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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 belowSelect...
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
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 moreAwards & 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.
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.
Interventions to Treat Obesity in Mexican Children and Adolescents: Systematic Review and Meta-Analysis.
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Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,567 Previous Clinical Trials
10,265,130 Total Patients Enrolled
27 Trials studying Obesity
17,589 Patients Enrolled for Obesity
Roshan Bastani, PhDPrincipal Investigator - University of California, Los Angeles
University of California, Los Angeles
4 Previous Clinical Trials
72,543 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My child is between 2.5 and 5 years old and attends the participating preschool.I am the main caregiver of a child aged 2.5-5 years who is in preschool.My preschool enrolls fewer than 20 children aged 2.5-5.My preschool site has at least 20 children aged 2.5-5 years.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention group
- Group 2: Control group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.