What side effects are associated with this type of intervention?

Behavioral modification through dietary education and structured eating plans, such as those used in the 'Eat My ABCs' program, generally have minimal side effects. These interventions focus on promoting healthy eating habits and increasing physical activity, which can lead to improved overall health and well-being. However, potential side effects may include initial resistance or frustration from children adapting to new routines, and in some cases, temporary feelings of hunger as they adjust to healthier portion sizes. It is important to ensure that dietary changes are balanced and provide adequate nutrition to support growth and development.

What prior FDA approvals exist?

The provided context does not mention specific FDA approvals for drugs targeting childhood obesity. However, the 'Eat My ABCs' program focuses on behavioral modification through dietary education and structured eating plans, which aligns with non-pharmacological approaches to managing childhood obesity. These approaches typically emphasize healthy eating habits, increased physical activity, and lifestyle changes rather than medication.

What other types of research exist?

Promising alternatives to the Eat My ABCs program for childhood obesity include: 1) Mindfulness-Based Eating Awareness Training (MB-EAT-A), which has shown success in increasing exercise and improving dietary habits in adolescents; 2) Video game-based interventions like Endeavor Rx, which can improve attention and potentially support better self-regulation and dietary choices; 3) Comprehensive behavioral and nutrition interventions that combine dietary education with behavioral strategies, as evidenced by successful programs in cystic fibrosis management.

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Behavioral Intervention

Nutrition Program for Childhood Obesity

Phase 2 & 3

Waitlist Available

Research Sponsored by Michigan State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from week 0 (time 1) to week 15 (time 2)

Awards & highlights

No Placebo-Only Group

Summary

This trial evaluates the 'Eat My ABCs' program, an initiative aimed at teaching healthy eating habits to low-income preschoolers in rural Michigan. The program includes fun learning activities, family engagement through letters, and a practical cookbook for parents.

Who is the study for?

This trial is for preschoolers aged 3-5 years enrolled in participating daycare classrooms, with parental consent. There are no specific exclusion criteria, so all children within this age range and setting can potentially participate.

What is being tested?

The 'Eat My ABCs' program is being tested to see if it helps improve the eating behaviors of Head Start preschoolers and positively affects their body measurements like BMI (Body Mass Index) and percent body fat.

What are the potential side effects?

Since 'Eat My ABCs' is a nutritional program rather than a medication, there aren't typical side effects. However, changes in diet may affect each child differently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from week 0 (time 1) to week 15 (time 2)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from week 0 (time 1) to week 15 (time 2)

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from week 0 (time 1) to week 15 (time 2) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Child's BMI

Percent body fat

Skin carotenoids

Secondary study objectives

Home eating environment

Household food insecurity

Parent fruit/vegetable/fiber intake

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Eat My ABCsExperimental Treatment1 Intervention

The experimental arm will receive the 14-week program including three main components: (1) "Eat My ABCs" child curriculum, (2) child fruit/vegetable letters to parents, and (3) program cookbook.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Eat My ABCs

2023

Completed Phase 3

~210

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Behavioral modification through dietary education and structured eating plans are common treatments for childhood obesity. These interventions work by teaching children and their families about healthy eating habits, portion control, and the importance of regular meals. Structured eating plans help to establish consistent eating patterns, reduce the intake of high-calorie, low-nutrient foods, and promote the consumption of fruits, vegetables, and whole grains. These strategies are crucial for childhood obesity patients as they address the root causes of unhealthy weight gain, promote long-term healthy behaviors, and can prevent the development of obesity-related health issues such as type 2 diabetes and cardiovascular diseases.