- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05144919
Biodiversity in the Diet in Vietnam
The Role of Agricultural Biodiversity in Thet Diet: a Vietnamese Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Son La Province
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Mai Son, Son La Province, Vietnam
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- villages: Characterized as Thai village. Only Thai villages will be selected for the study as agriculture practices, diets, food preferences, language and cultures can change drastically between ethnic groups.
- participants: i) 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. This age group is part of the critical 1000 day window for child development and marks the time when young children can potentially consume all foods from the household pot and consume a more diverse diet. As such, it is from this age group that biodiversity can have an effect on children's diets.
ii) 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.
Exclusion Criteria:
- villages: Urban center of commune/province as these villages/cities do not have agriculture or home garden opportunities
- participants: currently engaged in other agriculture or nutrition programme or intervention apart from what is offered by government extension workers
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control
The control group will continue to receive routine health check and nutrition education from health staff at commune health facilities.
Access to agriculture extension services as offered by provincial staff will also continue as normal.
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Experimental: Intervention
The intervention group will receive capacity building sessions on both Agriculture and Nutrition, in addition to access to routine health and nutrition checks, and agriculture extension as offered by commune and provincial staff as normal.
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Component 1 - Participatory Identification of Intervention Approach (PIIA) Component 2. Local stakeholder consultation Component 3. Sensitisation of community Diversity club will receive capacity building from a Village health worker based on the prioritised species selected in component 2. The following topics will be covered for each species selected for promotion:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Consumption of nutrient rich food groups
Time Frame: 24 months
|
Mean intakes (g) of Dark Green leafy vegetables, Vitamin A Rich Fruit and Vegetable and Legumes, nuts and seeds by mothers and young children.
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24 months
|
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Consumption of nutrient rich food groups
Time Frame: 24 months
|
Proportion of women and children consuming 3 Dark Green leafy vegetables, Vitamin A Rich Fruit and Vegetable and Legumes, nuts and seeds by mothers and young children.
|
24 months
|
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dietary quality
Time Frame: 24 months
|
Proportion of women and children reaching estimated average requirement (EAR) of iron and vitamin A
|
24 months
|
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Mean species richness consumed
Time Frame: 24 months
|
Mean species richness consumed
|
24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Food and nutrient intake
Time Frame: 24 months
|
Proportion of women and children reaching EAR of 16 key nutrients
|
24 months
|
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Nutritional Knowledge of Women
Time Frame: 24 months
|
Mean score from a set of nutrient and food specific questions
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24 months
|
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Individual Dietary Diversity Score
Time Frame: 24 months
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Individual Dietary Diversity Score by women and children
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24 months
|
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Minimum Dietary Diversity
Time Frame: 24 months
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Proportion of women and children that consumed 5 or more food groups (out of 10)
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24 months
|
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nutritional status
Time Frame: 24 months
|
Mean change from baseline in height-for-age Z-scores Mean change from baseline in weight-for-height Z-scores
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24 months
|
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Women's Empowerment
Time Frame: 24 months
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Decision making power on selection of species to cultivate, use at homestead and time spent
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24 months
|
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Consumption of processed foods and drinks
Time Frame: 24 months
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Mean daily intakes (g) of processed foods and drinks Mean proportion of daily energy, fat, salt and sugar intakes from processed foods
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24 months
|
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income
Time Frame: 24 months
|
Household Income from sale of home garden species, agriculture, off-farm employment
|
24 months
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2015/1205
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