What is the mechanism of action of this treatment?

Common treatments for obesity, particularly those similar to the multilevel preschool intervention, work by creating supportive environments that promote healthy eating and physical activity. These interventions operate on multiple levels, including organizational policies, teacher-led activities, parental involvement, and direct child engagement. Mechanisms of action include making healthier food choices the default option, increasing opportunities for physical activity, and reinforcing these behaviors at home. This comprehensive approach is crucial for obesity patients as it addresses various contributing factors, thereby enhancing the likelihood of sustainable, long-term improvements in health and behavior.

What side effects are associated with this type of intervention?

Common treatments for obesity, particularly those focusing on creating supportive environments for healthy eating and physical activity, generally have minimal direct side effects. However, potential challenges include initial resistance to lifestyle changes, the need for sustained motivation, and possible psychological impacts such as frustration or decreased self-esteem if immediate results are not seen. Additionally, there may be logistical issues such as the availability of healthy food options and safe spaces for physical activity. Overall, these interventions are considered safe and beneficial for long-term health.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of obesity, including orlistat, phentermine-topiramate, naltrexone-bupropion, and liraglutide. These medications primarily focus on appetite suppression and metabolic enhancement. However, the multilevel preschool intervention being studied, which emphasizes creating supportive environments for healthy eating and physical activity, aligns more closely with non-pharmacological approaches. These approaches include lifestyle modifications and behavioral interventions, which are critical in managing obesity, especially in children. While the FDA has not specifically approved environmental or behavioral interventions, they are widely recommended as first-line treatments for pediatric obesity.

What other types of research exist?

Promising, novel alternatives to the Multilevel Preschool Intervention for obesity treatment in 2024 include: 1) Digital health interventions, such as mobile apps and online platforms that provide personalized nutrition and physical activity guidance. 2) Community-based programs that engage families and local resources to create supportive environments for healthy living. 3) School-based interventions that integrate health education into the curriculum and promote active lifestyles through structured physical activities. 4) Policy-level interventions that address food accessibility and marketing regulations to create healthier food environments. 5) Behavioral economics approaches that use incentives and nudges to encourage healthier choices.

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Preschool Obesity Intervention for Childhood Obesity

N/A

Recruiting

Led By Roshan Bastani, PhD

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

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

Must have

Child must be 2.5-5 years old and enrolled in the participating preschool

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks post intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to help preschool children from low-income and minority communities in Los Angeles stay healthy by making their school environment more supportive of good eating and exercise habits. The study will observe if the children in the healthier environments gain less weight.

Who is the study for?

This trial is for preschools in the CCRC network with at least one classroom and 20 children aged 2.5-5 who eat one meal on-site daily. Teachers must be currently teaching a class, and caregivers need to read/write English or Spanish. It excludes home-based or special needs-only preschools, and those outside the CCRC network.

What is being tested?

The study tests a multilevel intervention aimed at promoting healthy eating and physical activity in underserved Los Angeles preschools. The effectiveness will be measured by changes in child BMI z-scores and parent-reported nutrition/physical activity habits.

What are the potential side effects?

Since this trial involves lifestyle interventions rather than medication, traditional side effects are not applicable. However, there may be indirect impacts such as resistance to change from staff or parents which could affect the study's outcomes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child is between 2.5 and 5 years old and attends the participating preschool.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks post intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks post intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks post intervention 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 BMI z-score

Secondary study objectives

Child nutrition behaviors

Child physical activity

Nutrition and physical activity policies and practices at preschool site level

+2 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: Intervention groupExperimental Treatment1 Intervention

Centers in the group will participate in the A-B-C Healthy Me/Soy Saludable multi- component nutrition and physical activity preschool intervention.

Group II: Control groupActive Control1 Intervention

Preschools in the group will continue with "usual care" practices. Control group preschools will receive intervention materials and accompanying instructions after follow-up measures are collected for each cohort.

0 / 1Eligibility criteria met

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

Common treatments for obesity, particularly those similar to the multilevel preschool intervention, work by creating supportive environments that promote healthy eating and physical activity. These interventions operate on multiple levels, including organizational policies, teacher-led activities, parental involvement, and direct child engagement. Mechanisms of action include making healthier food choices the default option, increasing opportunities for physical activity, and reinforcing these behaviors at home. This comprehensive approach is crucial for obesity patients as it addresses various contributing factors, thereby enhancing the likelihood of sustainable, long-term improvements in health and behavior.

Interventions to Treat Obesity in Mexican Children and Adolescents: Systematic Review and Meta-Analysis.