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Completed

NCT Number: NCT06642012

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

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Key information

Conditions

Malnutrition, Child Body Weight Body Weight Changes Cachexia Child Nutrition Disorders Growth Disorders Malnutrition Malnutrition, Mother Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Stunting Thinness Wasting Disease Wasting Syndrome Weight Loss

Age range

6 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Save the Children Somalia Office, Mogadishu, Somalia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cash only

Other

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

Cash + Social Behavior Change Communication

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.

Cash + top-up cash

Other

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

Primary outcomes

  1. 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:

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

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • Elrha
  • Ministry of Health, Somalia
  • Save the Children
  • UK Foreign, Commonwealth & Development Office (FCDO)

Registry information

Official study title

Comparing Effectiveness and Cost-effectiveness of Cash Plus Interventions in Preventing Acute Malnutrition in Somalia

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Oct 15, 2024
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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