What side effects are associated with this type of intervention?

Common treatments for obesity, such as behavioral and lifestyle modifications, are generally safe but may cause temporary muscle soreness and gastrointestinal changes. Pharmacotherapy, including medications like orlistat and semaglutide, can lead to gastrointestinal side effects such as oily stools, flatulence, nausea, vomiting, and diarrhea. Close monitoring is essential to manage these side effects effectively.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of obesity that complement behavioral and lifestyle modifications. Notable examples include liraglutide (Saxenda) and semaglutide (Wegovy), both of which are GLP-1 receptor agonists. These medications have shown efficacy in weight loss when combined with diet and exercise. Liraglutide was approved for chronic weight management in 2014, while semaglutide received approval in 2021. These drugs are designed to be used alongside lifestyle interventions, such as calorie restriction and increased physical activity, to enhance weight loss outcomes.

What other types of research exist?

Promising novel alternatives to behavioral and lifestyle modification for childhood obesity treatment in 2024 include: 1) Pharmacologic treatments such as extended-release exenatide (Bydureon BCise) and dulaglutide, which have shown efficacy in improving glycemic control and weight management in pediatric patients. 2) Bariatric surgery options like laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass, which have demonstrated significant weight loss and improvement in obesity-related comorbidities in adolescents. These alternatives offer additional options for patients who may not respond adequately to traditional behavioral and lifestyle interventions.

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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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

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.

0 / 2Eligibility criteria met

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.