Moderate Acute Malnutrition (MAM)
Conditions
Brief summary
The objective of this study is to test and compare the effectiveness and cost-effectiveness of four supplementary foods for the treatment of moderate acute malnutrition (MAM) in normal programmatic settings in Sierra Leone. Study participants will receive one of four test foods varying in energy and nutrient density as well as amounts provided. 1. Super Cereal Plus (SC+) at 800 kcal/d, 215 g/d (Control group) 2. Super Cereal (SC) and oil and sugar at 998 kcal/d - 200 g SC and 20 g oil and 20 g sugar, per day 3. Corn-soy Blend 14 (CSB14) and oil at 978 kcal/day - 150 g CSB14 and 45 g oil, per day 4. Plumpy'Sup - 500 kcal/d, 92 g/d This will be a prospective, randomised, controlled effectiveness trial. Aims 1. (Impact) To compare the effectiveness of four supplementary foods in the treatment of moderate acute malnutrition (MAM) in normal programmatic settings in Sierra Leone. 2. (Cost) To estimate the relative cost-effectiveness (marginal cost per child recovered from MAM, relative to comparison group, SC+) of implementing the feeding program using each commodity, taking into consideration costs of procurement/production and distribution 3. (Process) To evaluate the determinants of effectiveness including: consumption adherence, preparation compliance, targeting/sharing of supplement, food components and preparation, adverse effects of foods, water contamination, hygiene and health behaviors, SES, food security, perceived barriers Outcomes 1. Recovery from MAM 1. Percent of children recovered from MAM (defined as achieving mid-upper arm circumference (MUAC) ≥ 12.5 cm by 12 weeks once) 2. Percent default/non-response: children who do not recover after 12 weeks 3. Percent relapse: children who become MAM again within 6 months of recovery 2. Mean number of weeks to recovery Hypothesis The children with MAM fed Super Cereal and oil and sugar, CSB14 and oil or Plumpy'Sup will have similar recovery outcomes to those children fed Super Cereal Plus. Null: The children with MAM fed Super Cereal and oil and sugar, CSB14 and oil or Plumpy'Sup will have different recovery outcomes to those children fed Super Cereal Plus.
Interventions
DIETARY_SUPPLEMENTSuper Cereal Plus (SC+)
DIETARY_SUPPLEMENTSuper Cereal (SC), fortified oil, sugar
DIETARY_SUPPLEMENTPlumpy Sup
DIETARY_SUPPLEMENTCorn Soy Blend 14 (CSB14) and fortified oil
Sponsors
Washington University School of Medicine
Project Peanut Butter
United Nations World Food Programme (WFP)
United States Agency for International Development (USAID)
Tufts University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 59 Months
Healthy volunteers
Yes
Inclusion criteria
Beneficiary Children (Children 6 months to 59 months old) Inclusion Criteria * Child diagnosed with MAM and enrolled to receive a ration from a feeding site (i.e. enrolled in the SFP)
Exclusion criteria
* Children with bipedal oedema * Children receiving food rations from another organization (e.g. USAID or UNICEF) Beneficiary Mothers/Caretakers (Mothers/Caretakers of Children 6 months to 59 months old) Inclusion Criteria * Beneficiary Mother/Caretaker whose child is diagnosed with MAM and enrolled to receive a ration from a feeding site * Beneficiary Mother/Caretaker has no age restrictions for inclusion (Note: Mothers/caretakers will be asked to participate regardless of age and consented appropriately; it is possible some mothers may be minors) * Subject who is voluntarily willing to participate and indicates by signing (or marking with a thumbprint) the consent form.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recovery from MAM | 12 weeks | 1. Percent of children recovered from MAM (defined as achieving mid-upper arm circumference (MUAC) ≥ 12.5 cm by 12 weeks once) 2. Percent default/non-response: children who do not recover after 12 weeks 3. Percent relapse: children who become MAM again within 6 months of recovery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Growth rates | 12 weeks | Subjects will return to clinic every 2 weeks until MUAC of 12.5 cm is reached or until 12 weeks has elapsed. Follow-up recovery will then be measured at 6 months. At each clinic visit growth will be measured. |
| Duration of treatment | 12 weeks | Subjects will return to clinic every 2 weeks until MUAC of 12.5 cm is reached or until 12 weeks has elapsed. Follow-up recovery will then be measured at 6 months. Time to achieve MUAC of 12.5 cm will be documented. |
| Cost estimates for participation | 12 weeks | Average cost of treatment will be measured per participant, this includes intervention costs and any medical costs needed by participants. The study costs no money to participants. |
| Default reason | 12 weeks | If a child defaults, then the reason will be an outcome measure. Reasons to default include loss to follow-up (the child will be attempted to be contacted 3 times prior to being considered lost), death, or he/she enters into the inpatient clinic. |
| Change in recovery status after 12 weeks | 6 months | Any changes in recovery will be measured at 6 months at follow-up visits |
Other
| Measure | Time frame | Description |
|---|---|---|
| Relative cost-effectiveness | 12 weeks | To estimate the relative cost-effectiveness (marginal cost per child recovered from MAM, relative to comparison group, SC+) of implementing the feeding program using each commodity, taking into consideration costs of procurement/production and distribution |
| Determinants of effectiveness | 12 weeks | To evaluate the determinants of effectiveness including: consumption adherence, preparation compliance, targeting/sharing of supplement, food components and preparation, adverse effects of foods, hygiene and health behaviors, SES, food security, perceived barriers |
Outcome results
None listed