Mothers and CareGivers Investing in Children Study 2.0 (MAGIC 2)

Mothers and CareGivers Investing in Children: MAGIC 2.0

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.

Study Overview

• Status: Recruiting
• Conditions: Infant Growth; Childhood Obesity Prevention; Parenting Behavior
• Intervention / Treatment: Behavioral: MAGIC-SAFE; Behavioral: MAGIC-FEED

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.

• Study Type: Interventional
• Enrollment (Estimated): 266
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Deborah Jacobvitz, PhD
• Study Contact Backup: Name: Elizabeth Widen, PhD, RD; Phone Number: 512-471-0941; Email: widen.lab@austin.utexas.edu

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78723
      • Recruiting
      • Dell Pediatric Research Institute
      • Contact: Elizabeth Widen; Email: widen.lab@austin.utexas.edu
    • Austin, Texas, United States, 78712
      • Not yet recruiting
      • Sarah M. & Charles E. Seay Building
      • Contact: Deborah Jacobvitz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver nutrition knowledge	Caregiver nutrition knowledge assessed by the Infant Feeding Education Questionnaire.	0-24 months
Caregiver sensitivity	Caregiver responsive feeding/sensitivity with higher scores indicating greater sensitivity. Assessed by Chatoor's Feeding Scale, Hazen Sensitivity Scale and Nursing Child Assessment Feeding Scale.	0-24 months
Solid food introduction timing	Timing of solid food introduction (<6 mo, >=6 mo). Assessed by the adapted Infant Feeding Practices III Questionnaire.	0-8 months
Percentage body fat	Percentage body fat assessed via DXA.	13 & 24 months
Proportion with BMIZ >=95%ile	High BMI at 13 & 24 months	13 & 24 months
BMIZ change from 3 wk to 24 months	BMIZ change from 3 wk to 24 months assessed via anthropometrics and WHO Child Growth Standard.	0-24 months
Child self-regulation	Inhibitory control assessed via behavioral rating from the Barrier Box Tax with higher scores indicating greater regulation.	24 months
Caregiver infant feeding practices	Assessed by the Feeding Practices and Structure Questionnaire.	0-24 months
Baby Eating Behavior	Infant eating behaviors assessed via the Baby Eating Behavior Questionnaire.	~ 8 months
Child Eating Behavior	Child eating behaviors assessed via the Children's Eating Behavior Questionnaire.	24 months
Duration of exclusive breastfeeding	Duration of exclusive breastfeeding assessed via the adapted Infant Feeding Practices III Questionnaire.	0-24 months
Sugary beverages before 12 months	Introduction of sugary beverages prior to 12 months. Assessed via the adapted Infant Feeding Practices III questionnaire.	0-12 months
Child self-regulation	Assessed by the Brief Infant Toddler Social Emotional Assessment (BITSEA) with higher scores indicating greater self-regulation.	13 months

Collaborators and Investigators

• Sponsor: University of Texas at Austin
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Elizabeth Widen, PhD, RD, UT Austin; Principal Investigator: Deborah Jacobvitz, PhD, UT Austin

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: October 23, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Actual): December 5, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2025
• Last Update Submitted That Met QC Criteria: April 24, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Prevention; Trial; Parenting; Infant Feeding; Infant Nutrition
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pediatric Obesity
• Other Study ID Numbers: UT Austin IRB#STUDY00005620

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No