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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
Must not have
Families that don't speak English or Spanish as a primary language
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to reduce childhood obesity by using conversation techniques in healthcare settings. The focus is on children aged 2-8 who are overweight or obese, especially from diverse and low-income backgrounds. Healthcare providers will discuss weight management with parents and connect them with lifestyle coaches for additional support through phone calls. These conversation techniques have shown promise in promoting weight loss and positive health behavior changes in both adults and children.
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child is between 2-8 years old with a BMI in the 85th percentile or higher.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My family primarily speaks a language other than English or Spanish.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
Investigate how patient characteristics such as minority or low-income background and parental obesity modify the effect of the mBMI2Kids intervention (Heterogeneity of effects).
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
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
The most common treatments for obesity include behavioral and lifestyle modifications, pharmacotherapy, and surgical interventions. Behavioral and lifestyle modifications focus on changing eating habits, increasing physical activity, and employing behavioral strategies to support these changes.
These interventions help patients create a sustainable calorie deficit, leading to weight loss and improved health outcomes. Pharmacotherapy involves medications that reduce appetite or increase feelings of fullness, aiding in weight loss when combined with lifestyle changes.
Surgical options, such as gastric bypass or sleeve gastrectomy, physically alter the digestive system to limit food intake and nutrient absorption. These treatments are crucial for obesity patients as they address the underlying causes of weight gain and provide tools to achieve and maintain a healthier weight, thereby reducing the risk of obesity-related comorbidities.
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?
Kaiser PermanenteLead Sponsor
554 Previous Clinical Trials
27,725,154 Total Patients Enrolled
33 Trials studying Obesity
106,320 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,455 Previous Clinical Trials
4,328,515 Total Patients Enrolled
469 Trials studying Obesity
583,414 Patients Enrolled for Obesity
Corinna Koebnick, PhDPrincipal InvestigatorKaiser Permanente
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to receive motivational interviews and wellness coaching.My family primarily speaks a language other than English or Spanish.My child is between 2-8 years old with a BMI in the 85th percentile or higher.
Research Study Groups:
This trial has the following groups:- Group 1: Wellness Coaching for Families and Kids
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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