Condition category
Not Applicable
Date applied
29/04/2020
Date assigned
05/06/2020
Last edited
08/06/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Despite the progress towards ending hunger and malnutrition, more than 800 million people are still affected by undernutrition and another 2 billion by micronutrient malnutrition. Underutilized food including wild plants have now received recognition globally due to their nutritional potential and their ability to survive in harsh climatic conditions like Turkana county in Kenya and Tigray Region in Ethiopia. Although information on their nutrient composition, use and income potential is scanty and fragment, few studies available have shown that they have comparable and sometimes superior nutrient compositions. However, their utilization has been hampered by inadequate knowledge on their nutrition composition and better ways to prepare them appetizingly and a lack of knowledge on how to promote their utilization while still ensuring sustainability. A project is proposed that will use integrated participatory community-based approach to empower the community to develop action plans for their utilization for incomes, food security and resilience. Participatory methods that incorporate social and behavior change communication in the interventions have been shown to yield positive outcomes and are key to program sustainability. Few projects however exist where the community in involved right from the design stage and most have involved the communities in the intervention only sometimes with very minimal participation. The project will be implemented by Bioversity International and its partners – Save the children, regional governments, Concern International, Mekelle University, and other partners over a period of three years.

Who can participate?
Households in the Tigray region of Ethiopia and Turkana County in Kenya, with at least one woman aged 15 – 49 years and a child aged 6 - 59 months.

What does the study involve?
Communities that have been selected to receive this intervention will undergo empowerment through six training workshops that lead to development of a community plan of action and its subsequent implementations for a period of one year. The plans of actions developed will vary from one community to the other depending on their own choices and resources available to them. At the start of the project, seed money will be given to the community to fund some of the activities in the action plans. During the implementation, the communities will from time to time receive nutrition education including cooking demonstrations of some local recipes and technical training in line with the action plans being implemented. Communities that do not immediately fall within the intervention communities on the other will wait for at last one year after which they will also be guided through a similar exercise as the first group.

What are the possible benefits and risks of participating?
Communities will benefit from nutrition education sessions and training offered during the project implementation. This will help the beneficiary communities to improve nutrition and diets. The study has no risks to the participants.

Where is the study run from?
Alliance of Bioversity International and the International Center for Tropical Agriculture (CIAT)

When is the study starting and how long is it expected to run for?
June 2020 to August 2022

Who is funding the study?
BMZ: Federal Ministry for Economic Cooperation and Development (Kenya)

Who is the main contact?
Francis Oduor, f.oduor@cgiar.org

Trial website

Contact information

Type

Scientific

Primary contact

Mr Francis Oduor

ORCID ID

https://orcid.org/0000-0001-8082-6387

Contact details

CIAT - Kenya
Icipe Duduville Campus
Nairobi
823 - 00621
Kenya
+254 (0)720169559
francodhis@gmail.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

BIOVERSITY-01/2020

Study information

Scientific title

Cluster-randomized control trial to improve dietary and livelihood of communities in Turkana County (Kenya) and Tigray Region (Ethiopia) using integrated community-based approach

Acronym

Study hypothesis

A community-based participatory approach that empowers the community through nutrition education is effective in promoting the use of wild and underutilized plant species and can improve diet quality of women and children.
This study will be based on the successful concept of community based participatory approach used in a proof of concept study in Vihiga county (Boedecker et al., 2019) and will test the use of the approach in a different context in Turkana county and Tigray region.

Ethics approval

Approved 08/01/2020, Amref Ethics and Scientific Review Committee(ESRC) (PO Box 30125-00100, Nairobi, Kenya; +254 (0)20 699 4000; esrc.kenya@amref.org), ref: ESRC P688/2019

Study design

Randomized controlled cluster trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Quality of life

Patient information sheet

See additional file ISRCTN11778499_PIS_26May2020 (added 08/06/2020)

Condition

Dietary quality of women and children

Intervention

Study Design: Cluster – randomized controlled trial with an intervention arm and a control arm. The study period is three years and will be implemented in two phases comprising the preparatory phase or diagnostic phase and the intervention phase. The intervention phase will further be divided into two phases due to the participatory nature of the study – the intervention identification phase and the intervention implementation phase.

Sampling: Multi-stage sampling strategy will be used for sampling. In the first stage criterion sampling was used sample two sub-counties in Turkana county and two Kabeles in Tigray with rich diversity of wild edible plant species, accessible, good security levels, high food insecurity and no similar intervention programs currently. The second stage is the random sampling of twenty (20) clusters from each site. In Turkana County the clusters are the community units (CU) while in Tigray the clusters are the cushets.

Randomization: Prior to the randomization, a diagnostic study (Phase I) will be conducted in all the clusters to study the dietary patterns and the existing local agrobiodiversity. Results from the diagnostic survey will be used for pair-matching clusters in each of the countries. For each pair, one cluster will be randomized to control or intervention arm.

Treatment of the intervention clusters: The treatment in the study is the implementation of the Integrated Community based approach for farm, market and diet diversity developed by Bioversity International from the Vihiga proof of concept study. The intervention will be implemented in two phases: the participatory development of the Community Action Plans (CAP) and the implementation of the CAPs.

Phase II: The identification of intervention phase or participatory development of Community Action Plans: First, the community will be guided through a series of six workshops delivered leading to the development of a community action plan (CAP). In workshops I and II the results of the diagnostic study will be discussed in order to raise awareness on the nutrition situation in the community and to mediate basic nutrition knowledge as well as the importance of dietary diversity, with a focus on the diets of women and small children. Workshops III and IV will aim at identifying the factors influencing dietary intake in the community and to raise awareness on the nutrition potential of the local food environment with special attention to the neglected and underutilized foods. In addition, possible interventions to improve nutrition will be identified. In the last two workshops V and VI, the communities will be guided to develop CAPs including the timelines and budgets for the implementation of the identified interventions. Communities will also discuss how they intend to gather the necessary funds to implement their CAPs.

Phase III: The implementation of Community Action Plans or proper intervention phase: In this final phase the CAPs will be implemented in the community. A kick-off event marking the official launch of the interventional activities will be organized where partners and all other community members will be invited. A small financial incentive as an injection to the implementation of the CAPs will be given to each community by the project. During the kick-off event, the community will be requested to bring with them different food stuffs including the wild foods for learning and cooking demonstrations.

The CAPs will be implemented for about one year during which technical trainings in line with the activities specified in the CAPs, nutrition education activities and cooking demonstrations, trainings on community dynamics, leadership and entrepreneurial skills (farmer business schools), will be provided. Links with other groups such as women groups, mother clubs or farmer groups within the intervention communities will be actively sought to foster information and experience sharing.

Treatment of the control clusters: treatment in the control clusters will be delayed for one year after which the same treatment as the intervention clusters will be implemented.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Diets of the children and women as measured from baseline to endline as measured by multi-pass quantitative 24 hour recall on two non-consecutive days per subject per survey round by:
1. Dietary diversity scores (percentage of women/children meeting minimum dietary diversity)
2. Nutrient adequacy ratios of the women’s and children’s diets

Secondary outcome measures

At endline:
1. Income opportunities from marketing of wild foods and other locally available agrobiodiversity measured using household interviews
2. Caregiver knowledge and attitudes and practices related to diet quality and nutrition measured measured through a knowledge, attitudes and practices assessment using individual interviews
3. Household food security measured by Household Dietary Diversity Score (HDDS), Months of Adequate Household Food Provisioning (MAHFP); Household Food Insecurity Access Scale (HFIAS), Household Hunger Scale (HHS)
4. Women empowerment measured using reach and process Indicators, economic advancement indicators and agency or power indicators within the Woman’s Economic Empowerment Framework

Overall trial start date

01/07/2019

Overall trial end date

31/08/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Households with at least one woman aged 15 – 49 years and a child aged 6 - 59 months will be the main target for the study

Participant type

Healthy volunteer

Age group

Mixed

Gender

Both

Target number of participants

40 Clusters in two countries

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/06/2020

Recruitment end date

31/07/2021

Locations

Countries of recruitment

Ethiopia, Kenya

Trial participating centre

Tigray region
NA
Ethiopia

Trial participating centre

Turkana County
NA
Kenya

Sponsor information

Organisation

Bioversity International

Sponsor details

CIAT - Kenya
Icipe Duduville Campus
Nairobi
823 - 00621
Kenya
+254 (0)720169559
bioversity-kenya@cgiar.org

Sponsor type

Research organisation

Website

http://www.bioversityinternational.org/

Funders

Funder type

Government

Funder name

BMZ: Federal Ministry for Economic Cooperation and Development

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a publically available repository (https://dataverse.org)

Intention to publish date

31/08/2023

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

08/06/2020: The participant information sheet has been uploaded as an additional file. 26/05/2020: Trial’s existence confirmed by Amref Health Africa.