Plain English Summary
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
Study website
Contact information
Type
Scientific
Contact name
Ms Yunhee Kang
ORCID ID
Contact details
W2501
615 N. Wolfe Street
Johns Hopkins Bloomberg School
Baltimore
21205
United States of America
yukang@jhsph.edu
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effectiveness evaluation of community-based nutrition program in improving child growth and feeding practices in rural Eastern Ethiopia: a clustered randomized trial
Acronym
Study hypothesis
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
Study design
Clustered randomized trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Other
Study type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
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.
Secondary outcome measures
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.
Overall study start date
01/09/2012
Overall study end date
31/12/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Infants 6 to 24 months of age
Participant type(s)
Patient
Age group
Neonate
Sex
Both
Target number of participants
2064
Participant exclusion criteria
N/A
Recruitment start date
01/09/2012
Recruitment end date
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
Sponsor information
Organisation
World Vision Korea (Korea)
Sponsor details
77-1
Yeouinaru-ro
Yeongdeungpo-gu
Seoul
150-877
Korea
South
+82 (0)2 2078 7150
sungtae_kim@wvi.org
Sponsor type
Research organisation
Website
ROR
Funders
Funder type
Government
Funder name
World Vision Korea (E197814) (Korea)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Korea International Cooperation Agency (KOICA) (Korea)
Alternative name(s)
KOICA
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Korea, South
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|