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

NCT ID: NCT06642012

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3384 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-17

Study Completion Date

2024-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malnutrition, Child Wasting Disease Stunting Malnutrition Malnutrition, Mother

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Cash only

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Cash + Social Behavior Change Communication

Intervention Type OTHER

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 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.

Group Type EXPERIMENTAL

Cash + top-up cash

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cash only

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

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Save the Children

OTHER

Sponsor Role collaborator

Elrha

OTHER

Sponsor Role collaborator

Ministry of Health, Somalia

UNKNOWN

Sponsor Role collaborator

UK Foreign, Commonwealth & Development Office (FCDO)

UNKNOWN

Sponsor Role collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nadia Akseer, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Shelley Walton, MPH, RD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Said Mohamoud

Role: STUDY_DIRECTOR

Save the Children Somalia

Adam Abdulkadir

Role: STUDY_DIRECTOR

Save the Children Somalia

Qundeel Khattak

Role: STUDY_DIRECTOR

Save the Children International

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, United States

Site Status

Save the Children Somalia Office

Mogadishu, , Somalia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Somalia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

200011671

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB00024476

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Power of Peanuts School Feeding
NCT04349007 COMPLETED NA