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CompletedNCT03847662Updated Feb 20, 2019

Scaling up Small-Scale Food Processing to Promote Food Security Among Women Farmers in Rural Vietnam

An observational study in Food Insecurity, Stunting and Wasting, sponsored by National Institute of Nutrition, Vietnam. Completed. Open to participants aged 6 Months to 2 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-20.

Sponsored by National Institute of Nutrition, Vietnam · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
799
Ages
6 Months to 2 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Food Insecurity
  • Stunting
  • Wasting
  • Underweight
  • Anemia

Keywords

  • Food Insecurity
  • Stunting
  • Wasting
  • Underweight
  • Anemia
  • Complimentary Foods
  • Food Fortification
  • Complimentary Feeding
03

In context

Growth Disorders

227 studies on the registry are indexed under Growth Disorders; 25 are open to participants now.

This study's enrollment of 799 is above the median of 231 across 78 observational studies indexed under Growth Disorders.

Browse Growth Disorders studies →

Lead sponsor

National Institute of Nutrition, Vietnam is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 2 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Free from oedema
  • Free from physical and mental disabilities
  • Free from memory disorders and/or mental illness
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
799 participants (actual)
Patient registry
No

Groups and cohorts

  • Community Based Production and Access of Complimentary Foods

    Nine communes were randomly selected with the cluster inclusion criteria as having high levels of; agricultural production, childhood under-nutrition and food security. This was carried out in the three rural mountainous provinces of Lao Cai, Lai Chau, and Ha Giang. In each of these provinces, one district and three subsequent communes were selected, for a total of 9 communes. The districts of Bat Xat, Tam Duong, and Vi Xuyen were selected in Lao Cai, Lai Chau and Ha Giang province respectively. This second stage district sampling selected sites with similar characteristic of population density, area, number of women of reproductive age(15-35y), percentage of children(\<2y), income primarily from agricultural production, poverty and climate data. Changes were observed on food security and nutritional status with exposure to community based self reported purchasing local agricultural products and access to locally produced fortified complimentary foods.

06

What researchers measure

Primary outcomes

  1. Household Food Insecurity Access Scale

    Score from 1-27 indicating household food Insecurity. Where higher scores indicate greater food insecurity. This was taken at the beginning of intervention in Nov 2016 till completion in June 2018.

    Time frame: Nov 2016-June 2018

Secondary outcomes

  1. Weight in kilograms

    Stunting (Height-for-age Z score \<-2SD), Underweight (Weight-for-age Z score\<-2SD), Wasting (Weight-for-height Z score\<-2SD) compared with World Health Organization's growth charts.

    Time frame: Nov 2016-June 2018

  2. Height in Meters

    Stunting (Height-for-age Z score \<-2SD), Underweight (Weight-for-age Z score\<-2SD), Wasting (Weight-for-height Z score\<-2SD) compared with World Health Organization's growth charts.

    Time frame: Nov 2016-June 2018

  3. Age in Months

    Stunting (Height-for-age Z score \<-2SD), Underweight (Weight-for-age Z score\<-2SD), Wasting (Weight-for-height Z score\<-2SD) compared with World Health Organization's growth charts.

    Time frame: Nov 2016-June 2018

  4. Hemoglobin Levels of Children (<2y)

    Hemoglobin levels among Children participants assessed by finger prick blood sampling.

    Time frame: Nov 2016-June 2018

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided — It is not yet known if there will be a plan to make individual participant data available.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2016 to primary completion in Jun 2018, 19 months.

Of 42 observational studies under Growth Disorders, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 55. This study's 19 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 7, 2018
First posted
Feb 20, 2019
StartActual
Nov 3, 2016
Primary completionActual
Jun 5, 2018
CompletionActual
Jun 5, 2018
Last update
Feb 20, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03847662
Lead sponsor
National Institute of Nutrition, Vietnam
Collaborators
Toronto Metropolitan University, Global Affairs Canada, International Development Research Centre, Canada
Responsible party
Nguyen Do Huy (Principle Investigator, National Institute of Nutrition, Vietnam) — Principal investigator
First posted
Feb 20, 2019
Start date
Nov 3, 2016
Primary completion
Jun 5, 2018
Completion
Jun 5, 2018
Last update
Feb 20, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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