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临床试验/NCT01148641
NCT01148641已完成不适用

Acceptability of Lipid-based Nutrient Supplements (LNS) for Infants and Young Children in Guatemala

University of California, Davis1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2010年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
1
主要终点
amount of LNS sachets consumed in the home-use trial

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

年龄范围
6 Months 至 18 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Children 6-18 months of age.
  • Consuming solid foods for at least the past 30 days.
  • Apparently healthy and not presently suffering from an acute illness (e.g., fever, diarrhea, acute respiratory tract infection).
  • No known allergy to peanuts or other food products (as reported on the screening questionnaire by the mother/primary caregiver).
  • Not severely malnourished [mid-upper arm circumference (MUAC) > 115 mm].
  • Maternal/caregiver willingness to feed the infant with LNS over a maximum 3 test days, and over the 2 week home-use period, and report on his/her consumption and reactions and practices for daily use. Willingness to participate in discussion groups.
  • Planning to remain in study area for at least the following three weeks.

排除标准

  • Children under 6 months of age.
  • All subjects with known peanut, soy or milk allergies.
  • In poor health or ill at the time of recruitment.
  • Severely malnourished children [mid-upper arm circumference (MUAC) < 115 mm].
  • Not willing to participate in study procedures.
  • Leaving the study area in the following three weeks.

结局指标

主要结局

amount of LNS sachets consumed in the home-use trial

时间窗: 2 weeks

# of sachets consumed

amount of LNS consumed

时间窗: 2 weeks

Amount of LNS consumed in the test trial in grams

time of consumption

时间窗: 2 weeks

Avg how long it takes to eat the LNS mins

次要结局

  • qualitative assessment of mothers and caregivers opinions(2 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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