- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02626988
The Role of Agricultural Biodiversity in The Diet: a Vietnamese Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Agricultural biodiversity can have an important role in improving diet diversity, quality and nutrition and can be seen as the foundation of the food and nutrition value chain.
Increasing the availability and access to local agricultural and/or wild biodiversity genetic resources has the potential to increase production, making more food available for consumption as long as entitlements to access it exist. However, as the history of food security interventions has shown, increasing the production and supply of staple crops alone is not enough to improve food security or nutritional status. However, while agricultural diversification is an important component, it is not alone sufficient to improve diet diversity. Other system elements including women's education and knowledge, intra-household dynamics and women's status and cultural beliefs and practices that improves children's health and nutrition are important to ensure biodiversity has a successful role in improving dietary diversity and quality.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Son La Province
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Mai Son, Son La Province, Vietnam, 2136
- Jessica E Raneri
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
The intervention group will receive capacity building sessions on the 'Promotion of a biodiverse diet' and will include both Agriculture and Nutrition topics, in addition to access to routine health and nutrition checks, and agriculture extension as offered by commune and provincial staff as normal.
5 Sessions will be held in each village over 12 months.
|
Nutrition education combined with Agriculture Capacity building focused on a key set of nutritious crops.
Component (C) 1 - Participatory Identification of Intervention Approach (PIIA); C2 - Local stakeholder consultation; C3 - Sensitisation of community; C4 - Formation of Diversity club.
Club will receive capacity building from a Village health worker.
The following topics will be covered species selected for promotion: 1.
Where to locally source inputs and expected price, 2. How/when to prepare plots using organic inputs, 3. Planting and best-practice management practices, 4. Seed saving and storage and 4. Active Cooking demonstrations and Nutrition Education and counselling including Diversified cooking practices
|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean intakes (g) of Dark Green leafy vegetables, Vitamin A Rich Fruit and Vegetable and Legumes, nuts and seeds
Time Frame: 12 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.
Collected through administration of 24hour dietary recall
|
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 consuming Dark Green leafy vegetables, Vitamin A Rich Fruit and Vegetable and Legumes, nuts and seeds by mothers and young children.
Collected through administration of 24hour dietary recall
|
12 months
|
|
Proportion of women and children reaching EAR of iron and vitamin A
Time Frame: 12 months
|
Proportion of women and children reaching EAR of iron and vitamin A. Collected through administration of 24hour dietary recall
|
12 months
|
|
Mean species richness consumed daily
Time Frame: 12 months
|
Mean species richness consumed daily.
Collected through administration of 24hour dietary recall
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of women and children reaching EAR of 16 key nutrients
Time Frame: 12 months
|
Proportion of women and children reaching EAR of 16 key nutrients.
Collected through administration of 24hour dietary recall
|
12 months
|
|
Nutritional Knowledge of Women, score
Time Frame: 12 months
|
Nutrition Knowledge Score.
Collected through a Questionnaire.
|
12 months
|
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Individual Dietary Diversity Score - Women - Score constructed of number of food groups consumed out of 10
Time Frame: 12 months
|
Individual Dietary Diversity Score of women.
Score constructed of number of food groups consumed out of 10.
Collected through administration of 24hour dietary recall
|
12 months
|
|
Individual Dietary Diversity Score - Children. Score constructed of count of number of food groups consumed out of 7
Time Frame: 12 months
|
Individual Dietary Diversity Score children.
Score constructed of count of number of food groups consumed out of 7.Collected through administration of 24hour dietary recall
|
12 months
|
|
Minimum Dietary Diversity - Women - Proportion of women that consumed 5 or more food groups (out of 10).
Time Frame: 12 months
|
Proportion of women that consumed 5 or more food groups (out of 10).
Collected through administration of 24hour dietary recall
|
12 months
|
|
Minimum Dietary Diversity - Children - Proportion of children that consumed 4 or more food groups (out of 7).
Time Frame: 12 months
|
Proportion of children that consumed 4 or more food groups (out of 7).
Collected through administration of 24hour dietary recall
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12 months
|
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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
|
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) and used to calculate the final indicator
|
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
|
Stunting - Mean change from baseline in height-for-age Z-scores The following direct measurements will be collected Age (months), Height/Length (cm) and used to calculate the final indicator.
|
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
|
Underweight - Mean change from baseline in weight-for-age Z-scores The following direct measurements will be collected Age (months) and Weight (Kg) and used to calculate the final indicator
|
12 months
|
|
Mean daily intakes (g) of processed foods and drinks
Time Frame: 12 months
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Mean daily intakes (g) of processed foods and drinks.
Collected through administration of 24hour dietary recall
|
12 months
|
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Mean proportion of daily energy, fat, salt and sugar intakes from processed foods
Time Frame: 12 months
|
Mean proportion of daily energy, fat, salt and sugar intakes from processed foods.
Collected through administration of 24hour dietary recall
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jessica E Raneri, Bioversity International
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 (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BIOHTDIET2015JR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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