The Effects ofComplementary Feeding of Eggs on Infant Developmentand Growth in Guatemala: The Saqmolo Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Guide for Monitoring Child Development (GMCD)
研究概览
简要总结
The specific aims of this study are:
In a randomized controlled trial, the investigators will evaluate the impact of daily egg consumption during the complementary feeding period in addition to the local standard of nutrition care (i.e., intervention group), compared to the local standard of nutrition care alone (i.e., control group) on the following outcomes, in infants that are ~6-month old at baseline:
- Child development, as measured by global development scores (primary outcome)
- Growth, as measured by anthropometrics (secondary outcome)
- Diet quality, as measured by the World Health Organization infant and young child feeding indicators (secondary outcome)
Hypothesis: The investigators hypothesize that daily consumption of eggs during the complementary feeding period, in addition to the local standard of nutrition care, will improve child development, growth, and diet quality compared to the local standard of care alone.
详细描述
Background: Approximately 150 million children, or roughly one-quarter of children worldwide, experience stunting (low height-for-age), while 20% are underweight.1 World-wide, undernutrition is estimated to be responsible for 2.2 million deaths and 21% of Disability-Adjusted Life Years (DALYs) in children less than 5 years of age. 1 The recent United Nations Sustainable Development Goals call for reducing stunting and wasting in children <5 years by 40%, which would affect 90 million children worldwide 1.
The global attention to stunting is based on the premise that any intervention aimed at improving linear growth may subsequently lead to improvements in the correlates of stunting 2. In children, stunting is consistently associated with poor developmental outcomes3. However, optimal interventions to concurrently address stunting and child development still need to be identified3-9.
In Guatemala, stunting is a serious public health problem10,11. The overall prevalence of stunting in children under 5 years of age in Guatemala is close to 50% and is even higher (close to 70%) for indigenous children12. The majority of indigenous families in Guatemala live on less than $2 (USD) per day and have inadequate access to health and nutrition services.
Wuqu' Kawoq-Maya Health Alliance (MHA) (http://www.wuqukawoq.org) is a non-governmental organization, located in Tecpán, Guatemala, working with vulnerable indigenous communities to provide culturally and linguistically appropriate healthcare services. MHA is currently collaborating with the Academy of Nutrition and Dietetics/UNM on projects to address malnutrition in rural Guatemala.
This study will specifically focus on evaluating the impact of regular egg consumption from about 6-12 months of age, in addition to the local standard of nutrition care, as an intervention to improve development, growth and diet quality in Mayan children. Eggs are a rich source of nutrients important to child growth and development: essential fatty acids, choline, vitamins A, and B12, and bioavailable iron, zinc and iodine13. Individual components of eggs may be associated with improved cognitive development in healthy populations, as recently reviewed by Wallace14. Eggs are culturally acceptable as part of the typical Mayan diet, are generally more affordable than other animal-source foods and are relatively simple to store and prepare15. A recent study found that egg consumption (1 egg/d for 6 months) reduced stunting in mixed-indigenous rural Andean children in Ecuador by 47% (HR: 0.53; 95% CI: 0.38-0.88);16 however, child cognitive development was not assessed in this small intervention study. This study will address a gap in understanding the impact of egg consumption, combined with other common interventions to address undernutrition in low- and middle-income settings, on both child development and growth.
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 (Investigator)
入排标准
- 年龄范围
- 6 Months 至 9 Months(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants who are 6.0-9.0 months of age at baseline
- •At least one caregiver willing to provide oral informed consent
- •Planned residence in the study area for approximately the next 18 months
- •Singleton birth
排除标准
- •Infants with moderate to severe acute malnutrition (weight-for-length z-score < -2)
- •Infants with severe anemia (Hgb <7 g/dL per WHO guidelines, with adjustments for altitude as necessary)
- •Infants with a chronic medical condition that affects growth (e.g., congenital heart disease, genetic condition) as determined by the MHA staff physician
- •Infants whose caregivers have cognitive or other impairments that prevent them from being able to provide informed consent or to reliably provide information required for the developmental assessments
- •Infants with a known egg allergy
- •Infants with recalcitrant, moderate-to-severe atopic dermatitis
- •Infants with a history of anaphylaxis or serious allergic reaction to any substance requiring emergency medical care
- •Concurrent participation in any other clinical trial
研究组 & 干预措施
Control
The standard of nutrition care in Guatemala includes the following clinical care, as determined to be necessary by the MHA medical and nutrition teams: frequent growth monitoring, general nutrition education, parasite treatment, and multiple micronutrient supplementation.
干预措施: Standar of care (Other)
Intervention
The intervention group will receive an intervention to promote daily egg consumption for a six month period, in addition to the local standard of nutrition care. Specifically, intervention group participants will be provided with enough eggs for the infant to consume one egg, daily, for six months, and also with education on preparation and consumption of eggs.
干预措施: Eggs plus standard of care (Dietary Supplement)
结局指标
主要结局
Guide for Monitoring Child Development (GMCD)
时间窗: 6 months
The GMCD has been used in low- and middle-income countries in children ages 0-24 months and focuses on seven areas: expressive language, receptive language, fine motor, gross motor, relating, play, and self-help.
Caregiver Reported Child Development Instruments (CREDI)
时间窗: 6 months
The long form CREDI uses caregiver report and captures five domains: motor, language, cognition, social-emotional, and mental health. The CREDI is designed specifically to measure normal development within populations and has been tested in high, middle and low income countries The CREDI included a Guatemalan sample in the validation
次要结局
- length-for-age(6 months)
- Infant diet quality(6 months)
- changes in infant hemoglobin(6 months)
- weight-for-age(6 months)
- Head circumference(6 months)
