Clinical trial

Mothers and CareGivers Investing in Children Study 2.0

Recruiting now · Not applicable · 1 countries · Registry ID NCT06719102

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age0 Years to 90 Years

SexAll

Healthy volunteersAccepted

ConditionChildhood Obesity Prevention, Parenting Behavior, Infant Growth

Full registry criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Treatments and study arms

MAGIC-FEED

Behavioral

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.

MAGIC-SAFE

Behavioral

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.

Primary outcomes

Infant Body Mass Index Z-score (BMIZ) at 13 and 24 months13 & 24 months

Assessed via anthropometrics and WHO Child Growth Standards.

Infant dietary quality index0-13 months

Infant dietary quality index (IDQI) score with higher scores indicating higher dietary quality (Au et al. J Nutr 2023, 153(3): 741-748). Calculated with questionnaire data from an adapted Infant Feeding Practices III Food Frequency Questionnaire.

Infant self-regulation during feeding0-13 months

Infant self-regulation during feeding coded from video observation via the Nursing Child Assessment Feeding Scale.

Eating self-regulation24 months

Assessed via 'Eating in the Absence of Hunger' experiment using standard protocols (Asta et al. Pediatrics 2016;137(5):e20153786).

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Dell Pediatric Research Institute🇺🇸 Austin, Texas, United States

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Elizabeth WidenContact

Sarah M. & Charles E. Seay Building🇺🇸 Austin, Texas, United States

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Deborah JacobvitzContact