Operational research for Ethiopia Integrated Nutrition Project (EINP)

ISRCTN	ISRCTN89206590
DOI	https://doi.org/10.1186/ISRCTN89206590
Protocol serial number	N/A
Sponsor	World Vision Korea (Korea)
Funders	World Vision Korea (E197814) (Korea), Korea International Cooperation Agency (KOICA) (Korea)

Submission date: 30/08/2014
Registration date: 03/11/2014
Last edited: 03/11/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Malnutrition in children is a huge public health issue in Ethiopia and can negatively affect achievement in school, brain development, and productivity at work later in life. Thus to address this issue, appropriately designed nutrition interventions are important. We designed a community-based nutrition project called Ethiopia Integrated Nutrition Project (EINP), which includes three types of nutrition programs: 1) Community-based Participatory Nutrition Education (CPNE): providing 2 weeks of intensive nutrition education sessions to undernourished children and their mothers including cooking demonstrations with locally available foods, nutrition message discussion, hand washing practices, and a follow-up visit, 2) Essential Nutrition Action (ENA) activity: brief nutrition information sharing by voluntary community health workers or a community group once a month, and 3) Community-based Management of Acute Malnutrition (CMAM): providing therapeutic and supplementary foods to moderately or severely malnourished children. This study aims to find out the effectiveness of EINP in improving the childrens growth and the caregivers' feeding practices.

Who can participate?
Babies aged 6 to 12 months and their mothers living in the participating districts of Ethiopia can take part.

What does the study involve?
The districts are randomly divided into intervention and control groups. In the intervention area, the CPNE program, the ENA activity and the CMAM program will be conducted concurrently, and in the control area only the ENA activity and the CMAM program will be implemented. Undernourished children and their caregivers will receive the CPNE program, the ENA activity will target all mothers with children under two years old, and moderately or severely undernourished children will be admitted to the CMAM program.

What are the possible benefits and risks of participating?
While the potential benefits of participation are minimal, the risks associated with participation are also negligible. The time commitment for participation is less than one hour per interview. Participants may feel bored during the survey.

Where is the study run from?
Habro district, West Hararghe zone, and Melka Bello district, East Hararghe zone, Ethiopia.

When is the study starting and how long is it expected to run for?
September 2012 to December 2014.

Who is funding the study?
1. World Vision Korea (Korea)
2. Korea International Cooperation Agency ( KOICA ) (Korea)

Who is the main contact?
Yunhee Kang, ykang12@jhu.edu
Sarah Yeo, sara_yeo@wvi.org

Contact information

Ms Yunhee Kang
Scientific

W2501, 615 N. Wolfe Street
Johns Hopkins Bloomberg School
Baltimore
21205
United States of America

Email	yukang@jhsph.edu

Study information

Primary study design	Interventional
Study design	Clustered randomized trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Effectiveness evaluation of community-based nutrition program in improving child growth and feeding practices in rural Eastern Ethiopia: a clustered randomized trial
Study objectives	To examine the effectiveness of the CPNE program integrated with the ENA and CMAM programs in reducing the prevalence of stunting, underweight and wasting and improving height-for-age, weight-for-age and weight-for-height Z scores among children aged 6 to 24 months
Ethics approval(s)	Oromya Regional Health Bureau (ORHB), Ethiopia, 27/08/2012, ref. BEFO/AH/UTR/1-84/29021
Health condition(s) or problem(s) studied	Child undernutrition
Intervention	Community-based Participatory Nutrition Education (Behavior Change Communication form), Community-based Management of Acute Malnutrition, and Essential Nutrition Action activity (nutrition counselling) In the intervention area, the CPNE program, the ENA activity and the CMAM program will be conducted concurrently, and in the control area, the ENA activity and the CMAM program will be implemented only. Target children differ by type of intervention. Undernourished children and their caregivers will receive the CPNE program by project staff, the ENA activity will be given to all mothers with children under two years old as much as trained volunteers can visit households, and moderately or severely undernourished children will be admitted to the CMAM program. Besides we attempted to measure differences in child growth such as z-scores at whole the community level considering all children at 6 to 24 months of age not specifically at individual children level who directly receive interventions. Since the above programs, especially the CPNE program and the ENA activity, are publicly conducted in communities, we wanted to measure the direct and indirect effects of the interventions together.
Intervention type	Other
Primary outcome measure(s)	1. Length-for-age 2. Weight-for-age 3. Weight-for-length z scores 4. Prevalence of stunting, wasting and being underweight Children 6 to 12 months of age are measured by trained anthropometrists from the time of enrollment, at every 3 months, for five times, for their height with locally manufactured measuring boards nearest to 0.1 cm and weight with electronic weighing scales to nearest 0.01 kg. For example, a child whose age is 9 months old at enrollment will be measured at 9, 12, 15, 18, and 21 months old.
Key secondary outcome measure(s)	Complementary feeding practices such as dietary diversity and feeding frequency, and hand washing practices Mothers will be asked at the same timepoints that the primary outcomes are measured about her feeding and hygienic practices, e.g. how and what she fed child in the last 24 hours, and when she washed her hands by enumerators, through household visits.
Completion date	31/12/2014

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	2064
Key inclusion criteria	Infants 6 to 24 months of age
Key exclusion criteria	N/A
Date of first enrolment	01/09/2012
Date of final enrolment	31/12/2014

Locations

Countries of recruitment

Ethiopia
United States of America

Study participating centre

W2501, 615 N. Wolfe Street,

Baltimore
21205
United States of America

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes