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Completed

NCT Number: NCT03455647

Enhancing Milk Consumption for Improved 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.

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Key information

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ruhango District, Ruhango, Southern Province, Rwanda

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ASF promotion plus Girinka

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. Child dairy milk consumption

    Time frame: Baseline at study initiation

    Measurement based on 24 hour recall of consumption amount

  4. Child milk consumption

    Time frame: Endline (approximately one year)

    Measurement based on 24 hour recall of consumption amount

  5. 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

  6. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Maternal body-mass index

    Time frame: Baseline at study initiation

    Measurement based on weight and standing height.

  6. Maternal body-mass index

    Time frame: Endline (approximately one year)

    Measurement based on weight and standing height.

Sponsors and collaborators

Lead sponsor

RTI International

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 6, 2018
Registry last updated
Mar 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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