Malnutrition, ChildNCT04101487
Cash Transfers to Increase Dietary Diversity in Grand Gedeh County, Liberia
A study testing Cash Transfer and Cash Transfers and Nutrition Education in people with Malnutrition, Child, run by Boston Children's Hospital at 1 site in Liberia.
Trial summary
The investigators aim to evaluate the efficacy of a cash transfer and nutrition education program delivered by community health assistants to increase dietary diversity among children 6 to 23 months of age in Grand Gedeh County, Liberia. Read more about this study
- Who is it for?
- Ages 6 to 23 monthsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition, Child
- What is being tested?
- Cash Transfer and Cash Transfers and Nutrition Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 599 participants
- Where
- 1 siteLiberia
- Study dates
- 15 Oct 2019to 1 Nov 2022
- 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 6 to 23 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants 6 to 23 months of age
- Participants with consenting caregivers to have monthly visits and to participate in the program
- Caregivers of all ages will be included
Who cannot join
- Participants who are younger than 6 months of age (children < 6 months of age are encouraged to exclusively breastfeed, making dietary diversity irrelevant in this age group)
- Participants older than 23 months of age
- Participants with non-consenting caregivers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cluster Randomized Trial to Study the Effect of Cash Transfers and Nutrition Education on Dietary Diversity Among Children 6-23 Months of Age in Grand Gedeh County, Liberia: A Pilot Study
The investigators aim to evaluate the efficacy of a cash transfer and nutrition education program delivered by community health assistants to increase dietary diversity among children 6 to 23 months of age in Grand Gedeh County, Liberia.
Read the detailed description
Worldwide, more than one in five children suffer from chronic malnutrition. In Liberia, there are more than 230,000 children suffering from chronic malnutrition and 32% of children under five are stunted. Previous studies have shown that inadequate dietary diversity is strongly associated with stunting in children under two years of age. An interventional package including cash transfers and education has the potential to improve dietary diversity and long-term outcomes such as improved growth and reduced rates of stunting among children.
The investigators' objective is to evaluate the efficacy of a cash transfer and nutrition education program delivered by community health assistants to increase dietary diversity among children 6 to 23 months of age in Grand Gedeh County, Liberia. The investigators will conduct a pilot, cluster randomized trial in 45 communities. The investigators hypothesize that a multi-pronged interventional package aimed at strengthening the household environment will result in improved dietary diversity for children 6 to 23 months of age. Moreover, the investigators also hypothesize that unconditional cash transfers will result in improved dietary diversity for children 6 to 23 months of age in Grand Gedeh County, Liberia.
- Conditions
- Malnutrition, Child
- Being tested
- Cash Transfer, Cash Transfers and Nutrition Education
- Keywords
- Cash Transfers, Liberia, Stunting, Dietary diversity
- Medical subject headings
- Child Nutrition Disorders, Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cash TransferOther
Monthly cash transfers
Cash Transfers and Nutrition EducationOther
Cash transfers every month and structured nutrition education provided at household level by community health assistants based on a nutrition education handbook
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants in this arm will receive routine monthly visits along with survey administration and the regular package of health services provided at the facility level and at home by community health assistants |
| Cash Transfers | Experimental | Participants in this arm will receive routine monthly visits along with the regular package of health services provided at the facility level and at home by community health assistants and unconditional cash transfers every month Receives: Other: Cash Transfer |
| Cash Transfers and Nutrition Education | Experimental | Participants in this arm will receive routine monthly visits along with the regular package of health services provided at the facility level and at home by community health assistants, unconditional cash transfers every month, and structured nutrition education provided at household level by community health assistants based on a structured nutrition education handbook. Receives: Other: Cash Transfers and Nutrition Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in proportion of children 6 to 23 months of age who meet minimum dietary diversity scores (DDS) over the study period as reported by caregivers
The DDS has been widely used to measure the sum of diverse food groups consumed in a 24-hour period
Measured: 6 months
Secondary outcomes (9)
Meal frequency
Mean self-reported meal frequency over the 24-hour period prior to monthly CHA visits
Measured: 6 months
Increase in child weight in kilograms
changes in child weight in kilograms during the study period measured with digital scale (UNISCALE)
Measured: 6 months
Increase in mid upper arm circumference in centimeters
changes in mid upper arm circumference in centimeters measured with MUAC tape measure
Measured: 6 months
Increase in child length/height in centimeters
changes in child length/height in centimeters during the study period measured with Height Board
Measured: 6 months
Health care utilization (clinic)
number of clinic visits for illnesses (including type of illness)
Measured: 6 months
Health care utilization (hospital)
hospitalizations (if any) during the study period
Measured: 6 months
Health care utilization (antimicrobials)
use of antibiotics/antimalarials during the study period
Measured: 6 months
Health care utilization (nutritional support)
if the child received supplementary nutritional support (e.g. ready to use therapeutic food RUTF)
Measured: 6 months
Knowledge, attitudes, and practices
caregiver's knowledge, attitudes, and practices (KAP) of infant and young child feeding
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start15 Oct 2019
- Primary completion31 Jul 2021
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malnutrition, ChildStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 599 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- UNICEF
- Responsible party
- Principal investigator, Michelle Niescierenko, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04101487
- Sponsor's protocol ID
- P00031767
- Status last verified
- Mar 2023
- First submitted
- 27 Jun 2019
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rees CA, Cleon D, Davis AB, Sammy AM, Britto CD, Massaquoi W, Forkpa OW, Johnson AJ, Hook VF, MaCauley JA, Pewu GF, Gorpue M, Gborie A, Brown TT, Fannieh A, Dweh T, Marley RB, Baysah MK, Nowine NN, Niescierenko M, Zaizay L. Cash transfers and nutrition education to improve dietary diversity among children aged 6-23 months in Grand Gedeh County, Liberia: a cluster-randomized trial. J Trop Pediatr. 2022 Oct 6;68(6):fmac096. doi: 10.1093/tropej/fmac096.
PubMed 36350714
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomized Trial to Study the Effect of Cash Transfers and Nutrition Education on Dietary Diversity Among Children 6-23 Months of Age in Grand Gedeh County, Liberia: A Pilot Study
- ClinicalTrials.gov ID
- NCT04101487
- Acronym / sponsor ID
- P00031767
- Conditions
- Malnutrition, Child
- Keywords
- Cash Transfers, Liberia, Stunting, Dietary diversity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 599 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- UNICEF
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 24 Sep 2019 (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.
The investigators aim to evaluate the efficacy of a cash transfer and nutrition education program delivered by community health assistants to increase dietary diversity among children 6 to 23 months of age in Grand Gedeh County, Liberia.
Detailed description
Worldwide, more than one in five children suffer from chronic malnutrition. In Liberia, there are more than 230,000 children suffering from chronic malnutrition and 32% of children under five are stunted. Previous studies have shown that inadequate dietary diversity is strongly associated with stunting in children under two years of age. An interventional package including cash transfers and education has the potential to improve dietary diversity and long-term outcomes such as improved growth and reduced rates of stunting among children.
The investigators' objective is to evaluate the efficacy of a cash transfer and nutrition education program delivered by community health assistants to increase dietary diversity among children 6 to 23 months of age in Grand Gedeh County, Liberia. The investigators will conduct a pilot, cluster randomized trial in 45 communities. The investigators hypothesize that a multi-pronged interventional package aimed at strengthening the household environment will result in improved dietary diversity for children 6 to 23 months of age. Moreover, the investigators also hypothesize that unconditional cash transfers will result in improved dietary diversity for children 6 to 23 months of age in Grand Gedeh County, Liberia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants in this arm will receive routine monthly visits along with survey administration and the regular package of health services provided at the facility level and at home by community health assistants |
| Cash Transfers | Experimental | Other: Cash TransferParticipants in this arm will receive routine monthly visits along with the regular package of health services provided at the facility level and at home by community health assistants and unconditional cash transfers every month |
| Cash Transfers and Nutrition Education | Experimental | Other: Cash Transfers and Nutrition EducationParticipants in this arm will receive routine monthly visits along with the regular package of health services provided at the facility level and at home by community health assistants, unconditional cash transfers every month, and structured nutrition education provided at household level by community health assistants based on a structured nutrition education handbook. |
Who may qualify
- Ages
- 6 to 23 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Participants 6 to 23 months of age
- Participants with consenting caregivers to have monthly visits and to participate in the program
- Caregivers of all ages will be included
Key exclusion criteria (3 listed)
- Participants who are younger than 6 months of age (children < 6 months of age are encouraged to exclusively breastfeed, making dietary diversity irrelevant in this age group)
- Participants older than 23 months of age
- Participants with non-consenting caregivers
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 |
|---|---|---|
| Cash TransferMonthly cash transfers | Other | Cash Transfers |
| Cash Transfers and Nutrition EducationCash transfers every month and structured nutrition education provided at household level by community health assistants based on a nutrition education handbook | Other | Cash Transfers and Nutrition Education |
Primary outcome
Change in proportion of children 6 to 23 months of age who meet minimum dietary diversity scores (DDS) over the study period as reported by caregivers
Time frame: 6 months
The DDS has been widely used to measure the sum of diverse food groups consumed in a 24-hour period
9 secondary outcomes
Meal frequency
Time frame: 6 months
Increase in child weight in kilograms
Time frame: 6 months
Increase in mid upper arm circumference in centimeters
Time frame: 6 months
Increase in child length/height in centimeters
Time frame: 6 months
Health care utilization (clinic)
Time frame: 6 months
Health care utilization (hospital)
Time frame: 6 months
Health care utilization (antimicrobials)
Time frame: 6 months
Health care utilization (nutritional support)
Time frame: 6 months
Knowledge, attitudes, and practices
Time frame: 6 months
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 10 Jan 2025.
- Results publication: PubMed 36350714Rees CA, Cleon D, Davis AB, Sammy AM, Britto CD, Massaquoi W, Forkpa OW, Johnson AJ, Hook VF, MaCauley JA, Pewu GF, Gorpue M, Gborie A, Brown TT, Fannieh A, Dweh T, Marley RB, Baysah MK, Nowine NN, Niescierenko M, Zaizay L. Cash transfers and nutrition education to improve dietary diversity among children aged 6-23 months in Grand Gedeh County, Liberia: a cluster-randomized trial. J Trop Pediatr. 2022 Oct 6;68(6):fmac096. doi: 10.1093/tropej/fmac096.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cash Transfer and Cash Transfers and Nutrition Education in people with Malnutrition, Child, run by Boston Children's Hospital at 1 site in Liberia.
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 3 inclusion and 3 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 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Liberia. 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?
Change in proportion of children 6 to 23 months of age who meet minimum dietary diversity scores (DDS) over the study period as reported by caregivers (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04101487, which also lists 1 linked publication.
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 10 Jan 2025.