ClinicalTrials.gg
CompletedNCT03455647Updated Mar 11, 2021

Enhancing Milk Consumption for Improved Nutrition in Rwanda

An interventional study of ASF promotion plus Girinka in Inadequate Child Growth, sponsored by RTI International. Completed at 2 sites in Rwanda. Open to female participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-11.

Sponsored by RTI International · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
746
Allocation
Randomized
Ages
18 Years to 49 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Inadequate Child Growth

Keywords

  • stunting
  • underweight
  • wasting
03

In context

Growth Disorders

227 studies on the registry are indexed under Growth Disorders; 25 are open to participants now.

This study's enrollment of 746 is above the median of 413 across 143 interventional studies indexed under Growth Disorders.

Browse Growth Disorders studies →

Lead sponsor

RTI International is the lead sponsor of 84 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Failure to meet inclusion criteria
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
746 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • BehavioralASF 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline at study initiation

  2. 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.

    Time frame: Endline (approximately one year)

  3. Child dairy milk consumption

    Measurement based on 24 hour recall of consumption amount

    Time frame: Baseline at study initiation

  4. Child milk consumption

    Measurement based on 24 hour recall of consumption amount

    Time frame: Endline (approximately one year)

  5. Child dietary diversity

    Measurement based on 24 hour recall of consumption and calculated using the World Health Organization child dietary diversity indicator

    Time frame: Baseline at study initiation

  6. Child dietary diversity

    Measurement based on 24 hour recall of consumption and calculated using the World Health Organization child dietary diversity indicator

    Time frame: Endline (approximately one year)

Secondary outcomes

  1. 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.

    Time frame: Baseline at study initiation

  2. 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.

    Time frame: Endline (approximately one year)

  3. 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.

    Time frame: Baseline at study initiation

  4. 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.

    Time frame: Endline (approximately one year)

  5. Maternal body-mass index

    Measurement based on weight and standing height.

    Time frame: Baseline at study initiation

  6. Maternal body-mass index

    Measurement based on weight and standing height.

    Time frame: Endline (approximately one year)

07

Study locations

2 sites
  • Ruhango District
    Ruhango, Southern Province, Rwanda
  • Nyabihu District
    Nyabihu, Western Province, Rwanda
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2018 to primary completion in Aug 2020, 28 months.

Of 77 non-industry interventional studies with no phase under Growth Disorders, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 30. This study's 28 months is above that.

Counting every sponsor, half of 78 studies reached it within 23 months; a quarter within 12 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 28, 2018
First posted
Mar 6, 2018
StartActual
Apr 23, 2018
Primary completionActual
Aug 31, 2020
CompletionActual
Aug 31, 2020
Last update
Mar 11, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03455647
Lead sponsor
RTI International
Collaborators
The International Livestock Research Institute (ILRI), University of Rwanda, TechnoServe
Responsible party
Sponsor
First posted
Mar 6, 2018
Start date
Apr 23, 2018
Primary completion
Aug 31, 2020
Completion
Aug 31, 2020
Last update
Mar 11, 2021

Study contacts

Valerie Flax, PhD, MPH
principal investigator · RTI International

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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