Cash Plus Interventions for Prevention of Acute Malnutrition in Children Under 5 and Their Mothers in Somalia

Comparing Effectiveness and Cost-effectiveness of Cash Plus Interventions in Preventing Acute Malnutrition in Somalia

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.

Study Overview

• Status: Completed
• Conditions: Malnutrition; Stunting; Malnutrition, Child; Wasting Disease; Malnutrition, Mother
• Intervention / Treatment: Other: Cash only; Other: Cash + Social Behavior Change Communication; Other: Cash + top-up cash

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.

• Study Type: Interventional
• Enrollment (Actual): 3384
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Somalia
  • Mogadishu, Somalia
    • Save the Children Somalia Office
• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins Bloomberg School of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1: Cash only; Arm 1 participants received the cash only intervention. Households in this arm received 1 mobile cash transfer per month for 6 months.	Other: Cash only; Households received 1 mobile cash transfer per month for 6 months.
Experimental: Arm 2: Cash + Social Behavior Change Communication (SBCC); Arm 2 participants received the cash + social behavior change communication intervention. Household received 1 mobile cash transfer per month for 6 months but mothers also received an SBCC package that included interpersonal communication (1:1 consultations for mothers), bi-monthly group sessions on key health and nutrition topics, and cooking demonstrations.	Other: Cash + Social Behavior Change Communication; Households received 1 mobile cash transfer per month for 6 months but mothers also received an SBCC package that included interpersonal communication (1:1 consultations for mothers), bi-monthly group sessions on key health and nutrition topics, and cooking demonstrations.
Experimental: Arm 3: Cash + top-up cash; Arm 3 participants received the cash + top-up cash intervention. Households received 1 mobile cash transfer per month for 6 months, receiving the base cash amount plus an additional cash top-up amount.	Other: Cash + top-up cash; Households received 1 mobile cash transfer per month for 6 months, receiving the base cash amount plus an additional cash top-up amount.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Wasting Prevalence	Child under 5 wasting prevalence was an aggregate measure of children's nutritional status based on the child's MUAC, weight-for-height z-score (WHZ) measurements, and the present of edema. Using the 2013 WHO guidelines on management of severe acute malnutrition in infants and children, at each study timepoint, children were measured and classified as: without acute malnutrition (MUAC >= 125 mm and WHZ >= -2 SD and no edema),; with moderate acute malnutrition (115 mm <= MUAC < 124.9 mmm and/or -3<=WHZ<-2 and no edema),; severe acute malnutrition (MUAC < 115 mm and/or WHZ <-3 and/or edema). Prevalence was estimated with 95% confidence intervals and changes in prevalence were calculated between baseline, 3 months, and 6 months.	Baseline, 3 months, and 6 months
Maternal Wasting Prevalence	Aggregate measure of maternal mid-upper arm circumference (MUAC) measured at each time point using standard MUAC tape to the nearest 0.1cm. Mothers were classified as 1) Overweight (MUAC > 300 mm), 2) Normal (300>MUAC>=230mm) or 3) With moderate acute malnutrition (MUAC < 230 mm). Prevalence was estimated with 95% confidence intervals and changes in prevalence were calculated between baseline, 3 months, and 6 months.	Baseline, 3 months, and 6 months
Child Mid-Upper Arm Circumference	Child mid-upper arm circumference (MUAC) was measured to the nearest 0.1 cm by program staff at each study timepoint using standard MUAC tape.	Baseline, 3 months, and 6 months
Child Weight-for-Height	Child weight-for-height is an aggregate measure using standard anthropometric measures for weight and height. Child weight was measured to the nearest 0.01 kg using a stand on scale and child height was measured to the nearest 0.1 cm using a wooden length board. Weight-for-height z-scores (WHZ) were calculated using 2006 Word Health Organization child growth standards module in STATA. Weight-for-height compares a child's weight to the weight of a child of the same height and sex from a standard 2006 WHO reference population. This weight-for-height z-score is measured in standard deviations from the median weight for children of the same height and sex. The calculation for Z-score is (X-m)/SD; X is the participant child's weight, m is the median weight for children of the same height and sex in the WHO reference population, and SD is the standard deviation of the weight of the reference population. Z-scores range from -5 to 5.	Baseline, 3 months, and 6 months

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: Save the Children; Elrha; UK Foreign, Commonwealth & Development Office (FCDO); Ministry of Health, Somalia
• Investigators: Principal Investigator: Nadia Akseer, PhD, Johns Hopkins University; Principal Investigator: Shelley Walton, MPH, RD, Johns Hopkins University; Study Director: Said Mohamoud, Save the Children Somalia; Study Director: Adam Abdulkadir, Save the Children Somalia; Study Director: Qundeel Khattak, Save the Children International

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2023
• Primary Completion (Actual): December 25, 2023
• Study Completion (Actual): January 30, 2024

Study Registration Dates

• First Submitted: October 9, 2024
• First Submitted That Met QC Criteria: October 14, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Estimated): September 8, 2025
• Last Update Submitted That Met QC Criteria: September 4, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Malnutrition; Wasting; Cash Transfer; Humanitarian; Social Behavior Change Communication; Somalia
• Additional Relevant MeSH Terms: Pathologic Processes; Nutrition Disorders; Metabolic Diseases; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Malnutrition; Child Nutrition Disorders; Growth Disorders; Wasting Syndrome; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Intracellular Signaling Peptides and Proteins; Apoptosis Regulatory Proteins; Carrier Proteins; Death Domain Receptor Signaling Adaptor Proteins; Adaptor Proteins, Signal Transducing; Tumor Necrosis Factor Receptor-Associated Peptides and Proteins; CASP8 and FADD-Like Apoptosis Regulating Protein
• Other Study ID Numbers: IRB00024476; 200011671 (Other Grant/Funding Number: Elrha)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This data was collected on a vulnerable population linked to a large scale cash assistance program in Somalia. The data may be available upon request with permission from local study investigators.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No