Acceptability of LNS for Infants and Young Children in Guatemala
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Observational

Summary: 
      This study aims to assess the acceptability of lipid-based nutrient supplements (LNS) for use
      as nutritional supplements for infants and young children in Guatemala.

      The study was conducted in three phases. Phase 1 was a test-feeding to compare the
      acceptability of two different flavors of LNS (peanut and cinnamon) in infants and young
      children and their mothers or caregivers in terms of taste, smell and texture, as well as
      amount of the test-dose consumed. In Phase 2, children in the Phase 1 trial received a 2-week
      supply of one of the LNS products, which they consumed daily in their homes for 14 days under
      real-life conditions. Direct observation of supplement use and in-depth interviews with
      mothers, caregivers and health staff providing services in communities will be part of this
      phase too. In Phase 3, focus group discussions (FGD) were held with participants (mothers and
      caregivers) as well as with health staff providing services in communities to discuss
      different aspects of infant and child feeding and best ways for the LNS product to be used in
      the context of Guatemala.

      We hypothesized that both flavors of LNS would be accepted by Guatemalan infants and young
      children children and their mothers or caregivers.
    

Detailed description: 
      The study was carried out in two communities in the Suchitepéquez Department in partnership
      with Funcafé, a NGO subcontracted by the Ministry of Health (MOH) to implement the Programa
      de Extension de Cobertura (PEC) in Suchitepéquez. PEC provides basic medical care in remote
      communities that have limited access to MOH's health centers. This acceptability study was
      conducted in communities where PEC was implemented by Funcafé.

      The children were randomly selected from a list of beneficiaries of PEC served by Funcafé and
      invited to participate. Eligibility for participation in the study was determined at the time
      of recruitment in the homes of potential participants, by administration of a screening
      questionnaire by study staff.

      All caregivers who completed the home use trial were invited to participate in the FGD.
      Funcafé staff members (i.e. Institutional facilitators, Community facilitators and Community
      monitors) were randomly selected from the employee roster and potential participants were
      invited to participate in FGD using a standard recruitment script.

      The study was approved by the IRB of the University of California, Davis. Unawareness of
      whether a child was intolerant of peanut or milk products did not prevent participation, but
      the child was provided with a small dose of LNS (~5 g) and asked to remain under observation
      by study staff for at least one hour. After this initial test, caregivers were also given the
      project's mobile phone number to call in case there were any symptoms during the next few
      hours. No allergic reactions or other adverse effects were observed or reported in any
      subject.

      During the Test-feeding trial, the order of the versions of LNS tested was randomly
      determined for each subject. At the first home visit after recruitment (Day 0), the primary
      caregivers of the children were given an orientation about LNS. During the orientation,
      background data (e.g., socioeconomic and demographic information) were collected using a
      structured questionnaire and the experimental procedures were practiced, including initial
      tasting of the LNS mixed with food and completion of the tasting questionnaire, but no data
      on amount consumed or organoleptic preferences were recorded. The second home visit was Test
      Day 1, during which the actual tasting was recorded. All children were apparently healthy and
      had not eaten any food (including breast milk) during the previous hour, but during that time
      water was allowed. Caregivers were asked to provide 40 g (~3 tablespoons) of the
      complementary food they usually give to their children that was available at home, to which
      10 g (~2 teaspoons) of LNS were mixed. The mother/caregiver of the child was asked to consume
      one teaspoon of the LNS + food mixture (~ 5 g), and then to feed the rest (~ 45 g) to the
      child after the mixture was re-weighed. The mother or caretaker rated the mixture's color,
      aroma, flavor and consistency based on her own opinion, and her perception of the infant's
      degree of liking using a 5-point pictorial hedonic scale (i.e., dislike very much, dislike,
      neutral, like, like very much). In order to test the different flavored LNS a third home
      visit was conducted (Test Day 2). The same procedures described above for Test Day 1 were
      followed on Day 2, but each child tasted the other LNS flavor. No overall or organoleptic
      (i.e., color, odor, taste and consistency) preferences were assessed on Day 2. Thus, total
      participation in this phase lasted 3 days, including the initial orientation day. At each
      test-feeding day, we collected data on infant's health (i.e., nasal discharge, cough,
      difficulty breathing, fever, diarrhea, vomit/nausea, ear infection, and any other symptom)
      and any possible reaction to the test meal.

      For the Home use trial, primary caregivers of children who participated in the test-feeding
      trial received a two-week supply of LNS, which they were asked to add to their infants'
      prepared food each day. The daily ration of LNS was 20 g/day, provided in two 10-g sachets.
      In order to avoid bias, the LNS flavor to be distributed during the home-use trial was
      randomly assigned without taking into account the child's preference (if any) as explained
      above. To ensure that subjects consumed the entire daily ration, caregivers were instructed,
      to mix each sachet with 2-3 tablespoons of the home-prepared food, to be fed to the child
      before the rest of the food was offered.

      After the end of the first week of supplementation, a field worker visited the household of
      each participant to count the empty (used) sachets and ask questions about any child illness.
      At the end of two weeks, a field worker visited each participant in his/her home to repeat
      the morbidity questionnaire and conduct an exit interview with the mother/caregiver to assess
      their perceptions, use and possible intra-household distribution of the product,
      ease/difficulty of providing the supplement 2 times/day, and foods used to mix with the
      supplement.

      In addition, open ended questions were asked at the exit interview to explore the caregivers'
      views about important characteristics of foods appropriate for infants and young children,
      opportunities and barriers to using a nutrient supplement "just for children of a certain
      age" in the family, perceptions of the use of LNS for children, and recognition of the
      problem of malnutrition in their communities.

      The FGD were led by an experienced focus group facilitator, assisted by a note-taker who
      audio-recorded the discussions and took notes on group dynamics and non-verbal interactions
      between participants. Each focus group included 8-10 participants, and lasted for
      approximately 60-90 minutes.

      Four FGD (two per community) were conducted with primary caregivers of the children who had
      consumed LNS during the test-feeding and the home-use trial. The main purpose of the FGD was
      to get input on appropriate supplement names and packaging designs for the LNS product in
      Guatemala, flavors appropriate for infants and young children, and appropriate messages for
      promotion of LNS for children. A brainstorming approach was used to explore possible names
      for the supplement, followed by secret vote to short list the names based on participants'
      preferences. Exploration of ideas about packaging designs started with drawings which were
      then organized by theme. A discussion to generate consensus on the key elements that the
      label should include was facilitated. A group design for the packaging was the final product
      of FGD.

      The main objective of the FGD with Funcafé personnel was to elicit their opinion on how the
      LNS could be incorporated into Funcafé's program operation.
    

Intervention name(s): LNS
Intervention type(s): Dietary Supplement
Intervention description(s): Infants and young children will receive 10 g of LNS for test trial during 3 consecutive days (crossover design) and thereafter, 20 g per day for 14 days.
Other intervention name(s): Lipid-based nutrient supplement
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        - Children 6-18 months of age.
      
Keywords: Lipid-based supplements; LNS; Acceptability; Infant nutrition; Guatemala; Malnutrition