Mothers and CareGivers Investing in Children Study 2.0 (NCT06719102) | Clinical Trial Compass
RecruitingNot Applicable
Mothers and CareGivers Investing in Children Study 2.0
United States266 participantsStarted 2025-02-13
Plain-language 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.
Who can participate
Age range
0 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Infant Body Mass Index Z-score (BMIZ) at 13 and 24 months