Clinical trial NCT06719102: Mothers and CareGivers Investing in Children Study 2.0
Official title: Mothers and CareGivers Investing in Children: MAGIC 2.0
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Childhood Obesity Prevention
Parenting Behavior
Infant Growth
Keywords: Parenting
Infant Feeding
Infant Nutrition
Prevention
Trial
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2024-12-05
Enrollment: 266
Sex: ALL
Minimum age (years): 0
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Infant Body Mass Index Z-score (BMIZ) at 13 and 24 months
timeFrame: 13 & 24 months
measure: Infant dietary quality index
timeFrame: 0-13 months
measure: Infant self-regulation during feeding
timeFrame: 0-13 months
measure: Eating self-regulation
timeFrame: 24 months
Secondary outcomes:
measure: Caregiver nutrition knowledge
timeFrame: 0-24 months
measure: Caregiver sensitivity
timeFrame: 0-24 months
measure: Solid food introduction timing
timeFrame: 0-8 months
measure: Percentage body fat
timeFrame: 13 & 24 months
measure: Proportion with BMIZ >=95%ile
timeFrame: 13 & 24 months
measure: BMIZ change from 3 wk to 24 months
timeFrame: 0-24 months
measure: Child self-regulation
timeFrame: 24 months
measure: Caregiver infant feeding practices
timeFrame: 0-24 months
measure: Baby Eating Behavior
timeFrame: ~ 8 months
measure: Child Eating Behavior
timeFrame: 24 months
measure: Duration of exclusive breastfeeding
timeFrame: 0-24 months
measure: Sugary beverages before 12 months
timeFrame: 0-12 months
measure: Child self-regulation
timeFrame: 13 months
Other outcomes:
Locations:
city: Austin
country: United States
facility: Sarah M. & Charles E. Seay Building
state: Texas
city: Austin
country: United States
facility: Dell Pediatric Research Institute
state: Texas
Study officials:
affiliation: UT Austin
name: Elizabeth Widen, PhD, RD
role: PRINCIPAL_INVESTIGATOR
affiliation: UT Austin
name: Deborah Jacobvitz, PhD
role: PRINCIPAL_INVESTIGATOR
References: