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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01593423
Other study ID # H12-00451
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2012
Est. completion date August 2014

Study information

Verified date November 2016
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 900
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
plant-based Homestead Food Production
The village model farm will be provided with the necessary inputs to establish their farm including saplings seeds etc.
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.
a comparison group
No intervention.

Locations

Country Name City State
Cambodia Rural Cambodia Phnom Penh Prey Veng

Sponsors (1)

Lead Sponsor Collaborator
University of British Columbia

Country where clinical trial is conducted

Cambodia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline in nutritionally related biochemical measures at 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 24-hour dietary recall At baseline and 22 months
Secondary Mid-upper arm circumference At baseline and 22 months
Secondary Household Food Security Scale At baseline and 22 months