Mothers and CareGivers Investing in Children Study 2.0
Part of paid clinical trials in Austin, Texas.
- Sponsor
- University of Texas at Austin
- Study ID
- NCT06719102
- Status
- Recruiting
Conditions
- Childhood Obesity Prevention
- Infant Growth
- Parenting Behavior
Eligibility Criteria
- Sex
- ALL
- Age
- 0 Years - 90 Years
- Healthy Volunteers
- Accepted
Interventions
- MAGIC-FEED — BEHAVIORALParents 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 — BEHAVIORALParents 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 Details
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.
Key Dates
- Start date
- Feb 13, 2025
- Status verified
- Jun 2026
- Primary completion
- Dec 31, 2028
- Completion
- Dec 31, 2029
Study Design
- Enrollment
- 266 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Placebo Comparator: MAGIC-SAFEParents 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-FEEDParents 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.
Primary Outcome Measure
Infant Body Mass Index Z-score (BMIZ) at 13 and 24 months [ Time Frame: 13 & 24 months ]
Central Contacts
- Elizabeth Widen, PhD, RD512-471-0941
- Deborah Jacobvitz, PhD
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Dell Pediatric Research Institute | Austin | Texas | 78723 | Elizabeth Widen |
| Sarah M. & Charles E. Seay Building | Austin | Texas | 78712 | Deborah Jacobvitz |
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