Enhancing Milk Consumption for Improved Nutrition in Rwanda

Inadequate Child Growth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03455647
• Other study ID #: 0215801
• Status: Completed
• Phase: N/A
• Start date: April 23, 2018
• Est. completion date: August 31, 2020

Study information

• Verified date: March 2020
• Source: RTI International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 746
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Inadequate Child Growth

Intervention

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.

Locations

Country	Name	City	State
Rwanda	Nyabihu District	Nyabihu	Western Province
Rwanda	Ruhango District	Ruhango	Southern Province

Sponsors (4)

Lead Sponsor	Collaborator
RTI International	TechnoServe, The International Livestock Research Institute (ILRI), University of Rwanda

Country where clinical trial is conducted

Rwanda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	Child dairy milk consumption	Measurement based on 24 hour recall of consumption amount	Baseline at study initiation
Primary	Child milk consumption	Measurement based on 24 hour recall of consumption amount	Endline (approximately one year)
Primary	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
Primary	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	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	Maternal body-mass index	Measurement based on weight and standing height.	Baseline at study initiation
Secondary	Maternal body-mass index	Measurement based on weight and standing height.	Endline (approximately one year)