Obesity Prevention for Childhood Obesity

(MAGIC 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: 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

165 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The incidence of childhood obesity in the United States has steadily increased over the past 30 years but has begun to level off in recent years. Epidemiological evidence indicates that obesity may transmitted across multiple generations. The current study seeks to: 1) evaluate the extent to which mothers and other important caregivers affect their mothers' parenting; 2) examine whether an intervention aimed at improving diet quality and enhancing responsive feeding to improves parental responsivity and feeding behavior and infants' weight trajectories over time; 3) examine the effects of early life feeding and caregiver sensitivity on health and development; and 4) examine feasibility of food distribution along with the feeding intervention.

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 the Obesity Prevention for Childhood Obesity treatment safe for humans?

The research articles reviewed do not provide specific safety data for the Obesity Prevention for Childhood Obesity treatment. They focus on prevention strategies and interventions without mentioning safety concerns. ^{1 2 3 4 5}

How does the Obesity Prevention Group treatment differ from other treatments for childhood obesity?

The Obesity Prevention Group treatment is unique because it focuses on prevention rather than using drugs or surgery, which are not effective for childhood obesity. It involves identifying risk factors and implementing lifestyle changes, such as improving nutrition and increasing physical activity, to prevent obesity from developing. ^{1 6 7 8 9}

What data supports the effectiveness of the treatment Obesity Prevention Group for childhood obesity?

Research shows that group-based behavioral therapy can help children manage obesity by improving their diet and physical activity habits. Additionally, multidisciplinary programs that involve families and target high-risk groups have shown positive outcomes in reducing obesity in children. ^{1 8 10 11 12}

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+

Published Research Related to This Trial

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]

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]

Citations

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

A Novel Home-Based Intervention for Child and Adolescent Obesity: The Results of the Whānau Pakari Randomized Controlled Trial. [2018]

2. Netherlands pubmed.ncbi.nlm.nih.gov

[Favourable short-term effects of a multidisciplinary, behavioural therapy, group treatment for overweight or obese children]. [2007]

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

Weighing risk: the expert committee's recommendations in practice. [2016]

4. Italy pubmed.ncbi.nlm.nih.gov

Pediatric obesity prevention and management. [2006]

5. Brazil 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?]. [2020]

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

Parenting support to prevent overweight during regular well-child visits in 0-3 year old children (BBOFT+ program), a cluster randomized trial on the effectiveness on child BMI and health behaviors and parenting. [2020]

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

Prevention and Treatment of Pediatric Obesity: A Strategy Involving Children, Adolescents and the Family for Improved Body Composition. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

[Preventing Obesity in Children: Which Factors Impede and Which Facilitate the Parental Access to Prevention Programmes?]. [2018]

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

Prevention of obesity in infancy and early childhood: a National Institutes of Health workshop. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

[Current Guidelines to Prevent Obesity in Childhood and Adolescence]. [2016]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Current Guidelines for Obesity Prevention in Childhood and Adolescence. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Interventions to prevent obesity in children and adolescents: a systematic literature review. [2022]