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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist children with overweight or obesity using fun, educational tools called Eatable Alphabet cards. These cards teach children about nutrition playfully, potentially influencing their weight and related behaviors. Participants will receive either standard care, which includes personalized nutrition advice, or standard care plus the Eatable Alphabet cards. Children eligible for the trial are those new to the Cohen Children's Medical Center POWER Kids program, aged 2-10, and English-speaking. As an unphased trial, this study provides a unique opportunity for children to engage in innovative learning while contributing to valuable research on childhood nutrition.

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 prior data suggests that the Eatable Alphabet cards are safe for children?

Research shows that Eatable Alphabet cards safely teach kids about nutrition. Designed to make learning about healthy eating fun, Eatable Alphabet involves no medicine or physical treatment, so there are no side effects. Studies have found that family-focused programs like Eatable Alphabet, which emphasize behavior, can effectively reduce the risk of childhood obesity. These programs are well-received because they focus on learning and behavior changes instead of medical treatments. Therefore, Eatable Alphabet cards can safely complement traditional care, offering kids and families an enjoyable way to learn about nutrition and manage weight. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard care for childhood obesity, which typically involves dietary assessments and counseling, the Eatable Alphabet introduces an innovative educational tool designed to engage children and their families in a fun, interactive way. Researchers are excited about this approach because it supplements traditional nutrition education with a set of colorful, engaging alphabet cards that make learning about healthy foods enjoyable and memorable. This method aims to create a more lasting impact on children's eating habits by involving them actively in the learning process, potentially leading to better adherence to healthy lifestyle changes.

What evidence suggests that Eatable Alphabet cards are effective for childhood obesity?

Research shows that the Eatable Alphabet cards, which participants in this trial may receive, are a promising tool for teaching kids about nutrition. These cards help young children learn about healthy foods in a fun and interactive way. Although specific data on these cards' impact on weight is limited, similar tools have improved eating habits, aiding weight management. Studies on similar programs suggest that teaching kids about healthy eating early can positively change their eating habits and may help reduce obesity rates over time. Overall, using these engaging tools alongside traditional advice, provided in the usual care arm of this trial, may enhance efforts to manage and prevent obesity in children. ^{2 6 7 8 9}

Who Is on the Research Team?

Michelle W Katzow, MD, MS

Principal Investigator

Northwell Health and Feinstein Institutes for Medical Research

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05166629

Eatable Alphabet as a Nutrition Education Tool | ... This pilot randomized controlled trial will test the effectiveness of Eatable Alphabet cards, a child friendly nutrition education tool, on child weight and ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK612636/

Evidence review for effectiveness and acceptability of weight ... In children in Year 6 (10–11 years), obesity prevalence increased from 21.0% in 2019/20 to 25.5% in 2020/21. A briefing for NICE guideline developers and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7734784/

The effectiveness of pediatric obesity prevention policies In the current meta-analysis, we summarized the results of controlled trials that evaluated the effect of obesity prevention policies in children and ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06486493?term=AREA%5BConditionSearch%5D(%22Pediatric%20Obesity%22)&rank=5

Impact of a Playful Family Education Strategy With ICT on ... Can digital reinforcement might decrease body weight, BMI, body fat mass and waist circumference in overweight or obese children? Does dietary habits might be ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2833516

Parenting Training Plus Behavioral Treatment for Children ... The findings suggest that FBT reduces weight status in children with overweight or obesity but that additional intensive PT does not further improve outcomes.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4322210/

Service evaluation of the GOALS family-based childhood ... This study reports ecologically valid data from a childhood obesity treatment intervention as it was delivered in practice. This is the first article to use ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2667368125000622

Systematic Review of Parental Influence on Pediatric Obesity Family-centred behavioral interventions, particularly those incorporating booster supports, effectively reduce childhood obesity risk.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10770754/

Special considerations for the adolescent with obesity Data from 2018 find a significant increase to 19.3 % (obesity) and 6.1 % (severe obesity) for US children [1]. A recent cross-sectional study of ...

9. clinicaltrials.gov clinicaltrials.gov/ct2/keydates/NCT04552678

Healthy Bodies Project to Prevent Childhood Obesity The goal of this study is to evaluate components of a preschool-based intervention designed to (1) increase children's nutrition knowledge, (2) increase ...