Combined Nutrition and Parenting Study

Официальное название

Impact of Combined Nutrition, Responsive Parenting, and Health Intervention on Childhood Development Study

Обзор

This study aims to evaluate whether early childhood development is improved by a bundled set of interventions that promote responsive stimulation and improved nutrition by the provision of eggs and dried fish (nutrient-dense animal source foods), and whether, in combination, these stimulation and nutrition interventions are more effective than responsive stimulation or food provision alone.

Подробное описание

The BUNDLE study will examine the effects of a 7-month nutrition and caregiving intervention for female and male caregivers delivered by trained adult community facilitators in rural communities across Liberia. The study will use a four-arm 2x2 factorial cluster randomized design to test the effectiveness of the interventions on primary outcomes of child cognitive, language, motor, and socio-emotional development. In this study, 2240 children aged 6 to 30 months will be recruited from 160 rural communities randomized to a comparison arm or one of the three intervention arms. The comparison arm will receive the local standard of care. Three intervention arms will also receive either a responsive stimulation intervention with female and male caregivers, provision of eggs and dried fish accompanied by nutrition education, or responsive stimulation + provision of eggs and dried fish. We hypothesize that child development will be improved in all intervention arms compared to the comparison arm and in the combined intervention arm compared to the single intervention arms.

Вмешательства

• Поведенческое Responsive stimulation, female and male caregivers
  Caregiving-related social and behavior change (SBC) messages and activities for primary female and secondary (male or female) caregivers focused on responsive stimulation, encompassing responsive caregiver-child interactions and the provision of early learning opportunities.
• Другое Food provision and nutrition education
  Provision of eggs and dried Bonny fish. Nutrition-related social and behavior change (SBC) messages focused on infant and young child feeding (IYCF), the importance of feeding the child eggs and dried fish, and ways to feed these foods to the child.

Первичные конечные точки

• Cognitive Development [Срок оценки: 7 months]
• Language Development [Срок оценки: 7 months]
• Motor Development [Срок оценки: 7 months]
• Socio-emotional Development [Срок оценки: 7 months]

Вторичные конечные точки (12)

• Child height or length-for-age z-score [Срок оценки: 7 months]
• Child weight-for-age z-score [Срок оценки: 7 months]
• Child weight-for-height (or length) z-score [Срок оценки: 7 months]
• Child egg consumption [Срок оценки: 7 months]
• Child fish consumption [Срок оценки: 7 months]
• Child dietary diversity [Срок оценки: 7 months]
• Responsive feeding [Срок оценки: 7 months]
• Early learning opportunities [Срок оценки: 7 months]
• Primary female caregiver social support [Срок оценки: 7 months]
• Primary female caregiver responsive caregiver-child interactions [Срок оценки: 7 months]
• Male caregiver responsive caregiver-child interactions [Срок оценки: 7 months]
• Secondary female caregiver responsive caregiver-child interactions [Срок оценки: 7 months]

Критерии участия

Критерии включения

• Resides in selected community in Liberia
• Household has a child aged 6-30 months at study enrollment
• Child has a primary female caregiver and second (male or female) caregiver ≥ 18 years of age
• Caregivers and child intend to continue residing in the study area for the follow-up duration
• Both primary and second caregiver provide informed consent

Критерии исключения

• Children with known allergies to eggs or fish
• Caregivers with cognitive and severe physical disabilities who are unable to implement intervention activities
• Children with developmental disabilities

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Liberia · 4 центра

• Plan International — Kakata
• Plan International — Sanniquellie
• Plan International — Tubmanburg
• Plan International — Voinjama

Идентификаторы

NCT: NCT07490899 · 1R01HD116874-01 · 1R01HD116874-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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