Food InsecurityNCT03847662
Scaling up Small-Scale Food Processing to Promote Food Security Among Women Farmers in Rural Vietnam
An observational study of Food Insecurity and Stunting, run by National Institute of Nutrition, Vietnam.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 months to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Insecurity, Stunting, Wasting
- How many people
- 799 participants
- Where
- No sites listed yet
- Study dates
- 3 Nov 2016to 5 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 2 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Child participants must be younger than 2y at baseline.
- Caregivers must volunteer and were required to give informed written consent
Who cannot join
- Free from oedema
- Free from physical and mental disabilities
- Free from memory disorders and/or mental illness
About this study
Official title: Scaling up Small-Scale Food Processing: A Strategy to Promote Food Security Among Women Subsistence Farmers in Rural Vietnam
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.
- Conditions
- Food Insecurity, Stunting, Wasting, Underweight, Anemia
- Keywords
- Food Insecurity, Stunting, Wasting, Underweight, Anemia, Complimentary Foods, Food Fortification, Complimentary Feeding
- Medical subject headings
- Growth Disorders, Cachexia, Thinness, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Nov 2016-June 2018
Secondary outcomes (4)
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.
Measured: Nov 2016-June 2018
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.
Measured: Nov 2016-June 2018
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.
Measured: Nov 2016-June 2018
Hemoglobin Levels of Children (<2y)
Hemoglobin levels among Children participants assessed by finger prick blood sampling.
Measured: Nov 2016-June 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start3 Nov 2016
- Primary completion5 Jun 2018
- Study completion5 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food InsecurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 799 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Nutrition, Vietnam
- Sponsor type
- Other government
- Collaborators
- Toronto Metropolitan University, Global Affairs Canada, International Development Research Centre, Canada
- Responsible party
- Principal investigator, Nguyen Do Huy, National Institute of Nutrition, Vietnam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03847662
- Sponsor's protocol ID
- CIFSRF 108124
- Status last verified
- Feb 2019
- First submitted
- 7 Nov 2018
- Last updated
- 20 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make individual participant data available.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scaling up Small-Scale Food Processing: A Strategy to Promote Food Security Among Women Subsistence Farmers in Rural Vietnam
- ClinicalTrials.gov ID
- NCT03847662
- Acronym / sponsor ID
- CIFSRF 108124
- Conditions
- Food Insecurity, Stunting, Wasting, Underweight, Anemia
- Keywords
- Food Insecurity, Stunting, Wasting, Underweight, Anemia, Complimentary Foods, Food Fortification, Complimentary Feeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 799 participants (actual)
- Lead sponsor
- National Institute of Nutrition, VietnamOther government
- Collaborators
- Toronto Metropolitan University, Global Affairs Canada, International Development Research Centre, Canada
- Study start
- 3 Nov 2016 (actual)
- Primary completion
- 5 Jun 2018 (actual)
- Study completion
- 5 Jun 2018 (actual)
- First posted
- 20 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 months to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- Child participants must be younger than 2y at baseline.
- Caregivers must volunteer and were required to give informed written consent
Key exclusion criteria (3 listed)
- Free from oedema
- Free from physical and mental disabilities
- Free from memory disorders and/or mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Weight in kilograms
Time frame: Nov 2016-June 2018
Height in Meters
Time frame: Nov 2016-June 2018
Age in Months
Time frame: Nov 2016-June 2018
Hemoglobin Levels of Children (<2y)
Time frame: Nov 2016-June 2018
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
- Video Overview of the Project (CIFSRF 108124)Link provided by the sponsor.
- CIFSRF reportLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make individual participant data available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Insecurity and Stunting, run by National Institute of Nutrition, Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Household Food Insecurity Access Scale (time frame: Nov 2016-June 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2019.