Nutrition-sensitive Agricultural Interventions for Ethiopia (ATONU)

August 21, 2018 updated by: Wafaie Fawzi, Harvard School of Public Health (HSPH)

Evaluation of Integrated Agriculture and Nutrition Sensitive Interventions for the African Chicken Genetic Gains (ACGG) Program in Ethiopia

This study aims at evaluating the impact of integrating nutrition sensitive behavioral change communication (BCC) in the context of increased household production of chicken and eggs on women and children diet.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The Agriculture to Nutrition (ATONU) Project, led by the Food, Agriculture and Natural Resources Policy Analysis Network (FANRPAN), aims to develop, implement, and evaluate nutrition-sensitive interventions within the context of existing agricultural programs with the goal of improving the nutritional status of women of reproductive age and young children, particularly in the first 1000 days of life. Specifically, ATONU will implement a nutrition sensitive intervention in collaboration with the ACGG Program. ACGG is evaluating the agricultural productivity of high-producing chicken genotypes in Ethiopia and will be providing 20-30 chickens to small-scale chicken-producing households for an 18-month on-farm evaluation. These households will also be provided with regular technical input on good chicken production practices, and ACGG investigators will aim to reach women as well as men in participating households.

ATONU will implement an additional nutrition-sensitive intervention among ACGG households that will use behavior change communication (BCC) to encourage consumption of chicken products (meat and eggs); good water, sanitation, and hygiene (WASH) practices in poultry production; use of income from sale of chicken products to improve nutrition; empowerment of women in decision-making around chicken production and sale; and home gardening of nutrient-dense vegetables to improve dietary quality within the household. Qualitative work is supporting development of this intervention.

ACGG's intervention to increase chicken production may improve the nutritional status of women and children through increasing access to chicken meat and eggs for household consumption and empowering women by giving them access to income, which could be used for purchase of other nutrient-dense foods. However, increasing production and income alone may not necessarily translate into improved diets or nutritional outcomes. ATONU's intervention will specifically encourage the use of chicken products and income to provide nutritious diets for women of reproductive age, emancipated minors and young children through extensive nutrition behavior change communication. Further, recognizing that lack of availability of nutrient-dense foods in local markets may be an important barrier to a diverse and nutritious diet, the home gardening component of ATONU's intervention seeks to increase the availability of nutrient-dense vegetables at household level.

The ACGG program is operating in diverse agroecologies in Ethiopia. Within its target areas, the program listed villages in which chicken production was an important activity and, from this list, randomly selected villages in which to implement its intervention. In a subset of these ACGG villages, ATONU will implement its intervention. As a result, there will be two groups of ACGG villages: those receiving only the poultry production intervention, and those receiving the poultry production intervention coupled with ATONU's nutrition-sensitive intervention. Allocation of ACGG villages to one of these two groups will be done randomly. Investigators will evaluate the nutritional impact of these two interventions among smallholder chicken-producing households in Ethiopia. Specifically, investigators will use the two groups of villages described above and a third group of ACGG-eligible villages that ACGG did not choose for intervention to conduct a cluster-randomized controlled trial with the goal of evaluating the effect of the ACGG and ATONU interventions on maternal and child diets, nutritional status, and health.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2117

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ethiopia
      • Addis Ababa, Ethiopia, Box 26751/1000
        • Addis Continental Institute of Public Health (ACIPH)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 49 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Households in one of the two ACGG treatment arms will be eligible for inclusion if they meet all of the following criteria:

  1. Are participating in the ACGG program
  2. Have at least one woman of reproductive age (18-49 years at enrollment) or emancipated minor (girl aged 15 to less than 18 years)
  3. Plan to remain in the study area throughout the study duration
  4. Provide informed consent.

Households in the control arm will be eligible for inclusion if they meet all of the following criteria:

  1. Meet the criteria for participating in the ACGG program, namely, they have produced chickens for at least two years and are currently keeping no more than 50 chickens with interest to expand production in the future
  2. Have at least one woman of reproductive age (18-49 years at enrollment) or emancipated minor (girl aged 15 to less than 18 years)
  3. Plan to remain in the study area throughout the study duration
  4. Provide informed consent.

Exclusion Criteria:

  • Households will be excluded if they fail to meet any of the criteria listed above

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ACGG & ATONU
ACGG high-producing chicks to households along with provision of technical input on production and ATONU Nutrition sensitive BCC on poultry-specific aspects of nutrition, WASH, women's empowerment, and use of income combined with home gardening.
Other: ACGG
50 high-producing chicks to households along with provision of technical input on production
Other Names:
  • Chicken intensification
Behavioral: BCC
Nutrition sensitive BCC on poultry-specific aspects of nutrition, WASH, women's empowerment, and use of income combined with home gardening.
Other Names:
  • ATONU
Active Comparator: ACGG only
ACGG high-producing chicks to households along with provision of technical input on production
Other: ACGG
50 high-producing chicks to households along with provision of technical input on production
Other Names:
  • Chicken intensification
No Intervention: Control
ACGG eligible households in non-ACGG villages receiving standard of care agricultural and health services as provided in Ethiopia

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Diet quality for women and emancipated minors using the standard FAO/FANTA MDD-W dietary diversity score questionnaire,
Time Frame: 18 months
For each woman or emancipated minor in each study group (ACGG alone, ACGG plus ATONU, and Control), the number of food groups consumed in the previous day, out of the 10 food groups listed on the standard FAO/FHI360 MDD-W dietary diversity score questionnaire
18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Diet quality for young children using the standard dietary diversity score questionnaire developed by the by Food and Nutrition Technical Assistance Project and Academy for Educational Development.
Time Frame: 18 months
For each young child in each study group (ACGG alone, ACGG plus ATONU, and Control), the number of food groups consumed in the previous day, out of the 8 groups listed (FGI-8) on the standard dietary diversity score questionnaire developed by Food and Nutrition Technical Assistance Project and Academy for Educational Development. The dietary diversity score is based on consumption of 8 food groups in the past 24 hours.
18 months
Anemia in women and emancipated minors as defined by hemoglobin (Hb) levels cut off points of Hb < 12 g/dl for non pregnant women and Hb < 11g/dl for pregnant women
Time Frame: 18 months
Defining Anemia in women and emancipated minors in the three study groups (ACGG alone, ACGG plus ATONU, and Control) using Hb cut off adjusted for altitude as per the WHO 2011 guidelines
18 months
Anemia in children as defined by hemoglobin (Hb) levels cut off points of Hb < 11 g/dl
Time Frame: 18 months
Defining Anemia in children in the three study groups (ACGG alone, ACGG plus ATONU, and Control) using Hb cut off adjusted for altitude as per the WHO 2011 guidelines
18 months
Body Mass Index (BMI in kg/m^2 ) for women and emancipated minors in the three study groups (ACGG alone, ACGG plus ATONU, and Control)
Time Frame: 18 months
For each woman and emancipated minor, BMI will be calculated by dividing body weight(kg) by the square of participant height (m^2). BMI values will be analyzed as continuous data.
18 months
Growth in height for children (Height for Age) in the three study groups (ACGG alone, ACGG plus ATONU, and Control)
Time Frame: 18 months
Height for age will be assessed and presented as Z scores as per the WHO children height for age growth charts for boys and girls
18 months
Weight in children (Weight for Age) in the three study groups (ACGG alone, ACGG plus ATONU, and Control)
Time Frame: 18 months
Weight for age in children will be assessed and presented as Z scores as per the WHO children weight for age charts for boys and girls
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Harvard School of Public Health (HSPH)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Addis Continental Institute of Public Health
The International Livestock Research Institute (ILRI)
Food, Agriculture and Natural Resources Policy Analysis Network

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wafaie W Fawzi, DrPH,MBBS, Harvard School of Public Health (HSPH)
  • Principal Investigator: Yemane Berhane, PhD, Addis Continental Institute of Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 8, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 8, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 11, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 23, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSPH-16-0912

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

data sharing agreement in progress

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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