IGHID 12601 - Improving Neurodevelopment With an Intestinal Health and Caregivers' Intervention in the surOeste, Guatemala: The INICIO-Guatemala Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Mullen Scales of Early Learning (MSEL) Early Learning Composite Score (ELC)
研究概览
简要总结
The goal of this randomized controlled trial (RCT) is to evaluate an intestinal health-targeted nutritional intervention and a caregiver training program, individually and combined, on childhood neurodevelopment (ND) in rural southwest Guatemala.
The main questions it aims to answer are: what is the impact of an intestinal-targeted nutritional intervention on child ND and what is the added benefit of a caregiver intervention on child ND.
The primary endpoint is the Mullen Scales of Early Learning (MSEL) Early Learning Composite (ELC) Score at 24 months. Secondary endpoints include MSEL subdomain scores (gross motor, fine motor, expressive language, receptive language, visual reception).
Researchers will compare child ND between the four study arms using a factorial design: (1) intestinal health-targeted nutritional intervention, (2) caregiving training program, (3) combined intestinal health-targeted nutritional intervention and caregiving training program, and (4) active control.
Participants will be randomized as mother-child dyads at 6 months of age and followed until 24 months of age.
详细描述
The investigators plan to enroll 400 pregnant women during the second trimester of pregnancy; randomization of mother-child dyads into the four study groups will occur at 6 months of infant age; infants will be followed through 24 months of age. Randomization will occur using a 2×2 factorial design into the four groups. The nutritional intervention, Nutri-INICIO, is a fortified maize-bean-rice bran porridge intended to improve intestinal health and growth. The caregiver intervention, the Mediational Intervention for Sensitizing Caregivers (MISC), consists of twice-monthly, video-feedback-based training sessions from 12-24 months to enhance responsive caregiving.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 0 Days 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The investigators will offer enrollment to pregnant in the Trifinio region of southwest Guatemala and will enroll their newborns after birth.
- •Inclusion Criteria:
- •Pregnant woman in the second trimester of pregnancy
- •Pregnant woman =>15 years of age
- •Plan to live in the study area during pregnancy and up to 24 months after giving birth
- •Newborns born to enrolled women will join the study at birth
排除标准
- •Pregnant woman less than 15 years of age
- •Planning to move during the study
- •Not willing or able to participate in the interventions, including following instructions for preparing the food, completing the adherence forms, participating in the caregiving sessions
- •Women who do not sign the consent form for their or their child's participation
- •Infants who require a hospital stay after birth of 21 days or longer
研究组 & 干预措施
Nutritional Intervention and Caregiver Intervention
Children in this arm will receive the Nutri-INICIO intervention between 6 and 24 months of age and their caregivers will be trained in the MISC between 12 and 24 months of child age.
干预措施: Mediational Intervention for Sensitizing Caregivers (MISC (Behavioral)
Nutritional Intervention
Children in this arm will receive the Nutri-INICIO intervention between 6 and 24 months of age.
干预措施: Nutri-INICIO (Dietary Supplement)
Caregiver Intervention
Caregivers of child participants in this arm will be trained in the Mediational Intervention for Sensitizing Caregivers (MISC) between 12 and 24 months of child age.
干预措施: Mediational Intervention for Sensitizing Caregivers (MISC (Behavioral)
Active Control
Children in this arm will receive the same number of study visits as the experimental groups and will receive essential components of the Minister of Health's childcare package, including micronutrient supplementation.
干预措施: Active Control (Other)
Nutritional Intervention and Caregiver Intervention
Children in this arm will receive the Nutri-INICIO intervention between 6 and 24 months of age and their caregivers will be trained in the MISC between 12 and 24 months of child age.
干预措施: Nutri-INICIO (Dietary Supplement)
结局指标
主要结局
Mullen Scales of Early Learning (MSEL) Early Learning Composite Score (ELC)
时间窗: 24 months of age
Comprehensive neurodevelopment score, combining scores from the four "cognitive" domains of fine motor, visual reception, receptive language, and expressive language. Z-scores for each of the 4 domains will be calculated by regressing raw score for age. The mean of those four Z-scores will make up the Early Learning Composite Z-score. The score will range from -3 to +3, with the higher score indicating more advanced neurodevelopment.
次要结局
- Mullen Scales of Early Learning Gross Motor Domain(24 months)
- Mullen Scales of Early Learning Fine Motor Domain(24 months)
- Mullen Scales of Early Learning Visual Reception Domain(24 months)
- Mullen Scales of Early Learning Receptive Language Domain(24 months)
- Mullen Scales of Early Learning Expressive Language Domain(24 months)