The INICIO-Guatemala Study

Официальное название

IGHID 12601 - Improving Neurodevelopment With an Intestinal Health and Caregivers' Intervention in the surOeste, Guatemala: The INICIO-Guatemala Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка Nutri-INICIO
  Nutri-INICIO, is a fortified maize-bean-rice bran porridge intended to improve intestinal health and growth. Caregivers will be instructed on Nutri-INICIO preparation methods. Children 6-11 months old will receive a 20 gram daily serving, children 12-17 months old will receive a 30 gram daily serving, children 18-24 months old will receive a 40 gram daily serving. The investigators will ensure receipt of the essential components of the ministry of health childcare package including micronutrient
• Поведенческое Mediational Intervention for Sensitizing Caregivers (MISC
  The Mediational Intervention for Sensitizing Caregivers (MISC) consists of twice-monthly, video-feedback-based training sessions from 12-24 months to enhance responsive caregiving. The investigators will ensure receipt of the essential components of the ministry of health childcare package including micronutrient supplementation and anti-parasite prophylaxis. Participants will also receive anemia screening and treatment as appropriate.
• Другое Active Control
  The control group will receive the same number of visits as the experimental groups and the investigators will ensure receipt of the essential components of the ministry of health childcare package including micronutrient supplementation and anti-parasite prophylaxis. Participants will also receive anemia screening and treatment as appropriate.

Первичные конечные точки

• Mullen Scales of Early Learning (MSEL) Early Learning Composite Score (ELC) [Срок оценки: 24 months of age]

Вторичные конечные точки (5)

• Mullen Scales of Early Learning Gross Motor Domain [Срок оценки: 24 months]
• Mullen Scales of Early Learning Fine Motor Domain [Срок оценки: 24 months]
• Mullen Scales of Early Learning Visual Reception Domain [Срок оценки: 24 months]
• Mullen Scales of Early Learning Receptive Language Domain [Срок оценки: 24 months]
• Mullen Scales of Early Learning Expressive Language Domain [Срок оценки: 24 months]

Критерии участия

The investigators will offer enrollment to pregnant in the Trifinio region of southwest Guatemala and will enroll their newborns after birth.

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Guatemala · 1 центр

• Fundacion para la Salud Integral de los Guatemaltecos — Coatepeque

Идентификаторы

NCT: NCT07383428 · 26-0089 · R01HD116306

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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