Clinical trial NCT03455647: Enhancing Milk Consumption for Improved Nutrition in Rwanda
Official title: Enhancing Milk Quality and Consumption for Improved Income and Nutrition in Rwanda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inadequate Child Growth
Keywords: stunting
underweight
wasting
Lead sponsor: RTI International
Sponsor class: OTHER
Collaborators: name: The International Livestock Research Institute (ILRI)
name: University of Rwanda
name: TechnoServe
First posted: 2018-03-06
Enrollment: 746
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Child height-for-age z-score (HAZ)
timeFrame: Baseline at study initiation
measure: Child height-for-age z-score (HAZ)
timeFrame: Endline (approximately one year)
measure: Child dairy milk consumption
timeFrame: Baseline at study initiation
measure: Child milk consumption
timeFrame: Endline (approximately one year)
measure: Child dietary diversity
timeFrame: Baseline at study initiation
measure: Child dietary diversity
timeFrame: Endline (approximately one year)
Secondary outcomes:
measure: Child weight-for-height z-score (WHZ)
timeFrame: Baseline at study initiation
measure: Child weight-for-height z-score (WHZ)
timeFrame: Endline (approximately one year)
measure: Child weight for age z-score (WAZ)
timeFrame: Baseline at study initiation
measure: Child weight for age z-score (WAZ)
timeFrame: Endline (approximately one year)
measure: Maternal body-mass index
timeFrame: Baseline at study initiation
measure: Maternal body-mass index
timeFrame: Endline (approximately one year)
Other outcomes:
Locations:
city: Ruhango
country: Rwanda
facility: Ruhango District
state: Southern Province
city: Nyabihu
country: Rwanda
facility: Nyabihu District
state: Western Province
Study officials:
affiliation: RTI International
name: Valerie Flax, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: