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Childhood Obesity PreventionMAGIC 2NCT06719102

Mothers and CareGivers Investing in Children Study 2.0

A study testing MAGIC-FEED and MAGIC-SAFE in people with Childhood Obesity Prevention and Parenting Behavior, run by University of Texas at Austin at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 0 to 90 yearsHealthy volunteers can take part
What is being tested?
MAGIC-FEED and MAGIC-SAFE
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
266 participants
Where
2 sitesUnited States
Study dates
13 Feb 2025to 31 Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Elizabeth Widen, PhD, RD contact

512-471-0941

widen.lab@austin.utexas.edu

Deborah Jacobvitz, PhD contact

United States2 sites, 2 recruiting

  • Sarah M. & Charles E. Seay Building

    Austin, Texas, 78712

    Deborah Jacobvitz

    Not yet recruiting

  • Dell Pediatric Research Institute

    Austin, Texas, 78723

    Elizabeth Widen, widen.lab@austin.utexas.edu

    Recruiting

Other trials in United States

About this study

Official title: 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.
Read the 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.

Being tested
MAGIC-FEED, MAGIC-SAFE
Keywords
Parenting, Infant Feeding, Infant Nutrition, Prevention, Trial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MAGIC-FEEDBehavioural

    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-SAFEBehavioural

    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 groups in NCT06719102
Study groupRoleWhat they receive
MAGIC-SAFEPlacebo comparatorParents 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.
Receives: Behavioral: MAGIC-SAFE
MAGIC-FEEDExperimentalParents 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.
Receives: Behavioral: MAGIC-FEED

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Assessed via anthropometrics and WHO Child Growth Standards.

    Measured: 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.

    Measured: 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.

    Measured: 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).

    Measured: 24 months

Secondary outcomes (13)

  1. Caregiver nutrition knowledge

    Caregiver nutrition knowledge assessed by the Infant Feeding Education Questionnaire.

    Measured: 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.

    Measured: 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.

    Measured: 0-8 months

  4. Percentage body fat

    Percentage body fat assessed via DXA.

    Measured: 13 & 24 months

  5. Proportion with BMIZ >=95%ile

    High BMI at 13 \& 24 months

    Measured: 13 & 24 months

  6. BMIZ change from 3 wk to 24 months

    BMIZ change from 3 wk to 24 months assessed via anthropometrics and WHO Child Growth Standard.

    Measured: 0-24 months

  7. Child self-regulation

    Inhibitory control assessed via behavioral rating from the Barrier Box Tax with higher scores indicating greater regulation.

    Measured: 24 months

  8. Caregiver infant feeding practices

    Assessed by the Feeding Practices and Structure Questionnaire.

    Measured: 0-24 months

  9. Baby Eating Behavior

    Infant eating behaviors assessed via the Baby Eating Behavior Questionnaire.

    Measured: ~ 8 months

  10. Child Eating Behavior

    Child eating behaviors assessed via the Children's Eating Behavior Questionnaire.

    Measured: 24 months

  11. Duration of exclusive breastfeeding

    Duration of exclusive breastfeeding assessed via the adapted Infant Feeding Practices III Questionnaire.

    Measured: 0-24 months

  12. Sugary beverages before 12 months

    Introduction of sugary beverages prior to 12 months. Assessed via the adapted Infant Feeding Practices III questionnaire.

    Measured: 0-12 months

  13. Child self-regulation

    Assessed by the Brief Infant Toddler Social Emotional Assessment (BITSEA) with higher scores indicating greater self-regulation.

    Measured: 13 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2024
  2. Study start13 Feb 2025
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
266 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06719102
Sponsor's protocol ID
UT Austin IRB#STUDY00005620
Acronym
MAGIC 2
Status last verified
Jun 2026
First submitted
23 Oct 2024
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing MAGIC-FEED and MAGIC-SAFE in people with Childhood Obesity Prevention and Parenting Behavior, run by University of Texas at Austin at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Elizabeth Widen, PhD, RD (512-471-0941, widen.lab@austin.utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Infant Body Mass Index Z-score (BMIZ) at 13 and 24 months (time frame: 13 & 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06719102.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.

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