Clinical trial NCT03152227: Nutrition-sensitive Agricultural Interventions for Ethiopia
Official title: Evaluation of Integrated Agriculture and Nutrition Sensitive Interventions for the African Chicken Genetic Gains (ACGG) Program in Ethiopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Modification
Health Behavior
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: The International Livestock Research Institute (ILRI)
name: Addis Continental Institute of Public Health
name: Food, Agriculture and Natural Resources Policy Analysis Network
First posted: 2017-05-12
Enrollment: 2117
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims at evaluating the impact of integrating nutrition sensitive behavioral change communication (BCC) in the context of increased household production of chicken and eggs on women and children diet.

Detailed description: The Agriculture to Nutrition (ATONU) Project, led by the Food, Agriculture and Natural Resources Policy Analysis Network (FANRPAN), aims to develop, implement, and evaluate nutrition-sensitive interventions within the context of existing agricultural programs with the goal of improving the nutritional status of women of reproductive age and young children, particularly in the first 1000 days of life. Specifically, ATONU will implement a nutrition sensitive intervention in collaboration with the ACGG Program. ACGG is evaluating the agricultural productivity of high-producing chicken genotypes in Ethiopia and will be providing 20-30 chickens to small-scale chicken-producing households for an 18-month on-farm evaluation. These households will also be provided with regular technical input on good chicken production practices, and ACGG investigators will aim to reach women as well as men in participating households.

ATONU will implement an additional nutrition-sensitive intervention among ACGG households that will use behavior change communication (BCC) to encourage consumption of chicken products (meat and eggs); good water, sanitation, and hygiene (WASH) practices in poultry production; use of income from sale of chicken products to improve nutrition; empowerment of women in decision-making around chicken production and sale; and home gardening of nutrient-dense vegetables to improve dietary quality within the household. Qualitative work is supporting development of this intervention.

ACGG's intervention to increase chicken production may improve the nutritional status of women and children through increasing access to chicken meat and eggs for household consumption and empowering women by giving them access to income, which could be used for purchase of other nutrient-dense foods. However, increasing production and income alone may not necessarily translate into improved diets or nutritional outcomes. ATONU's intervention will specifically encourage the use of chicken products and income to provide nutritious diets for women of reproductive age, emancipated minors and young children through extensive nutrition behavior change communication. Further, recognizing that lack of availability of nutrient-dense foods in local markets may be an important barrier to a diverse and nutritious diet, the home gardening component of ATONU's intervention seeks to increase the availability of nutrient-dense vegetables at household level.

The ACGG program is operating in diverse agroecologies in Ethiopia. Within its target areas, the program listed villages in which chicken production was an important activity and, from this list, randomly selected villages in which to implement its intervention. In a subset of these ACGG villages, ATONU will implement its intervention. As a result, there will be two groups of ACGG villages: those receiving only the poultry production intervention, and those receiving the poultry production intervention coupled with ATONU's nutrition-sensitive intervention. Allocation of ACGG villages to one of these two groups will be done randomly. Investigators will evaluate the nutritional impact of these two interventions among smallholder chicken-producing households in Ethiopia. Specifically, investigators will use the two groups of villages described above and a third group of ACGG-eligible villages that ACGG did not choose for intervention to conduct a cluster-randomized controlled trial with the goal of evaluating the effect of the ACGG and ATONU interventions on maternal and child diets, nutritional status, and health.

Eligibility criteria: Inclusion Criteria:

Households in one of the two ACGG treatment arms will be eligible for inclusion if they meet all of the following criteria:

1. Are participating in the ACGG program
2. Have at least one woman of reproductive age (18-49 years at enrollment) or emancipated minor (girl aged 15 to less than 18 years)
3. Plan to remain in the study area throughout the study duration
4. Provide informed consent.

Households in the control arm will be eligible for inclusion if they meet all of the following criteria:

1. Meet the criteria for participating in the ACGG program, namely, they have produced chickens for at least two years and are currently keeping no more than 50 chickens with interest to expand production in the future
2. Have at least one woman of reproductive age (18-49 years at enrollment) or emancipated minor (girl aged 15 to less than 18 years)
3. Plan to remain in the study area throughout the study duration
4. Provide informed consent.

Exclusion Criteria:

* Households will be excluded if they fail to meet any of the criteria listed above

Primary outcomes:
measure: Diet quality for women and emancipated minors using the standard FAO/FANTA MDD-W dietary diversity score questionnaire,
timeFrame: 18 months
Secondary outcomes:
measure: Diet quality for young children using the standard dietary diversity score questionnaire developed by the by Food and Nutrition Technical Assistance Project and Academy for Educational Development.
timeFrame: 18 months
measure: Anemia in women and emancipated minors as defined by hemoglobin (Hb) levels cut off points of Hb < 12 g/dl for non pregnant women and Hb < 11g/dl for pregnant women
timeFrame: 18 months
measure: Anemia in children as defined by hemoglobin (Hb) levels cut off points of Hb < 11 g/dl
timeFrame: 18 months
measure: Body Mass Index (BMI in kg/m^2 ) for women and emancipated minors in the three study groups (ACGG alone, ACGG plus ATONU, and Control)
timeFrame: 18 months
measure: Growth in height for children (Height for Age) in the three study groups (ACGG alone, ACGG plus ATONU, and Control)
timeFrame: 18 months
measure: Weight in children (Weight for Age) in the three study groups (ACGG alone, ACGG plus ATONU, and Control)
timeFrame: 18 months
Other outcomes:
Locations:
city: Addis Ababa
country: Ethiopia
facility: Addis Continental Institute of Public Health (ACIPH)
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Wafaie W Fawzi, DrPH,MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Addis Continental Institute of Public Health
name: Yemane Berhane, PhD
role: PRINCIPAL_INVESTIGATOR
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