Eatable Alphabet for Childhood Obesity

Overseen By Michelle W Katzow, MD, MS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Northwell Health

Disqualifiers: No caregiver available

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

Compensation: Varies

Number of Visits: 1

Duration: 1 month

160 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

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

What data supports the effectiveness of the treatment Eatable Alphabet for childhood obesity?

The research highlights that children who adhere to dietary recommendations in multicomponent weight management programs show significant reductions in weight status. This suggests that treatments focusing on dietary adherence, like Eatable Alphabet, could be effective in managing childhood obesity. ^{1 2 3 4 5}

How does the Eatable Alphabet treatment differ from other treatments for childhood obesity?

The Eatable Alphabet treatment is unique because it likely focuses on promoting healthy eating patterns through educational and dietary interventions, which may include increasing the intake of fruits, vegetables, and whole grains, unlike other treatments that might focus on medication or exercise alone. ^{6 7 8 9 10}

What is the purpose of this trial?

This pilot randomized controlled trial will test the effectiveness of Eatable Alphabet cards, a child friendly nutrition education tool, on child weight and related behaviors in a clinical sample of 2 to 10-year-old children with overweight/obesity, referred to a pediatric weight management program.

Research Team

Michelle W Katzow, MD, MS

Principal Investigator

Northwell Health and Feinstein Institutes for Medical Research

Eligibility Criteria

This trial is for children aged 2-10 who are new patients at the Cohen Children's Medical Center POWER Kids weight management program and have not been seen there in the past two years. They must be overweight or obese, and a caregiver must be available to give consent.

Inclusion Criteria

English-speaking

New patient at Cohen Children's Medical Center POWER Kids weight management program (defined as not having been seen by the program within the past 2 years)

My child is between 2 and 10 years old.

Exclusion Criteria

No appropriate caregiver available for consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive usual care in the weight management program, with the intervention group also receiving Eatable Alphabet cards

1 month

1 visit (in-person)

Follow-up

Participants are monitored for changes in vegetable consumption, fruit consumption, and BMI over time

6 months

Multiple visits (in-person)

Treatment Details

Interventions

• Eatable Alphabet
• Usual Care

Trial Overview The study is testing 'Eatable Alphabet' cards as a nutrition education tool against usual care practices to see if they help manage child weight and improve related behaviors in young children with overweight/obesity issues.

Participant Groups

Group I: Usual Care Experimental Treatment 1 Intervention

Usual care in the POWER Kids weight management program includes a nutrition assessment and education by a registered dietician nutritionist (RD). This includes taking a detailed dietary history, and providing individualized counseling, motivational interviewing, and nutrition education handouts/ web-based resources.

Group II: Eatable Alphabet Experimental Treatment 1 Intervention

The intervention group will receive usual care, as described above, plus a set of Eatable Alphabet cards, which will be utilized during the visit for counseling and education, and given to the family to take home and use as they wish.

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

Findings from Research

A quality improvement project in two children's hospitals led to a significant increase in the diagnosis of obesity among hospitalized children, reaching 70.2% for those with elevated BMI.

When obesity was documented, patients were 35 times more likely to receive at least one intervention during their hospital stay, highlighting the importance of proper diagnosis in facilitating effective management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality Improvement Project to Promote Identification and Treatment of Children With Obesity Admitted to Hospital. Myers, J., Werk, LN., Hossain, MJ., et al.[2021]

A patient-centered decision tool was developed to help address childhood obesity by identifying common goals between parents and healthcare providers, based on qualitative interviews with 44 parents and focus groups with 81 participants.

The tool, which includes a modified growth chart and sections for discussing patient-centered goals, was found to be acceptable and potentially useful, highlighting the importance of engaging families in obesity interventions for Latino children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a patient-centered outcome for targeting early childhood obesity across multiple stakeholders. Foster, BA., Winkler, P., Weinstein, K., et al.[2022]

Pediatric obesity is a growing global issue, particularly affecting disadvantaged children, and is linked to serious health risks like type 2 diabetes, hypertension, and sleep apnea, stemming from poor lifestyle choices and environmental factors.

Effective interventions require a coordinated effort from governments, communities, and healthcare providers, including public education, school meal reforms, and personalized support for families, as well as new pharmacological approaches targeting appetite control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An overview of pediatric obesity. Lee, WW.[2007]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Quality Improvement Project to Promote Identification and Treatment of Children With Obesity Admitted to Hospital. [2021]

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

Developing a patient-centered outcome for targeting early childhood obesity across multiple stakeholders. [2022]

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

Treating Children and Adolescents With Obesity: Characteristics of Success. [2023]

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

A systematic review of satisfaction and pediatric obesity treatment: new avenues for addressing attrition. [2022]

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

Influence of obesity on clinical outcomes in hospitalized children: a systematic review. [2021]

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

Dietary Patterns and Childhood Obesity Risk: A Systematic Review. [2021]

7. Denmark pubmed.ncbi.nlm.nih.gov

An overview of pediatric obesity. [2007]

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

The role of dietary fiber in the development and treatment of childhood obesity. [2017]

9. Canada pubmed.ncbi.nlm.nih.gov

Childhood obesity: food, nutrient, and eating-habit trends and influences. [2016]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Dietary Patterns, Weight Perception and Obesity Status, among 10-12-Year-Old Children; an Epidemiological Study in Greece. [2021]