Food SupplyNCT02786368
Scale up of Enhanced Homestead Food Production in Cambodia
A study testing EHFP group in people with Food Supply, run by University of British Columbia at 1 site in Canada.
Trial summary
This project is a delayed pragmatic delayed-intervention cluster randomized control study in a subset of households (n=600) enrolled in a larger scale up program of enhanced homestead food production (EHFP) in Cambodia. Read more about this study
- Who is it for?
- Ages 6 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Food Supply
- What is being tested?
- EHFP group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,318 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2016to May 2018
- 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 6 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Women of reproductive age (15-49 y)
- Child aged 6 - 59 months
- Demonstrate a willingness to cost-share on EHFP inputs
- Have suitable land for Enhanced Homestead Food Production activities
Who cannot join
- Not meeting the above inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Scale up of Enhanced Homestead Food Production for Improved Household Food Security and Nutrition in Cambodia
This project is a delayed pragmatic delayed-intervention cluster randomized control study in a subset of households (n=600) enrolled in a larger scale up program of enhanced homestead food production (EHFP) in Cambodia. The trial is designed to evaluate the impact of EHFP (home gardens only; home garden and fishponds; home gardens and poultry) versus control group on dietary intake of women and youngest child, household food security, income, and production throughout the agricultural cycle. Following administration of the baseline survey 300 households will be randomized to the EHFP package of their choosing (Intervention Group) for two years. The other 300 households will not receive any intervention during the first year and will act as the control group; data will be collected monthly on production and income generated from gardening (and other homestead food production activities) and at two points throughout the year 24-hour dietary recall data will be collected from the women head of the household (aged 15-49y) and the youngest child between the ages of 6 - 59 months. After one year, the control group will be offered the intervention (EHFP package of their choice) fully subsidized and the project team will collect identical data on intervention group for one year as described for the control group.
Read the detailed description
Cambodia's economy has improved remarkably in the last decade, yet 80% of households experience some form of poverty, and 20% are severely impoverished. Food insecurity and its sequelae remain a problem, especially among rural farmers. As a solution Helen Keller International (HKI) implements a Enhanced Homestead Food Production (EHFP) model in Cambodia. EHFP, focusing on women farmers, fosters year-round environmentally sustainable production of nutrient-rich fruits, vegetables and animal-source foods. The program provides initial farming inputs coupled with technical assistance, nutrition education, and training on marketing and gender equity.
In 2012, HKI together with the University of British Columbia (UBC), conducted a 22-month randomized control trial of EHFP, known as 'Fish on Farms'. Using HKI's approach, 900 women farmers were randomized to three groups: 1) plant-based EHFP; 2) EHFP plus fishponds; or 3) a control. Remarkably, in less than two years working with women farmers, Fish on Farms established 300 fishponds and 600 gardens. In the fishponds, small nutrient-rich fish were raised for household consumption and larger fish were raised for consumption or sale. After two years, households in both EHFP arms saw improvements in food production, income generation, food security, dietary diversity, and dietary intake of certain micronutrients relative to the control. However, the randomized-control trial (RCT) approach did have a number of issues, and gaps that need to be addressed were identified. Attrition was high, perhaps in part because of better opportunities for women, but also because women were not given a choice in the type of HFP activity to participate in. Further, the project provided many inputs for free so the women were not as invested as they might have otherwise been. Other issues identified were a lack of market access for sale of produce and fish, gender inequities, and a need to better capture the seasonality of food production and consumption at the household level.
Building on lessons learned from the pilot study (Fish on Farms), this pragmatic delayed-intervention cluster randomized control study includes rigorous monitoring of production throughout the agricultural cycle as well as multiple 24-hour dietary recalls with improved methodology and frequency to better capture dietary intake. Women are self-selecting to participate, and are provided access to micro-credit institutions or other cost-sharing options so that women have a greater financial stake in EHFP leading to more successful farmers. Participants will also able to select from more EHFP options that include home gardens, poultry and fish.
The ultimate goal of the program is to provide evidence of an integrated model of EHFP that has scalability and sustainability to improve the livelihoods of Cambodians and possibly the larger region.
- Conditions
- Food Supply
- Being tested
- Control group, EHFP group
- Keywords
- Food Production, Inadequacy, Dietary zinc, Iron, vitamin A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupBehavioural
A comparison group; no intervention for year 1, EHFP after 1 year of program implementation.
EHFP groupBehavioural
Intervention group: training; inputs cost-sharing for EHFP activities.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | For year one, this arm will receive no intervention. Usual agriculture production and income will be assessed monthly for one year. Additionally, every season (twice yearly), household food security and usual dietary intake of woman of reproductive age (WRA) and their child aged 6-59 mo will also be collected. After one year of implementation, this group will be offered the Enhanced Homestead Food Production package fully subsidized, as well as training on nutrition, WASH, gender and business/marketing. Receives: Behavioral: Control group |
| EHFP group | Experimental | Households will receive training and inputs for an Enhanced Homestead Food Production (EHFP) package. Participants will also receive educational components through inter-personal behavioural change communication on nutrition (Essential Nutrition Actions), Water Sanitation and Hygiene (WASH), gender, and business/marketing. Receives: Behavioral: EHFP group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in mean intake of zinc
Sample size was calculated to detect a difference in zinc and vitamin A intake between any two groups, with 80% power and alpha of 0.05, assuming a 30% attrition. Measured by 24 hour dietary recall surveys with repeat recalls on a sub-set of the sample in order to adjust for intra-individual variations in intake and provide an estimate of usual intake.
Measured: Measurements will be made for women of reproductive age and the youngest child in the household (> 6 mo < 60 mo) at baseline and ~ 7 months later
Difference in mean intake of vitamin A
Sample size was calculated to detect a difference in zinc and vitamin A intake between any two groups, with 80% power and alpha of 0.05, assuming a 30% attrition. Measured by 24 hour dietary recall surveys with repeat recalls on a sub-set of the sample in order to adjust for intra-individual variations in intake and provide an estimate of usual intake.
Measured: Measurements will be made for women of reproductive age aand the youngest child in the household (> 6 mo < 60 mo) at baseline and ~ 7 months later
Secondary outcomes (10)
Household food security
Measured with a questionnaire to calculate the Household Food Insecurity Access Scale score. Unit: percentage of households.
Measured: Baseline (2016) through to study completion, on average 2 years
Women's empowerment / gender equity
Measured by questionnaire using the Women's Empowerment in Agriculture Index (WEAI) household decision-making on production and use of money modules. Percentage of women over a calculated score.
Measured: Baseline (2016) through to study completion, on average 2 years
Incremental net monetary benefit
The economic evaluation of the program will take the form of a cost-benefit analysis from the perspective of the project. Costs will be determined from HKI's budget sheets and input use (resource use) reported by study participants monthly. Benefits will be measured in terms of total kilograms of each variety of food produced over a 12 month period (collected every month) and monetized using local market values that are collected every month.
Measured: Monthly for 1 year
WASH practices
Using questionnaire on knowledge, percentage of women giving adequate answer.
Measured: Baseline (2016) through to study completion, on average 2 years
Difference in mean energy intake
Measured by 24 hour dietary recall surveys with repeat recalls on a sub-set of the sample in order to adjust for intra-individual variations in intake and provide an estimate of usual intake.
Measured: Measurements will be made for women of reproductive age and the youngest child in the household (> 6 mo < 60 mo) at baseline and ~ 7 months later
Difference in mean protein intake
Measured by 24 hour dietary recall surveys with repeat recalls on a sub-set of the sample in order to adjust for intra-individual variations in intake and provide an estimate of usual intake.
Measured: Measurements will be made for women of reproductive age and the youngest child in the household (> 6 mo < 60 mo) at baseline and ~ 7 months later
Difference in mean fat intake
Measured by 24 hour dietary recall surveys with repeat recalls on a sub-set of the sample in order to adjust for intra-individual variations in intake and provide an estimate of usual intake.
Measured: Measurements will be made for women of reproductive age and the youngest child in the household (> 6 mo < 60 mo) at baseline and ~ 7 months later
Difference in mean riboflavin intake
Measured by 24 hour dietary recall surveys with repeat recalls on a sub-set of the sample in order to adjust for intra-individual variations in intake and provide an estimate of usual intake.
Measured: Measurements will be made for women of reproductive age and the youngest child in the household (> 6 mo < 60 mo) at baseline and ~ 7 months later
Difference in mean thiamin intake
Measured by 24 hour dietary recall surveys with repeat recalls on a sub-set of the sample in order to adjust for intra-individual variations in intake and provide an estimate of usual intake.
Measured: Measurements will be made for women of reproductive age and the youngest child in the household (> 6 mo < 60 mo) at baseline and ~ 7 months later
Difference in mean iron intake
Measured by 24 hour dietary recall surveys with repeat recalls on a sub-set of the sample in order to adjust for intra-individual variations in intake and provide an estimate of usual intake.
Measured: Measurements will be made for women of reproductive age and the youngest child in the household (> 6 mo < 60 mo) at baseline and ~ 7 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food SupplyStudies 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
- 1,318 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Helen Keller International, International Development Research Centre, Canada
- Responsible party
- Principal investigator, Tim Green, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02786368
- Sponsor's protocol ID
- H15-00720
- Status last verified
- May 2017
- First submitted
- 18 May 2016
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scale up of Enhanced Homestead Food Production for Improved Household Food Security and Nutrition in Cambodia
- ClinicalTrials.gov ID
- NCT02786368
- Acronym / sponsor ID
- H15-00720
- Conditions
- Food Supply
- Keywords
- Food Production, Inadequacy, Dietary zinc, Iron, vitamin A
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,318 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Helen Keller International, International Development Research Centre, Canada
- Study start
- Apr 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 1 Jun 2016 (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.
This project is a delayed pragmatic delayed-intervention cluster randomized control study in a subset of households (n=600) enrolled in a larger scale up program of enhanced homestead food production (EHFP) in Cambodia. The trial is designed to evaluate the impact of EHFP (home gardens only; home garden and fishponds; home gardens and poultry) versus control group on dietary intake of women and youngest child, household food security, income, and production throughout the agricultural cycle. Following administration of the baseline survey 300 households will be randomized to the EHFP package of their choosing (Intervention Group) for two years. The other 300 households will not receive any intervention during the first year and will act as the control group; data will be collected monthly on production and income generated from gardening (and other homestead food production activities) and at two points throughout the year 24-hour dietary recall data will be collected from the women head of the household (aged 15-49y) and the youngest child between the ages of 6 - 59 months. After one year, the control group will be offered the intervention (EHFP package of their choice) fully subsidized and the project team will collect identical data on intervention group for one year as described for the control group.
Detailed description
Cambodia's economy has improved remarkably in the last decade, yet 80% of households experience some form of poverty, and 20% are severely impoverished. Food insecurity and its sequelae remain a problem, especially among rural farmers. As a solution Helen Keller International (HKI) implements a Enhanced Homestead Food Production (EHFP) model in Cambodia. EHFP, focusing on women farmers, fosters year-round environmentally sustainable production of nutrient-rich fruits, vegetables and animal-source foods. The program provides initial farming inputs coupled with technical assistance, nutrition education, and training on marketing and gender equity.
In 2012, HKI together with the University of British Columbia (UBC), conducted a 22-month randomized control trial of EHFP, known as 'Fish on Farms'. Using HKI's approach, 900 women farmers were randomized to three groups: 1) plant-based EHFP; 2) EHFP plus fishponds; or 3) a control. Remarkably, in less than two years working with women farmers, Fish on Farms established 300 fishponds and 600 gardens. In the fishponds, small nutrient-rich fish were raised for household consumption and larger fish were raised for consumption or sale. After two years, households in both EHFP arms saw improvements in food production, income generation, food security, dietary diversity, and dietary intake of certain micronutrients relative to the control. However, the randomized-control trial (RCT) approach did have a number of issues, and gaps that need to be addressed were identified. Attrition was high, perhaps in part because of better opportunities for women, but also because women were not given a choice in the type of HFP activity to participate in. Further, the project provided many inputs for free so the women were not as invested as they might have otherwise been. Other issues identified were a lack of market access for sale of produce and fish, gender inequities, and a need to better capture the seasonality of food production and consumption at the household level.
Building on lessons learned from the pilot study (Fish on Farms), this pragmatic delayed-intervention cluster randomized control study includes rigorous monitoring of production throughout the agricultural cycle as well as multiple 24-hour dietary recalls with improved methodology and frequency to better capture dietary intake. Women are self-selecting to participate, and are provided access to micro-credit institutions or other cost-sharing options so that women have a greater financial stake in EHFP leading to more successful farmers. Participants will also able to select from more EHFP options that include home gardens, poultry and fish.
The ultimate goal of the program is to provide evidence of an integrated model of EHFP that has scalability and sustainability to improve the livelihoods of Cambodians and possibly the larger region.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Behavioral: Control groupFor year one, this arm will receive no intervention. Usual agriculture production and income will be assessed monthly for one year. Additionally, every season (twice yearly), household food security and usual dietary intake of woman of reproductive age (WRA) and their child aged 6-59 mo will also be collected. After one year of implementation, this group will be offered the Enhanced Homestead Food Production package fully subsidized, as well as training on nutrition, WASH, gender and business/marketing. |
| EHFP group | Experimental | Behavioral: EHFP groupHouseholds will receive training and inputs for an Enhanced Homestead Food Production (EHFP) package. Participants will also receive educational components through inter-personal behavioural change communication on nutrition (Essential Nutrition Actions), Water Sanitation and Hygiene (WASH), gender, and business/marketing. |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Women of reproductive age (15-49 y)
- Child aged 6 - 59 months
- Demonstrate a willingness to cost-share on EHFP inputs
- Have suitable land for Enhanced Homestead Food Production activities
Key exclusion criteria (1 listed)
- Not meeting the above 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 |
|---|---|---|
| Control groupA comparison group; no intervention for year 1, EHFP after 1 year of program implementation. | Behavioural | Control group |
| EHFP groupIntervention group: training; inputs cost-sharing for EHFP activities. | Behavioural | EHFP group |
Primary outcome
Difference in mean intake of zinc
Time frame: Measurements will be made for women of reproductive age and the youngest child in the household (> 6 mo < 60 mo) at baseline and ~ 7 months later
Sample size was calculated to detect a difference in zinc and vitamin A intake between any two groups, with 80% power and alpha of 0.05, assuming a 30% attrition. Measured by 24 hour dietary recall surveys with repeat recalls on a sub-set of the sample in order to adjust for intra-individual variations in intake and provide an estimate of usual intake.
Difference in mean intake of vitamin A
Time frame: Measurements will be made for women of reproductive age aand the youngest child in the household (> 6 mo < 60 mo) at baseline and ~ 7 months later
Sample size was calculated to detect a difference in zinc and vitamin A intake between any two groups, with 80% power and alpha of 0.05, assuming a 30% attrition. Measured by 24 hour dietary recall surveys with repeat recalls on a sub-set of the sample in order to adjust for intra-individual variations in intake and provide an estimate of usual intake.
10 secondary outcomes
Household food security
Time frame: Baseline (2016) through to study completion, on average 2 years
Women's empowerment / gender equity
Time frame: Baseline (2016) through to study completion, on average 2 years
Incremental net monetary benefit
Time frame: Monthly for 1 year
WASH practices
Time frame: Baseline (2016) through to study completion, on average 2 years
Difference in mean energy intake
Time frame: Measurements will be made for women of reproductive age and the youngest child in the household (> 6 mo < 60 mo) at baseline and ~ 7 months later
Difference in mean protein intake
Time frame: Measurements will be made for women of reproductive age and the youngest child in the household (> 6 mo < 60 mo) at baseline and ~ 7 months later
Difference in mean fat intake
Time frame: Measurements will be made for women of reproductive age and the youngest child in the household (> 6 mo < 60 mo) at baseline and ~ 7 months later
Difference in mean riboflavin intake
Time frame: Measurements will be made for women of reproductive age and the youngest child in the household (> 6 mo < 60 mo) at baseline and ~ 7 months later
Difference in mean thiamin intake
Time frame: Measurements will be made for women of reproductive age and the youngest child in the household (> 6 mo < 60 mo) at baseline and ~ 7 months later
Difference in mean iron intake
Time frame: Measurements will be made for women of reproductive age and the youngest child in the household (> 6 mo < 60 mo) at baseline and ~ 7 months later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EHFP group in people with Food Supply, run by University of British Columbia at 1 site in Canada.
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 4 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: status not confirmed, as of the sponsor's last update on 11 May 2017. 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 Canada. 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. 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?
Results are not available in the source record.
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?
Difference in mean intake of zinc (time frame: Measurements will be made for women of reproductive age and the youngest child in the household (> 6 mo < 60 mo) at baseline and ~ 7 months later). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2017.