Health TrialsbyHealthPanel

Mothers and CareGivers Investing in Children Study 2.0

ConditionsChildhood Obesity PreventionParenting BehaviorInfant Growth
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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

266 Participants
are divided into 2 treatment groups
Group A: MAGIC-SAFEPlacebo comparator 1 intervention
Group B: MAGIC-FEEDExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Assessed via anthropometrics and WHO Child Growth Standards.

Time frame
13 & 24 months
2

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.

Time frame
0-13 months
3

Infant self-regulation during feeding

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

Time frame
0-13 months
4

Eating self-regulation

Assessed via 'Eating in the Absence of Hunger' experiment using standard protocols (Asta et al. Pediatrics 2016;137(5):e20153786).

Time frame
24 months

Secondary outcomes

1

Caregiver nutrition knowledge

Caregiver nutrition knowledge assessed by the Infant Feeding Education Questionnaire.

Time frame
0-24 months
2

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.

Time frame
0-24 months
3

Solid food introduction timing

Timing of solid food introduction (\<6 mo, \>=6 mo). Assessed by the adapted Infant Feeding Practices III Questionnaire.

Time frame
0-8 months
4

Percentage body fat

Percentage body fat assessed via DXA.

Time frame
13 & 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Texas at Austin

Lead sponsor

National Institutes of Health (NIH)

Collaborator

Source ClinicalTrials.gov
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