BiodiversityNCT05144919
Biodiversity in the Diet in Vietnam
A study testing Promotion of a biodiverse diet in people with Biodiversity and Food Intake, run by University Ghent at 1 site in Vietnam.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 to 23 monthsHealthy volunteers can take part
- Conditions the study is for
- Biodiversity, Food Intake, Nutritional Status
- What is being tested?
- Promotion of a biodiverse diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteVietnam
- Study dates
- Nov 2015to Jan 2017
- Phase
- Interventional
- 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 to 23 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Agricultural Biodiversity in Thet Diet: a Vietnamese Study
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.
- Conditions
- Biodiversity, Food Intake, Nutritional Status
- Being tested
- Promotion of a biodiverse diet
- Keywords
- Biodiversity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promotion of a biodiverse dietBehavioural
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:
- Where to locally source inputs and expected price
- How/when to prepare plots using organic inputs
- Planting and best-practice management practices
- Seed saving and storage
- Possible intercropping combinations OR ecosystem services provided Component 4. Active Cooking demonstrations and Nutrition Education and counselling: Diversified cooking practices
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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. |
| Intervention | Experimental | 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. Receives: Behavioral: Promotion of a biodiverse diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consumption of nutrient rich food groups
Mean intakes (g) of Dark Green leafy vegetables, Vitamin A Rich Fruit and Vegetable and Legumes, nuts and seeds by mothers and young children.
Measured: 24 months
Consumption of nutrient rich food groups
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.
Measured: 24 months
dietary quality
Proportion of women and children reaching estimated average requirement (EAR) of iron and vitamin A
Measured: 24 months
Mean species richness consumed
Mean species richness consumed
Measured: 24 months
Secondary outcomes (8)
Food and nutrient intake
Proportion of women and children reaching EAR of 16 key nutrients
Measured: 24 months
Nutritional Knowledge of Women
Mean score from a set of nutrient and food specific questions
Measured: 24 months
Individual Dietary Diversity Score
Individual Dietary Diversity Score by women and children
Measured: 24 months
Minimum Dietary Diversity
Proportion of women and children that consumed 5 or more food groups (out of 10)
Measured: 24 months
nutritional status
Mean change from baseline in height-for-age Z-scores Mean change from baseline in weight-for-height Z-scores
Measured: 24 months
Women's Empowerment
Decision making power on selection of species to cultivate, use at homestead and time spent
Measured: 24 months
Consumption of processed foods and drinks
Mean daily intakes (g) of processed foods and drinks Mean proportion of daily energy, fat, salt and sugar intakes from processed foods
Measured: 24 months
income
Household Income from sale of home garden species, agriculture, off-farm employment
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study startNov 2015
- Primary completionDec 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BiodiversityStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- HealthBridge
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144919
- Sponsor's protocol ID
- 2015/1205
- Status last verified
- Dec 2021
- First submitted
- 2 Dec 2021
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Agricultural Biodiversity in Thet Diet: a Vietnamese Study
- ClinicalTrials.gov ID
- NCT05144919
- Acronym / sponsor ID
- 2015/1205
- Conditions
- Biodiversity, Food Intake, Nutritional Status
- Keywords
- Biodiversity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- HealthBridge
- Study start
- Nov 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 3 Dec 2021 (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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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. |
| Intervention | Experimental | Behavioral: Promotion of a biodiverse dietThe 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. |
Who may qualify
- Ages
- 6 to 23 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Promotion of a biodiverse dietComponent 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: 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 5. Possible intercropping combinations OR ecosystem services provided Component 4. Active Cooking demonstrations and Nutrition Education and counselling: Diversified cooking practices | Behavioural | Intervention |
Primary outcome
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.
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.
dietary quality
Time frame: 24 months
Proportion of women and children reaching estimated average requirement (EAR) of iron and vitamin A
Mean species richness consumed
Time frame: 24 months
Mean species richness consumed
8 secondary outcomes
Food and nutrient intake
Time frame: 24 months
Nutritional Knowledge of Women
Time frame: 24 months
Individual Dietary Diversity Score
Time frame: 24 months
Minimum Dietary Diversity
Time frame: 24 months
nutritional status
Time frame: 24 months
Women's Empowerment
Time frame: 24 months
Consumption of processed foods and drinks
Time frame: 24 months
income
Time frame: 24 months
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 3 Dec 2021.
- Related InfoLink provided by the sponsor.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promotion of a biodiverse diet in people with Biodiversity and Food Intake, run by University Ghent at 1 site in 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 3 inclusion and 2 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 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Consumption of nutrient rich food groups (time frame: 24 months). The study lists 4 primary outcomes in all. 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 3 Dec 2021.