Enhancing Milk Consumption for Improved Nutrition in Rwanda

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: Completed
• Conditions: Inadequate Child Growth
• Intervention / Treatment: Behavioral: ASF promotion plus Girinka

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: Interventional
• Enrollment (Actual): 746
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Child height-for-age z-score (HAZ)	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)	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	Measurement based on 24 hour recall of consumption amount	Baseline at study initiation
Child milk consumption	Measurement based on 24 hour recall of consumption amount	Endline (approximately one year)
Child dietary diversity	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	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

Outcome Measure	Measure Description	Time Frame
Child weight-for-height z-score (WHZ)	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)	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)	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)	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	Measurement based on weight and standing height.	Baseline at study initiation
Maternal body-mass index	Measurement based on weight and standing height.	Endline (approximately one year)

Collaborators and Investigators

• Sponsor: RTI International
• Collaborators: University of Rwanda; The International Livestock Research Institute (ILRI); TechnoServe
• Investigators: Principal Investigator: Valerie Flax, PhD, MPH, RTI International

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2018
• Primary Completion (Actual): August 31, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: February 28, 2018
• First Submitted That Met QC Criteria: February 28, 2018
• First Posted (Actual): March 6, 2018

Study Record Updates

• Last Update Posted (Actual): March 11, 2021
• Last Update Submitted That Met QC Criteria: March 9, 2021
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: wasting; stunting; underweight
• Other Study ID 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