What side effects are associated with this type of intervention?

Common treatments for childhood obesity, such as nutrition education and healthy eating curriculums, generally have minimal side effects. These interventions focus on improving food literacy and promoting healthier food choices, which can lead to positive outcomes like better nutrition and weight management. However, some children may experience initial resistance to dietary changes or increased physical activity, which can cause temporary discomfort or frustration. In rare cases, significant dietary changes without proper guidance may lead to nutritional deficiencies. Overall, these treatments are considered safe and beneficial when implemented correctly.

What prior FDA approvals exist?

The FDA has approved medications such as liraglutide for the treatment of type 2 diabetes in children, which can also aid in weight management. However, for childhood obesity, the focus has largely been on lifestyle interventions, including nutrition education and promoting healthy eating habits, similar to the Healthy Eating Curriculum trial. This trial aims to improve food literacy and acceptance through education, which aligns with the broader approach of using dietary and lifestyle modifications to manage childhood obesity.

What other types of research exist?

Promising alternatives to the Healthy Eating Curriculum for childhood obesity include: 1) Behavioral and nutrition interventions, which have shown success in improving energy intake and growth in children with conditions like cystic fibrosis. 2) The Dietary Approaches to Stop Hypertension (DASH) diet, which has been effective in managing blood pressure and could be adapted for weight management. 3) Integrative health approaches such as biofeedback and guided imagery, which can help manage stress and improve overall well-being. 4) Probiotics, which have shown potential in improving gut health and possibly influencing weight management. These alternatives should be discussed with a healthcare provider to tailor the best approach for the individual child.

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Behavioral Intervention

Nutrition Education for Childhood Obesity

N/A

Recruiting

Led By Lori A Francis, Ph.D.

Research Sponsored by Penn 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 baseline to post-intervention (~6 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to teach preschool children from low-income families about healthy foods. It uses a program that includes lessons on nutrition for both children and their parents. By exposing children to new foods and educating them, the program hopes to improve their knowledge and acceptance of nutritious foods.

Who is the study for?

This trial is for preschool children aged 3 to 5 who are enrolled in participating childcare centers, primarily serving families eligible for the Supplemental Nutrition Assistance Program (SNAP) in Pennsylvania.

What is being tested?

The study tests a nutrition education program aimed at improving food literacy and acceptance among preschoolers. It compares outcomes of those with just this program to those also receiving a healthy eating curriculum and parent education.

What are the potential side effects?

Since this trial involves educational interventions rather than medical treatments, there are no direct physical side effects. However, changes in diet or food preferences as a result of the intervention could occur.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to post-intervention (~6 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to post-intervention (~6 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to post-intervention (~6 months) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Children's Food Acceptance

Children's Food Choices

Children's Food Knowledge

+2 more

Secondary study objectives

Child Weight Status/Adiposity

Other study objectives

Child food requests (parent report)

Childcare Provider Demographics

Childcare Provider Feeding Beliefs

+10 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Healthy Bodies Project Plus (HBP+)Experimental Treatment4 Interventions

Intervention classrooms will receive the Eating the Alphabet curriculum described above for comparison classrooms, in addition to (1) the Healthy Eating curriculum, (2) classroom materials and teacher training designed to improve the classroom food and mealtime environment in ways that increase food acceptance, and (3) parent/caregiver education on responsive food parenting.

Group II: Healthy Bodies Project Comparison (HBP)Active Control1 Intervention

All classrooms will receive the Eating the Alphabet curriculum, which includes 27 lessons that introduce children to a new fruit or vegetable from A-Z each week. Parents in comparison and intervention classrooms will receive access to web-based parent resources related to the Eating the Alphabet curriculum (e.g., food of the week fact sheets with recipes and suggestions for use, and coloring pages).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Parent Education

2016

N/A

~620

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

The most common treatments for childhood obesity, particularly those similar to the Healthy Eating Curriculum trial, focus on educational and behavioral interventions. These programs aim to improve food literacy and acceptance, teaching children and their parents about nutrition and healthy eating habits. By increasing awareness of healthy foods and promoting physical activity, these interventions help reduce the intake of high-calorie, low-nutrient foods and encourage healthier lifestyle choices. This approach is essential for childhood obesity patients as it addresses the underlying causes of obesity and fosters sustainable, long-term healthy behaviors.