Mothers and CareGivers Investing in Children Study 2.0
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-90
SponsorUniversity of Texas at Austin
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- MAGIC-FEED
- MAGIC-SAFE
Treatment groups
266 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Texas at Austin
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov