Clinical trial NCT06642012: Cash Plus Interventions for Prevention of Acute Malnutrition in Children Under 5 and Their Mothers in Somalia
Official title: Comparing Effectiveness and Cost-effectiveness of Cash Plus Interventions in Preventing Acute Malnutrition in Somalia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition, Child
Wasting Disease
Stunting
Malnutrition
Malnutrition, Mother
Keywords: Social Behavior Change Communication
Cash Transfer
Humanitarian
Malnutrition
Wasting
Somalia
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Save the Children
name: Elrha
name: Ministry of Health, Somalia
name: UK Foreign, Commonwealth & Development Office (FCDO)
First posted: 2024-10-15
Enrollment: 3384
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This trial studied different combinations of cash assistance to families that live in food insecure areas of Somalia and aimed to understand if this cash assistance provided reduced malnutrition of children and mothers.

Detailed description: This study was a mixed-methods cluster-randomized controlled trial implemented in the Bay and Hiran regions of Somalia to study monthly cash assistance interventions across 3 study arms. The intervention was provided for 6 months and included cash plus social and behavior change communication intervention. The investigators studied which combination of assistance was most effective and cost-effective at reducing and preventing child and maternal malnutrition (wasting, stunting, etc.). Enrolled participants were children under 5 and mothers of children under 5. The investigators collected qualitative, quantitative, and cost data to study the intervention across study arms, household experiences with receiving cash, and household factors related to malnutrition. Quantitative household data and anthropometry was collected at baseline, 3 months, and 6 months. Qualitative data was collected through focus group discussions on health/nutrition topics with mothers and fathers of children under 5 who participated in the study. Cost data was collected in consultation with study and program staff to evaluate the cost-efficiency, cost-effectiveness, and societal costs of the intervention. Investigators also monitored the local markets for food availability and price fluctuations to understand its impact on malnutrition in the communities where the trial was being implemented.

Eligibility criteria: Inclusion Criteria for Child Participants:

* Enrolled in Save the Children Cash Plus for Nutrition Program
* Ages 6-59 months at baseline
* Mother is enrolled in the study

Exclusion Criteria for Child Participants:

* Received treatment for wasting at baseline
* Had an episode of severe acute malnutrition in the past 12 months

Inclusion Criteria for Mothers:

* Enrolled in Save the Children Cash Plus for Nutrition Program
* At least 18 years old at baseline
* Have a child that is 6-59 months old at baseline
* Voluntarily willing to participant through signed consent form.

Exclusion Criteria for Mothers:

* Currently receiving treatment for wasting
* Had an episode of severe acute malnutrition in the past 12 months

Primary outcomes:
measure: Child Wasting Prevalence
timeFrame: Baseline, 3 months, and 6 months
measure: Maternal Wasting Prevalence
timeFrame: Baseline, 3 months, and 6 months
measure: Child Mid-Upper Arm Circumference
timeFrame: Baseline, 3 months, and 6 months
measure: Child Weight-for-Height
timeFrame: Baseline, 3 months, and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bloomberg School of Public Health
state: Maryland
city: Mogadishu
country: Somalia
facility: Save the Children Somalia Office
Study officials:
affiliation: Johns Hopkins University
name: Nadia Akseer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Shelley Walton, MPH, RD
role: PRINCIPAL_INVESTIGATOR
affiliation: Save the Children Somalia
name: Said Mohamoud
role: STUDY_DIRECTOR
affiliation: Save the Children Somalia
name: Adam Abdulkadir
role: STUDY_DIRECTOR
affiliation: Save the Children International
name: Qundeel Khattak
role: STUDY_DIRECTOR
References: