Mothers and CareGivers Investing in Children Study 2.0

NCT06719102 | Recruiting DMC

• 1 other identifier: UT Austin IRB#STUDY00005620
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 2

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

Keywords

Parenting; Infant Feeding; Infant Nutrition; Prevention; Trial

Outcome Measures

Primary Outcomes (4)

• Infant Body Mass Index Z-score (BMIZ) at 13 and 24 months

  Assessed via anthropometrics and WHO Child Growth Standards.

  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.

  0-13 months

• Infant self-regulation during feeding

  Infant self-regulation during feeding coded from video observation via the Nursing Child Assessment Feeding Scale.

  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).

  24 months

Secondary Outcomes (13)

• Caregiver nutrition knowledge

  0-24 months

• Caregiver sensitivity

  0-24 months

• Solid food introduction timing

  0-8 months

• Percentage body fat

  13 & 24 months

• Proportion with BMIZ >=95%ile

  13 & 24 months

Study Arms (2)

MAGIC-SAFE

PLACEBO COMPARATOR

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.

Behavioral: MAGIC-SAFE

MAGIC-FEED

EXPERIMENTAL

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.

Behavioral: MAGIC-FEED

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-FEED

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.

MAGIC-SAFE

Eligibility Criteria

• Age: 0 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas at Austin: lead
• National Institutes of Health (NIH): collaborator

Study Sites (2)

Sarah M. & Charles E. Seay Building

Austin, Texas, 78712, United States

NOT YET RECRUITING

Dell Pediatric Research Institute

Austin, Texas, 78723, United States

RECRUITING

Study Officials

• Elizabeth Widen, PhD, RD

  UT Austin

  PRINCIPAL INVESTIGATOR

• Deborah Jacobvitz, PhD

  UT Austin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Widen, PhD, RD

CONTACT

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

Deborah Jacobvitz, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: December 5, 2024
• Study Start: February 13, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

US (2)