Inadequate Child GrowthNCT03455647
Enhancing Milk Consumption for Improved Nutrition in Rwanda
A study testing ASF promotion plus Girinka in people with Inadequate Child Growth, run by RTI International at 2 sites in Rwanda.
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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Inadequate Child Growth
- What is being tested?
- ASF promotion plus Girinka
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 746 participants
- Where
- 2 sitesRwanda
- Study dates
- 23 Apr 2018to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
Show all 15Show fewer
- 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
Who cannot join
- Failure to meet inclusion criteria
Trial locations and contacts
2 sites in 1 country.
Rwanda2 sites
Nyabihu District
Nyabihu, Western Province
Ruhango District
Ruhango, Southern Province
About this study
Official title: Enhancing Milk Quality and Consumption for Improved Income and 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.
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.
- Conditions
- Inadequate Child Growth
- Being tested
- ASF promotion plus Girinka
- Keywords
- stunting, underweight, wasting
- Medical subject headings
- Growth Disorders, Thinness, Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASF promotion plus GirinkaBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Endline (approximately one year)
Child dairy milk consumption
Measurement based on 24 hour recall of consumption amount
Measured: Baseline at study initiation
Child milk consumption
Measurement based on 24 hour recall of consumption amount
Measured: 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
Measured: 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
Measured: Endline (approximately one year)
Secondary outcomes (6)
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.
Measured: Baseline at study initiation
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.
Measured: Endline (approximately one year)
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.
Measured: Baseline at study initiation
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.
Measured: Endline (approximately one year)
Maternal body-mass index
Measurement based on weight and standing height.
Measured: Baseline at study initiation
Maternal body-mass index
Measurement based on weight and standing height.
Measured: Endline (approximately one year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start23 Apr 2018
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inadequate Child GrowthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 746 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- The International Livestock Research Institute (ILRI), University of Rwanda, TechnoServe
- Responsible party
- Sponsor
- Investigators
- Valerie Flax, PhD, MPH, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03455647
- Sponsor's protocol ID
- 0215801
- Status last verified
- Mar 2020
- First submitted
- 28 Feb 2018
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Milk Quality and Consumption for Improved Income and Nutrition in Rwanda
- ClinicalTrials.gov ID
- NCT03455647
- Acronym / sponsor ID
- 0215801
- Conditions
- Inadequate Child Growth
- Keywords
- stunting, underweight, wasting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 746 participants (actual)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- The International Livestock Research Institute (ILRI), University of Rwanda, TechnoServe
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 6 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ASF Promotion plus Girinka | Experimental | Behavioral: ASF promotion plus GirinkaParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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
- Household is located in a comparison cell
Key exclusion criteria (1 listed)
- Failure to meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASF promotion plus GirinkaBehavior 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. | Behavioural | ASF Promotion plus Girinka |
Primary outcome
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.
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.
Child dairy milk consumption
Time frame: Baseline at study initiation
Measurement based on 24 hour recall of consumption amount
Child milk consumption
Time frame: Endline (approximately one year)
Measurement based on 24 hour recall of consumption amount
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
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
6 secondary outcomes
Child weight-for-height z-score (WHZ)
Time frame: Baseline at study initiation
Child weight-for-height z-score (WHZ)
Time frame: Endline (approximately one year)
Child weight for age z-score (WAZ)
Time frame: Baseline at study initiation
Child weight for age z-score (WAZ)
Time frame: Endline (approximately one year)
Maternal body-mass index
Time frame: Baseline at study initiation
Maternal body-mass index
Time frame: Endline (approximately one year)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Individual participant dataSharing planned: Yes
Related trials for Inadequate Child Growth
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Noonan Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valerie Flax, PhD, MPH principal investigator
RTI International
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASF promotion plus Girinka in people with Inadequate Child Growth, run by RTI International at 2 sites in Rwanda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child height-for-age z-score (HAZ) (time frame: Baseline at study initiation). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.