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

September 4, 2025 updated by: Johns Hopkins Bloomberg School of Public Health

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3384

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Child Wasting Prevalence
Time Frame: Baseline, 3 months, and 6 months

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
Time Frame: Baseline, 3 months, and 6 months
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
Time Frame: Baseline, 3 months, and 6 months
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
Time Frame: Baseline, 3 months, and 6 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins Bloomberg School of Public Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Save the Children
Elrha
UK Foreign, Commonwealth & Development Office (FCDO)
Ministry of Health, Somalia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 25, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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