Obesity Prevention for Childhood Obesity

(MAGIC Trial)

Enrolling by invitation at 1 trial location

Overseen By Deborah Jacobvitz, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas at Austin

Disqualifiers: Metabolic issues, Feeding issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how caregivers can influence healthy feeding habits in infants to prevent childhood obesity. It will test whether coaching parents on recognizing hunger cues and providing nutrition advice can improve feeding behaviors and infants' weight over time. Participants may receive food items to support a healthy diet. Mothers with babies aged 4 to 5 months and other caregivers involved in feeding are well-suited for this trial.

As an unphased trial, this study offers a unique opportunity to contribute to important research on infant nutrition and obesity prevention.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that teaching parents about nutrition and healthy eating can safely help prevent childhood obesity. Studies have focused on helping parents recognize when their children are truly hungry or full. This method supports healthy eating habits and is generally easy for families to follow.

In this study, the Obesity Prevention Group will coach parents on feeding their children. Previous research has not identified any serious safety issues with these educational programs. These programs aim to change behaviors like diet and feeding habits, which are non-invasive and usually safe for both parents and children. Participants in similar studies have not reported any major problems, making this a promising and safe option for families who want to prevent obesity in their children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it offers an innovative approach to preventing childhood obesity by focusing on parental education and practical support. Unlike current options that often emphasize diet plans and exercise for children, this trial provides responsive feeding coaching to help parents recognize their child's hunger and fullness cues. It also offers nutrition coaching that guides the introduction of foods based on textures and feeding styles, which is unique. Additionally, the inclusion of grocery items like fruits and vegetables before each intervention visit makes it easier for families to adopt healthier eating habits. This holistic, family-centered approach aims to instill healthy behaviors early on, potentially leading to long-term benefits.

What evidence suggests that this trial's treatments could be effective for childhood obesity?

Research shows that when parents learn to recognize their child's hunger and fullness signals, children tend to maintain a healthier weight. Studies have found that non-responsive feeding, such as food restriction, increases the likelihood of weight problems in children. One study discovered that early education for parents on healthy feeding habits can better manage children's weight as they grow. In this trial, the Obesity Prevention Group provides guidance on nutrition and feeding to support this approach. Additionally, one arm of the trial offers boxes of healthy food options, which improves diet quality and helps prevent obesity in children. ^{1 6 7 8 9}

Who Is on the Research Team?

Deborah Jacobvitz, PhD

Principal Investigator

University of Texas at Austin

Elizabeth Widen, PhD, RD

Principal Investigator

University of Texas at Austin

Are You a Good Fit for This Trial?

This trial is for mothers and other caregivers with babies aged 4 to 5 months, aiming to prevent childhood obesity by influencing parenting. It's not suitable for mothers under 16 or babies with metabolic/feeding problems.

Inclusion Criteria

People other than the mother are helping to take care of the baby.

Infants between the ages of 4 and 5 months old.

You are a mother with a baby between 4 to 5 months old.

Exclusion Criteria

Mothers younger than 16 years of age.

Babies with problems related to how they process food.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Parents receive responsive feeding coaching and nutrition coaching, with hands-on demonstrations and grocery items provided.

24 months

Regular visits (in-person and virtual)

Follow-up

Participants are monitored for infants' BMI percentile and dietary intake at 12 and 24 months.

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Obesity Prevention Group

Trial Overview The study tests if providing food boxes and teaching about obesity prevention can improve diet quality, responsive feeding, and infants' weight over time compared to a group learning about infant safety and injury prevention.

How Is the Trial Designed?

Group I: Obesity Prevention Group + Food Boxes Experimental Treatment 1 Intervention

Parents will be provided with responsive feeding coaching to help them recognize hunger and satiety cues and nutrition coaching that involves recommending a sequence of introducing complementary foods that corresponds with food textures and feeding styles, breast/bottle weaning, healthy snacking and hands on demonstrations for healthy food options. Parents will also be provided with grocery items (fruits, vegetables, meat) prior to each intervention visit to facilitate a healthy family diet.

Group II: Obesity Prevention Group Experimental Treatment 1 Intervention

Parents will be provided with responsive feeding coaching to help them recognize hunger and satiety cues and nutrition coaching that involves recommending a sequence of introducing complementary foods that corresponds with food textures and feeding styles, breast/bottle weaning, healthy snacking and hands on demonstrations for healthy food options.

Group III: Infant Safety and Injury Prevention Group Active Control 1 Intervention

Parents will be provided with information about safe sleeping, car seats, baby-proofing, etc., delivered during virtual visits, participant binder and newsletter.

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

St. David's Foundation

Collaborator

Trials

1

Recruited

170+

National Cattlemen's Beef Association

Collaborator

Trials

26

Recruited

1,300+

Egg Nutrition Center

Collaborator

Trials

16

Recruited

1,300+

National Pork Board

Collaborator

Trials

6

Recruited

390+

National Cattlemen's Beef Association

Industry Sponsor

National Cattlemen's Beef Association, a contractor to the Beef Checkoff

Industry Sponsor

Published Research Related to This Trial

The ProActive Kids Foundation's early intervention program significantly improved body composition in 884 overweight and obese youth aged 5 to 17 over an 8-week period, demonstrating effective weight management strategies.

Involving families in the program, which included education on mental health, nutrition, and physical activity, led to sustainable improvements in weight, body fat, and BMI, highlighting the importance of a supportive environment in tackling pediatric obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention and Treatment of Pediatric Obesity: A Strategy Involving Children, Adolescents and the Family for Improved Body Composition. Moxley, E., Habtzghi, D., Klinkhamer, N., et al.[2019]

A six-month study involving 38 children aged 7 to 13 showed that both individual and group strategies for managing childhood obesity led to positive changes in physical activity and eating habits.

The group educational program was particularly effective in increasing physical activity levels and reducing total cholesterol, while individual assistance improved fruit and vegetable intake, demonstrating that both approaches are viable for treating childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Individual outpatient care versus group education programs. Which leads to greater change in dietary and physical activity habits for obese children?]. de Mello, ED., Luft, VC., Meyer, F.[2020]

Citations

1. publications.aap.org publications.aap.org/pediatrics/article/132/1/e109/31296/Outcomes-of-an-Early-Feeding-Practices

Outcomes of an Early Feeding Practices Intervention to ... The goal of this study was to evaluate outcomes of a universal intervention to promote protective feeding practices that commenced in infancy ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2211335525000920

The effectiveness of school-based obesity prevention ... The aim of this study is to synthesise the effects of child obesity prevention programs on diet, physical activity, tobacco smoking and alcohol intake.

3. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT03817021

ONE PATH: Optimizing Nutrition Education for Parents and ... The ONE PATH: Optimizing Nutrition Education for Parents And Teachers for Healthy growth study will rigorously test the efficacy of responsive feeding (RF) and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3040906/

A Systematic Review of Responsive Feeding and Child ... The most consistent finding has been a positive association between nonresponsive feeding (ie restriction) and child weight status.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8227398/

Nutritional Strategies for Childhood Obesity Prevention The aim of this review is to analyze the nutritional interventions that can be implemented to prevent childhood obesity.

6. withpower.com withpower.com/trial/phase-pediatric-obesity-10-2019-c3704

Obesity Prevention for Childhood Obesity (MAGIC Trial) Research shows that group-based behavioral therapy can help children manage obesity by improving their diet and physical activity habits. Additionally, ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04177472

Mothers and CareGivers Investing in Children Obesity Prevention Group + Food Boxes. Parents will be provided with responsive feeding coaching to help them recognize hunger and satiety cues and nutrition ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3965661/

Preventing obesity in infants and toddlers in child care This study evaluated a pilot intervention to improve the nutrition and physical activity environments of child care centers serving infants and toddlers.

9. sciencedirect.com sciencedirect.com/science/article/pii/S0002916522032397

Caregiver feeding practices and child weight outcomes Restrictive feeding practices are associated with increased weight gain and higher weight status, and pressuring feeding practices are associated with decreased ...