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Implementation Strategies for Childhood Obesity Prevention

N/A

Recruiting

Led By Taren M Swindle, Ph.D.

Research Sponsored by University of Arkansas

Eligibility Criteria Checklist

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

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare a low-intensity implementation strategy to a more tailored, adaptive strategy that starts with low-intensity support and steps up to higher intensity support as needed.

Who is the study for?

This trial is for early care and education settings not currently using the WISE program, serving at least 15 children aged 3 to 5. They must be in certain regions of Arkansas or Louisiana, participate in specific food programs, and agree to join in activities and data collection.

What is being tested?

The study tests 'Together, We Inspire Smart Eating' (WISE), aiming to improve kids' diets through hands-on experiences with fruits/veggies, educator role modeling, positive feeding practices, and a mascot. It compares low vs high-intensity strategies for better adoption.

What are the potential side effects?

Since this intervention focuses on educational practices rather than medical treatments, traditional side effects are not applicable. However, there may be indirect impacts on children's behavior or preferences.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Fidelity to WISE Evidence-Based Practices using the WISE fidelity observational measure

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Non-Responders Increasing to High IntensityExperimental Treatment2 Interventions

This group will include those not achieving desired levels of fidelity by the October assessment who will be randomized to have high intensity support added (low intensity + holistic individualized facilitation, tailored educational materials).

Group II: Non-Responders Continue Low IntensityActive Control1 Intervention

This group will include those not achieving desired levels of fidelity by the October assessment who will be randomized to continue receiving low intensity implementation support (i.e., formal commitments, local champions, implementation blueprint, reminder cutting boards, task-focused implementation).

Group III: Early Responders to Low IntensityActive Control1 Intervention

Early responders will include those with targeted levels of fidelity by the October assessment. They will continue to receive low intensity implementation support (i.e., formal commitments, local champions, implementation blueprint, reminder cutting boards, task-focused implementation).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Low Intensity

2005

N/A

~240

High Intensity

2017

N/A

~480