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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02786368
Other study ID # H15-00720
Secondary ID
Status Active, not recruiting
Phase N/A
First received May 18, 2016
Last updated May 9, 2017
Start date April 2016
Est. completion date May 2018

Study information

Verified date May 2017
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1318
Est. completion date May 2018
Est. primary completion date March 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 59 Months
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Not meeting the above inclusion criteria

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Control group
A comparison group; no intervention for year 1, EHFP after 1 year of program implementation.
EHFP group
Intervention group: training; inputs cost-sharing for EHFP activities.

Locations

Country Name City State
Canada Timothy D Green Vancouver British Columbia

Sponsors (3)

Lead Sponsor Collaborator
University of British Columbia Helen Keller International, International Development Research Centre, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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
Primary 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. 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 Household food security Measured with a questionnaire to calculate the Household Food Insecurity Access Scale score. Unit: percentage of households. Baseline (2016) through to study completion, on average 2 years
Secondary 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. Baseline (2016) through to study completion, on average 2 years
Secondary 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. Monthly for 1 year
Secondary WASH practices Using questionnaire on knowledge, percentage of women giving adequate answer. Baseline (2016) through to study completion, on average 2 years
Secondary 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. 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
Secondary 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. 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
Secondary 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. 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
Secondary 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. 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
Secondary 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. 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
Secondary 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. 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
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