Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000291381
Ethics application status
Approved
Date submitted
18/01/2017
Date registered
24/02/2017
Date last updated
24/02/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Strengthening food and nutrition security through family poultry and crop integration in Tanzania and Zambia
Scientific title
Do community-based vaccination programs against Newcastle disease in village chickens and strategic improvements to crop systems, compared to existing poultry and crop systems, improve height-for-age Z-scores in young children in rural Tanzania and Zambia?
Secondary ID [1] 290960 0
FSC/2012/023
Universal Trial Number (UTN)
U1111-1186-8211
Trial acronym
Nkuku4U
Linked study record
No

Health condition
Health condition(s) or problem(s) studied:
Childhood stunting 301701 0
Condition category
Condition code
Diet and Nutrition 301400 301400 0 0
Other diet and nutrition disorders
Public Health 301401 301401 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a cluster randomised controlled trial. Interventions include two components:

(1) Community-based Newcastle disease control programs
Members of participating communities, selected in consultation with local leaders, will participate in a three-day theoretical and practical training workshop to prepare them to work as “community poultry vaccinators”. Workshops will be led by government personnel, with tertiary qualifications in animal health and production, and experience in the training program in question and in approaches to adult learning who have participated in initial master trainer workshops led by USyd veterinary personnel. The thermotolerant I-2 Newcastle disease vaccine (produced by Tanzania Vaccine Institute in Tanzania and Central Veterinary Research Institute in Zambia) will be administered to chickens via eyedrop on a fee-for-service basis, during vaccination campaigns conducted every four months.

(2) Strategic interventions to improve crop production and reduce crop losses
Analysis of existing farming systems and participatory discussions with community members will inform a series of crop interventions within each project cluster, according to identified constraints to agricultural production. Interventions such as improved seed varieties and crop diversity, storage methods and cultivation and weeding practices will be demonstrated in centralised farming plots, presented during training workshops and made available to community members. One two-day training workshops will be held in each project cluster, led by government agricultural officers, with involvement of local agricultural extensionists.

No intervention will be applied to humans.

Communities will be randomised to receive or not receive village chicken ND vaccination campaigns in the first year and a crop intervention in the second year. For ethical and logistical reasons interventions will be offered to “control” (delayed intervention) communities after a delay of 12 months.
Intervention code [1] 296908 0
Prevention
Comparator / control treatment
Delayed intervention.
There will be a 12 month delay between intervention and delayed intervention clusters.
Control group
Active

Outcomes
Primary outcome [1] 300796 0
Height-for-age Z-scores (HAZ) of children.

Length or height measurements will be conducted by trained health personnel, using a portable child measuring board (sourced through UNICEF supply division) to the precision of 0.1 cm.
Timepoint [1] 300796 0
At 6 monthly intervals to 24 months
Secondary outcome [1] 330879 0
% Minimum dietary diversity, measured by proportion of children 6-23 months of age who consumed foods from four or more food groups.

This will be determined from a 24-hour food recall collected through structured interviews with the mother (or primary caretaker) of enrolled children on a six-monthly basis.
Timepoint [1] 330879 0
At baseline in each cluster, at 6 monthly intervals to 24 months.
Secondary outcome [2] 330880 0
% any breastfeeding (breast milk, with or without other forms of food or liquids) among children recruited at less than 12 months of age.

The status of each child as exclusively breastfed / receiving breast milk and other foods or liquids / non-breastfed will be recorded on a fortnightly basis, by trained enumerators from each project cluster, based on mother’s self-report.
Timepoint [2] 330880 0
At 6, 12, 18 and 24 months.
Secondary outcome [3] 330881 0
Vitamin A in blood spots from children.

This will be performed in a subset of four communities (clusters) in Tanzania and four communities (clusters) in Zambia.
Timepoint [3] 330881 0
Baseline, 12 months and 48 months.
Secondary outcome [4] 331696 0
Iron in blood spots and haemoglobin in capillary blood from children.

This will be performed in a subset of four communities (clusters) in Tanzania and four communities (clusters) in Zambia.
Timepoint [4] 331696 0
Baseline, 12 months and 48 months.

Eligibility
Key inclusion criteria
Children aged under 24 months of age at the time of enrolment, from households which currently keep chickens or which have kept chickens in the previous 2 years and intend to keep chickens again in the future, and which intend to reside within the project site for the duration of the study.
Minimum age
No limit
Maximum age
24 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Multiple children meeting criteria for inclusion (i.e. under 24 months of age at the time of enrolment, from households which currently keep chickens or which have kept chickens in the previous 2 years and intend to keep chickens again in the future, and which intend to reside within the project site for the duration of the study) within a single household. In this case, the youngest child will be enrolled. Households unwilling to participate in the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This is a cluster randomised controlled trial. Twenty communities (clusters) from Tanzania (12) and Zambia (8) have been identified in collaboration with partner agencies in each country. Enrolment of participants is performed prior to allocation of clusters as immediate or delayed intervention.

A community-wide census is conducted door-to-door in each cluster to generate lists of children (a) under 12 months of age and (b) 12-24 months of age, from households which meet criteria for inclusion in the study (i.e. from households which currently keep chickens or which have kept chickens in the previous 2 years and intend to keep chickens again in the future, and which intend to reside within the project site for the duration of the study). Random sampling (drawing eligible participant codes “from a hat”) is used to select participants, first drawing from the list of children under 12 months, and then, if numbers are insufficient, from the list of children 12-24 months.

Four communities (clusters) served by the same health facility were recruited and identified as belonging to the same stratum. Within each of these five strata, names of the clusters are drawn at random, in the presence of local leaders and other representatives, to allocate two communities as immediate intervention and two communities as delayed intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The project design involves 20 communities (clusters), stratified in groupings of four communities which are served by the same health facility. In each group of four, randomisation (drawing cluster codes “from a hat”) will be used to allocate two communities into immediate intervention and two into delayed intervention groups.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Communities will be allocated as immediate intervention or delayed intervention (12 month delay) within the stratifications (groupings of four communities served by a single health centre). The project involves staggered entry of clusters, with all clusters receiving both of the intervention components during the study.

(1) Community-based Newcastle disease control programs
Members of participating communities, selected in consultation with local leaders, will participate in a three-day theoretical and practical training workshop to prepare them to work as “community poultry vaccinators”. The thermotolerant I-2 Newcastle disease vaccine (produced by Tanzania Vaccine Institute in Tanzania and Central Veterinary Research Institute in Zambia) will be administered to chickens via eyedrop on a fee-for-service basis, during vaccination campaigns conducted every four months.

(2) Strategic interventions to improve crop production and reduce crop losses
Analysis of existing farming systems and participatory workshops with community members will inform a series of crop interventions within each project cluster, according to identified constraints to agricultural production. Interventions such as improved seed varieties and crop diversity, storage methods and cultivation and weeding practices will be demonstrated in centralised farming plots and made available to community members.

No intervention will be applied to humans.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In each of the 20 communities, at least 60 children under 2 years of age and their mothers will be enrolled in the first year of implementation. The sample size calculation was based on an estimated baseline stunting rate of 35% with an aim of reducing this to 25% by the end of the project, i.e. a 10% reduction, giving 80% power to detect this difference as significant at the 2-sided 5% level, assuming an intra-cluster correlation coefficient of 0.014.
The primary analysis will be a comparison of stunting rates between the 10 communities receiving immediate ND vaccination and the 10 communities receiving the delayed intervention. Stunting is defined as height-for-age more than 2 standard deviations below the WHO child growth standard median.

Secondary analyses will compare height-for-age and prevalence of stunting between children in households in intervention communities and those in delayed intervention communities, taking into account clustering within communities and adjusting for the following potential confounders using multi-level modelling: birth weight, breastfeeding, diet, infection episodes, household wealth and mother’s education level.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
1/05/2014
Date of last participant enrolment
Anticipated
Actual
1/01/2016
Date of last data collection
Anticipated
1/12/2018
Actual
Sample size
Target
1200
Accrual to date
Final
1381
Recruitment outside Australia
Country [1] 8587 0
Tanzania, United Republic Of
State/province [1] 8587 0
Manyoni District, Singida Region; Mpwapwa District, Dodoma Region
Country [2] 8588 0
Zambia
State/province [2] 8588 0
Rufunsa District, Lusaka Province

Funding & Sponsors
Funding source category [1] 295377 0
Government body
Name [1] 295377 0
Australian Centre for International Agricultural Research
Country [1] 295377 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Robyn Alders
Address
Room 4114, Level 4E Charles Perkins Centre D17
The University of Sydney, Camperdown NSW 2006, Australia
Country
Australia
Secondary sponsor category [1] 294199 0
Individual
Name [1] 294199 0
Professor Mu Li
Address [1] 294199 0
Room 307, Edward Ford Building A27
The University of Sydney, Camperdown NSW 2006 Australia
Country [1] 294199 0
Australia
Other collaborator category [1] 279398 0
Government body
Name [1] 279398 0
Tanzania Veterinary Laboratory Agency
Address [1] 279398 0
Physical address: Temeke Veterinary Compound, Mandela Road, Dar es Salaam

Postal address: PO Box 9254, Dar es Salaam
Country [1] 279398 0
Tanzania, United Republic Of
Other collaborator category [2] 279399 0
Government body
Name [2] 279399 0
Department of Veterinary Services, Ministry of Fisheries and Livestock
Address [2] 279399 0
Physical address: Third floor, Mulungushi House, Independence Avenue, Ridgeway, Lusaka

Postal address: PO Box 50060, Lusaka
Country [2] 279399 0
Zambia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296709 0
National Medical Research Institute
Ethics committee address [1] 296709 0
3 Barack Obama Drive / PO Box 9653
11101 Dar es Salaam, Tanzania
Ethics committee country [1] 296709 0
Tanzania, United Republic Of
Date submitted for ethics approval [1] 296709 0
Approval date [1] 296709 0
20/02/2014
Ethics approval number [1] 296709 0
NIMR/HQ/R.8a/Vol.IX/1690
Ethics committee name [2] 296710 0
Human Research Ethics Committee, The University of Sydney
Ethics committee address [2] 296710 0
Human Ethics Office
Margaret Telfer Building K07
The University of Sydney, Camperdown NSW 2006, Australia
Ethics committee country [2] 296710 0
Australia
Date submitted for ethics approval [2] 296710 0
Approval date [2] 296710 0
31/03/2014
Ethics approval number [2] 296710 0
2014/209
Ethics committee name [3] 296711 0
Human Research Ethics Committee, The University of Sydney
Ethics committee address [3] 296711 0
Human Ethics Office
Margaret Telfer Building K07
The University of Sydney, Camperdown NSW 2006, Australia
Ethics committee country [3] 296711 0
Australia
Date submitted for ethics approval [3] 296711 0
Approval date [3] 296711 0
07/10/2014
Ethics approval number [3] 296711 0
2014/772
Ethics committee name [4] 296712 0
Tropical Diseases Research Centre Ethics Review Committee
Ethics committee address [4] 296712 0
TDRC Ethics Review Committee
Box 71769, Ndola, Zambia
Ethics committee country [4] 296712 0
Australia
Date submitted for ethics approval [4] 296712 0
Approval date [4] 296712 0
11/05/2015
Ethics approval number [4] 296712 0
IRB Registration Number 00002911; FWA Number: 00003729

Summary
Brief summary
Despite increases in agricultural production over the past two decades, malnutrition rates in children have not diminished significantly in many developing countries. Undernutrition affects health, physical and cognitive development capacity in children as well as productivity in adulthood. Recent reviews indicate that agricultural research interventions have had little impact on childhood nutrition, with poor research project design being a contributing factor to this disappointing outcome.

Food and nutrition security are particularly crucial in Tanzania and Zambia where the national prevalence of stunting (chronic restriction of growth) in children under five years of age has been estimated to be 42% and 45%, respectively. Sustainably addressing the nutrition component of food security in Tanzania and Zambia is critical and was raised as a priority by senior government personnel in both countries. Also, as research indicates that resources under the control of women are more likely to be used to support the education and nutrition of children, we are testing if improving women’s production of family poultry and crops can have a beneficial impact on children’s overall nutritional status and health.

We aim to enhance traditional village chicken-crop systems as a sustainable solution to the ongoing nutritional challenges in Africa. Rural communities that rely on rain fed crops often go through severe hunger periods just prior to the major harvesting season when their stored grains have been exhausted. These significant peaks and troughs in household food availability are reduced when there is diversity in family farming activities. By improving village poultry health and welfare, families have greater access to poultry meat and eggs which are a source of high quality protein, bioavailable micronutrients and income. Poultry manure can also contribute to increased soil fertility for the production of indigenous vegetables at the household level, further diversifying the range of foods eaten.
Trial website
http://sydney.edu.au/vetscience/research/Nkuku4U/

http://aciar.gov.au/aifsc/projects/strengthening-food-and-nutrition-security-through-family-poultry-and-crop-integration
Trial related presentations / publications
Publications
Alders, R., Aongola, A., Bagnol, B., de Bruyn, J., Kimboka, S., Kock, R., Li, M., Maulaga, W., McConchie, R., Mor, S., Msami, H., Mulenga, F., Mwala, M., Mwale, S., Rushton, J., Simpson, J., Victor, R., Yongolo, C. and Young, M. 2014. Using a One Health approach to promote food and nutrition security in Tanzania and Zambia. Planet@Risk 2(3):187-190.
Bagnol, B., Clarke, E., Li, M., Maulaga, W., Lumbwe, H., McConchie, R., de Bruyn, J. and Alders, R.G. 2016. Transdisciplinary project communication and knowledge sharing experiences in Tanzania and Zambia through a One Health lens. Frontiers in Public Health 4:10. doi: 10.3389/fpubh.2016.00010
Fritz, S., Alders, R., Bagnol, B., Msami, H. and Mtambo, K. 2015. Tanzania's food security: seeking sustainable agricultural intensification and dietary diversity. In: U.S. Nagothu (ed), Food Security and Development: Country case studies. Earthscan, Routledge, Abingdon, UK. pp. 174-204.
Queenan, K., Alders, R., Maulaga, W., Lumbwe, H., Rukambile, E., Zulu, E., Bagnol, B. and Rushton, J. 2016. A rapid appraisal of the indigenous chicken market in Tanzania and Zambia. Are they ready for improved outputs from village production systems? Journal of Livestock Research for Rural Development [accepted]
Conference Abstracts
Bagnol, B., Li, M., Lumbwe, H., Maulaga, W., de Bruyn, J. and Alders, RG. 2016. Research for new policy options: Raising village chickens to tackle food and nutrition insecurity. Oral presentation to be given at the XXV World's Poultry Congress (WPC2016) 5-9 September, Beijing. [oral presentation]
de Bruyn, J. 2015. "Let them eat eggs: Exploring constraints to the contribution of eggs to food and nutrition security in central Tanzania." Faculty of Veterinary Science Postgraduate Conference, University of Sydney, 28 October 2015, Abstract Booklet, p. 33
de Bruyn, J., Alders, R., Bagnol, B., Darnton-Hill, I., Li, M., Maulaga, W. and Lumbwe, H. 2014. Family Poultry and Food Sovereignty: Exploring locally-appropriate, sustainable solutions to child undernutrition in sub-Saharan Africa. Agri-Food XXI Conference: Food, People and Planet. Sydney, 24-26 November, 2014.
de Bruyn, J., Alders, R., Bagnol, B., Darnton-Hill, I., Kock, R., Li, M., Lumbwe, H., Maulaga, W., Rushton, J., and Wong, J. 2015. Taking a nutrition-sensitive approach to improving village poultry value-chain efficiency in sub-Saharan Africa. World Veterinary Poultry Association Congress. Cape Town, 7-11 September 2015, e-Booklet (oral presentation) p. 115.
de Bruyn, J., Alders, R., Bagnol, B., Guyonnet V., McGregor, O., and Thieme, O. 2015. Let them eat eggs: Promoting the vital contributions of eggs to food and nutrition security in resource-poor settings. GRF One Health Conference. Davos, 4-7 October 2015 Available:https://www.conftool.pro/onehealth2015/index.php?page=browseSessions&form_session=67
de Bruyn, J., Maulaga, W., Rukambile, E., Bagnol, B., Li, M., Darnton-Hill, I., Thomson, P., Simpson, J., Mor, S. and Alders, R. 2016. Chicken ownership positively associated with length-for-age Z-scores of infants and young children in central Tanzania. Abstract submitted to Conference on Agri-Health Research at ANH Academy Week, Addis Ababa, 20-24 June 2016. [poster presentation]
Magoke, G. 2015. "Determining susceptibility of village chickens to aflatoxin exposure and contamination of village grains and village chicken products in Tanzania." Faculty of Veterinary Science Postgraduate Conference, University of Sydney, 28 October 2015, Abstract Booklet, p. 59
Maulaga, W., Rukambile, E., Alders, R., de Bruyn, J., Muyengi, E., Lyimo, E., Moshi, G., Bagnol, B., McConchie, R., and Mramba, F. 2016. Supporting Policy Implementation through Collaboration: Sustainable Solutions to the Food and Nutrition Security Challenge in Tanzania. International One Health Ecohealth Conference, 3-7 December 2016, Melbourne. Abstract Booklet Nº 959.
Rukambile, E., Maulaga, W., de Bruyn, J., Bagnol, B., Alders, R., and Mramba, F. 2015. An overview on the village chicken keeping practices at Sanza Ward in Singida region and proposed areas of intervention. 33rd Tanzania Veterinary Association Conference, 1-3 December, 2015, Arusha International Conference Centre, Tanzania.
Presentations
Alders, R. 2015. Animal health and food and nutrition security through an ecohealth lens. Food and Agriculture Organization of the United Nations, Rome, 6 July 2015. 25 minutes.
Alders, R. 2015. From village chickens to maternal and child health: food and nutrition security through an ecohealth lens. Leverhulme Center for Integrative Research on Agriculture and Health, London, UK, 12 June 2015. 45 minutes.
Alders, R. 2015. Livestock, a lifeline for smallholder farmers. AgTalks, International Fund for Agricultural Development, Rome, 9 July 2015. 12 minutes. Available: https://www.youtube.com/watch?v=hmKiZmGuoGQ
de Bruyn, J. 2014. "Ethical, Efficient Approaches to Improving Food and Nutrition Security in sub-Saharan Africa." Lunchtime Seminar, Faculty of Veterinary Science, University of Sydney. 11 September, 2014.
de Bruyn, J. 2014. "Healthy Chickens, Healthy Children: Sustainable contributions to human nutrition through the control of Newcastle disease in village poultry." Postgraduate Research Conference, Faculty of Veterinary Science, University of Sydney. 5 November, 2014.
de Bruyn, J, Alders, R, Bagnol, B, Costa, R, Msami, H and Young, M. 2014. "Opportunities for improving village poultry value chains: Experiences from Singida District in central Tanzania". National Workshop on Strengthening Poultry Producers Through Organised Action in Zimbabwe, Harare, 3-5 December 2014.
McConchie, R. 2015. "Farming Systems Analysis in Tanzania." Australia Africa Conference, Australian National University, Canberra, 27 August 2015.
Maulaga, W., Lumbwe, H., Niputu, S. and Jong, J. 2015. "Agricultural Research for Women, by Women." ACIAR Seminar, Canberra, 25 August 2015.
Rukambile, E., Maulaga, E., de Bruyn, J., Bagnol, B., Alders, R. and Mramba, F. 2015. An overview on the village chicken keeping practices at Sanza Ward in Singida region and proposed areas of intervention. 33rd Tanzania Veterinary Association Conference, 1 - 3 December, 2015, Arusha International Conference Centre, Tanzania.
Public notes

Contacts
Principal investigator
Name 71842 0
A/Prof Robyn Alders
Address 71842 0
Room 4113, Level 4E Charles Perkins Centre D17
The University of Sydney
Camperdown NSW 2006
Country 71842 0
Australia
Phone 71842 0
+61 2 8627 1771 or +61 467 603 370
Fax 71842 0
Email 71842 0
[email protected]
Contact person for public queries
Name 71843 0
A/Prof Robyn Alders
Address 71843 0
Room 4113, Level 4E Charles Perkins Centre D17
The University of Sydney
Camperdown NSW 2006
Country 71843 0
Australia
Phone 71843 0
+61 2 8627 1771 or +61 467 603 370
Fax 71843 0
Email 71843 0
[email protected]
Contact person for scientific queries
Name 71844 0
A/Prof Robyn Alders
Address 71844 0
Room 4113, Level 4E Charles Perkins Centre D17
The University of Sydney
Camperdown NSW 2006
Country 71844 0
Australia
Phone 71844 0
+61 2 8627 1771 or +61 467 603 370
Fax 71844 0
Email 71844 0
[email protected]

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