Mothers and CareGivers Investing in Children Study 2.0

Part of paid clinical trials in Austin, Texas.

Sponsor
University of Texas at Austin
Study ID
NCT06719102
Status
Recruiting

Conditions

  • Childhood Obesity Prevention
  • Infant Growth
  • Parenting Behavior

Eligibility Criteria

Sex
ALL
Age
0 Years - 90 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Feb 13, 2025
Status verified
Jun 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
266 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Placebo Comparator: 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.
  • Experimental: 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.

Primary Outcome Measure

Infant Body Mass Index Z-score (BMIZ) at 13 and 24 months [ Time Frame: 13 & 24 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Dell Pediatric Research InstituteAustinTexas78723
Elizabeth Widen
Sarah M. & Charles E. Seay BuildingAustinTexas78712
Deborah Jacobvitz

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