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Enhanced Well-Child Visits for Childhood Obesity Prevention (ENCIRCLE Trial)

N/A
Waitlist Available
Led By Lisa Bailey-Davis, DEd, RD
Research Sponsored by Geisinger Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age (20-months to 59-months, 29-days old)
Parent age > 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-year
Awards & highlights

ENCIRCLE Trial Summary

This trial will compare two different enhancements to well-child visits in order to prevent obesity, by promoting family-centered counseling. The advantages of these enhancements will be measured in terms of parent involvement in counseling, lifestyle behaviors, and food resource management.

Who is the study for?
This trial is for lower-income families with preschool-aged children (20 months to almost 5 years) at risk of obesity, who are English-speaking and committed to an 18-month study. Eligible participants have a BMI over the 50th percentile and receive or qualify for assistance programs like WIC or SNAP. Families planning to move or change health systems within two years, those with major depression, serious medical conditions, or another child in the study cannot join.Check my eligibility
What is being tested?
The study compares standard well-child visits against enhanced versions aimed at preventing childhood obesity among rural preschoolers. The enhancements include family-centered counseling on lifestyle behaviors and food resource management during these visits.See study design
What are the potential side effects?
Since this trial focuses on preventive medicine through counseling rather than medication, traditional side effects are not applicable. However, there may be indirect impacts related to changes in diet and activity levels as advised during counseling.

ENCIRCLE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My child is between 20 months and just under 5 years old.
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I am a parent and over 18 years old.
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I am a parent and I speak English.

ENCIRCLE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
difference in difference in BMI z-score, based on WHO growth standards
Secondary outcome measures
Food Resource Management
Modified Version of Perceived Involvement in Care Scale
United States Household Food Security Survey Module: Six-Item Short Form
Other outcome measures
BMIz extended
Percent over BMI (BMI50)
Proportion of Children Overweight and Obese
+1 more

ENCIRCLE Trial Design

3Treatment groups
Active Control
Group I: Standard of CareActive Control1 Intervention
Participants will attend regularly scheduled well child visits (WCV) that follow standard clinical guidelines. Well child visits will include review of history, age-appropriate measurements (height/length, weight, body mass index (BMI), blood pressure), sensory and developmental screenings, physical exam, immunizations, oral health review, and anticipatory guidance (preventive counseling).
Group II: Patient Reported Outcome + Food CareActive Control1 Intervention
Participants will receive all Arm 2 components, in addition to be referred to both the Geisinger Wellness Program for a Parent Training Program and a grocery store nutritionist for a tour aligned with the Cooking Matters program.
Group III: Patient Reported OutcomeActive Control1 Intervention
Arm 2 builds on the standard of care WCV by adding a patient reported outcome measure, the Family Nutrition and Physical Activity risk assessment, to inform family-centered preventative counseling during clinical care.

Find a Location

Who is running the clinical trial?

University of NebraskaOTHER
536 Previous Clinical Trials
1,141,886 Total Patients Enrolled
Geisinger ClinicLead Sponsor
147 Previous Clinical Trials
1,875,753 Total Patients Enrolled
Penn State UniversityOTHER
353 Previous Clinical Trials
123,681 Total Patients Enrolled

Media Library

Patient Reported Outcome Well Child Visit Clinical Trial Eligibility Overview. Trial Name: NCT04406441 — N/A
Childhood Obesity Research Study Groups: Standard of Care, Patient Reported Outcome + Food Care, Patient Reported Outcome
Childhood Obesity Clinical Trial 2023: Patient Reported Outcome Well Child Visit Highlights & Side Effects. Trial Name: NCT04406441 — N/A
Patient Reported Outcome Well Child Visit 2023 Treatment Timeline for Medical Study. Trial Name: NCT04406441 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age limit for this trial end at 65 years old?

"For this particular study, researchers are looking for patients that fall in the 20-59 month age range."

Answered by AI

What are the requirements to qualify for participating in this research?

"This study, which is looking for 2,025 participants, needs lower-income children between the ages of 20 months and 59 months who are struggling with obesity. To qualify, applicants must meet the following additional criteria: a positive food insecurity screening, a BMI in the top 50th percentile for their age and gender, a willingness to attend follow-up appointments, and a stable residence."

Answered by AI
~45 spots leftby May 2024