NCT03455647

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
746

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 6, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

April 23, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

March 11, 2021

Status Verified

March 1, 2020

Enrollment Period

2.4 years

First QC Date

February 28, 2018

Last Update Submit

March 9, 2021

Conditions

Keywords

stuntingunderweightwasting

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (6)

  • Child weight-for-height z-score (WHZ)

    Baseline at study initiation

  • Child weight-for-height z-score (WHZ)

    Endline (approximately one year)

  • Child weight for age z-score (WAZ)

    Baseline at study initiation

  • Child weight for age z-score (WAZ)

    Endline (approximately one year)

  • Maternal body-mass index

    Baseline at study initiation

  • +1 more secondary outcomes

Study Arms (3)

ASF Promotion plus Girinka

EXPERIMENTAL

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

Girinka only

NO INTERVENTION

Participants have received a cow from the government of Rwanda through the Girinka program and will not receive any intervention from the study.

Girinka eligible

NO INTERVENTION

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

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.

ASF Promotion plus Girinka

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe target population is mothers with a child between the ages of 12 and 29 months at study initiation. The child may be male or female.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ruhango District

Ruhango, Southern Province, Rwanda

Location

Nyabihu District

Nyabihu, Western Province, Rwanda

Location

MeSH Terms

Conditions

Growth DisordersThinnessCachexia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBody WeightSigns and SymptomsWeight LossBody Weight Changes

Study Officials

  • Valerie Flax, PhD, MPH

    RTI International

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2018

First Posted

March 6, 2018

Study Start

April 23, 2018

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

March 11, 2021

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

Locations