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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02249286
Other study ID # CCC-HFP
Secondary ID
Status Completed
Phase N/A
First received September 5, 2014
Last updated March 4, 2016
Start date January 2014
Est. completion date October 2015

Study information

Verified date March 2016
Source Jimma University
Contact n/a
Is FDA regulated No
Health authority Ethiopia: Ethical Review Committee
Study type Interventional

Clinical Trial Summary

In Ethiopia, a child-centered counseling approach is hypothesized to be more effective than the current nutrition and health education when investment on home-based food production is used as a platform for nutrition education. This project is proposed to evaluate the efficacy of a food-based package integrating child-centered nutrition counseling and home-based food production using a between-group comparative intervention study. The intervention comprises child-centered nutrition counseling for caretakers and support for 'developed' gardens and improved backyard poultry production.


Description:

Growth faltering among Ethiopian infants and young children is one of the highest in sub-Saharan Africa. Nutrition education on infant and young child feeding has shown good potential to improve growth of young children whenever it is accessible, context-based and integrated with locally available resources. The current nutrition education in Ethiopia, however, appears to be general and lacks the essential components for success. It is mainly didactic and lacks a motivational approach that can enhance the self-efficacy of mothers for behavior change. Another important barrier for nutrition education to become effective is that rural mothers have limited access to nutrient-dense foods that are recommended to be fed to young children. Therefore, it is expected that low food access by poor households together with the less motivational approach used may hamper the effectiveness of the current nutrition education in the country. In Ethiopia, a child-centered counseling approach is hypothesized to be more effective than the current nutrition and health education when investment on home-based food production is used as a platform for nutrition education. This project is proposed to evaluate the efficacy of a food-based package integrating child-centered nutrition counseling and home-based food production using a between-group comparative intervention study. The intervention comprises child-centered nutrition counseling for caretakers and support for 'developed' gardens and improved backyard poultry production; whereas the control will only receive the agriculture extension and the existing health and nutrition education in the area. Two Primary Healthcare Units (one intervention and one control group) will be selected from Jimma Zone using relevant criteria. A total of 404 (i.e. 202 in each of intervention and control areas) households with infants of age < 12 months will participate in the study for 18 months. The efficacy of the intervention will be assessed by its effect on child growth and infant and child feeding index as primary outcomes. Besides the effect on dietary adequacy and growth, the project aims at evaluating the interactive processes in a longitudinal way to provide evidence on the possible success factors and barriers encountered. Therefore, secondary outcomes include household production, income and expenditure in relation to the home-based food production; diet diversity; feeding and care practices, and morbidity. Data will be compared between intervention and control groups using linear mixed-effects models and generalized linear models.


Recruitment information / eligibility

Status Completed
Enrollment 404
Est. completion date October 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender Both
Age group 3 Months to 12 Months
Eligibility Inclusion Criteria:

- infants less than 12 month

- are permanent residents in the area;

- have no plan to move away during the intervention period;

- are willing to adopt the agriculture activities; and

- have adequate place and time to adopt developed gardens & backyard poultry production

Exclusion Criteria:

- infants with severe acute malnutrition warranting referral to nutrition rehabilitation program with Ready-To-Use Therapeutic foods

- severely ill infants with clinical complications warranting hospital referral; and

- infants with obvious congenital or chronic abnormalities that impair feeding or physical growth measurements.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Child Centered Nutrition Counseling
The intervention comprises child-centered nutrition counseling for caretakers and support for 'developed' gardens and improved backyard poultry production; whereas the control will only receive the agriculture extension and the existing health and nutrition education in the area
Other:
no intervention
the control will only receive the agriculture extension and the existing health and nutrition education in the area

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Jimma University Flemish Interuniversity Council (VLIR), Nestlé Foundation

Outcome

Type Measure Description Time frame Safety issue
Primary Child growth [-Prevalence of stunting ][<-2SD] prevalence of stunting will be determined by height for age (Ht/Age) using height /length measured in the recumbent position to the nearest 0.1 cm using a measuring board with an upright wooden base and movable headpiece. as well actual age of child will be taken and expressed in terms of Z score. baseline,18 month No
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