CClinicalTrials.gg
CompletedNCT06642012Updated Sep 8, 2025

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

An interventional study of Cash only and Cash + Social Behavior Change Communication in Malnutrition, Child, Wasting Disease and Stunting, sponsored by Johns Hopkins Bloomberg School of Public Health. Completed at 2 sites in 2 countries. Open to participants aged 6 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-08.

Sponsored by Johns Hopkins Bloomberg School of Public Health · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled May 2023, registered Oct 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
3,384
Allocation
Randomized
Ages
6 Months and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Malnutrition, Child
  • Wasting Disease
  • Stunting
  • Malnutrition
  • Malnutrition, Mother

Keywords

  • Social Behavior Change Communication
  • Cash Transfer
  • Humanitarian
  • Malnutrition
  • Wasting
  • Somalia
03

In context

Child Nutrition Disorders

164 studies on the registry are indexed under Child Nutrition Disorders; 34 are open to participants now.

This study's enrollment of 3,384 is above the median of 428 across 130 interventional studies indexed under Child Nutrition Disorders.

Browse Child Nutrition Disorders studies →

Lead sponsor

Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 364 studies on the registry; 41 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
3,384 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • OtherCash only

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

  • OtherCash + 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.

  • OtherCash + 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, 3 months, and 6 months

  2. 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.

    Time frame: Baseline, 3 months, and 6 months

  3. 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.

    Time frame: Baseline, 3 months, and 6 months

  4. 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.

    Time frame: Baseline, 3 months, and 6 months

07

Study locations

2 sites
  • Johns Hopkins Bloomberg School of Public Health
    Baltimore, Maryland 21205, United States
  • Save the Children Somalia Office
    Mogadishu, Somalia
08

References and documents

Publications

  • Akseer N, Alier KK, Grounds S, Garretson S, Mohamud S, Khattak Q, Tripaldi M, Loddo F, Mohamoud SA, Mahdi AY, Nur MA, Abdiqadir SM, Mitchell E, Kees A, Mahat MB, Gure M, Jibril DI, Gedi D, P'Rajom MO, Omer M, Farah A, Osman MA, Adan AM, Mohamoud FM, Mohamoud AM, Mohamed AA, Abdi AA, Abdulkadir A, Walton S. The effectiveness and cost-effectiveness of cash plus interventions to prevent acute malnutrition in Somalia: evidence from an adaptive cluster randomised control trial. J Glob Health. 2026 May 8;16:04111. doi: 10.7189/jogh.16.04111. PubMed 42100906 ↗
  • Walton S, Alier KK, Garretson S, Grounds S, Khattak Q, Tripaldi M, Loddo F, Mohamoud SA, Nur MA, Abdiqadir SM, Mitchell E, Mahat MB, Gure M, Jibril DI, Gedi D, Ocircan M, Ismail MO, Farah AA, Mohamed AA, Mohamed AA, Akseer N. Design and methodology of a cluster-randomised controlled trial on cash plus interventions for preventing child wasting in Somalia. J Glob Health. 2026 Feb 27;16:04018. doi: 10.7189/jogh.16.04018. PubMed 41757817 ↗
  • Alier KK, Walton S, Grounds S, Garretson S, Mohamoud SA, Nur MA, Abdiqadir SM, Mahat MB, P'Rajom MO, Ismail MO, Farah AA, Khattak Q, Schofield L, Tripaldi M, Loddo F, Sinibaldi P, Mohamed F, Mohamed AA, Mohamed AA, Akseer N. Levels and determinants of child wasting relapse: a prospective cohort study from Somalia. J Glob Health. 2026 Feb 13;16:04019. doi: 10.7189/jogh-16-04019. PubMed 41717987 ↗
  • 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. PubMed 41384499 ↗
  • 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. PubMed 41383165 ↗

Individual participant data

Plan to share: No — 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06642012
Lead sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Save the Children, Elrha, Ministry of Health, Somalia, UK Foreign, Commonwealth & Development Office (FCDO)
Responsible party
Sponsor
First posted
Oct 15, 2024
Start date
May 17, 2023
Primary completion
Dec 25, 2023
Completion
Jan 30, 2024
Last update
Sep 8, 2025

Study contacts

Nadia Akseer, PhD
principal investigator · Johns Hopkins University
Shelley Walton, MPH, RD
principal investigator · Johns Hopkins University
Said Mohamoud
study director · Save the Children Somalia
Adam Abdulkadir
study director · Save the Children Somalia
Qundeel Khattak
study director · Save the Children International

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion