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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)
Be younger than 18 years old
Must not have
Parents with self-reported major depression will be excluded.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-year
Awards & highlights
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child is between 20 months and just under 5 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My parents do not have a history of major depression.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-year
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 moreTrial 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
544 Previous Clinical Trials
1,142,948 Total Patients Enrolled
Geisinger ClinicLead Sponsor
149 Previous Clinical Trials
1,881,453 Total Patients Enrolled
Penn State UniversityOTHER
359 Previous Clinical Trials
123,907 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My child is between 20 months and just under 5 years old.You have certain medical conditions like cancer, type 1 diabetes, or major developmental delays such as autism.My parents do not have a history of major depression.I am a parent and over 18 years old.Another child in your family is already part of the study.Your body mass index (BMI) is higher than the average for your age and sex according to the World Health Organization growth standards.I am a parent and I speak English.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care
- Group 2: Patient Reported Outcome + Food Care
- Group 3: Patient Reported Outcome
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.
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