calculate the FCS; a higher FCS score indicates better food security. Household food security status is categorized using the following thresholds: 0-28 poor; 28.5-42 borderline; and >42 for acceptable.
Measured: baseline, 2 years
Change in minimum dietary diversity (%)
The minimum dietary diversity (MDD) score is a population-level indicator to assess diet diversity as part of infant and young child feeding (IYCF) practices. Data are gathered from a questionnaire administered to the child's caregiver, usually as part of the IYCF module. Respondents are asked to indicate whether or not the child consumed any food over the previous 24 hours from each of eight food groups. The seven food groups included in the questionnaire are: grains, legumes and nuts, dairy products, flesh foods, eggs, vitamin A rich fruits and vegetables, other fruits and vegetables.
Measured: baseline, 2 years
Secondary outcomes (2)
Change in the prevalence of stunting (%)
Children will be measured for length (cm) among children 6 to 23 months of age. The length measures will be used to create indices of length-for-age (LAZ) z-score based on the World Health Organization (WHO) child growth standard. The prevalence of stunting (%) is defined as LAZ<-2.
The prevalence of stunting (%) among children in the Ifaa enhanced intervention, Ifaa enhanced + livelihoods intervention versus. Ifaa basic group at endline (2 year) adjusting for the difference in the prevalence of stunting (%) at baseline between two areas.
Measured: baseline, 2 years
Change in the prevalence of wasting (%)
Children will be measured for length (cm) and weight (kg) among children months. The length and weight measures will be used to create indices of weight-for-length (WLZ) z-score based on the WHO child growth standards.
The prevalence of wasting (%) among children in the Ifaa enhanced intervention, Ifaa enhanced + livelihoods intervention versus. Ifaa basic group at endline (2 year) adjusting for the difference in the prevalence of stunting (%) at baseline between two areas.
Measured: baseline, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start21 May 2023
- Primary completion5 Jul 2025
- Study completion5 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional WastingStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,317 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Responsible party
- Sponsor
- Investigators
- Shannon Doocy, PhD, Principal investigator, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA, 21205
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825716
- Sponsor's protocol ID
- IRB00023765
- Status last verified
- Dec 2025
- First submitted
- 11 Apr 2023
- Last updated
- 24 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ifaa Effectiveness Evaluation: A Comparison of Multisectoral Food Security and Resilience Interventions in the Oromia Region of Ethiopia
- ClinicalTrials.gov ID
- NCT05825716
- Acronym / sponsor ID
- IRB00023765
- Conditions
- Nutritional Wasting, Nutritional Stunting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,317 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Study start
- 21 May 2023 (actual)
- Primary completion
- 5 Jul 2025 (actual)
- Study completion
- 5 Jul 2025 (actual)
- First posted
- 24 Apr 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.
The Ifaa Project is a USAID-funded Resilience and Food Security Activity (RFSA) that is being implemented by Catholic Relief Services (CRS) and partners in the East Hararghe Zone of the Oromia Region in Ethiopia. Ifaa targets households that are participating in the Productive Safety Net Programme (PSNP) which is a social protection program administered by the Government of Ethiopia that provides food and cash assistance to vulnerable households. The Ifaa Project will deliver multi-sectoral programming in 241 kebeles (sub-districts) in nine woredas (districts) of East Hararghe Zone, however, intervention packages vary by location. The proposed effectiveness evaluation will quantify the impacts of three different intervention packages in terms of key project indicators in the areas of household food security, diet, and child nutrition.
Detailed description
The Ifaa Project will deliver multi-sectoral programming in 241 kebeles (sub-districts) in nine woredas (districts) of East Hararghe Zone, however, intervention packages vary by location. The three Ifaa intervention packages that will be delivered to PSNP beneficiaries based on the beneficiaries residence location include: 1) the Ifaa basic package; 2) enhanced package without livelihoods; and 3) enhanced package with livelihoods. The proposed effectiveness evaluation will quantify the impacts of three different intervention packages in terms of key project indicators in the areas of household food security, diet, and child nutrition. As the Ifaa consortium learning partner, Johns Hopkins School of Public Health (JHSPH) has been requested to design an effectiveness evaluation of the different intervention packages to compare their outcomes among beneficiary households.
To align the evaluation with project aims, key project indicators are used as study outcome measures. The specific objectives of the evaluation are to quantify the impact of Ifaa interventions as follows:
- At the household level, Poor or Borderline Food Consumption Score (FCS)
- at the individual level, change in minimum dietary diversity among children <5 years A secondary objective is to examine Ifaa impacts on child nutrition indicators, including measures of both acute and chronic malnutrition.
A longitudinal cohort design will be used to compare the effectiveness of three Ifaa intervention packages among PSNP beneficiaries in Eastern Hararghe: 1) the Ifaa basic package; 2) enhanced package without livelihoods; and 3) enhanced package with livelihoods. Under this approach, the enrolled households will have either a pregnant woman or children <24 months of age. Households will be followed over a two-year period, with the baseline and endline survey conducted at a similar time in the calendar year to avoid seasonal changes in food security. The magnitude of change in key indicators over time will be assessed for each group; if needed, adjusted models will be used to account for baseline differences between groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ifaa Basic | – | Other: Ifaa Basiccomparison group |
| Ifaa Enhanced | – | Behavioral: Ifaa Enhancedintervention group 1 |
| Ifaa Enhanced + Livelihoods | – | Other: Ifaa Enhanced + Livelihoodsintervention group 2 |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The overall goal of the Ifaa Project is to improve food security of vulnerable households in targeted PSNP communities, contributing to a sustained reduction in rural poverty. To achieve this goal, Ifaa will provide additional multi-sectoral interventions to benefit further 60,000 PSNP households in the Oromia region, which is Ethiopia's largest, most populous region and also one of its poorest. The study population is PSNP beneficiaries that are participating in the Ifaa Project.
Key inclusion criteria (4 listed)
- Households are PSNP clients
- Households are Ifaa Project beneficiaries that are planned participants in: 1) Savings and Internal Lending Communities (SILC) groups (Ifaa Basic); 2) SILC Groups AND Care Groups (Ifaa and Enhanced); or 3) SILC groups AND Care Groups AND a Livelihoods Pathway.
- Households have a pregnant woman OR at least one child <36 months of age
- Households have an adult member that is capable of giving informed consent and completing an interview
Key exclusion criteria (2 listed)
- Child-headed households (all members age 17yrs or less)
- Individuals not mentally able to give informed consent and complete an interview
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 |
|---|---|---|
| Ifaa Basic* PSNP Systems: (1) Provision of food aid commodities (wheat, oil, and pulse) per the PSNP transfer schedule for 3-6 months; 2) Food System Taskforce (FSTF) capacity building, and 3) private sector engagement * Health and Nutrition: 1) Government of Ethiopia (GoE) basic health extension program; 2) GoE supportive supervision coaching; 3) GoE-led community social behavior change (SBC) sessions; and 4) Community Management of Acute Malnutrition (CMAM) Programming. * Water and Sanitation: 1) Water infrastructure development; 2) improved governance via water, sanitation and hygiene (WASH) committees; and 3) water source monitoring. * Natural Resource Management: 1) Public works projects; 2) community training in planning and sustaining community assets; 3) Implementation of the environment and social management framework; 4) enhance participation of watershed committees | Other | Ifaa Basic |
| Ifaa Enhanced* PSNP Systems: 1) establishment and training of Community Technical Coordinating Forum; 2) Case management capacity building; and 3) private sector construction of infrastructure * Health and Nutrition:1) the Care Group Model approach; 2) home garden promotion; 3) the nutrition budget calculator; and 4) labor and time-saving technologies. * Community-level interventions are 1) adolescent nutrition school clubs; 2) religious leader mobilization and training vulnerable groups; 3) audio toolkit against harmful traditional practice; 4) enhanced SBC tools for health/nutrition promotion; 5) additional health extension programs * Water and Sanitation: 1) Community Led Total Sanitation and Hygiene; 2) WASH systems assessments and strengthening; 3) Ensuring water quality and safety via routine monitoring; 4) Private sector engagement of WASH-related businesses; | Behavioural | Ifaa Enhanced |
| Ifaa Enhanced + Livelihoods* Additional resources provided to the groups, including 1) Engagement of Private Service Providers to enable access to sustainable credit and larger loans; 2) Financial Education using an expanded 'Smart Skills' curriculum focusing on savings, smart borrowing and effective financial management; and 3) Life Skills Training for Youth. * Additional supports include: 1) Seven Steps of Marketing Training; 2) Climate Smart Agriculture to reduce water needs and increase soil health and vegetation coverage; 3) Producers Groups and linkages to markets/suppliers/buyers; Selected financial institutions will be provided with a credit guarantee fund and capacity-building support to help facilitate loans. Private sector value chain assessment and financing. Additional private sector engagement and linkage facilitation. | Other | Ifaa Enhanced + Livelihoods |
Primary outcome
Change in Poor or Borderline Food Consumption Score (%)
Time frame: baseline, 2 years
The food consumption score (FCS) reflects the diversity and frequency of household food and nutritional intake consumed in the seven days preceding the survey and is an indicator used globally. The consumption frequency of eight food groups is assessed in the preceding 7 days, and weighted scores for each food group are summed to calculate the FCS; a higher FCS score indicates better food security. Household food security status is categorized using the following thresholds: 0-28 poor; 28.5-42 borderline; and >42 for acceptable.
Change in minimum dietary diversity (%)
Time frame: baseline, 2 years
The minimum dietary diversity (MDD) score is a population-level indicator to assess diet diversity as part of infant and young child feeding (IYCF) practices. Data are gathered from a questionnaire administered to the child's caregiver, usually as part of the IYCF module. Respondents are asked to indicate whether or not the child consumed any food over the previous 24 hours from each of eight food groups. The seven food groups included in the questionnaire are: grains, legumes and nuts, dairy products, flesh foods, eggs, vitamin A rich fruits and vegetables, other fruits and vegetables.
2 secondary outcomes
Change in the prevalence of stunting (%)
Time frame: baseline, 2 years
Change in the prevalence of wasting (%)
Time frame: baseline, 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
Related trials for Nutritional Wasting
Not yet recruiting
Gut-Liver-Muscle Axis in Cancer Cachexia
Head & Neck Cancer
RecruitingObservational study
Hospital-Based Prospective Cohort of Malnutrition Under 6-Month Study (HOSPIC-6-Study)
Malnutrition, Infant, Malnutrition
Not yet recruitingObservational study
Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia
Malnutrition, Sarcopenia
RecruitingObservational study
Investigating the Link Between Advanced Glycation End Products (AGEs) and Muscle Wasting in Sarcobesity
Sarcopenia, Obesity
Recruiting
Milk Fat Globule Membrane-Enhanced RUTF for Children With Severe Acute Malnutrition
Severe Acute Malnutrition, Cognitive Impairment
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.
Shannon Doocy, PhD principal investigator
Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA, 21205
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutritional Wasting and Nutritional Stunting, run by Johns Hopkins Bloomberg School of Public Health 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 24 Dec 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Poor or Borderline Food Consumption Score (%) (time frame: baseline, 2 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 24 Dec 2025.