NCT02786368

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,318

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

May 11, 2017

Status Verified

May 1, 2017

Enrollment Period

1.9 years

First QC Date

May 18, 2016

Last Update Submit

May 9, 2017

Conditions

Keywords

Food ProductionInadequacyDietary zincIronvitamin A

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (10)

  • Household food security

    Baseline (2016) through to study completion, on average 2 years

  • Women's empowerment / gender equity

    Baseline (2016) through to study completion, on average 2 years

  • Incremental net monetary benefit

    Monthly for 1 year

  • WASH practices

    Baseline (2016) through to study completion, on average 2 years

  • Difference in mean energy 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

  • +5 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: EHFP group

Interventions

Control groupBEHAVIORAL

A comparison group; no intervention for year 1, EHFP after 1 year of program implementation.

Control group
EHFP groupBEHAVIORAL

Intervention group: training; inputs cost-sharing for EHFP activities.

EHFP group

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Timothy D Green

Vancouver, British Columbia, V6T1Z4, Canada

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

May 18, 2016

First Posted

June 1, 2016

Study Start

April 1, 2016

Primary Completion

March 1, 2018

Study Completion

May 1, 2018

Last Updated

May 11, 2017

Record last verified: 2017-05

Locations