Recruiting

Observational Study

Sponsor:

University of Texas at Austin

Code:

NCT06719102

Conditions

Childhood Obesity Prevention

Parenting Behavior

Infant Growth

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Accepted

Interventions

MAGIC-FEED

MAGIC-SAFE

Study Details

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.

Conditions

Childhood Obesity Prevention

Parenting Behavior

Infant Growth

Study ID

NCT06719102

Start date

Feb 13, 2025

Status verified date

Jun, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

266 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

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.

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.

Primary outcome measure

  • Infant Body Mass Index Z-score (BMIZ) at 13 and 24 months [ Time Frame: 13 & 24 months ]
  • Infant dietary quality index [ Time Frame: 0-13 months ]
  • Infant self-regulation during feeding [ Time Frame: 0-13 months ]
  • Eating self-regulation [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Elizabeth Widen, PhD, RD

512-471-0941widen.lab@austin.utexas.edu

Locations

Dell Pediatric Research Institute

Recruiting

Austin, Texas, United States, 78723

Contacts

Elizabeth Widen

widen.lab@austin.utexas.edu

More Information

Sponsor

University of Texas at Austin

Last update posted

Jun 10, 2026

Last verified

Jun, 2026

Keywords

  • Parenting
  • Infant Feeding
  • Infant Nutrition
  • Prevention
  • Trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas at Austin on 2026-06-10.