Enhancing Milk Consumption for Improved Nutrition in Rwanda

March 9, 2021 updated by: RTI International

Enhancing Milk Quality and Consumption for Improved Income and Nutrition in Rwanda

This study is a mixed-methods cluster-randomized controlled trial in Rwanda designed to measure the impact of a dairy asset transfer program with or without nutrition education promoting the home consumption of dairy milk and other animal source foods.

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

The purpose of this research is to contribute to efforts for improving the consumption of milk in Rwanda. It will do so by generating and communicating evidence on the nutritional benefits of including animal source food (ASF) in diets of young children and pregnant and lactating women through nutrition education. The proposed project draws upon the work of a Government of Rwanda program - the One Cow per Poor Family (Girinka) program. The Girinka program (2006 - present) is a country-wide program whose goal is to increase household income and reduce child malnutrition among poor households through livestock asset transfer. The study has two main objectives. First, researchers will measure the impact of a nutrition education/ASF promotion intervention on child and maternal nutritional status in households that have received a cow through the Girinka program. Second, researchers will compare nutrition outcomes in the Girinka + nutrition education and Girinka only groups to individuals in households that are eligible for Girinka, but have not yet received a cow. The nutrition education/ASF promotion intervention will be designed and overseen by a local organization and implemented through Government of Rwanda community health workers. The main study outcomes are child height-for-age z-score, child milk consumption, and child dietary diversity. The secondary outcomes are child weight-for-age z-score, child weight-for-height z-score, and maternal body-mass index. The researchers plan to randomly assign all cells in two districts to receive the nutrition education intervention or no intervention. The study will enroll a cohort of 687 mother-child pairs (229 per study arm). The aim is to enroll children 12-17 months of age at baseline; however, if there are not adequate numbers of households that meet all other eligibility criteria, then the child age range will be expanded to 12-29 months of age at baseline. The research team will conduct baseline and endline surveys to measure differences between the groups. At endline, researchers will collect qualitative data from participants and community health workers in the intervention arm to triangulate with the survey findings.

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.
746

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Rwanda
    • Southern Province
      • Ruhango, Southern Province, Rwanda
        • Ruhango District
    • Western Province
      • Nyabihu, Western Province, Rwanda
        • Nyabihu District

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

18 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Arm 1:

  • Household is located in an intervention cell
  • Household received a cow under the government of Rwanda Girinka program before 2017
  • Household contains a mother 18-49 years of age
  • Household contains a child between the ages of 12 and 29 months at baseline

Arm 2:

  • Household is located in a comparison cell
  • Household received a cow under the government of Rwanda Girinka program before 2017
  • Household contains a mother 18-49 years of age
  • Household contains a child between the ages of 12 and 29 months at baseline

Arm 3:

-- Household is located in a comparison cell

  • Household is eligible to receive a cow under the government of Rwanda Girinka program
  • Household contains a mother 18-49 years of age
  • Household contains a child between the ages of 12 and 29 months at baseline

Exclusion Criteria:

  • Failure to meet inclusion criteria

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: 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.
Experimental: ASF Promotion plus Girinka
Participants have received a cow from the government of Rwanda through the Girinka program and will receive an animal source food promotion intervention from the study.
Behavioral: ASF promotion plus Girinka
Behavior change communication promoting the consumption of milk produced in the household and other optimal maternal and child nutrition practices. The intervention will be implemented by government of Rwanda Community Health Workers.
No Intervention: Girinka only
Participants have received a cow from the government of Rwanda through the Girinka program and will not receive any intervention from the study.
No Intervention: Girinka eligible
Participants are eligible to receive a cow through the government of Rwanda Girinka program, but have not yet received a cow. They will not receive any intervention from the study.

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 height-for-age z-score (HAZ)
Time Frame: Baseline at study initiation
Measure child recumbent length in triplicate and age reported by mother. HAZ will be calculated using the World Health Organization standard.
Baseline at study initiation
Child height-for-age z-score (HAZ)
Time Frame: Endline (approximately one year)
Measure child recumbent length in triplicate and age reported by mother. HAZ will be calculated using the World Health Organization standard.
Endline (approximately one year)
Child dairy milk consumption
Time Frame: Baseline at study initiation
Measurement based on 24 hour recall of consumption amount
Baseline at study initiation
Child milk consumption
Time Frame: Endline (approximately one year)
Measurement based on 24 hour recall of consumption amount
Endline (approximately one year)
Child dietary diversity
Time Frame: Baseline at study initiation
Measurement based on 24 hour recall of consumption and calculated using the World Health Organization child dietary diversity indicator
Baseline at study initiation
Child dietary diversity
Time Frame: Endline (approximately one year)
Measurement based on 24 hour recall of consumption and calculated using the World Health Organization child dietary diversity indicator
Endline (approximately one year)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Child weight-for-height z-score (WHZ)
Time Frame: Baseline at study initiation
Measurement based on recumbent length and body weight measured in triplicate. WHZ will be calculated using the World Health Organization standard.
Baseline at study initiation
Child weight-for-height z-score (WHZ)
Time Frame: Endline (approximately one year)
Measurement based on recumbent length and body weight measured in triplicate. WHZ will be calculated using the World Health Organization standard.
Endline (approximately one year)
Child weight for age z-score (WAZ)
Time Frame: Baseline at study initiation
Measurement based on weight measured in triplicate and age reported by mother. WAZ will be calculated based on the World Health Organization standard.
Baseline at study initiation
Child weight for age z-score (WAZ)
Time Frame: Endline (approximately one year)
Measurement based on weight measured in triplicate and age reported by mother. WAZ will be calculated based on the World Health Organization standard.
Endline (approximately one year)
Maternal body-mass index
Time Frame: Baseline at study initiation
Measurement based on weight and standing height.
Baseline at study initiation
Maternal body-mass index
Time Frame: Endline (approximately one year)
Measurement based on weight and standing height.
Endline (approximately one year)

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.
RTI International

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.
University of Rwanda
The International Livestock Research Institute (ILRI)
TechnoServe

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: Valerie Flax, PhD, MPH, RTI International

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 (Actual)

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.
April 23, 2018

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.
August 31, 2020

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.
August 31, 2020

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).
February 28, 2018

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.
February 28, 2018

First Posted (Actual)

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.
March 6, 2018

Study Record Updates

Last Update Posted (Actual)

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 11, 2021

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 9, 2021

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, 2020

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.
  • 0215801

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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