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Wellness Coaching for Childhood Obesity (WC4K Trial)

N/A

Recruiting

Led By Corinna Koebnick, PhD

Research Sponsored by Kaiser Permanente

Eligibility Criteria Checklist

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

Must have

Eligible Children age 2-8 have a body mass index in the 85 percentile or higher

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

WC4K Trial Summary

This trialaims to create a feasible & sustainable intervention to address childhood obesity in primary care settings that can be widely adopted.

Who is the study for?

This trial is for families with children aged 2-8 who are in the 85th percentile or higher for body mass index (BMI), indicating obesity. The study is open to those attending one of the 25 participating clinics offering motivational interview counseling. Families must speak English or Spanish as their primary language to join.Check my eligibility

What is being tested?

The study tests a modified intervention designed to lower BMI in children, making it practical and sustainable in real-world clinical settings without needing many resources. It involves wellness coaching tailored for families and kids, aiming to provide effective strategies against childhood obesity.See study design

What are the potential side effects?

Since this trial focuses on wellness coaching rather than medication, there aren't typical drug side effects. However, participants may experience lifestyle adjustment challenges or emotional responses related to changes in diet and activity levels during the program.

WC4K Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My child is between 2-8 years old with a BMI in the 85th percentile or higher.

WC4K Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determine the effectiveness and dose-response relationship of a pragmatic, system-integrated child-hood obesity intervention using mBMI2Kids (a modified BMI2 approach) at follow-up.

Secondary outcome measures

Investigate how patient characteristics such as minority or low-income background and parental obesity modify the effect of the mBMI2Kids intervention (Heterogeneity of effects).

WC4K Trial Design

1Treatment groups

Experimental Treatment

Group I: Wellness Coaching for Families and KidsExperimental Treatment1 Intervention

For clinics assigned to mBMI2Kids intervention, Pediatricians will be trained in Motivational Interviewing (MI) and behavioral intervention. Pediatricians will conduct up to 3 sessions with each parent (3 x 10 min) and refer patients electronically to experienced MI-trained lifestyle coaches. With full access to the electronic medical record coaches will call referred families (child's BMI-for-age ≥85th percentile) and deliver a telephonic MI counseling over two years (6 x 45 min) simultaneous with pediatricians. 49 clinics will be selected with 24 participating in the intervention and 25 providing patients with usual care.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kaiser PermanenteLead Sponsor

538 Previous Clinical Trials

24,106,493 Total Patients Enrolled

33 Trials studying Obesity

106,450 Patients Enrolled for Obesity

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,307,992 Total Patients Enrolled

446 Trials studying Obesity

582,338 Patients Enrolled for Obesity

Corinna Koebnick, PhDPrincipal InvestigatorKaiser Permanente

Media Library

Wellness Coaching for Families and Kids Clinical Trial Eligibility Overview. Trial Name: NCT05143697 — N/A

Obesity Research Study Groups: Wellness Coaching for Families and Kids

Obesity Clinical Trial 2023: Wellness Coaching for Families and Kids Highlights & Side Effects. Trial Name: NCT05143697 — N/A

Wellness Coaching for Families and Kids 2023 Treatment Timeline for Medical Study. Trial Name: NCT05143697 — N/A

Frequently Asked Questions

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

To what extent is this experiment involving human subjects?

"Affirmative. Clinicaltrials.gov has reported that this research endeavour, published on May 16th 2022 and revised most recently in December 21st 2022, is presently recruiting participants. In total 11880 individuals are needed to be recruited from one medical centre for the study to proceed."

Answered by AI

Does this clinical investigation include participants over the age of twenty?

"According to the criteria, suitable applicants for this trial are between 2 and 8 years old. The database contains 245 trials for patients younger than 18 and 617 studies targeting those above 65."

Answered by AI

Is participation allowed in this research endeavor?

"In order to meet the selection criteria of this trial, potential participants must be aged between 2 and 8 years old with a BMI in the obese range. A total of 11880 patients need to be recruited."

Answered by AI

Are new participants currently being admitted to this research project?

"Indeed. According to information hosted on clinicaltrials.gov, this medical experiment was first posted on May 16th 2022 and is still recruiting participants. 11880 patients need to be recruited from one distinct location."

Answered by AI