- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01593423
Food Security and Nutrition in Rural Cambodia
May 8, 2023 updated by: Tim Green, University of British Columbia
Integration of Small-scale Aquaculture With Homestead Food Production for Improved Household Food Security and Nutrition in Rural Cambodia
The project is a three arm randomized control trial in rural Cambodia designed to evaluate the impact of homestead food production (home gardens) with and without fish ponds versus control on household food security, dietary intake of women and youngest child, biochemical nutritional status of women, and household livelihoods over a 22 month period.
Baseline and end line surveys will be conducted that involve questionnaires and a blood sample.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
900
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Prey Veng
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Phnom Penh, Prey Veng, Cambodia
- Rural Cambodia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Must be represented by a woman.
- Must fall within the "poor" category in terms of community wealth rankings.
- Must have access to land (including homestead) for agriculture cultivation.
- Must have sufficient access to labor to undertake the homestead production activities.
- Must have a keen interest in participating in this action.
- Must have a least one child less than five years of age (in 80% of the target households).
- Have suitable land for pond and preferably own a small pond
In addition village model farm owners will:
- Have at least 1,200 square meters of land that can be used to establish the model farm;
- Have some disposable income to invest in the model farm for fencing and land preparation;
- Be productive, open to new ideas and willing to provide assistance to other households in the village;
- Be able and willing to maintain the VMF throughout the year;
- Commit to providing inputs and marketing support to group members at least during the project.
Exclusion Criteria:
- None, only that they don't meet the inclusion criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Control
|
No intervention.
|
Experimental: Homestead Food Production plus small pond aquaculture
|
In the case of the aquaculture arm a pond will be dug if there is not an existing pond and fingerlings and brood stocks will be provided.
Hatcheries will be established if there is not one within a reasonable distance of the farms.
|
Active Comparator: plant-based Homestead Food Production
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The village model farm will be provided with the necessary inputs to establish their farm including saplings seeds etc.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in nutritionally related biochemical measures at 22 months
Time Frame: At baseline and 22 months
|
Haemoglobin (g/l) Haematocrit (%) Serum Ferritin (ng/ml) White Cell Count (x109/l) Red Cell Count (x1012/l) Mean Corpuscular Volume (fl) Mean Cell Haemoglobin (pg) Red Cell Width % Platelet Count (x109/l) Neutrophils % Eosinophils % Lymphocytes % Monocytes % Neutrophils # (x109/l) Eosinophils # (x109/l) Lymphocytes # (x109/l) Monocytes # (x109/l) C-Reactive Protein (mg/l)
|
At baseline and 22 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
24-hour dietary recall
Time Frame: At baseline and 22 months
|
At baseline and 22 months
|
Mid-upper arm circumference
Time Frame: At baseline and 22 months
|
At baseline and 22 months
|
Household Food Security Scale
Time Frame: At baseline and 22 months
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At baseline and 22 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tim Green, PhD, University of British Columbia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Williams BA, Cochrane KM, Fischer JAJ, Aljaadi AM, McAnena L, Ward M, McNulty H, Kroeun H, Green TJ, Whitfield KC, Karakochuk CD. The Homozygous Hemoglobin EE Variant Is Associated with Poorer Riboflavin Status in Cambodian Women of Reproductive Age. J Nutr. 2020 Jul 1;150(7):1943-1950. doi: 10.1093/jn/nxaa119.
- Michaux KD, Hou K, Karakochuk CD, Whitfield KC, Ly S, Verbowski V, Stormer A, Porter K, Li KH, Houghton LA, Lynd LD, Talukder A, McLean J, Green TJ. Effect of enhanced homestead food production on anaemia among Cambodian women and children: A cluster randomized controlled trial. Matern Child Nutr. 2019 May;15 Suppl 3(Suppl 3):e12757. doi: 10.1111/mcn.12757.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
April 20, 2012
First Submitted That Met QC Criteria
May 4, 2012
First Posted (Estimate)
May 8, 2012
Study Record Updates
Last Update Posted (Actual)
May 10, 2023
Last Update Submitted That Met QC Criteria
May 8, 2023
Last Verified
November 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- H12-00451
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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