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Nutrition-sensitive Agricultural Interventions for Ethiopia (ATONU)

Primary Purpose

Dietary Modification, Health Behavior

Status
Completed
Phase
Not Applicable
Locations
Ethiopia
Study Type
Interventional
Intervention
ACGG
BCC
Sponsored by
Harvard School of Public Health (HSPH)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dietary Modification

Eligibility Criteria

15 Years - 49 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Addis Continental Institute of Public Health (ACIPH)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

ACGG & ATONU

ACGG only

Control

Arm Description

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.

ACGG high-producing chicks to households along with provision of technical input on production

ACGG eligible households in non-ACGG villages receiving standard of care agricultural and health services as provided in Ethiopia

Outcomes

Primary Outcome Measures

Diet quality for women and emancipated minors using the standard FAO/FANTA MDD-W dietary diversity score questionnaire,
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

Secondary Outcome Measures

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.
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.
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
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
Anemia in children as defined by hemoglobin (Hb) levels cut off points of Hb < 11 g/dl
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
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)
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.
Growth in height for children (Height for Age) in the three study groups (ACGG alone, ACGG plus ATONU, and Control)
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
Weight in children (Weight for Age) in the three study groups (ACGG alone, ACGG plus ATONU, and Control)
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

Full Information

First Posted
November 11, 2016
Last Updated
August 21, 2018
Sponsor
Harvard School of Public Health (HSPH)
Collaborators
The International Livestock Research Institute (ILRI), Addis Continental Institute of Public Health, Food, Agriculture and Natural Resources Policy Analysis Network
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1. Study Identification

Unique Protocol Identification Number
NCT03152227
Brief Title
Nutrition-sensitive Agricultural Interventions for Ethiopia
Acronym
ATONU
Official Title
Evaluation of Integrated Agriculture and Nutrition Sensitive Interventions for the African Chicken Genetic Gains (ACGG) Program in Ethiopia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
May 8, 2018 (Actual)
Study Completion Date
May 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard School of Public Health (HSPH)
Collaborators
The International Livestock Research Institute (ILRI), Addis Continental Institute of Public Health, Food, Agriculture and Natural Resources Policy Analysis Network

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dietary Modification, Health Behavior

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACGG & ATONU
Arm Type
Experimental
Arm Description
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.
Arm Title
ACGG only
Arm Type
Active Comparator
Arm Description
ACGG high-producing chicks to households along with provision of technical input on production
Arm Title
Control
Arm Type
No Intervention
Arm Description
ACGG eligible households in non-ACGG villages receiving standard of care agricultural and health services as provided in Ethiopia
Intervention Type
Other
Intervention Name(s)
ACGG
Other Intervention Name(s)
Chicken intensification
Intervention Description
50 high-producing chicks to households along with provision of technical input on production
Intervention Type
Behavioral
Intervention Name(s)
BCC
Other Intervention Name(s)
ATONU
Intervention Description
Nutrition sensitive BCC on poultry-specific aspects of nutrition, WASH, women's empowerment, and use of income combined with home gardening.
Primary Outcome Measure Information:
Title
Diet quality for women and emancipated minors using the standard FAO/FANTA MDD-W dietary diversity score questionnaire,
Description
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
Time Frame
18 months
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
18 months
Title
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
Description
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
Time Frame
18 months
Title
Anemia in children as defined by hemoglobin (Hb) levels cut off points of Hb < 11 g/dl
Description
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
Time Frame
18 months
Title
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)
Description
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.
Time Frame
18 months
Title
Growth in height for children (Height for Age) in the three study groups (ACGG alone, ACGG plus ATONU, and Control)
Description
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
Time Frame
18 months
Title
Weight in children (Weight for Age) in the three study groups (ACGG alone, ACGG plus ATONU, and Control)
Description
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
Time Frame
18 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Households in one of the two ACGG treatment arms will be eligible for inclusion if they meet all of the following criteria: Are participating in the ACGG program Have at least one woman of reproductive age (18-49 years at enrollment) or emancipated minor (girl aged 15 to less than 18 years) Plan to remain in the study area throughout the study duration Provide informed consent. Households in the control arm will be eligible for inclusion if they meet all of the following criteria: 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 Have at least one woman of reproductive age (18-49 years at enrollment) or emancipated minor (girl aged 15 to less than 18 years) Plan to remain in the study area throughout the study duration Provide informed consent. Exclusion Criteria: Households will be excluded if they fail to meet any of the criteria listed above
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wafaie W Fawzi, DrPH,MBBS
Organizational Affiliation
Harvard School of Public Health (HSPH)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yemane Berhane, PhD
Organizational Affiliation
Addis Continental Institute of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Addis Continental Institute of Public Health (ACIPH)
City
Addis Ababa
ZIP/Postal Code
Box 26751/1000
Country
Ethiopia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
data sharing agreement in progress
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Nutrition-sensitive Agricultural Interventions for Ethiopia

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