- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04101487
Cash Transfers to Increase Dietary Diversity in Grand Gedeh County, Liberia
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Zwedru, Liberia
- Grand Geddeh County Health Office
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
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
|
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.
|
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
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
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
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P00031767
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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