Moderate Acute Malnutrition (MAM) and Severe Acute Malnutrition (SAM) in Sierra Leone
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The long-term objective of this proposal is to develop and demonstrate an effective,
      integrated and streamlined protocol to treat moderate acute malnutrition (MAM) and
      non-complicated severe acute malnutrition (SAM) in children during humanitarian emergencies.

      Hypothesis: An integrated management protocol for MAM and SAM will achieve greater community
      coverage and a greater individual recovery rate than standard care.
    

Detailed description: 
      Specific Aim 1: Implement an integrated protocol in Sierra Leone for the management of MAM
      and non-complicated SAM that uses a single anthropometric indicator as well as the same food.
      Standard care refers to traditional, segregated treatment of MAM and SAM.

      Hypothesis: An integrated management protocol for MAM and SAM will achieve greater community
      coverage and a greater individual recovery rate than standard care.

      Methods Eligible subjects will be children with MAM or non-complicated SAM aged 6-59 months.
      MAM is defined as MUAC < 12.5 cm, but ≥ 11.5 cm. Non-complicated SAM will be defined as MUAC
      < 11.5 cm, or + or ++ bilateral edema, and having an acceptable appetite. An acceptable
      appetite will be judged by giving the child 30 g of RUTF and asking the mother to feed this
      food to the child over 20 minutes. Children with SAM who are able to consume this RUTF will
      be eligible for the study. Children unable to consume the RUTF or presenting with IMCI
      warning signs (convulsions, altered mental status, respiratory distress) will be considered
      to have complicated SAM and will be referred for inpatient treatment. Only the youngest child
      with malnutrition in each household will be enrolled; older siblings will be treated
      operationally using the same protocol. Exclusion criteria include children with obvious
      chronic debilitating illness like cerebral palsy or congenital abnormalities, or having
      received treatment for MAM or SAM in the previous two months. If any child needs immediate
      medical care s/he will be offered treatment or transport to the nearest health center, and
      not enrolled.

      Informed consent will be sought from the caretakers of all eligible children by a nurse
      familiar with the study and fluent in the caretaker's native language. Duration of the study
      and participation requirements will be explained. Informed consent will be given verbally and
      in writing.

      Study design This is a cluster randomized, unblinded, clinical controlled trial conducted in
      children comparing integrated treatment of SAM and MAM with standard treatment. The primary
      outcomes will be treatment coverage and recovery rate. The very obvious differences in
      integrated and standard care makes subject and staff blinding impossible.

      Ten study sites in rural and peri-urban Sierra Leone, where treatment for SAM and MAM is
      currently offered, will be selected by the Ministry of Health and Sanitation National
      Nutrition Program Sierra Leone and the PI for the study. Site managers will be consulted and
      their cooperation will be solicited prior to definitively selecting sites.

      The minimum sample size will be 900 children with MAM and 900 with SAM, 450 receiving
      integrated care and 450 receiving standard care in each group. Assuming that recovery rate is
      75%, this sample size will detect an improvement in the recovery rate to 80% on the
      integrated protocol, with 95% specificity and 82% power.

      Participation Integrated Protocol Upon enrollment demographic information will be collected,
      weight, height and MUAC will be measured, simple health history obtained, and children will
      be assessed for edema. Information will be recorded on a standard data collection card.
      Enough RUTF will be dispensed for 2 weeks of therapy, and children will be asked to return
      for follow-up every 2 weeks. Children with SAM will initially be given oral amoxicillin twice
      daily for a week and asked to return for follow-up every 2 weeks. Once children with SAM
      achieve MUAC >11.5 cm, the RUTF dose will be reduced.

      Upon follow-up, caretakers of children will be questioned about symptoms of acute illness,
      compliance with study foods and food intolerance or allergy. If edema persists or MUAC is ≤
      12.5 cm, an additional two weeks of RUTF will be dispensed. If the child is judged to have
      altered mental status, respiratory distress or an acute clinical illness needing medical
      care, the child will be referred to the health center for complicated SAM and withdrawn.

      If MUAC > 12.5 cm, the child will be given lipid-based nutrient supplements (LNS), a bed net,
      albendazole, zinc, referral for immunizations compliant with current WHO recommendations,
      oral rehydration salts to give if the child has more than three loose watery stools in 24
      hours, and asked to return for follow-up in 1, 3 and 6 months. Caretakers will be instructed
      to seek medical care sooner if the child has fever, poor appetite or signs of an acute
      illness.

      If the child is between 6-24 months of age, the caretaker will participate in enhanced
      breastfeeding counseling, carried out by the Care Group model. A Care Group is a team of 10
      to 15 trained volunteers who provide health and nutrition education to residents within 10 to
      15 households each, with the aim of changing behavior and health practices. Each integrated
      program center will implement one or several Care Groups depending on the number of 6-24
      month old children enrolled in the program. The Care Group model is built upon multiplication
      of volunteer effort, peer support and community mobilization, thereby creating a social
      movement involving the entire community to foster positive behavior change. The key message
      is appropriate complementary feeding with continued breastfeeding in 6-24 month old children.
      Ancillary messages to be included are family planning, immediate and exclusive breastfeeding
      of infants 0-5 months, and safe hygiene practices. All health and community health workers
      involved in the project will follow a one week Care Group training to support adequate
      complementary feeding for the 6-24 month olds.

      Participation Standard Protocol These children will receive treatment in accordance with the
      'National protocol for community-based management of acute malnutrition' of Sierra Leone,
      which reflects standard practice worldwide. The management scheme uses weight-for-height
      z-score (WHZ) to categorize children and includes separate care for MAM and non-complicated
      SAM, using different foods.

      A research assistant will be assigned to the standard care sites to collect informed consent,
      data, and to assess the availability of foods and supplies. If food is not available, the
      study will supply, as it is essential for making a valid comparison between the two
      protocols.

      Integrated Protocol Foods Children participating in the integrated treatment protocol will
      receive, as a supplement to the normal diet, 75 kcal/kg/d RUTF when MUAC ≥ 11.5 cm and edema
      has resolved, whether s/he was enrolled for MAM or SAM. Children with MUAC < 11.5 cm will
      receive 175 kcal/kg/d RUTF. Caretakers will be instructed to give her child the appropriate
      food for the child's nutritional status.

      RUTF for the integrated program will be formulated to comply with the new United Nations (UN)
      ready-to-use supplemental food (RUSF) requirements. RUTF for a 7.5 kg child at 75 kcal/kg/d
      meets or exceeds the Dietary Reference Intake, except for calcium, phosphorus, potassium,
      riboflavin and vitamin K, which should be provided in breast milk or the habitual diet.

      Children randomized to be in the integrated protocol group will be given a six-week supply of
      a 50 g LNS to complement their home diet after graduation. LNS is a mixture of peanut butter,
      fat and the correct mixture of micronutrients to achieve one Required Daily Amounts (RDA)/d
      for most vitamins and minerals.

      Coverage The Simplified Lot Quality Assurance Sampling (LQAS) Evaluation of Access and
      Coverage (SLEAC) method will be used to assess coverage. The ten treatment centers (five
      standard and five integrated) will each be assessed for coverage using simple surveys. SLEAC
      identifies the category of coverage (e.g. low, medium, high) of each treatment center,
      according to a threshold value, d, calculated as follows: where n is the sample size and p is
      the standard against which coverage is being evaluated. The Sphere minimum standard of
      coverage is 50% for rural areas, 70% for urban areas and 90% for camp settings11, so p = 50%
      for coverage assessments in rural areas, and d = 21 in this scenario. The sample size for
      each treatment center, n, is 42 (single sided test, 90% power, 5% significance with a control
      coverage estimated at 20% and intervention coverage estimated at 50%). Since it is likely
      that more than the exact number of cases will be found, d will be recalculated after coverage
      assessment. Villages to be visited for surveying are determined by the centric systematic
      area sampling or quadrat method (selects villages to visit based on geographic location), or
      by listing all villages and systematically selecting villages in the targeted catchment area
      for the program, depending on whether a map is available. Sampling ceases after all selected
      villages are visited, regardless of whether the quota of cases is achieved earlier or not.

      House-to-house sampling must be carried out to ensure that all MAM cases are found. This will
      additionally allow discovery of all SAM cases. Surveying of 14 areas with 15 mid-level health
      management staff and one principal surveyor required 44 days. It will take the same staff
      size ~32 working days to complete the survey for this protocol.

      Data Analysis Anthropometric indices will be calculated using Anthro v 3.1 (WHO) based on the
      WHO's 2006 Child Growth Standards. Data will be tabulated and analyzed using the statistical
      computer program SPSS 13.0 and Microsoft® Excel. A primary outcome is recovery under the
      integrated program and the standard protocol. Recovery at 1, 3 and 6 months follow-up with
      the standard protocol will be compared to the integrated protocol. The other primary outcome,
      coverage, is assessed by comparing survey data from each region; the number of cases found
      that have been treated are compared to the threshold value, d, and areas are categorized as
      having low, moderate or high coverage. All coverage analysis will be carried out according to
      previous published methods.

      Secondary outcomes are growth rates, duration of treatment, cost estimates for participation,
      reasons for defaulting and identification of risk factors for poor outcomes. Comparisons
      between treatments will be made using Chi-square test for categorical outcomes and ANOVA for
      continuous outcomes. P < 0.05 will be statistically significant.

      Specific Aim 2 will be conducted by International Medical Corps (IMC) Specific Aim 2:
      Evaluate the effectiveness of breastfeeding education and counseling on breast milk intake in
      6-24 month-old children receiving RUTF in Sierra Leone.

      Hypothesis: An active, peer counseling program to preserve/promote breastfeeding in MAM
      infants will result in greater breast milk consumption than standard care.

      Methods Subjects: Eligible subjects will be children aged 6-24 months enrolled in the trial
      described in Specific Aim 1 that have reached MUAC > 12.5 cm. IMC will enroll children
      between 6-24 months of age whose caretaker will participate in enhanced breastfeeding
      counseling, carried out by the Care Group model or a modified version tailored to the context
      of the research program.

      Study design IMC will assist each integrated program center to implement one or several Care
      Groups depending on the number of 6-24 month old children enrolled in the program. The key
      message for this group of care givers will focus on appropriate complementary feeding with
      continued breastfeeding in 6-24 month old children Ancillary messages to be included are
      family planning, health care seeking behaviors, and safe hygiene practices. IMC will train
      all community health workers involved in the project in a one week intensive training on the
      Care Group approach to support adequate complementary feeding for the 6-24 month olds.

      Participation Caretakers will be approached for sub study enrollment immediately upon
      successful completion of therapy for MAM, during the interval when their children are
      receiving the LNS.

      It is anticipated that the children whose mother received the Care Group counseling will have
      greater breast milk intake. There are ample numbers of eligible children in the study such
      that if a mother chooses not to participate or drops out after agreeing, a replacement can be
      easily found.
    

Intervention name(s): Integrated Protocol; Current protocol
Intervention type(s): Other; Other
Intervention description(s): Implement an integrated protocol in Sierra Leone for the management of MAM and non-complicated SAM that uses a single anthropometric indicator as well as the same food but in different doses to treat the continuum of malnutrition. MAM children will be given 75 g/kg/day of RUTF whereas SAM will be given 175 gr/kg/day of RUTF until MUAC>12.5 cm is reached. Then child will be given LNS, a bed net, albendazole, zinc, referral for immunizations compliant with current WHO recommendations, oral rehydration salts to give if the child has more than three loose watery stools in 24 hours, and asked to return for follow-up in 1, 3 and 6 months. Caretakers will be instructed to seek medical care sooner if the child has fever, poor appetite or signs of an acute illness.; Current protocol for treating MAM in emergencies is supplemental food distribution, often providing a fortified blended food (FBF) that requires cooking. This treatment is the standard today for treating children with MAM.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MAM; SAM