Integrating Nutrition Education & Household Food Production for Child Nutrition

March 4, 2016 updated by: Abebe Gebremariam, Jimma University

Child-Centred Counselling and Home-Based Food Production to Improve Dietary Adequacy and Growth of Young Children in Southwest Ethiopia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
404

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: No intervention
Experimental: Child Centered Nutrition Counseling
The intervention comprises child-centered nutrition counseling for caretakers and support for 'developed' gardens and improved backyard poultry production.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Child growth [-Prevalence of stunting ][<-2SD]
Time Frame: baseline,18 month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jimma University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Nestlé Foundation
Flemish Interuniversity Council (VLIR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Abebe Gebremariam, Professor, Jimma University
  • Principal Investigator: Alemayehu Argaw, Mr, Jimma University
  • Principal Investigator: Lieven Huybregts, Dr, University Ghent
  • Principal Investigator: Patrick Kolsteren, Professor, University Ghent
  • Principal Investigator: Mulusew Gerbaba, Mr., Jimma University
  • Principal Investigator: Solomon Demeke, Professor, Jimma University
  • Principal Investigator: Joep Grosemans, Mr., Provincial university college Limburg
  • Principal Investigator: Amanuel Tesfay, Mr., Jimma University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CCC-HFP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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