AzTrials
AzTrials

Malnutrition, ChildNCT06642012

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

A study testing Cash only, Cash + Social Behavior Change Communication and Cash + top-up cash in people with Malnutrition, Child and Wasting Disease, run by Johns Hopkins Bloomberg School of Public Health at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 more about this study

Who is it for?
Ages 6 months and olderHealthy volunteers can take part
Conditions the study is for
Malnutrition, Child, Wasting Disease, Stunting
What is being tested?
Cash only, Cash + Social Behavior Change Communication and Cash + top-up cash
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,384 participants
Where
2 sitesin 2 countries
Study dates
17 May 2023to 30 Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site
  • Johns Hopkins Bloomberg School of Public Health

    Baltimore, Maryland, 21205

Other trials in United States

Somalia1 site
  • Save the Children Somalia Office

    Mogadishu

About this study

Official title: 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.

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.

Being tested
Cash only, Cash + Social Behavior Change Communication, Cash + top-up cash
Keywords
Social Behavior Change Communication, Cash Transfer, Humanitarian, Malnutrition, Wasting, Somalia
Medical subject headings
Child Nutrition Disorders, Wasting Syndrome, Growth Disorders, Malnutrition, Cachexia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cash onlyOther

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

  • Cash + Social Behavior Change CommunicationOther

    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.

  • Cash + top-up cashOther

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

Study groups in NCT06642012
Study groupRoleWhat they receive
Arm 1: Cash onlyActive comparatorArm 1 participants received the cash only intervention. Households in this arm received 1 mobile cash transfer per month for 6 months.
Receives: Other: Cash only
Arm 2: Cash + Social Behavior Change Communication (SBCC)ExperimentalArm 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.
Receives: Other: Cash + Social Behavior Change Communication
Arm 3: Cash + top-up cashExperimentalArm 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.
Receives: Other: Cash + top-up cash

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Baseline, 3 months, and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2024
  2. Study start17 May 2023
  3. Primary completion25 Dec 2023
  4. Study completion30 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,384 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06642012
Sponsor's protocol ID
IRB00024476
Other IDs
200011671
Status last verified
Sep 2025
First submitted
9 Oct 2024
Last updated
8 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

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

Questions about this trial

What is this clinical trial studying?

A study testing Cash only, Cash + Social Behavior Change Communication and Cash + top-up cash in people with Malnutrition, Child and Wasting Disease, run by Johns Hopkins Bloomberg School of Public Health at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Somalia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Child Wasting Prevalence (time frame: Baseline, 3 months, and 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06642012, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in