NCT02626988

Brief Summary

What is the role of Agricultural biodiversity in improving diet diversity, quality and nutrition?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 10, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

August 5, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2017

Completed
Last Updated

August 13, 2021

Status Verified

August 1, 2021

Enrollment Period

1.4 years

First QC Date

December 3, 2015

Last Update Submit

August 7, 2021

Conditions

Keywords

Diet DiversityBiodiversityAgrobiodiversityNutritionVietnam

Outcome Measures

Primary Outcomes (4)

  • 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

    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

    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

    12 months

  • Mean species richness consumed daily

    Mean species richness consumed daily. Collected through administration of 24hour dietary recall

    12 months

Secondary Outcomes (11)

  • Proportion of women and children reaching EAR of 16 key nutrients

    12 months

  • Nutritional Knowledge of Women, score

    12 months

  • Individual Dietary Diversity Score - Women - Score constructed of number of food groups consumed out of 10

    12 months

  • Individual Dietary Diversity Score - Children. Score constructed of count of number of food groups consumed out of 7

    12 months

  • Minimum Dietary Diversity - Women - Proportion of women that consumed 5 or more food groups (out of 10).

    12 months

  • +6 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

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

Intervention

Eligibility Criteria

Age12 Months - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jessica E Raneri

Mai Sơn, Sơn La Province, 2136, Vietnam

Location

Study Officials

  • Jessica E Raneri

    Bioversity International

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2015

First Posted

December 10, 2015

Study Start

August 5, 2016

Primary Completion

December 11, 2017

Study Completion

December 11, 2017

Last Updated

August 13, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will share

Data will be made publically available upon publication of research results. It will be made available on the BioversityDataverse website. It will be anonymized.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
within 2 years of collection of endline data
Access Criteria
Agrees to open access license

Locations