NCT06642012

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,384

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 17, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
Last Updated

September 8, 2025

Status Verified

September 1, 2025

Enrollment Period

7 months

First QC Date

October 9, 2024

Last Update Submit

September 4, 2025

Conditions

Keywords

Social Behavior Change CommunicationCash TransferHumanitarianMalnutritionWastingSomalia

Outcome Measures

Primary Outcomes (4)

  • 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: 1. without acute malnutrition (MUAC \>= 125 mm and WHZ \>= -2 SD and no edema), 2. with moderate acute malnutrition (115 mm \<= MUAC \< 124.9 mmm and/or -3\<=WHZ\<-2 and no edema), 3. 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

Study Arms (3)

Arm 1: Cash only

ACTIVE COMPARATOR

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

Arm 2: Cash + Social Behavior Change Communication (SBCC)

EXPERIMENTAL

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

Arm 3: Cash + top-up cash

EXPERIMENTAL

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

Interventions

Households received 1 mobile cash transfer per month for 6 months.

Arm 1: Cash only

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.

Arm 2: Cash + Social Behavior Change Communication (SBCC)

Households received 1 mobile cash transfer per month for 6 months, receiving the base cash amount plus an additional cash top-up amount.

Arm 3: Cash + top-up cash

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Received treatment for wasting at baseline
  • Had an episode of severe acute malnutrition in the past 12 months
  • 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.
  • Currently receiving treatment for wasting
  • Had an episode of severe acute malnutrition in the past 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

Save the Children Somalia Office

Mogadishu, Somalia

Location

Related Publications (2)

  • Grounds S, Walton S, Alier KK, Garretson S, Mohamoud SA, Abdiqadir SM, Khattak Q, Nur MA, Mohamoud AM, Ismail MO, Mahat MB, Mohamed AA, Mohamed AA, Tripaldi M, Akseer N. Assessing the correlates of wasting among children under five and their mothers in the Bay and Hiran regions of Somalia. J Glob Health. 2025 Dec 12;15:04308. doi: 10.7189/jogh.15.04308.

  • Garretson S, Walton S, Alier KK, Grounds S, Khattak Q, Mohamoud SA, Farah AA, Mohamud FM, Mohamoud AM, Mahdi A, Ismail MO, Mahat MB, Loddo F, Tripaldi M, Akseer N. Analysing concordance between MUAC, MUACZ, and WHZ in diagnosing acute malnutrition among children under five in Somalia. J Glob Health. 2025 Dec 12;15:04258. doi: 10.7189/jogh.15.04258.

MeSH Terms

Conditions

Child Nutrition DisordersWasting SyndromeGrowth DisordersMalnutritionCachexia

Interventions

CASP8 and FADD-Like Apoptosis Regulating Protein

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesMetabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsWeight LossBody Weight ChangesBody WeightSigns and SymptomsThinness

Intervention Hierarchy (Ancestors)

Death Domain Receptor Signaling Adaptor ProteinsAdaptor Proteins, Signal TransducingIntracellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsTumor Necrosis Factor Receptor-Associated Peptides and ProteinsApoptosis Regulatory ProteinsCarrier ProteinsProteins

Study Officials

  • Nadia Akseer, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR
  • Shelley Walton, MPH, RD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR
  • Said Mohamoud

    Save the Children Somalia

    STUDY DIRECTOR
  • Adam Abdulkadir

    Save the Children Somalia

    STUDY DIRECTOR
  • Qundeel Khattak

    Save the Children International

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2024

First Posted

October 15, 2024

Study Start

May 17, 2023

Primary Completion

December 25, 2023

Study Completion

January 30, 2024

Last Updated

September 8, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

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.

Locations