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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 August 2021
Main ID:  NCT02626988
Date of registration: 03/12/2015
Prospective Registration: Yes
Primary sponsor: Bioversity International
Public title: The Role of Agricultural Biodiversity in The Diet: a Vietnamese Study
Scientific title: The Role of Agricultural Biodiversity in The Diet: a Vietnamese Study
Date of first enrolment: August 5, 2016
Target sample size: 180
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02626988
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Vietnam
Contacts
Name:     Jessica E Raneri
Address: 
Telephone:
Email:
Affiliation:  Bioversity International
Key inclusion & exclusion criteria

Inclusion Criteria:

- Woman of reproductive age (between 15-49 years) who are the mother or primary
caregiver of a child between 12 and 23 months of age.

- Both the woman and the child should be permanent residents in the village selected and
do not temporarily migrate outside the village cluster during the year.

- Reside in a Thai Village

Exclusion Criteria:

- Reside in a village that is the Urban center of commune/province

- Currently engaged in other agriculture or nutrition programme or Intervention apart
from what is offered by government extension workers



Age minimum: 12 Months
Age maximum: 55 Years
Gender: All
Health Condition(s) or Problem(s) studied
Biodiversity
Food Intake
Intervention(s)
Behavioral: Promotion of a biodiverse diet
Primary Outcome(s)
Mean species richness consumed daily [Time Frame: 12 months]
Mean intakes (g) of Dark Green leafy vegetables, Vitamin A Rich Fruit and Vegetable and Legumes, nuts and seeds [Time Frame: 12 months]
Proportion of women and children consuming Dark Green leafy vegetables, Vitamin A Rich Fruit and Vegetable and Legumes, nuts and seeds by mothers and young children [Time Frame: 12 months]
Proportion of women and children reaching EAR of iron and vitamin A [Time Frame: 12 months]
Secondary Outcome(s)
Child nutritional status - Wasting/Overweight - Mean change from baseline in weight-for-height Z-scores. The following measurements will be directly collected Height/Length (cm) and Weight (Kg) [Time Frame: 12 months]
Individual Dietary Diversity Score - Children. Score constructed of count of number of food groups consumed out of 7 [Time Frame: 12 months]
Proportion of women and children reaching EAR of 16 key nutrients [Time Frame: 12 months]
Child nutritional status - Underweight - Mean change from baseline in weight-for-age Z-scores The following direct measurements will be collected Age (months) and Weight (Kg) [Time Frame: 12 months]
Individual Dietary Diversity Score - Women - Score constructed of number of food groups consumed out of 10 [Time Frame: 12 months]
Mean daily intakes (g) of processed foods and drinks [Time Frame: 12 months]
Minimum Dietary Diversity - Children - Proportion of children that consumed 4 or more food groups (out of 7). [Time Frame: 12 months]
Child nutritional status - Stunting - Mean change from baseline in height-for-age Z-scores The following direct measurements will be collected Age (months), Height/Length (cm) [Time Frame: 12 months]
Minimum Dietary Diversity - Women - Proportion of women that consumed 5 or more food groups (out of 10). [Time Frame: 12 months]
Mean proportion of daily energy, fat, salt and sugar intakes from processed foods [Time Frame: 12 months]
Nutritional Knowledge of Women, score [Time Frame: 12 months]
Secondary ID(s)
BIOHTDIET2015JR
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
HealthBridge
University Ghent
Center for Agriculture and Ecological Studies
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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