Parenting Programs for Infant Growth

(MAGIC 2 Trial)

Recruiting at 1 trial location

Overseen By Deborah Jacobvitz, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas at Austin

Disqualifiers: Physical disabilities, NICU stay, multiples, others

Compensation: Varies

Number of Visits: Unknown

266 Participants Needed

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment MAGIC-FEED, MAGIC-SAFE for infant growth?

Research shows that interventions promoting breastfeeding, such as professional support and self-efficacy programs, can improve breastfeeding rates and self-efficacy, which are linked to better infant growth and health outcomes. These findings suggest that similar approaches in parenting programs like MAGIC-FEED and MAGIC-SAFE could be effective in supporting infant growth. ^{1 2 3 4 5}

Is the Parenting Programs for Infant Growth treatment safe for humans?

The research articles reviewed do not provide specific safety data for the Parenting Programs for Infant Growth treatment or its related names like MAGIC-FEED or MAGIC-SAFE. They focus on dietary interventions and obesity prevention in infants, but do not address the safety of these specific programs. ^{6 7 8 9 10}

How is the treatment MAGIC-FEED, MAGIC-SAFE different from other treatments for infant growth?

MAGIC-FEED and MAGIC-SAFE are unique because they focus on parenting programs to support healthy infant growth, potentially preventing obesity by promoting responsive feeding and parenting practices. Unlike other treatments that may focus on direct medical interventions, these programs aim to educate and engage parents in establishing healthy habits early in their child's life. ^{10 11 12 13 14}

Research Team

Elizabeth Widen, PhD, RD

Principal Investigator

UT Austin

Deborah Jacobvitz, PhD

Principal Investigator

UT Austin

Eligibility Criteria

This trial is for mothers and caregivers with a single infant aged 3-6 weeks, born at or after 37 weeks gestation. Participants must be over 18, live in the Austin area, speak English or Spanish, and be the primary caregiver. Excluded are those with infants who had extended NICU stays, multiples births, non-consenting to video recording, planning to move from Austin soon, or infants with conditions affecting feeding/growth.

Inclusion Criteria

I am at least 18 years old.

I am the mother and the primary caregiver.

I speak English or Spanish.

Exclusion Criteria

Infant experienced NICU stay >7 days

Twins, triplets, or other multiples

Mothers that do not consent to being video recorded with their baby

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Parents receive either MAGIC-FEED or MAGIC-SAFE interventions delivered via virtual visits, binder, website, and newsletters

12 months

Regular virtual visits

Follow-up

Participants are monitored for safety and effectiveness after intervention, focusing on infant BMIZ and dietary quality

12 months

Treatment Details

Interventions

• MAGIC-FEED
• MAGIC-SAFE

Trial Overview The study tests two programs: MAGIC-FEED+ (focusing on caregiver nutrition knowledge and infant diet) and MAGIC-SAFE (targeting other aspects of parenting). It's a randomized control trial aiming to see how these interventions affect infant health behaviors and BMIZ at 13 months using frameworks like RE-AIM and PRISM for evaluation.

Participant Groups

Group I: MAGIC-FEED Experimental Treatment 1 Intervention

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 II: MAGIC-SAFE Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

Interventions aimed at helping mothers of infants with medical issues should be evidence-based, focusing on informed decision-making and support for lactation initiation and maintenance.

Strategies should include both counseling and practical methods to increase milk production, specifically tailored to the needs of premature and at-risk infants rather than relying on general practices for healthy infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breastfeeding in the special care nursery. Prematures and infants with medical problems. Meier, PP.[2019]

A study involving 722 first-time mothers showed that professional breastfeeding telephone support significantly increased the rates of any and exclusive breastfeeding at 1 and 2 months postpartum compared to standard care.

The telephone support intervention led to a 63% higher likelihood of continuing any breastfeeding at 1 month and a 89% higher likelihood of exclusive breastfeeding at the same time point, suggesting that ongoing support is crucial for improving breastfeeding duration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Professional breastfeeding support for first-time mothers: a multicentre cluster randomised controlled trial. Fu, IC., Fong, DY., Heys, M., et al.[2022]

A breastfeeding self-efficacy intervention significantly improved breastfeeding self-efficacy and exclusive breastfeeding rates at 4 weeks postpartum in 'Baby-Friendly' certified hospitals, with a notable effect size (AOR 2.32).

In contrast, the same intervention had no positive impact on breastfeeding outcomes in non-Baby-Friendly hospitals, highlighting the importance of supportive hospital practices for the effectiveness of such interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a breastfeeding self-efficacy intervention: do hospital practices make a difference? Otsuka, K., Taguri, M., Dennis, CL., et al.[2022]

Many women stop breastfeeding due to the misconception that their baby is not satisfied, often misinterpreting normal infant behaviors like increased crying or restless sleeping as problems with breastfeeding.

The Roadmap to Breastfeeding Success is an evidence-based project designed to support mothers in achieving their breastfeeding goals by providing professionals with resources and best practices, ultimately promoting the health of families and communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Roadmap to Breastfeeding Success: Teaching Child Development to Extend Breastfeeding Duration. Tedder, J.[2021]

A systematic review and meta-analysis of 35 studies found that breastfeeding promotion interventions did not significantly affect child weight or height, indicating limited impact on overall growth.

However, these interventions were associated with a modest but significant reduction in body mass index (BMI) or weight-for-height z scores, particularly in both low- and high-income settings, suggesting a nuanced effect on child growth metrics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of breastfeeding promotion interventions on child growth: a systematic review and meta-analysis. Giugliani, ER., Horta, BL., Loret de Mola, C., et al.[2022]

The systematic review analyzed 50 studies on dietary mycotoxins and their potential impact on child growth and health, but found very low quality evidence and uncertainty regarding their effects on malnutrition and immunity in children under 5 years old.

While some associations between specific mycotoxins (like aflatoxins and fumonisins) and child malnutrition could not be ruled out, the review highlighted the need for more rigorous studies with larger sample sizes and better detection methods to clarify these relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary mycotoxins exposure and child growth, immune system, morbidity, and mortality: a systematic literature review. Tesfamariam, K., De Boevre, M., Kolsteren, P., et al.[2020]

A review of infant feeding studies identified 82 unique outcomes across nine domains, highlighting a significant focus on breastfeeding duration and the introduction of solids, which were reported in over half of the studies.

The findings suggest that there is considerable variability in how outcomes are defined and reported, indicating the need for a standardized Core Outcome Set (COS) to improve consistency in measuring the effectiveness of interventions aimed at preventing childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a core outcome set for childhood obesity prevention: A systematic review. Matvienko-Sikar, K., Griffin, C., McGrath, N., et al.[2023]

Breastfeeding is associated with a 13% reduced risk of overweight and obesity later in life, based on high-quality studies, although some confounding factors may still exist.

Lowering the protein content in infant formula shows promise as a strategy to reduce the risk of obesity in children, while other nutritional factors like the timing of introducing complementary foods and sugar intake do not consistently correlate with later obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional interventions or exposures in infants and children aged up to 3 years and their effects on subsequent risk of overweight, obesity and body fat: a systematic review of systematic reviews. Patro-Gołąb, B., Zalewski, BM., Kołodziej, M., et al.[2022]

A systematic review identified 29 randomized controlled trials aimed at preventing childhood obesity, primarily conducted in high-income countries, with interventions focusing on diet, activity, sleep, and parenting education.

While 11 trials reported on child weight-related outcomes, most lacked the power to show significant effects; however, many did report improvements in healthy practices like breastfeeding and physical activity among intervention groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Registered Randomized Controlled Trials for the Prevention of Obesity in Infancy. Mihrshahi, S., Jawad, D., Richards, L., et al.[2021]

A set of 12 child feeding and obesity prevention messages was developed and pretested with 23 parents of children aged birth to 24 months, showing that most messages were well understood and considered important and feasible for implementation.

However, some messages, particularly those about starting solid foods and encouraging self-feeding, were viewed as more challenging to implement, indicating a need for further research on how diverse parents can effectively use these guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Qualitative Pretesting of Child Feeding and Obesity Prevention Messages for Parents of Infants and Toddlers. Heller, RL., Mobley, AR.[2021]

The HAPPY intervention, aimed at reducing obesity risk in infants of overweight/obese women, was found to be feasible and acceptable, with positive feedback from participants and high fidelity in delivery, despite low attendance rates.

While the study was not large enough to confirm a definitive effect, there was a promising trend suggesting a potential reduction in infant weight at 12 months, indicating that the intervention may help lower the risk of obesity in infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The HAPPY (Healthy and Active Parenting Programmme for early Years) feasibility randomised control trial: acceptability and feasibility of an intervention to reduce infant obesity. McEachan, RRC., Santorelli, G., Bryant, M., et al.[2022]

Rapid weight gain (RWG) during infancy is a significant risk factor for childhood obesity, and it should be routinely screened in healthcare settings to identify infants who may need additional support.

When RWG is identified, healthcare professionals should engage families in non-stigmatizing discussions about healthy practices, focusing on topics like breastfeeding, sleep, and responsive parenting to help establish healthy habits and potentially reduce obesity risk later in life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The care of infants with rapid weight gain: Should we be doing more? Fangupo, L., Daniels, L., Taylor, R., et al.[2023]

The Tools for Teen Moms trial is a randomized control trial involving 100 low-income adolescent mothers aimed at improving infant feeding practices through a social media intervention, which includes daily challenges and support over 6 weeks.

The primary goal of the intervention is to promote healthy feeding habits and reduce rapid weight gain in infants during the first six months of life, potentially lowering the risk of early childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tools for teen moms to reduce infant obesity: a randomized clinical trial. Horodynski, MA., Silk, K., Hsieh, G., et al.[2022]

The INSIGHT study is a randomized controlled trial involving 316 first-time mothers and their newborns, testing a responsive parenting intervention aimed at preventing obesity by promoting self-regulation in feeding and reducing the risk of overeating.

The main outcome measured is the BMI z-score at age 3 years, with additional assessments on infant weight gain patterns, maternal feeding styles, and maternal health, which could provide valuable insights for future obesity prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) study. Paul, IM., Williams, JS., Anzman-Frasca, S., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Breastfeeding in the special care nursery. Prematures and infants with medical problems. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Professional breastfeeding support for first-time mothers: a multicentre cluster randomised controlled trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of a breastfeeding self-efficacy intervention: do hospital practices make a difference? [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The Roadmap to Breastfeeding Success: Teaching Child Development to Extend Breastfeeding Duration. [2021]

5. Norway pubmed.ncbi.nlm.nih.gov

Effect of breastfeeding promotion interventions on child growth: a systematic review and meta-analysis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Dietary mycotoxins exposure and child growth, immune system, morbidity, and mortality: a systematic literature review. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Developing a core outcome set for childhood obesity prevention: A systematic review. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Nutritional interventions or exposures in infants and children aged up to 3 years and their effects on subsequent risk of overweight, obesity and body fat: a systematic review of systematic reviews. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

A Review of Registered Randomized Controlled Trials for the Prevention of Obesity in Infancy. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Development and Qualitative Pretesting of Child Feeding and Obesity Prevention Messages for Parents of Infants and Toddlers. [2021]

11. England pubmed.ncbi.nlm.nih.gov

The HAPPY (Healthy and Active Parenting Programmme for early Years) feasibility randomised control trial: acceptability and feasibility of an intervention to reduce infant obesity. [2022]

12. Australia pubmed.ncbi.nlm.nih.gov

The care of infants with rapid weight gain: Should we be doing more? [2023]

13. England pubmed.ncbi.nlm.nih.gov

Tools for teen moms to reduce infant obesity: a randomized clinical trial. [2022]

14. England pubmed.ncbi.nlm.nih.gov

The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) study. [2022]