Community Based Management of Malnutrition
Condition: Severe and Moderate Malnutrition
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      Malnutrition is the leading cause of death in children in developing countries, especially
      Pakistan. According to World Health Organization about 60% of all deaths, occurring among
      children aged less than five years in developing countries, could be attributed to
      malnutrition.

      Community-based therapeutic care attempts to maximize population-level impact through
      improved coverage, access, and cost-effectiveness of treatment. Such community-based
      nutrition packages can provide effective care to the majority of acutely malnourished
      children as outpatients, using techniques of community mobilization to engage the affected
      population and maximize coverage and compliance. Children with SAM without medical
      complications are treated in an outpatient therapeutic program with ready-to-use therapeutic
      food and routine medications.

      The Ready-to-use Therapeutic Food (RUTF) and Fortified Supplementary food has revolutionized
      the treatment of moderate and severe malnutrition. The advantage of these commodities is that
      they are ready-to-use paste which does not need to be mixed with water, thereby avoiding the
      risk of bacterial proliferation in case of accidental contamination.
    

Detailed description: 
      Aim:

      To evaluate the effectiveness of Ready to Use Therapeutic food and food supplement
      (Nutributter) in the treatment of Moderate and Severe malnutrition in rural Pakistan when
      administered at community level

      Primary objectives:

        -  To assess the acceptability, feasibility and effectiveness of Nutributter and Fortified
           supplementary food (RUTF) in the treatment of moderate malnutrition in children less
           than three years of age in community settings.

        -  To assess the acceptability, feasibility and effectiveness of RUTF in the treatment of
           severe malnutrition in children less than three years of age in community settings.

      Methodology:

      Study Design: Community based, step wedge randomized trial

      Sample size estimation:

      Total Population of the study area: 60268. Estimated under 5 years of age Population: 9040
      (Assuming 15% of Total population. Estimated Population between 6 months to 3 years: 4520
      (Assuming 50% of Under 5 Population)

      Sample Size for Moderate Malnutrition:

      It is estimated that the Prevalence of Moderately Malnourished: 20% Therefore 20% of 4520:
      904. We anticipate recruiting 1000 cases (96 about 10% extra for any loss to follow-ups or
      drop outs)

      Sample Size For Severe Malnutrition:

      It is estimated that the prevalence of Severe Acute Malnutrition is 8%. Therefore 8% of 4520:
      360. We anticipate recruiting 400 cases (40 about 10% extra for any loss to follow-ups or
      drop outs)
    

Intervention name(s): RUTF
Intervention type(s): Dietary Supplement
Intervention description(s): Children with severe malnutrition will be treated with a daily dose of RUTF till their weight for age z scores no longer fall in severe malnutrition group
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: RUTF; SAM; Nutributter