Nutrition-sensitive Agricultural Interventions for Ethiopia

Health Behavior Clinical Trial

— ATONU  

Official title:

Evaluation of Integrated Agriculture and Nutrition Sensitive Interventions for the African Chicken Genetic Gains (ACGG) Program in Ethiopia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03152227
• Other study ID #: HSPH-16-0912
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: May 8, 2018

Study information

• Verified date: August 2018
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2117
• Est. completion date: May 8, 2018
• Est. primary completion date: May 8, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Dietary Modification
• Health Behavior

Intervention

Other:
• ACGG
50 high-producing chicks to households along with provision of technical input on production

Behavioral:
• BCC
Nutrition sensitive BCC on poultry-specific aspects of nutrition, WASH, women's empowerment, and use of income combined with home gardening.

Locations

Country	Name	City	State
Ethiopia	Addis Continental Institute of Public Health (ACIPH)	Addis Ababa

Sponsors (4)

Lead Sponsor	Collaborator
Harvard School of Public Health	Addis Continental Institute of Public Health, Food, Agriculture and Natural Resources Policy Analysis Network, International Livestock Research Institute

Country where clinical trial is conducted

Ethiopia, 

References & Publications (11)

Balarajan Y, Ramakrishnan U, Ozaltin E, Shankar AH, Subramanian SV. Anaemia in low-income and middle-income countries. Lancet. 2011 Dec 17;378(9809):2123-35. doi: 10.1016/S0140-6736(10)62304-5. Epub 2011 Aug 1. — View Citation

Black RE, Victora CG, Walker SP, Bhutta ZA, Christian P, de Onis M, Ezzati M, Grantham-McGregor S, Katz J, Martorell R, Uauy R; Maternal and Child Nutrition Study Group. Maternal and child undernutrition and overweight in low-income and middle-income countries. Lancet. 2013 Aug 3;382(9890):427-451. doi: 10.1016/S0140-6736(13)60937-X. Epub 2013 Jun 6. Review. Erratum in: Lancet. 2013. 2013 Aug 3;382(9890):396. — View Citation

Iannotti LL, Lutter CK, Bunn DA, Stewart CP. Eggs: the uncracked potential for improving maternal and young child nutrition among the world's poor. Nutr Rev. 2014 Jun;72(6):355-68. doi: 10.1111/nure.12107. Epub 2014 May 7. Review. — View Citation

Lee AC, Katz J, Blencowe H, Cousens S, Kozuki N, Vogel JP, Adair L, Baqui AH, Bhutta ZA, Caulfield LE, Christian P, Clarke SE, Ezzati M, Fawzi W, Gonzalez R, Huybregts L, Kariuki S, Kolsteren P, Lusingu J, Marchant T, Merialdi M, Mongkolchati A, Mullany LC, Ndirangu J, Newell ML, Nien JK, Osrin D, Roberfroid D, Rosen HE, Sania A, Silveira MF, Tielsch J, Vaidya A, Willey BA, Lawn JE, Black RE; CHERG SGA-Preterm Birth Working Group. National and regional estimates of term and preterm babies born small for gestational age in 138 low-income and middle-income countries in 2010. Lancet Glob Health. 2013 Jul;1(1):e26-36. doi: 10.1016/S2214-109X(13)70006-8. Epub 2013 Jun 25. Erratum in: Lancet Glob Health. 2013 Aug;1(2):e76. — View Citation

Leroy JL, Frongillo EA. Can interventions to promote animal production ameliorate undernutrition? J Nutr. 2007 Oct;137(10):2311-6. Review. — View Citation

Marquis GS, Habicht JP, Lanata CF, Black RE, Rasmussen KM. Breast milk or animal-product foods improve linear growth of Peruvian toddlers consuming marginal diets. Am J Clin Nutr. 1997 Nov;66(5):1102-9. — View Citation

Olofin I, McDonald CM, Ezzati M, Flaxman S, Black RE, Fawzi WW, Caulfield LE, Danaei G; Nutrition Impact Model Study (anthropometry cohort pooling). Associations of suboptimal growth with all-cause and cause-specific mortality in children under five years: a pooled analysis of ten prospective studies. PLoS One. 2013 May 29;8(5):e64636. doi: 10.1371/journal.pone.0064636. Print 2013. — View Citation

Ruel MT, Alderman H; Maternal and Child Nutrition Study Group. Nutrition-sensitive interventions and programmes: how can they help to accelerate progress in improving maternal and child nutrition? Lancet. 2013 Aug 10;382(9891):536-51. doi: 10.1016/S0140-6736(13)60843-0. Epub 2013 Jun 6. Erratum in: Lancet. 2013 Aug 10;382(9891):506. — View Citation

Stevens GA, Finucane MM, Paciorek CJ, Flaxman SR, White RA, Donner AJ, Ezzati M; Nutrition Impact Model Study Group (Child Growth). Trends in mild, moderate, and severe stunting and underweight, and progress towards MDG 1 in 141 developing countries: a systematic analysis of population representative data. Lancet. 2012 Sep 1;380(9844):824-34. doi: 10.1016/S0140-6736(12)60647-3. Epub 2012 Jul 5. — View Citation

Sudfeld CR, McCoy DC, Danaei G, Fink G, Ezzati M, Andrews KG, Fawzi WW. Linear growth and child development in low- and middle-income countries: a meta-analysis. Pediatrics. 2015 May;135(5):e1266-75. doi: 10.1542/peds.2014-3111. Epub 2015 Apr 6. Review. — View Citation

Victora CG, Adair L, Fall C, Hallal PC, Martorell R, Richter L, Sachdev HS; Maternal and Child Undernutrition Study Group. Maternal and child undernutrition: consequences for adult health and human capital. Lancet. 2008 Jan 26;371(9609):340-57. doi: 10.1016/S0140-6736(07)61692-4. Review. Erratum in: Lancet. 2008 Jan 26;371(9609):302. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diet quality for women and emancipated minors using the standard FAO/FANTA MDD-W dietary diversity score questionnaire,	For each woman or emancipated minor in each study group (ACGG alone, ACGG plus ATONU, and Control), the number of food groups consumed in the previous day, out of the 10 food groups listed on the standard FAO/FHI360 MDD-W dietary diversity score questionnaire	18 months
Secondary	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.	For each young child in each study group (ACGG alone, ACGG plus ATONU, and Control), the number of food groups consumed in the previous day, out of the 8 groups listed (FGI-8) on the standard dietary diversity score questionnaire developed by Food and Nutrition Technical Assistance Project and Academy for Educational Development. The dietary diversity score is based on consumption of 8 food groups in the past 24 hours.	18 months
Secondary	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	Defining Anemia in women and emancipated minors in the three study groups (ACGG alone, ACGG plus ATONU, and Control) using Hb cut off adjusted for altitude as per the WHO 2011 guidelines	18 months
Secondary	Anemia in children as defined by hemoglobin (Hb) levels cut off points of Hb < 11 g/dl	Defining Anemia in children in the three study groups (ACGG alone, ACGG plus ATONU, and Control) using Hb cut off adjusted for altitude as per the WHO 2011 guidelines	18 months
Secondary	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)	For each woman and emancipated minor, BMI will be calculated by dividing body weight(kg) by the square of participant height (m^2). BMI values will be analyzed as continuous data.	18 months
Secondary	Growth in height for children (Height for Age) in the three study groups (ACGG alone, ACGG plus ATONU, and Control)	Height for age will be assessed and presented as Z scores as per the WHO children height for age growth charts for boys and girls	18 months
Secondary	Weight in children (Weight for Age) in the three study groups (ACGG alone, ACGG plus ATONU, and Control)	Weight for age in children will be assessed and presented as Z scores as per the WHO children weight for age charts for boys and girls	18 months