Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03847662
Recruitment Status : Completed
First Posted : February 20, 2019
Last Update Posted : February 20, 2019
Sponsor:
Collaborators:
Ryerson University
Global Affairs Canada
International Development Research Centre, Canada
Information provided by (Responsible Party):
Nguyen Do Huy, National Institute of Nutrition, Vietnam

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.

Condition or disease
Food Insecurity Stunting Wasting Underweight Anemia

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.


Layout table for study information
Study Type : Observational
Actual Enrollment : 799 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Scaling up Small-Scale Food Processing: A Strategy to Promote Food Security Among Women Subsistence Farmers in Rural Vietnam
Actual Study Start Date : November 3, 2016
Actual Primary Completion Date : June 5, 2018
Actual Study Completion Date : June 5, 2018

Group/Cohort
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.




Primary Outcome Measures :
  1. Household Food Insecurity Access Scale [ Time Frame: Nov 2016-June 2018 ]
    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.


Secondary Outcome Measures :
  1. Weight in kilograms [ Time Frame: Nov 2016-June 2018 ]
    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.

  2. Height in Meters [ Time Frame: Nov 2016-June 2018 ]
    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.

  3. Age in Months [ Time Frame: Nov 2016-June 2018 ]
    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.

  4. Hemoglobin Levels of Children (<2y) [ Time Frame: Nov 2016-June 2018 ]
    Hemoglobin levels among Children participants assessed by finger prick blood sampling.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Months to 2 Years   (Child)
Sexes Eligible for Study:   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.

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

Additional Information:
Layout table for additonal information
Responsible Party: Nguyen Do Huy, Principle Investigator, National Institute of Nutrition, Vietnam
ClinicalTrials.gov Identifier: NCT03847662     History of Changes
Other Study ID Numbers: CIFSRF 108124
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It is not yet known if there will be a plan to make individual participant data available.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nguyen Do Huy, National Institute of Nutrition, Vietnam:
Food Insecurity
Stunting
Wasting
Underweight
Anemia
Complimentary Foods
Food Fortification
Complimentary Feeding

Additional relevant MeSH terms:
Layout table for MeSH terms
Wasting Syndrome
Cachexia
Growth Disorders
Thinness
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrition Disorders
Pathologic Processes