Clinical trial NCT03847662: Scaling up Small-Scale Food Processing to Promote Food Security Among Women Farmers in Rural Vietnam
Official title: Scaling up Small-Scale Food Processing: A Strategy to Promote Food Security Among Women Subsistence Farmers in Rural Vietnam
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Food Insecurity
Stunting
Wasting
Underweight
Anemia
Keywords: Food Insecurity
Stunting
Wasting
Underweight
Anemia
Complimentary Foods
Food Fortification
Complimentary Feeding
Lead sponsor: National Institute of Nutrition, Vietnam
Sponsor class: OTHER_GOV
Collaborators: name: Toronto Metropolitan University
name: Global Affairs Canada
name: International Development Research Centre, Canada
First posted: 2019-02-20
Enrollment: 799
Sex: ALL
Minimum age (years): 6
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Perspective participants from these 9 communes, were invited to participate based on the inclusion criteria of the project and randomization lists will be made from the lists of children (\< 2y) from the commune health centers. From these lists, 800 children will be randomly selected and categorized by age into different groups: 100 infants of 0-5 months, 400 infants of 6-12 months, and 200 children of 12-23 months will be selected.

A initial cross-sectional Baseline survey with a was conducted from October to November 2016, with Caregiver-Child(\<2y) pairs (n=799) in the provinces of Lai Chau, Lao Cai and Ha Giang.

Brief summary: This repeated measures, cluster randomized, cohort trial design was carried out in three provinces in the northern mountainous area of Vietnam. Communes here were randomly selected for community based interventions with local production complimentary foods and marketing and distribution of fortified complimentary foods.

Detailed description: In rural northern Vietnam, childhood stunting rates are high. In Lào Cai province, female subsistence farmers grow crops, but face barriers sending produce to markets. The present intervention purchases local crops from local women subsistence farmers which are processed in local small-scale food processing facilities to produce instant fortified complementary foods for weaning.

Methods: A repeated measures survey was conducted from October to November 2016, with Caregiver-Child(\<2y) pairs (n=800) in the provinces of Lai Chau, Lao Cai and Ha Giang. Anthropometric data of mother/child dyads was assessed and logistic regression analysis of stunted and underweight children explored associated factors. These included: core infant and young child feeding practices indicators, food insecurity, antenatal care check-ups, core water/sanitation, anemia and hygiene indicators.

This project leveraged the experience of the National Institute of Nutrition of Vietnam to ensure HACCP standards during manufacture. Locally grown rice was combined with a Zn/Fe premix before extrusion and hammer-milling. Local vegetables such as: "Sweet leaf" (Sauropus androgynous), pumpkin, Shiitake mushrooms (Lentinula edodes) and carrots were made into complimentary foods and sold locally.

Eligibility criteria: Inclusion Criteria:

* Child participants must be younger than 2y at baseline.
* Caregivers must volunteer and were required to give informed written consent

Exclusion Criteria:

* Free from oedema
* Free from physical and mental disabilities
* Free from memory disorders and/or mental illness

Primary outcomes:
measure: Household Food Insecurity Access Scale
timeFrame: Nov 2016-June 2018
Secondary outcomes:
measure: Weight in kilograms
timeFrame: Nov 2016-June 2018
measure: Height in Meters
timeFrame: Nov 2016-June 2018
measure: Age in Months
timeFrame: Nov 2016-June 2018
measure: Hemoglobin Levels of Children (<2y)
timeFrame: Nov 2016-June 2018
Other outcomes:
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