Food IntakeNCT02626988
The Role of Agricultural Biodiversity in The Diet: a Vietnamese Study
A study testing Promotion of a biodiverse diet in people with Food Intake and Biodiversity, run by Bioversity International at 1 site in Vietnam.
Trial summary
What is the role of Agricultural biodiversity in improving diet diversity, quality and nutrition? Read more about this study
- Who is it for?
- Ages 12 months to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Intake, Biodiversity
- 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
- 180 participants
- Where
- 1 siteVietnam
- Study dates
- 5 Aug 2016to 11 Dec 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 12 months to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
What is the role of Agricultural biodiversity in improving diet diversity, quality and nutrition?
Read the 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.
- Conditions
- Food Intake, Biodiversity
- Being tested
- Promotion of a biodiverse diet
- Keywords
- Diet Diversity, Biodiversity, Agrobiodiversity, Nutrition, Vietnam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promotion of a biodiverse dietBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Promotion of a biodiverse diet |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean intakes (g) of Dark Green leafy vegetables, Vitamin A Rich Fruit and Vegetable and Legumes, nuts and seeds
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
Measured: 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
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
Measured: 12 months
Proportion of women and children reaching EAR of iron and vitamin A
Proportion of women and children reaching EAR of iron and vitamin A. Collected through administration of 24hour dietary recall
Measured: 12 months
Mean species richness consumed daily
Mean species richness consumed daily. Collected through administration of 24hour dietary recall
Measured: 12 months
Secondary outcomes (11)
Proportion of women and children reaching EAR of 16 key nutrients
Proportion of women and children reaching EAR of 16 key nutrients. Collected through administration of 24hour dietary recall
Measured: 12 months
Nutritional Knowledge of Women, score
Nutrition Knowledge Score. Collected through a Questionnaire.
Measured: 12 months
Individual Dietary Diversity Score - Women - Score constructed of number of food groups consumed out of 10
Individual Dietary Diversity Score of women. Score constructed of number of food groups consumed out of 10. Collected through administration of 24hour dietary recall
Measured: 12 months
Individual Dietary Diversity Score - Children. Score constructed of count of number of food groups consumed out of 7
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
Measured: 12 months
Minimum Dietary Diversity - Women - Proportion of women that consumed 5 or more food groups (out of 10).
Proportion of women that consumed 5 or more food groups (out of 10). Collected through administration of 24hour dietary recall
Measured: 12 months
Minimum Dietary Diversity - Children - Proportion of children that consumed 4 or more food groups (out of 7).
Proportion of children that consumed 4 or more food groups (out of 7). Collected through administration of 24hour dietary recall
Measured: 12 months
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)
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
Measured: 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)
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.
Measured: 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)
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
Measured: 12 months
Mean daily intakes (g) of processed foods and drinks
Mean daily intakes (g) of processed foods and drinks. Collected through administration of 24hour dietary recall
Measured: 12 months
Mean proportion of daily energy, fat, salt and sugar intakes from processed foods
Mean proportion of daily energy, fat, salt and sugar intakes from processed foods. Collected through administration of 24hour dietary recall
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study start5 Aug 2016
- Primary completion11 Dec 2017
- Study completion11 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food IntakeStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioversity International
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent, HealthBridge, Center for Agriculture and Ecological Studies
- Responsible party
- Sponsor
- Investigators
- Jessica E Raneri, Principal investigator, Bioversity International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626988
- Sponsor's protocol ID
- BIOHTDIET2015JR
- Status last verified
- Aug 2021
- First submitted
- 3 Dec 2015
- Last updated
- 13 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data will be made publically available upon publication of research results. It will be made available on the BioversityDataverse website. It will be anonymized.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Agricultural Biodiversity in The Diet: a Vietnamese Study
- ClinicalTrials.gov ID
- NCT02626988
- Acronym / sponsor ID
- BIOHTDIET2015JR
- Conditions
- Food Intake, Biodiversity
- Keywords
- Diet Diversity, Biodiversity, Agrobiodiversity, Nutrition, Vietnam
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Bioversity InternationalUniversity, hospital or other
- Collaborators
- University Ghent, HealthBridge, Center for Agriculture and Ecological Studies
- Study start
- 5 Aug 2016 (actual)
- Primary completion
- 11 Dec 2017 (actual)
- Study completion
- 11 Dec 2017 (actual)
- First posted
- 10 Dec 2015 (estimated)
- 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.
What is the role of Agricultural biodiversity in improving diet diversity, quality and nutrition?
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Promotion of a biodiverse dietThe 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. |
| 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. |
Who may qualify
- Ages
- 12 months to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 dietNutrition 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 | Behavioural | Intervention |
Primary outcome
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
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
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
Mean species richness consumed daily
Time frame: 12 months
Mean species richness consumed daily. Collected through administration of 24hour dietary recall
11 secondary outcomes
Proportion of women and children reaching EAR of 16 key nutrients
Time frame: 12 months
Nutritional Knowledge of Women, score
Time frame: 12 months
Individual Dietary Diversity Score - Women - Score constructed of number of food groups consumed out of 10
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
Minimum Dietary Diversity - Women - Proportion of women that consumed 5 or more food groups (out of 10).
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 - 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
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
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
Mean daily intakes (g) of processed foods and drinks
Time frame: 12 months
Mean proportion of daily energy, fat, salt and sugar intakes from processed foods
Time frame: 12 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 13 Aug 2021.
- Individual participant dataSharing planned: Yes. Data will be made publically available upon publication of research results. It will be made available on the BioversityDataverse website. It will be anonymized.
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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.
Jessica E Raneri principal investigator
Bioversity International
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 Food Intake and Biodiversity, run by Bioversity International 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 13 Aug 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?
Mean intakes (g) of Dark Green leafy vegetables, Vitamin A Rich Fruit and Vegetable and Legumes, nuts and seeds (time frame: 12 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 13 Aug 2021.