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Completed

NCT Number: NCT02460848

Effects of Cash Transfers on Severe Acute Malnutrition

Cash transfer, aims to strengthen food security for vulnerable households by giving families enough purchasing power to consume an adequate and balanced diet, maintain a good standard of hygiene, access health services, and invest in their own means of food production in addition to their children's growth and development.

While cash transfer to vulnerable households has shown a long-term positive impact on growth and on malnutrition-related mortality in children aged 0-5 years, there is little conclusive evidence their effectiveness in Sub-Saharan Africa that cash transfer has a direct effect on the Community-based Management of Acute Malnutrition (CMAM). Here, the investigators will perform a cluster-randomized trial to investigate during 6 months the effects of unconditional cash transfers on the management of severe acute malnutrition (SAM) in children from 6 to 59 months according to the national protocol in the Democratic Republic of Congo.

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Key information

Conditions

Severe Malnutrition Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Severe Acute Malnutrition

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Save the Children

Mbuji-Mayi, East Kasai, B.P. 440, Democratic Republic of the Congo

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Living in the catchment area of one of the 20 outpatient therapeutic program site participating in this cluster randomized trial;
  • 6-59 months of age;
  • Weight for Height Zscore <-3 SD (WHO Growth Standards 2006) and/or Mid-Upper Arm Circumference <115mm and/or with bilateral edema;
  • No major clinical complications;
  • Positive appetite test;
  • Accept to participate at the study.

Exclusion criteria

  • Not living in the catchment area of the outpatient therapeutic program site of the cluster randomized trial;
  • Weight-for-Height Z-score ≥-3 (WHO Growth Standards 2006) and Mid-Upper Arm Circumference ≥115mm without bilateral edema;
  • Major clinical complications;
  • Failure to appetite test;
  • Refuse to participate at the study.

Treatment and study plan

Outpatient therapeutic program, counseling and cash transfer

Other

Each household will receive an unconditional cash transfer of $40 value every month during a 6 months' period.

The amount of cash per household per month was defined according to the results of the Household Economy Approach survey. This amount represents 70% of supplement to the monthly average household income characterized as very poor to meet their basic needs. This threshold corresponds to the total of food and income necessary to cover 100% of energy needs food (2100 kcal per day per person), the costs associated with the preparation and consumption of food (e.g. salt, soap, kerosene and / or firewood for cooking and basic lighting) and finally all expenses for access to water for human consumption.

Outpatient therapeutic program and counseling

Other

Primary outcomes

  1. Recovery rate in the outpatient therapeutic program

    Time frame: At 6 week

    Recovery is defined for patient of 6 to 59 months old as Weight-for-Height Z-score ≥-1.5 SD (WHO Growth Standards 2006) or Mid-Upper Arm Circumference ≥125mm at two consecutive visits and absence of bilateral edema for 14 days.

Secondary outcomes

  1. Recovery rate in the outpatient therapeutic program

    Time frame: At 8 week

  2. Length of stay in the outpatient therapeutic program

    Time frame: One month (average)

  3. Default rate in the outpatient therapeutic program

    Time frame: Two weeks

    Patient who failed to appear for two consecutive weeks during the follow-up visits.

  4. Relapse rate

    Time frame: At 2, 3 and 4 months following discharge

    Patient who reach inclusion criteria within 2 months following discharge.

  5. Transfer rate from outpatient therapeutic program to inpatient therapeutic program

    Time frame: One month average

    Patient who develop signs of a serious medical complication according to the national protocol are transfer to the inpatient therapeutic program.

  6. Failure rate in the outpatient therapeutic program

    Time frame: Up to three months

    Patients who failed to reach after 3 months the recovery criteria.

  7. Morbidity rate

    Time frame: At 6 week, 8 week and 6 month

    ARI, diarrhoea, anaemia and malaria incidence. Morbidity will be assessed every week in the outpatient therapeutic program and every month after discharge by a locally pre-tested standardized questionnaire.

  8. Death rate

    Time frame: At 6 week, 8 week and 6 month

    Death from any cause during follow-up.

  9. Weight gain

    Time frame: At 6 week, 8 week and 6 month

    Weight gain will be assessed every week in the outpatient therapeutic program and every month after discharge.

  10. Mid-Upper Arm Circumference gain

    Time frame: At 6 week, 8 week and 6 month

    Mid-upper arm circumference gain will be assessed every week in the outpatient therapeutic program and every month after discharge.

  11. Change in Growth rates

    Time frame: At 6 month

    Growth will be measured every week in the outpatient therapeutic program and every month after discharge.

  12. Diet replacement & Intra-household dispatching of the therapeutic food

    Time frame: One month average

    Diet replacement & Intra-household dispatching of the therapeutic food will be assessed with the household every week during the recovery period by a locally pre-tested standardized questionnaire.

  13. Change in the Individual Dietary Diversity Score (IDDS)

    Time frame: At 6 week, 8 week and 6 month

    IDDS for measurement of food access of the children will be assessed with the household every week during the recovery period and every month after discharge by a locally pre-tested standardized questionnaire.

  14. Change in the Household Dietary Diversity Score (HDDS)

    Time frame: At 6 month

    HDDS for measurement of food access will be assessed with the household at the beginning and the end of the study by a locally pre-tested standardized questionnaire.

  15. Satisfaction of parents and acceptability

    Time frame: At 6 month

    Survey will be conducted in the households at the end of the study.

Sponsors and collaborators

Lead sponsor

UNICEF

Other

Collaborators

  • Save the Children

Registry information

Official study title

Effects of Unconditional Cash Transfers on the Management of Severe Acute Malnutrition (SAM) in the Democratic Republic of Congo: a Cluster Randomized Trial

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Jun 2, 2015
Registry last updated
Jan 5, 2016

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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