Mothers and CareGivers Investing in Children Study 2.0

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

266 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-13

Study Completion Date

2029-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Mothers and CareGivers Investing in Children

NCT04177472

Obesity, Childhood Parenting

ENROLLING_BY_INVITATION NA

Toddler Overweight Prevention Study Among Low-Income Families

NCT02615158

Overweight Obesity Depression

COMPLETED NA

Feeding My Baby - A National WIC Study

NCT02031978

Breast Feeding Infant Nutrition Childhood Obesity +3 more

UNKNOWN

Baby-Feed Web Application for Infant Caregivers to Improve Diets and Weight Gain

NCT05990439

Obesity, Childhood

COMPLETED NA

Mothers and Others: Family-based Obesity Prevention for Infants and Toddlers

NCT01938118

Obesity

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Childhood Obesity Prevention Parenting Behavior Infant Growth

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type PLACEBO_COMPARATOR

MAGIC-SAFE

Intervention Type 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.

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.

Group Type EXPERIMENTAL

MAGIC-FEED

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

0 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes