NCT03488680

Brief Summary

Child under nutrition is a major risk factor for ill health and mortality, contributes substantially to the burden of disease in low-income and middle-income countries and is associated with close to half of all child deaths. The prevalence of both underweight and stunting is highest in Africa and South-Central Asia. Ethiopia is one of the poorest countries in Sub- Saharan Africa, and child malnutrition is a serious public health problem where the rates for stunting (40%), underweight (25%) and wasting (9%) among children under 5 years are among the highest in the world. Globally, about 40% of child mortality less than two years is associated with inappropriate feeding practices. Optimal breastfeeding and appropriate complementary feeding could prevent 13% and 6% under-five mortality, respectively. Over two third of malnutrition is associated with inappropriate feeding practices during the first year of life. The first two years of life provides a critical window of opportunity for ensuring appropriate growth and development of children from generation to generation through optimal feeding. Hence, the objective of this study to evaluate the effectiveness of behavior change communication on optimal complementary feeding through community level actors in improving feeding practice, health and nutritional status of infants. A cluster-randomized controlled trial which was conducted in West Gojjam Zone, Northwest Ethiopia from May 9, 2016 to October, 2017. Behavior change communication on complementary feeding was conducted in the intervention kebeles/villages for 8 months. A validated interviewer administered structured questionnaire was used for collecting information on the study subjects both at the baseline and after intervention. Data will be checked, coded and double entered using EPI info and exported to SPSS version 21 for statistical analysis. The output of the study findings could be useful for health and nutrition policy makers and other concerned bodies in decision making and to design effective intervention strategies to improve feeding practices thus mitigating child malnutrition and improving their health and growth. The total budget needed to conduct the study is 7,000 US dollar.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
630

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 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

May 9, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 14, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2017

Completed
6 months until next milestone

First Posted

Study publicly available on registry

April 5, 2018

Completed
Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

1.3 years

First QC Date

June 14, 2016

Last Update Submit

April 4, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Linear growth

    Increase in linear growth (cm) after intervention

    8 months of intevention

Secondary Outcomes (3)

  • Dietary diversity score

    8 months of intervention

  • Health status

    8 months of intervention

  • Time of initiation of complementary food

    8 months of intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

Behavior change communication

Behavioral: Behavior change communication

Control group

NO INTERVENTION

No Behavior change communication

Interventions

Behavior change communication about optimal complementary feeding

Intervention group

Eligibility Criteria

Age1 Month - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All infants aged 0-6 months at the time of baseline survey,
  • Residents in the sampled villages

You may not qualify if:

  • Mother who are ill and unable to communicate
  • Infants with birth defects, impaired feeding and ill at the time of baseline survey.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jimma University

Jimma, 999, Ethiopia

Location

Related Publications (4)

  • Sun J, Dai Y, Zhang S, Huang J, Yang Z, Huo J, Chen C. Implementation of a programme to market a complementary food supplement (Ying Yang Bao) and impacts on anaemia and feeding practices in Shanxi, China. Matern Child Nutr. 2011 Oct;7 Suppl 3(Suppl 3):96-111. doi: 10.1111/j.1740-8709.2011.00353.x.

    PMID: 21929638BACKGROUND
  • Ayalew CA, Belachew T. Effect of complementary feeding behaviour change communication delivered through community-level actors on infant growth and morbidity in rural communities of West Gojjam Zone, Northwest Ethiopia: A cluster-randomized controlled trial. Matern Child Nutr. 2021 Jul;17(3):e13136. doi: 10.1111/mcn.13136. Epub 2021 Jan 6.

  • Abiyu C, Belachew T. Effect of complementary feeding behavior change communication delivered through community-level actors on the time of initiation of complementary foods in rural communities of West Gojjam zone, Northwest Ethiopia: a cluster-randomized controlled trial. BMC Pediatr. 2020 Nov 5;20(1):509. doi: 10.1186/s12887-020-02396-z.

  • Abiyu C, Belachew T. Effect of complementary feeding behavior change communication delivered through community-level actors on dietary adequacy of infants in rural communities of West Gojjam Zone, Northwest Ethiopia: A cluster-randomized controlled trial. PLoS One. 2020 Sep 3;15(9):e0238355. doi: 10.1371/journal.pone.0238355. eCollection 2020.

Related Links

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Chalachew Abiyu, MSc

    Jimma University, Jimma, Ethiopia

    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
Principal investigator

Study Record Dates

First Submitted

June 14, 2016

First Posted

April 5, 2018

Study Start

May 9, 2016

Primary Completion

August 17, 2017

Study Completion

October 6, 2017

Last Updated

April 5, 2018

Record last verified: 2018-04

Locations