Efficacy and Acceptability of RUTFs in Indonesia
Condition: Severe Acute Malnutrition
MeSH terms: Malnutrition; Severe Acute Malnutrition
Study type: Interventional

Summary: 
      Severe wasting or Severe Acute Malnutrition (SAM) continues to be a major public health
      problem in Indonesia, affecting more than 2 million children under 5 years old. A new
      approach to treat SAM is called Community-based management of acute malnutrition (CMAM),
      which has been designed to maximize the coverage and successful treatment of children with
      SAM, by providing Ready to Use Therapeutic Food (RUTF) through out-patient treatment. Since
      2019, UNICEF has been working intensively to facilitate the local production of RUTF. This
      present study aims to assess the acceptability and efficacy of three locally produced RUTFs
      compared to the standard peanut based RUTF.

      The study will be implemented in Bogor district. A total of 300 children with uncomplicated
      SAM, aged 6-59 months old, meeting the inclusion criteria will be included in the study. This
      study is designed as a randomized controlled trial. The children will be allocated to one of
      the five intervention (1 control, 4 experimental) arms. Each child will receive one type of
      RUTF product for eight consecutive weeks. The ration given to a child will be based on the
      need for an intake of ~ 170 kcal/kg BW/day. Data will be collected at baseline, at weekly
      intervals and at exit. The primary outcome of interest for the efficacy study is the relative
      weight gain of children consuming each of the local RUTFs compared with those consuming the
      standard RUTF. The primary outcome of the acceptability of the RUTFs will be the amount of
      product consumed during the eight-week efficacy trial.

      Differences in weight and height gain will be analyzed using ANCOVA, controlling for age,
      gender, food intake, and morbidity. Repeated measurement statistics will be used to analyze
      differences in growth patterns over the eight-week intervention.
    

Detailed description: 
      OBJECTIVES This study aims to assess the acceptability and efficacy to increase weight and
      mid upper arm circumference of children aged 6-59 months with severe acute malnutrition
      (SAM), of three locally produced RUTFs compared to the standard peanut based RUTF. The study
      will be implemented in Bogor district.

      METHODOLOGY Subjects inclusion criteria are reported elsewhere.

      Sample Size Calculation If the Indonesian RUTFs fulfil the WHO requirement of an average
      increase of 4 g/kg BW/day, a sample size of 60 children per group would allow detecting a 20%
      difference between control and intervention products, assuming a SD of 1.6 g/kg BW, a study
      design effect of 1.0, a significance of 0.05, a power of 0.80. If children fail to reach this
      4 g/kg BW target and only gain 2 g/kg BW/day, the sample size would still allow detection of
      a 30% difference between the control product and the local product. Since it will be a
      five-armed intervention, a total of 300 SAM children will be recruited in Bogor district.

      Anthropometric and Hemoglobin Measurements Training The training on anthropometric
      measurements will include repeated practice and comparison of intra- and inter-observer
      variation to ensure that the field team will have excellent skills in conducting the
      anthropometric measurements.

      Hemoglobin concentration will be measured using Hemocue 201+ device by (or under direct
      supervision of) a medical doctor, trained in the use of the equipment.

      Study Design This study is designed as an individually randomised controlled trial. Parents
      will be informed of the purpose, risks and benefits of the study and asked to sign the
      informed consent prior to inclusion of their child in the study.

      Each child will be randomly allocated to one of the five intervention arms.

      Acceptability Study The primary outcome of the acceptability of the RUTFs will be the amount
      of product consumed during the 8-week efficacy trial (long-term acceptability). An average
      consumption of at least 50% of the offered product during the 8-week efficacy trial will be
      considered acceptable.

      The secondary outcome of the acceptability study will be the consumption velocity of the
      RUTFs during the appetite test (short-term acceptability; see below).

      Efficacy Study The primary outcome of interest for the efficacy study is the relative weight
      gain of children consuming each of the local RUTFs compared with those consuming the standard
      RUTF. A difference of 20% in weight gain will be considered as physiologically significant.

      Randomization Prior to the appetite test, selected children with uncomplicated SAM will be
      randomized to one of the five intervention arms. The randomization list is made prior to
      recruitment by a member of the research team not present in the field (FTW). Children
      randomized to one arm will receive the standard RUTF product, and the other four arms will
      each receive one of four local RUTFs.

      Appetite Test The day after the screening, selected children will need to pass an appetite
      test prior to enrolment in the intervention.

      Design Each child will receive one type of RUTF products for eight consecutive weeks. Data
      will be collected at baseline, at weekly intervals and at exit. Children who completely
      refuse to eat the RUTF they have been allocated to for more than 4 days/week, for 2
      consecutive weeks, or children who lose or do not gain weight during 2 consecutive weekly
      visits, and/or develop allergic reaction and clinical symptoms during the course of the study
      will be dropped from the study and will be referred to the Puskesmas for treatment.

      A weekly supply of RUTF will be supplied during each of the weekly check-up visits.

      Baseline data General information on socio-economic status of the family, ethnicity,
      educational level of both parents, household food security, IYCF including 24 h food recall,
      use of micronutrient supplements (vitamin A, iron, syrup) and supplementary foods (PMT/Local
      PMT), morbidity history and current morbidity, duration of pregnancy, birth weight,
      immunization status, deworming, sex and age of the child, will be collected at baseline, in
      addition to height/length, weight, MUAC and hemoglobin concentration. All data will be
      recorded using a digital questionnaire on tablet computers.

      Monitoring The daily amount of RUTF intake of each child will be recorded by the
      mother/caregiver in a monitoring book provided by the study team. The field team will visit
      each child on a weekly basis to monitor the feeding and intake recording by the
      mother/caregiver, as well as any intra-household sharing of the RUTF.

      In addition to the weekly home visits, the PL will maintain regular daily communication with
      the mothers/caregivers through text messages.

      Data Analysis The baseline, monitoring, and endline data will be entered in a digital
      questionnaire by the field workers. The researcher will extract data from digital
      questionnaire into SPSS format. Data analyses will be done using SPSS.
    

Intervention name(s): Ready to use therapeutic foods
Intervention type(s): Dietary Supplement
Intervention description(s): locally produced therapeutic foods
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled trial
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Ready to use therapeutic food (RUTF); acceptability; local; children; rehabilitation