Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001803280
Ethics application status
Approved
Date submitted
26/10/2018
Date registered
6/11/2018
Date last updated
6/11/2018
Date data sharing statement initially provided
6/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of improved duck rearing on sale and consumption of ducks in rural households of flood-prone areas of Bangladesh
Scientific title
Impact of improved duck rearing on sale and consumption of ducks and dietary diversity of rural households in flood-prone areas of Bangladesh
Secondary ID [1] 296395 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eating behaviour 310142 0
Condition category
Condition code
Diet and Nutrition 308893 308893 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study was carried out over a period of 12 months from July 2016 to June 2017 in six villages of the Chittagong district, Bangladesh. The study was a cluster randomised controlled trial comprised of three arms with two villages randomly distributed per arm – an Intervention I, an Intervention II and a Control arm.

In each village, 25 households were randomly selected and received 15 ducklings, a bamboo basket for protecting ducklings from predators, and training in duck rearing. Intervention I and II households received deworming and vaccination against duck diseases, while duck feed were only provided to Intervention II households.

Ducklings were day-old unsexed ducks of a similar proportion of four breeds (Khaki Campbell, Indian Runner, Jinding and Pekin) purchased from the Regional Government Duck Breeding Farm, Sonagazi, Feni, Bangladesh. Their average initial weight was 40.0 g. Household owners were expected to take care of the ducks until sold or consumed over the 12-month period. They did not need to return any remaining ducks after the end of the trial.

The bamboo basket was provided to protect ducklings from predators and keep them warm in the first weeks after provision to the household.

Training in duck farming was provided to all households over a period of 10 days (1-10 July 2016). A training session lasted four hours and included all aspect of raising ducks, from breeding, hatching, incubation, brooding of ducks, housing, feeding, vaccination and the prevention and control of the main duck diseases. Two duck production experts from Chittagong Veterinary and Animal University (CVASU) delivered the training. At the end of the training, a question and answer session was conducted and a training manual in Bangla language was provided to all farmers.

Anthelmintics (Levamisole) were given to the ducklings in the two intervention groups first at the age of 40 days and then repeatedly every 60 days. Duck plague and duck cholera vaccines were provided from the Department of Livestock Services, Chittagong, Bangladesh. Duck plague vaccine was given intramusculary at the age of 30 days and duck cholera vaccine was given subcutaneously at the age of 60 days. Booster vaccinations were provided after 15 days and additional vaccinations were conducted every six months.

Duck feed supplied to households in the Intervention II group was commercially produced pellet feed (Diameter=5 mm; ME=3000 kcal/kg; CP=22%; CF=<5%; EE=<5%; Ca=0.9%; Pavail=0.4%; Lysine=1%; Methionine=0.4%). The feed was supplied at the rate of 1.0 kg per duckling per month over a period of four months.

A baseline questionnaire was used to collect the following data: number of household members, their age, occupation, level of education, livestock ownership, experience in duck farming, agricultural land size, approximate annual income, assets owned by the household (to develop a wealth status index) and household baseline dietary diversity.

A follow-up questionnaire was then administered every month to collect information about duck mortalities, the consumption and sale of ducks and eggs, the occurrence of adverse health events among household members within the last month and household dietary diversity in 24-hr period prior to the interview
Intervention code [1] 312767 0
Other interventions
Comparator / control treatment
Control households received a) 15 ducklings, b) a bamboo basket to protect ducklings and 3) training in duck production.
Control group
Active

Outcomes
Primary outcome [1] 307913 0
The Household Dietary Diversity Score was the primary outcome.

As questions on dietary diversity focused on the household level, the respondent was the person responsible for meal preparation for the household the in the 24-hr prior to the interview. The respondent was asked to recall all foods eaten inside the home during the previous day and night, by any member of the household.

Dietary diversity was recorded on the household level, and included all foods eaten by any member of the household, and exclude foods purchased and eaten outside the home18. Food items were categorized into 12 groups which included cereals (e.g. bread, rice noodles, biscuits, or any other foods made from millet, sorghum, maize, rice, wheat), roots and white tubers (e.g. potatoes, yams, manioc, cassava or any other foods made from roots or tubers), vegetables, fruits, meat, eggs, fish (fresh or dried fish and other seafood), legumes (e.g. beans, peas, lentils), nuts and seeds, milk and milk products (e.g. cheese, yogurt), oils and fats (e.g. butter, palm oil), sweets (e.g. honey, cookies) and condiments (e.g. coffee, tea, spices, soya sauce). The Household Dietary Diversity Score (HDDS) was the sum of the 12 food group scores (i.e. maximum score of 12).
Timepoint [1] 307913 0
Primary time point at baseline: July 2016 (Month 1)
Follow-up time points in monthly intervals: Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Secondary outcome [1] 353312 0
Adverse Health Event Score (sum of 30 adverse events occurring in the last month: 1.Allergy, 2. Arthritis, 3. Asthma, 4. Cancer, 5. Cold, 6. Constipation, 7. Convulsion,
8. Diabetes, 9. Diarrhoea, 10. Dysentery, 11. Eye Infection, 12. Fever, 13. Gastric problems,
14. Headache, 15. Heart problems, 16. High blood pressure, 16. Leg injury, 17. Jaundice, 18. Kidney infection, 19. Low blood pressure, 20. Mental problems, 21. Paralysis, 22. Pneumonia, 23. Pox, 24. Thalassemia, 25. Tonsillitis, 26. Tuberculosis, 27. Tumour, 28. Typhoid, 29. Vomiting, 30. Weakness)
Timepoint [1] 353312 0
Time point at baseline: July 2016 (Month 1)
Follow-up time points in monthly intervals: Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

Eligibility
Key inclusion criteria
Households were visited and assessed for four minimum conditions required for duck rearing: 1) a household member must have had at least one year of experience in duck rearing, 2) the household must have had an existing duck house, and 3) the household must have access to a water reservoir containing scavenging feeds and 4) the participating household member must have been willing to be involved in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/07/2016
Date of last participant enrolment
Anticipated
Actual
10/07/2016
Date of last data collection
Anticipated
Actual
30/06/2017
Sample size
Target
150
Accrual to date
Final
150
Recruitment outside Australia
Country [1] 20976 0
Bangladesh
State/province [1] 20976 0

Funding & Sponsors
Funding source category [1] 301003 0
Other Collaborative groups
Name [1] 301003 0
Leveraging Agriculture for Nutrition in South Asia Research (LANSA) Consortium
Country [1] 301003 0
India
Primary sponsor type
University
Name
Joerg Henning
Address
School of Veterinary Science
The University of Queensland
Gatton, QLD, 4343
Country
Australia
Secondary sponsor category [1] 300634 0
None
Name [1] 300634 0
Address [1] 300634 0
Country [1] 300634 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301759 0
The University of Queensland Behavioural & Social Sciences Ethical Review Committe
Ethics committee address [1] 301759 0
Ethics committee country [1] 301759 0
Australia
Date submitted for ethics approval [1] 301759 0
Approval date [1] 301759 0
27/05/2016
Ethics approval number [1] 301759 0
2016000342

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88006 0
A/Prof Joerg Henning
Address 88006 0
School of Veterinary Science, The University of Queensland, Gatton, QLD, 4343, Australia
Country 88006 0
Australia
Phone 88006 0
+61 7 5460 1846
Fax 88006 0
Email 88006 0
[email protected]
Contact person for public queries
Name 88007 0
Joerg Henning
Address 88007 0
School of Veterinary Science, The University of Queensland, Gatton, QLD, 4343, Australia
Country 88007 0
Australia
Phone 88007 0
+61 7 5460 1846
Fax 88007 0
Email 88007 0
[email protected]
Contact person for scientific queries
Name 88008 0
Joerg Henning
Address 88008 0
School of Veterinary Science, The University of Queensland, Gatton, QLD, 4343, Australia
Country 88008 0
Australia
Phone 88008 0
+61 7 5460 1846
Fax 88008 0
Email 88008 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data that will be used in a publication.
When will data be available (start and end dates)?
Data that available as soon as our manuscript has been accepted for publication and will be available for up to 5 years after publication.
Available to whom?
Specific researchers will have access to the data upon request on a case-by-case basis at the discretion of the primary sponsor.
Available for what types of analyses?
It will be available for descriptive analysis.
How or where can data be obtained?
Summarized data will available on a data sharing website (the data sharing website will be specified in the publication of this study). A data access agreement must be signed first before access to data will be provided.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIImpact of improved small-scale livestock farming on human nutrition2021https://doi.org/10.1038/s41598-020-80387-x
N.B. These documents automatically identified may not have been verified by the study sponsor.