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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
266
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.
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.
Sarah M. & Charles E. Seay Building
Austin, Texas, United States
NOT_YET_RECRUITINGDell Pediatric Research Institute
Austin, Texas, United States
RECRUITINGInfant Body Mass Index Z-score (BMIZ) at 13 and 24 months
Assessed via anthropometrics and WHO Child Growth Standards.
Time frame: 13 & 24 months
Infant dietary quality index
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.
Time frame: 0-13 months
Infant self-regulation during feeding
Infant self-regulation during feeding coded from video observation via the Nursing Child Assessment Feeding Scale.
Time frame: 0-13 months
Eating self-regulation
Assessed via 'Eating in the Absence of Hunger' experiment using standard protocols (Asta et al. Pediatrics 2016;137(5):e20153786).
Time frame: 24 months
Caregiver nutrition knowledge
Caregiver nutrition knowledge assessed by the Infant Feeding Education Questionnaire.
Time frame: 0-24 months
Caregiver sensitivity
Caregiver responsive feeding/sensitivity with higher scores indicating greater sensitivity. Assessed by Chatoor's Feeding Scale, Hazen Sensitivity Scale and Nursing Child Assessment Feeding Scale.
Time frame: 0-24 months
Solid food introduction timing
Timing of solid food introduction (\<6 mo, \>=6 mo). Assessed by the adapted Infant Feeding Practices III Questionnaire.
Time frame: 0-8 months
Percentage body fat
Percentage body fat assessed via DXA.
Time frame: 13 & 24 months
Proportion with BMIZ >=95%ile
High BMI at 13 \& 24 months
Time frame: 13 & 24 months
BMIZ change from 3 wk to 24 months
BMIZ change from 3 wk to 24 months assessed via anthropometrics and WHO Child Growth Standard.
Time frame: 0-24 months
Child self-regulation
Inhibitory control assessed via behavioral rating from the Barrier Box Tax with higher scores indicating greater regulation.
Time frame: 24 months
Caregiver infant feeding practices
Assessed by the Feeding Practices and Structure Questionnaire.
Time frame: 0-24 months
Baby Eating Behavior
Infant eating behaviors assessed via the Baby Eating Behavior Questionnaire.
Time frame: ~ 8 months
Child Eating Behavior
Child eating behaviors assessed via the Children's Eating Behavior Questionnaire.
Time frame: 24 months
Duration of exclusive breastfeeding
Duration of exclusive breastfeeding assessed via the adapted Infant Feeding Practices III Questionnaire.
Time frame: 0-24 months
Sugary beverages before 12 months
Introduction of sugary beverages prior to 12 months. Assessed via the adapted Infant Feeding Practices III questionnaire.
Time frame: 0-12 months
Child self-regulation
Assessed by the Brief Infant Toddler Social Emotional Assessment (BITSEA) with higher scores indicating greater self-regulation.
Time frame: 13 months
Deborah Jacobvitz, PhD
CONTACT
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