Cash Transfers to Increase Dietary Diversity in Grand Gedeh County, Liberia

January 8, 2025 updated by: Michelle Niescierenko, Boston Children's Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
599

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Liberia
      • Zwedru, Liberia
        • Grand Geddeh County Health Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 months to 1 year (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
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
Experimental: Cash Transfers
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
Other: Cash Transfer
Monthly cash transfers
Experimental: Cash Transfers and Nutrition Education
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.
Other: Cash Transfers and Nutrition Education
Cash transfers every month and structured nutrition education provided at household level by community health assistants based on a nutrition education handbook

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Meal frequency
Time Frame: 6 months
Mean self-reported meal frequency over the 24-hour period prior to monthly CHA visits
6 months
Increase in child weight in kilograms
Time Frame: 6 months
changes in child weight in kilograms during the study period measured with digital scale (UNISCALE)
6 months
Increase in mid upper arm circumference in centimeters
Time Frame: 6 months
changes in mid upper arm circumference in centimeters measured with MUAC tape measure
6 months
Increase in child length/height in centimeters
Time Frame: 6 months
changes in child length/height in centimeters during the study period measured with Height Board
6 months
Health care utilization (clinic)
Time Frame: 6 months
number of clinic visits for illnesses (including type of illness)
6 months
Health care utilization (hospital)
Time Frame: 6 months
hospitalizations (if any) during the study period
6 months
Health care utilization (antimicrobials)
Time Frame: 6 months
use of antibiotics/antimalarials during the study period
6 months
Health care utilization (nutritional support)
Time Frame: 6 months
if the child received supplementary nutritional support (e.g. ready to use therapeutic food RUTF)
6 months
Knowledge, attitudes, and practices
Time Frame: 6 months
caregiver's knowledge, attitudes, and practices (KAP) of infant and young child feeding
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Children's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
UNICEF

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 24, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P00031767

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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