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