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临床试验/NCT03399617
NCT03399617已完成不适用

Effect of an Innovative Behavioral Change Strategy and SQ-LNS on Stunting and Obesity in Children Living in Baja Verapaz, Guatemala

Inter-American Development Bank1 个研究点 分布在 1 个国家目标入组 1,280 人开始时间: 2018年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,280
试验地点
1
主要终点
Prevalence of anemia

研究概览

简要总结

The primary goal of this study is to assess the impact of an innovative strategy to prevent undernutrition and obesity in early childhood in children 0-24 months in Guatemala. This study is designed to evaluate the impact of promoting adequate infant an young child feeding practices and the use of SQ-LNS (Small Quantity Lipid-Based Nutrient Supplements) on the nutritional status of infants and young children. The study will be conducted in Baja Verapaz, Guatemala in conjunction with Fundazucar, Guatemala.

详细描述

SPOON Guatemala is an innovative strategy to prevent undernutrition and obesity in children aged 0-24 months living in high-poverty areas of Guatemala. SPOON focuses on improving feeding practices for infant and young children, including exclusive breastfeeding, and promote the use of home-fortification with peanut-based SQ-LNS (small quantity lipid-based nutrient supplements) through a novel behavior change strategy.

The study will recruit children between 0 and 3 months of age as well as pregnant women in the third trimester. Mothers or caregivers of eligible children will be invited to participate and a consent form obtain. Participation will start at 0-6 months and the intervention will last until children are 24 months. Participants will be randomly assigned at the community level to one of two groups: a control group and a treatment group. Participants in the control group will receive the standard services provided by their local health clinics in addition to a supply of micronutrient powders from 6-24 months of age, according to the national protocol. Participants in the treatment group will be randomly assigned at an individual level to receive two different interventions:

Treatment 1: This group will receive SQ-LNS supplement from 6-24 months and an innovative behavioral change strategy designed using ethnographic and marketing methods to promote adequate infant and young child feeding practices and the use of SQ-LNS. The strategy will be delivered to mothers or caregivers through individual home-visits, group sessions, and community mobilization activities.

Treatment 2. This group will receive micronutrient powders from 6-24 months and an innovative behavioral change strategy designed using ethnographic and marketing methods to promote adequate infant and young child feeding practices and the use of SQ-LNS. The strategy will be delivered to mothers or caregivers through individual home-visits, group sessions, and community mobilization activities.

A sample size of 500 children per group has been calculate to detect a minimum effect size of 0.2 with 95% level of significance and a 80% power for use of SQ-LNS. Additionally, a sample size of 40 communities and 500 children per group has been calculated to detect a minimum detectable effect size of 0.32 for communication.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
— 至 3 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Pregnant women in the third trimester or children 3 months of age
  • Living in the defined intervention areas
  • Children with no chronic diseases or congenital malformations
  • Not planning on moving far from the intervention area in the next 24 months

排除标准

  • Children with any chronic disease or congenital malformation
  • Caretakers of the children plan on moving in the next 24 months
  • Children with severe acute malnutrition

结局指标

主要结局

Prevalence of anemia

时间窗: Measured at 6 and 24 months of age

Population estimation of anemia using hemoglobin

Infant and young child feeding practices

时间窗: Measured at baseline and after 24 months of intervention

Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers

Height

时间窗: Measured at 6 and 24 months of age

Height-for-age z score obtained by measuring the height of participant children

Weight gain rate

时间窗: Constructed from weight measurements at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 months of age

Rate of weight gain from 0-24 months of age

Hemoglobin

时间窗: Measured at 6 and 24 months of age

Measurement of hemoglobin using a portable photometer

Prevalence of obesity in children

时间窗: Measured at 6 and 24 months of age

Population estimation of obesity using Population estimation of obesity using Body Mass Index (BMI)

Prevalence of stunting

时间窗: Measured at 6 and 24 months of age

Population estimation of stunting using height-for age \<-2 SD

次要结局

  • Adherence to Nutritional Supplement Regime(Measured every months from 6 months of age until the end of the intervention)
  • Exclusive Breastfeeding(Measured 24 months after the start of the intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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