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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04101487
Other study ID # P00031767
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 15, 2019
Est. completion date November 1, 2022

Study information

Verified date March 2023
Source Boston Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 599
Est. completion date November 1, 2022
Est. primary completion date July 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 23 Months
Eligibility 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 Design


Intervention

Other:
Cash Transfer
Monthly cash transfers
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

Locations

Country Name City State
Liberia Grand Geddeh County Health Office Zwedru

Sponsors (2)

Lead Sponsor Collaborator
Boston Children's Hospital UNICEF

Country where clinical trial is conducted

Liberia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 6 months
Secondary Meal frequency Mean self-reported meal frequency over the 24-hour period prior to monthly CHA visits 6 months
Secondary Increase in child weight in kilograms changes in child weight in kilograms during the study period measured with digital scale (UNISCALE) 6 months
Secondary Increase in mid upper arm circumference in centimeters changes in mid upper arm circumference in centimeters measured with MUAC tape measure 6 months
Secondary Increase in child length/height in centimeters changes in child length/height in centimeters during the study period measured with Height Board 6 months
Secondary Health care utilization (clinic) number of clinic visits for illnesses (including type of illness) 6 months
Secondary Health care utilization (hospital) hospitalizations (if any) during the study period 6 months
Secondary Health care utilization (antimicrobials) use of antibiotics/antimalarials during the study period 6 months
Secondary Health care utilization (nutritional support) if the child received supplementary nutritional support (e.g. ready to use therapeutic food RUTF) 6 months
Secondary Knowledge, attitudes, and practices caregiver's knowledge, attitudes, and practices (KAP) of infant and young child feeding 6 months
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