Household Food SecurityNCT01593423
Food Security and Nutrition in Rural Cambodia
A study testing plant-based Homestead Food Production, Homestead Food Production plus small pond aquaculture and a comparison group in people with Household Food Security, run by University of British Columbia at 1 site in Cambodia.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Household Food Security
- What is being tested?
- plant-based Homestead Food Production, Homestead Food Production plus small pond aquaculture and a comparison group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 900 participants
- Where
- 1 siteCambodia
- Study dates
- Jun 2012to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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).
Show all 13Show fewer
- 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.
Who cannot join
- None, only that they don't meet the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Household Food Security
- Being tested
- plant-based Homestead Food Production, Homestead Food Production plus small pond aquaculture, a comparison group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plant-based Homestead Food ProductionBehavioural
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 aquacultureBehavioural
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 groupBehavioural
No intervention.
| Study group | Role | What they receive |
|---|---|---|
| Homestead Food Production plus small pond aquaculture | Experimental | Not described Receives: Behavioral: Homestead Food Production plus small pond aquaculture |
| plant-based Homestead Food Production | Active comparator | Not described Receives: Behavioral: plant-based Homestead Food Production |
| Control | Sham comparator | Not described Receives: Behavioral: a comparison group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At baseline and 22 months
Secondary outcomes (3)
24-hour dietary recall
Measured: At baseline and 22 months
Mid-upper arm circumference
Measured: At baseline and 22 months
Household Food Security Scale
Measured: At baseline and 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2012 (estimated)
- Study startJun 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Household Food SecurityStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tim Green, University of British Columbia
- Investigators
- Tim Green, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01593423
- Sponsor's protocol ID
- H12-00451
- Status last verified
- Nov 2016
- First submitted
- 20 Apr 2012
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 32433728Michaux 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.
PubMed 31148398
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Small-scale Aquaculture With Homestead Food Production for Improved Household Food Security and Nutrition in Rural Cambodia
- ClinicalTrials.gov ID
- NCT01593423
- Acronym / sponsor ID
- H12-00451
- Conditions
- Household Food Security
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 8 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Homestead Food Production plus small pond aquaculture | Experimental | Behavioral: Homestead Food Production plus small pond aquaculture |
| plant-based Homestead Food Production | Active comparator | Behavioral: plant-based Homestead Food Production |
| Control | Sham comparator | Behavioral: a comparison group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (1 listed)
- None, only that they don't meet the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| plant-based Homestead Food ProductionThe village model farm will be provided with the necessary inputs to establish their farm including saplings seeds etc. | Behavioural | plant-based Homestead Food Production |
| Homestead Food Production plus small pond aquacultureIn 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. | Behavioural | Homestead Food Production plus small pond aquaculture |
| a comparison groupNo intervention. | Behavioural | Control |
Primary outcome
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)
3 secondary outcomes
24-hour dietary recall
Time frame: At baseline and 22 months
Mid-upper arm circumference
Time frame: At baseline and 22 months
Household Food Security Scale
Time frame: At baseline and 22 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Derived from this study: PubMed 32433728Williams 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.
- Derived from this study: PubMed 31148398Michaux 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Green, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing plant-based Homestead Food Production, Homestead Food Production plus small pond aquaculture and a comparison group in people with Household Food Security, run by University of British Columbia at 1 site in Cambodia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cambodia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in nutritionally related biochemical measures at 22 months (time frame: At baseline and 22 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01593423, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023; AzTrials last refreshed its copy on 7 Nov 2026.