NCT03152227

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,117

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2016

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 12, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2018

Completed
Last Updated

August 23, 2018

Status Verified

August 1, 2018

Enrollment Period

1.5 years

First QC Date

November 11, 2016

Last Update Submit

August 21, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    18 months

Secondary Outcomes (6)

  • 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.

    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

    18 months

  • Anemia in children as defined by hemoglobin (Hb) levels cut off points of Hb < 11 g/dl

    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)

    18 months

  • Growth in height for children (Height for Age) in the three study groups (ACGG alone, ACGG plus ATONU, and Control)

    18 months

  • +1 more secondary outcomes

Study Arms (3)

ACGG & ATONU

EXPERIMENTAL

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: ACGGBehavioral: BCC

ACGG only

ACTIVE COMPARATOR

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

Other: ACGG

Control

NO INTERVENTION

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

Interventions

ACGGOTHER

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

Also known as: Chicken intensification
ACGG & ATONUACGG only
BCCBEHAVIORAL

Nutrition sensitive BCC on poultry-specific aspects of nutrition, WASH, women's empowerment, and use of income combined with home gardening.

Also known as: ATONU
ACGG & ATONU

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Addis Continental Institute of Public Health (ACIPH)

Addis Ababa, Box 26751/1000, Ethiopia

Location

Related Publications (14)

  • Balarajan Y, Ramakrishnan U, Ozaltin E, Shankar AH, Subramanian SV. Anaemia in low-income and middle-income countries. Lancet. 2011 Dec 17;378(9809):2123-35. doi: 10.1016/S0140-6736(10)62304-5. Epub 2011 Aug 1.

    PMID: 21813172BACKGROUND
  • Black RE, Victora CG, Walker SP, Bhutta ZA, Christian P, de Onis M, Ezzati M, Grantham-McGregor S, Katz J, Martorell R, Uauy R; Maternal and Child Nutrition Study Group. Maternal and child undernutrition and overweight in low-income and middle-income countries. Lancet. 2013 Aug 3;382(9890):427-451. doi: 10.1016/S0140-6736(13)60937-X. Epub 2013 Jun 6.

    PMID: 23746772BACKGROUND
  • Iannotti LL, Lutter CK, Bunn DA, Stewart CP. Eggs: the uncracked potential for improving maternal and young child nutrition among the world's poor. Nutr Rev. 2014 Jun;72(6):355-68. doi: 10.1111/nure.12107. Epub 2014 May 7.

    PMID: 24807641BACKGROUND
  • Lee AC, Katz J, Blencowe H, Cousens S, Kozuki N, Vogel JP, Adair L, Baqui AH, Bhutta ZA, Caulfield LE, Christian P, Clarke SE, Ezzati M, Fawzi W, Gonzalez R, Huybregts L, Kariuki S, Kolsteren P, Lusingu J, Marchant T, Merialdi M, Mongkolchati A, Mullany LC, Ndirangu J, Newell ML, Nien JK, Osrin D, Roberfroid D, Rosen HE, Sania A, Silveira MF, Tielsch J, Vaidya A, Willey BA, Lawn JE, Black RE; CHERG SGA-Preterm Birth Working Group. National and regional estimates of term and preterm babies born small for gestational age in 138 low-income and middle-income countries in 2010. Lancet Glob Health. 2013 Jul;1(1):e26-36. doi: 10.1016/S2214-109X(13)70006-8. Epub 2013 Jun 25.

    PMID: 25103583BACKGROUND
  • Leroy JL, Frongillo EA. Can interventions to promote animal production ameliorate undernutrition? J Nutr. 2007 Oct;137(10):2311-6. doi: 10.1093/jn/137.10.2311.

    PMID: 17885016BACKGROUND
  • Marquis GS, Habicht JP, Lanata CF, Black RE, Rasmussen KM. Breast milk or animal-product foods improve linear growth of Peruvian toddlers consuming marginal diets. Am J Clin Nutr. 1997 Nov;66(5):1102-9. doi: 10.1093/ajcn/66.5.1102.

    PMID: 9356526BACKGROUND
  • Olofin I, McDonald CM, Ezzati M, Flaxman S, Black RE, Fawzi WW, Caulfield LE, Danaei G; Nutrition Impact Model Study (anthropometry cohort pooling). Associations of suboptimal growth with all-cause and cause-specific mortality in children under five years: a pooled analysis of ten prospective studies. PLoS One. 2013 May 29;8(5):e64636. doi: 10.1371/journal.pone.0064636. Print 2013.

    PMID: 23734210BACKGROUND
  • Ruel MT, Alderman H; Maternal and Child Nutrition Study Group. Nutrition-sensitive interventions and programmes: how can they help to accelerate progress in improving maternal and child nutrition? Lancet. 2013 Aug 10;382(9891):536-51. doi: 10.1016/S0140-6736(13)60843-0. Epub 2013 Jun 6.

    PMID: 23746780BACKGROUND
  • Stevens GA, Finucane MM, Paciorek CJ, Flaxman SR, White RA, Donner AJ, Ezzati M; Nutrition Impact Model Study Group (Child Growth). Trends in mild, moderate, and severe stunting and underweight, and progress towards MDG 1 in 141 developing countries: a systematic analysis of population representative data. Lancet. 2012 Sep 1;380(9844):824-34. doi: 10.1016/S0140-6736(12)60647-3. Epub 2012 Jul 5.

    PMID: 22770478BACKGROUND
  • Sudfeld CR, McCoy DC, Danaei G, Fink G, Ezzati M, Andrews KG, Fawzi WW. Linear growth and child development in low- and middle-income countries: a meta-analysis. Pediatrics. 2015 May;135(5):e1266-75. doi: 10.1542/peds.2014-3111. Epub 2015 Apr 6.

    PMID: 25847806BACKGROUND
  • Victora CG, Adair L, Fall C, Hallal PC, Martorell R, Richter L, Sachdev HS; Maternal and Child Undernutrition Study Group. Maternal and child undernutrition: consequences for adult health and human capital. Lancet. 2008 Jan 26;371(9609):340-57. doi: 10.1016/S0140-6736(07)61692-4.

    PMID: 18206223BACKGROUND
  • Passarelli S, Ambikapathi R, Gunaratna NS, Madzorera I, Canavan CR, Noor RA, Tewahido D, Berhane Y, Sibanda S, Sibanda LM, Madzivhandila T, Munthali BLM, McConnell M, Sudfeld C, Davison K, Fawzi W. The role of chicken management practices in children's exposure to environmental contamination: a mixed-methods analysis. BMC Public Health. 2021 Jun 8;21(1):1097. doi: 10.1186/s12889-021-11025-y.

  • Ambikapathi R, Passarelli S, Madzorera I, Canavan CR, Noor RA, Abdelmenan S, Tewahido D, Tadesse AW, Sibanda L, Sibanda S, Munthali B, Madzivhandila T, Berhane Y, Fawzi W, Gunaratna NS. Men's nutrition knowledge is important for women's and children's nutrition in Ethiopia. Matern Child Nutr. 2021 Jan;17(1):e13062. doi: 10.1111/mcn.13062. Epub 2020 Aug 4.

  • Passarelli S, Ambikapathi R, Gunaratna NS, Madzorera I, Canavan CR, Noor AR, Worku A, Berhane Y, Abdelmenan S, Sibanda S, Munthali B, Madzivhandila T, Sibanda LM, Geremew K, Dessie T, Abegaz S, Assefa G, Sudfeld C, McConnell M, Davison K, Fawzi W. A Chicken Production Intervention and Additional Nutrition Behavior Change Component Increased Child Growth in Ethiopia: A Cluster-Randomized Trial. J Nutr. 2020 Oct 12;150(10):2806-2817. doi: 10.1093/jn/nxaa181.

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Wafaie W Fawzi, DrPH,MBBS

    Harvard School of Public Health (HSPH)

    PRINCIPAL INVESTIGATOR
  • Yemane Berhane, PhD

    Addis Continental Institute of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

November 11, 2016

First Posted

May 12, 2017

Study Start

November 1, 2016

Primary Completion

May 8, 2018

Study Completion

May 8, 2018

Last Updated

August 23, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will share

data sharing agreement in progress

Locations