NCT03847662

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
799

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2016

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 3, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 20, 2019

Completed
Last Updated

February 20, 2019

Status Verified

February 1, 2019

Enrollment Period

1.6 years

First QC Date

November 7, 2018

Last Update Submit

February 18, 2019

Conditions

Keywords

Food InsecurityStuntingWastingUnderweightAnemiaComplimentary FoodsFood FortificationComplimentary Feeding

Outcome Measures

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.

    Nov 2016-June 2018

Secondary Outcomes (4)

  • Weight in kilograms

    Nov 2016-June 2018

  • Height in Meters

    Nov 2016-June 2018

  • Age in Months

    Nov 2016-June 2018

  • Hemoglobin Levels of Children (<2y)

    Nov 2016-June 2018

Study Arms (1)

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.

Eligibility Criteria

Age6 Months - 2 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Growth DisordersCachexiaThinnessAnemia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsWeight LossBody Weight ChangesBody WeightSigns and SymptomsHematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

November 7, 2018

First Posted

February 20, 2019

Study Start

November 3, 2016

Primary Completion

June 5, 2018

Study Completion

June 5, 2018

Last Updated

February 20, 2019

Record last verified: 2019-02