Mothers and CareGivers Investing in Children Study 2.0

Официальное название

Mothers and CareGivers Investing in Children: MAGIC 2.0

Обзор

The study will use a longitudinal, randomized control trial design to determine intervention impact on parent and child behaviors, and infant health. The two intervention groups include: 1) MAGIC-FEED+; and 2) MAGIC-SAFE. This trial is an efficacy trial of the MAGIC-FEED and MAGIC-SAFE program that has been successfully implemented with families as part of the MAGIC 1.0 program trial (IRB#: 2015040017). * The primary aim is to investigate each intervention's impact on infant BMIZ at 13 months. * The investigators will also assess the effect of MAGIC-FEED on caregiver nutrition knowledge and feeding practices, responsive feeding, infant diet, and child self-regulatory abilities and assess how these factors impact child self-regulation of eating and adiposity. * Finally, the investigators will determine if the interventions demonstrate the factors necessary to be a successful intervention as determined by the RE-AIM and PRISM frameworks.

Подробное описание

Obesity is a significant public health problem and risk begins early in life. In the US, over 19% of children ages 2-19 have obesity with 6% of these children classified with severe obesity. Obesity prevalence is lower among 2- to 5-year-old children (13.4%); however, by age 6, one in 5 children has obesity. Rapid weight gain over the first year of life is associated with overweight or obesity in toddlers and young children, which then tracks across the life course. It is critical to intervene on modifiable factors early in life to support healthy growth and prevent obesity. This trial is implemented across the first year in this population to support child diet quality, self-regulatory skills related to eating and growth to prevent obesity.

Interventions during the first year of life have been implemented to prevent child obesity. Most focus on breast and bottle feeding during the first 6 months or feeding across infancy. Few have demonstrated lasting effects beyond infancy on a relative body size measure that accounts for height such as BMIZ, and none have reported effects on long-term adiposity measured with a sensitive assessment tool or have successfully impacted long-term relative body size or adiposity. Further, prior RCTs have predominately been conducted via home visits. MAGIC 2.0 uses a virtual platform which will allows us to leverage the well-established effectiveness of home visiting to be accessible to caregivers with young children.

Вмешательства

• Поведенческое MAGIC-FEED
  Parents will be provided with responsive feeding coaching to help them recognize hunger and satiety cues and nutrition coaching that includes bottle-/breast-feeding and complementary feeding in alignment with the Dietary Guidelines. The intervention is delivered via virtual visits, binder, website and newsletters.
• Поведенческое MAGIC-SAFE
  Parents will be provided with information about age-appropriate safety topics, including safe sleeping, car seats, baby-proofing, etc. The intervention is delivered via virtual visits, binder, website and newsletters.

Первичные конечные точки

• Infant Body Mass Index Z-score (BMIZ) at 13 and 24 months [Срок оценки: 13 & 24 months]
• Infant dietary quality index [Срок оценки: 0-13 months]
• Infant self-regulation during feeding [Срок оценки: 0-13 months]
• Eating self-regulation [Срок оценки: 24 months]

Вторичные конечные точки (12)

• Caregiver nutrition knowledge [Срок оценки: 0-24 months]
• Caregiver sensitivity [Срок оценки: 0-24 months]
• Solid food introduction timing [Срок оценки: 0-8 months]
• Percentage body fat [Срок оценки: 13 & 24 months]
• Proportion with BMIZ >=95%ile [Срок оценки: 13 & 24 months]
• BMIZ change from 3 wk to 24 months [Срок оценки: 0-24 months]
• Child self-regulation [Срок оценки: 24 months]
• Caregiver infant feeding practices [Срок оценки: 0-24 months]
• Baby Eating Behavior [Срок оценки: ~ 8 months]
• Child Eating Behavior [Срок оценки: 24 months]
• Duration of exclusive breastfeeding [Срок оценки: 0-24 months]
• Sugary beverages before 12 months [Срок оценки: 0-12 months]

Критерии участия

Критерии включения

• A singleton infant 3-9 weeks of age, born ≥37 weeks gestation.
• The mother and other caregiver must be at least 18 years of age.
• The infant must live with the mother.
• Lives within the Austin metropolitan area.
• English or Spanish speaking.
• The primary caregiver must identify as the mother.

Критерии исключения

• Infant diagnosed with major physical disabilities and/or medical condition that affects feeding and growth, and/or born <37 weeks gestation.
• Infant experienced NICU stay >7 days.
• Twins, triplets, or other multiples.
• Mothers and/or other caregivers younger than 18 years old.
• Mothers that do not consent to being video recorded with their baby.
• Families that do not speak either English or Spanish will be excluded from this study. Families that only speak English or Spanish, or families that speak English or Spanish and another language, will be accepted.
• Do not plan to remain in Austin area for the next two years.

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

США · 2 центра

• Sarah M. & Charles E. Seay Building — Austin
• Dell Pediatric Research Institute — Austin

Идентификаторы

NCT: NCT06719102 · UT Austin IRB#STUDY00005620

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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