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临床试验/NCT04785352
NCT04785352已完成不适用

Grandi Byen: Supporting Child Growth and Development Through Integrated, Responsive Parenting, Nutrition and Hygiene

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2021年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
600
试验地点
1
主要终点
Child Development: Changes in ASQ Gross Motor score

研究概览

简要总结

The premise of this trial is that a combined nutrition (eggs) and parenting behavior intervention (responsive parenting combined with the reinforcement of animal source foods and improved WASH) will synergistically result in improved child growth, development, and reduced enteric disease outcomes over and above a nutrition only intervention and standard well baby care.

This study is a 3-arm longitudinal randomized controlled trial (RCT) to compare the following groups for effectiveness in reducing young child stunted growth and enhancing overall development:1) standard well-baby care, (n=200); 2) nutrition intervention (one egg per day for 6 months), (n=200); and 3) multicomponent Grandi Byen intervention (responsive parenting, nutrition, hygiene + one egg per day for 6 months), (n=200).

Infants will be enrolled between 6-8 months of age and followed longitudinally for one year.

详细描述

A disturbingly high number of young children around the world experience stunted growth and development with irreparable consequences through the lifespan. Determinants of stunted growth and development are multi-factorial, including interactions between biological, behavioral, social, and environmental conditions, yet the evidence-base is minimal for integrated approaches to tackle the interwoven factors. Our group recently found significant impacts from an egg intervention on young child growth and biomarkers of nutrition and brain development. The effects on important psychosocial indicators of child development, however, were not assessed. Building on these findings and those of our pilot study of a group-based, multicomponent intervention (Grandi Byen, Haitian Creole for "grow well"), this randomized controlled trial (RCT) seeks to examine a greater breadth of egg intervention outcomes, the synergistic effects of adding psychoeducational parenting to the egg intervention, and mediating biological, behavioral and social factors.

The 3-arm longitudinal RCT will be carried out in Cap-Haitien, Haiti, where our group has a decade of research experience, established partnerships, and a strong research infrastructure. It is representative of resource-poor urban contexts globally, where parents face common economic and environmental challenges to child growth and development. The trial will compare the following groups for effectiveness in reducing young child stunted growth and enhancing overall development: 1) standard well-baby care, (n=200); 2) nutrition intervention (one egg per day for 6 months), (n=200); and 3) multicomponent Grandi Byen intervention (responsive parenting, nutrition, hygiene + one egg per day for 6 months), (n=200). Infants will be enrolled between 6-8 months of age and followed longitudinally for one year.

The specific aims of this project are:

Aim 1 (primary): To demonstrate the reproducibility and feasibility of egg-based interventions in reducing childhood stunting, and test its impact on development. Hypothesis 1: Linear growth will be increased by 0.30 LAZ in children receiving one egg per day compared to standard care. Hypothesis 2: Children receiving the egg intervention will have better cognitive, motor and language development compared to standard care. Question 1 (exploratory): Does an egg-based intervention impact social-emotional development?

Aim 2 (primary): To investigate the incremental benefit of Grandi Byen compared to egg only and standard care groups on primary outcomes of child growth and development. Hypothesis 3: Children of mothers receiving Grandi Byen will increase linear growth by 0.10 LAZ compared to the egg intervention. Hypothesis 4: Children of mothers receiving Grandi Byen will have higher scores on child cognition, language, motor, and socio-emotional development, with an effect size of 0.36 on cognition, compared to standard care. An economic evaluation will be conducted to compare the efficiency of the interventions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Raters assessing responsive parenting and child development outcomes will be blind to the condition of mother-child dyads.

For investigators, they will be blinded to participants' assigned study arms before and during handling and analysis of the data.

入排标准

年龄范围
6 Months 至 8 Months(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Mothers/Caregivers 18 years or older of infants ages 6-8 months
  • •Infants ages 6-8 months
  • •Living in Petite Anse, Fort Saint Michel, Madeline, or similiar communities (Cap-Haitien, Haiti)

排除标准

  • •Multi-birth infant (twin, triplet, etc.)
  • •congenital health condition
  • •severe disabilities
  • •severely malnourished (WLZ<-3)
  • •child has an allergy to animal-source foods (specifically eggs, milk, or fish).

研究组 & 干预措施

Nutrition Intervention

Experimental

Children in this arm will receive one egg per day for six months.

干预措施: Nutrition Intervention (Dietary Supplement)

Grandi Byen

Experimental

This arm comprises a multicomponent intervention on responsive parenting, nutrition, hygiene, and one egg per day for six months for children.

干预措施: Grandi Byen (Behavioral)

Standard well-baby care

No Intervention

Children in this arm (control group), as well as children in the two intervention groups, will receive standard care as outlined in the Essential Package of Health Services by Haiti's Ministry of Public Health and Population (MSPP). This includes a World Health Organization (WHO) immunization schedule of vaccines, high dose vitamin A supplements, and growth monitoring and promotion.

结局指标

主要结局

Child Development: Changes in ASQ Gross Motor score

时间窗: Baseline and months 6 and 12

The Ages \& Stages Questionnaire (ASQ-3) will be used to assess and score children's gross motor development.

Child Development: Changes in ASQ Communication score

时间窗: Baseline and months 6 and 12

The Ages \& Stages Questionnaire (ASQ-3) will be used to assess and score children's communication skills.

Child Growth: Changes in weight-for-age Z-score (WAZ)

时间窗: Baseline and months 3, 6, 9, and 12

Child weight will be measured in kilograms (kg). Weight-for-age Z-scores will be calculated using the World Health Organization (WHO) growth standards, accounting for the child sex and age in months.

Child Growth: Changes in head circumference-for-age Z-score (HCZ)

时间窗: Baseline and months 3, 6, 9, and 12

Child head circumference will be measured in centimeters (cm). Head circumference-for-age Z-scores will be calculated using the World Health Organization (WHO) growth standards, accounting for the child sex and age in months.

Child Development: Changes in ASQ- Socio-Emotional (ASQ-SE) score

时间窗: Baseline and months 6 and 12

The Ages \& Stages Questionnaire: Socio-Emotional Questionnaire (ASQ-SE2) will be used to assess and score child socio-emotional development.

Child Development: Changes in ASQ Fine Motor score

时间窗: Baseline and months 6 and 12

The Ages \& Stages Questionnaire (ASQ-3) will be used to assess and score children's fine motor development.

Child Growth: Changes in length-for-age Z-score (LAZ)

时间窗: Baseline and months 3, 6, 9, and 12

Child length or height will be measured in centimeters (cm). Length-for-age Z-scores will be calculated using the World Health Organization (WHO) growth standards, accounting for the child sex and age in months.

Child Development: Changes in ASQ Problem Solving score

时间窗: Baseline and months 6 and 12

The Ages \& Stages Questionnaire (ASQ-3) will be used to assess and score children's problem solving skills.

次要结局

  • Child Nutrient Biomarkers: Changes in Plasma Concentration of Zinc (Zn)(Baseline and month 6)
  • Responsive Parenting: Changes in PICCOLO Encouragement Score(Baseline and months 6 and 12)
  • Child Bone Health: Changes in Bone Age Z-score(Baseline and months 3, 6, and 12)
  • Responsive Parenting: Changes in PICCOLO Affection Score(Baseline and months 6 and 12)
  • Responsive Parenting: Changes in PICCOLO Responsiveness Score(Baseline and months 6 and 12)
  • Child Nutrient Biomarkers: Changes in Plasma Concentration of Iodine (I)(Baseline and month 6)
  • Child Nutrient Biomarkers: Changes in Plasma Concentration of Selenium (Se)(Baseline and month 6)
  • Child Nutrient Biomarkers: Changes in Plasma Concentration of Docosahexaenoic acid (DHA)(Baseline and month 6)
  • Child Nutrient Biomarkers: Changes in Plasma Concentration of Choline(Baseline and month 6)
  • Child Nutrient Biomarkers: Changes in Plasma Concentration of Iron (Fe)(Baseline and month 6)
  • Child Dietary Intake(Baseline and months 6 and 12)
  • Responsive Parenting: Changes in HOME Scores(Baseline and months 6 and 12)
  • Child Morbidities(Baseline and months 3, 6, 9, 12)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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