Motivational Wellness Coaching to Reduce Childhood Obesity in Families and Kids

Study Overview
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Brief Summary
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Primary care settings lack interventions to address the childhood obesity epidemic that are feasible and sustainable without requiring significant resources. The investigators propose to modify and test an intervention shown to lower children's body mass index(BMI) so that it is feasible, sustainable, and easily disseminated in a real-world clinical setting. If successful, the investigators will be able to provide recommendations to providers and health care systems that help prioritize future intervention strategies and research investments to reduce obesity in children that can be quickly translated into other settings and widely adopted after the study period, with the goal of halting and reversing the childhood obesity epidemic.

Detailed Description
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Rates of childhood obesity in the United States (US) remain at historic highs. Before the age of 11 years, 18% of all children in the US are already obese; 26% of Hispanic and 24% of Black children are obese. Pediatric primary care settings are underutilized in preventing and treating childhood obesity. An evidence-based method for treatment of childhood obesity to help engage and motivate patients is Motivational Interviewing (MI). One recent successful study, BMI2 (for Brief Motivational Interviewing to Reduce Child Body Mass Index) directed at the parents of children in pediatric care practices lowered body mass index (BMI) significantly. MI-based approaches have been particularly successful for racial/ethnic minorities and low-income populations. However, the targeted MI dose of BMI2 requires significant resources, with MI sessions administered by the PCP and a registered dietician. It is unclear whether the impressive results of BMI2 can be replicated in a health care system with real-world conditions. It is challenging to find an effective intervention that is feasible and sustainable without requiring significant resources. Our overall goal is to reduce excess body weight in children in primary care. The investigators will conduct a cluster-randomized pragmatic trial in 50 pediatric clinics in Kaiser Permanente Southern California (KPSC) to test the effectiveness of a modified version of BMI2 intervention in pediatric clinics (25 intervention, 25 usual care with attention control, = 10,800 children). The clinics serve over 45,000 children aged 2-8 yrs who are overweight or obese with high racial/ethnic and socioeconomic diversity (53% Hispanic; 23% state-subsidized insurance). Using MI techniques, primary care providers (PCPs) will initiate and maintain discussion about weight management with parent (6 x 20 min) and refer patients electronically to experienced and MI-trained lifestyle coaches. With full access to the electronic medical record (EMR), coaches will call referred families (child's BMI-for-age ≥85th percentile) and deliver intervention via telephonic MI counseling over two years (6 x 45 min). Usual care clinics with attention control will include regular encounters and educational videos as attention control. Primary Aim: Determine the effectiveness and dose-response relationship of a pragmatic, system-integrated childhood obesity intervention using mBMI2Kids (a modified BMI2 approach) on BMI at 2-yr follow-up. Secondary Aim: Investigate how patient characteristics such as minority or low-income background and parental obesity modify the effect of the mBMI2Kids intervention (Heterogeneity of effects). IMPACT: This study has the potential for a highly significant shift in pediatric primary care practices. Our results will provide valuable guidance to providers and health care systems to help them effectively halt and reverse the childhood obesity epidemic. Our results can be quickly translated into other clinical care settings and endorse the meaningful use of EMR systems to support providers using tools and centralized approaches that make interventions scalable.

Official Title
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Integrated Motivational Interviewing to Reduce Childhood Obesity in a Large Health Maintenance Organization

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Wellness Coaching for Families and Kids


Participation Criteria
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Eligibility Criteria
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25 Eligible Intervention Clinics will provide motivational interview counseling and referrals to Wellness Coaching Eligible Children age 2-8 have a body mass index in the 85 percentile or higher. Exclusion criteria are families that don't speak English or Spanish as a primary language.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: The proposed study is a pragmatic cluster-randomized trial to test the impact of a modified version of the BMI2 intervention, which we have named mBMI2Kids. Target population are children aged 2-8 years with a BMI-for-age ≥85 percentile from 50 Kaiser Permanente pediatric clinics in Southern California. All children and their parent/guardian reached will be included according to the clinic in which they receive care (Intervention-to-treat approach).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Wellness Coaching for Families and Kids<br>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. 50 clinics will be selected with 25 participating in the intervention and 25 providing patients with usual care. | Behavioral: Wellness Coaching for Families and Kids<br>* The investigators propose to conduct a cluster-randomized pragmatic trial in 50 pediatric clinics in Kaiser Permanente Southern California (KPSC), to test the effectiveness of mBMI2Kids (a modified version of the BMI2 interven-tion) in pediatric clinics (randomization unit). Clinics serve over 45,000 children aged 2-8 yrs who are obese and have high racial/ethnic and socioeconomic diversity (53% Hispanic; 23% state-subsidized insurance). Clinics will be randomized into either 25 intervention or 25 usual care + attention control (enrolling 10,800 children). KP's long-standing electronic medical record (EMR) and stable membership, a research team embedded in care, existing team of lifestyle coaches, and ability to rapidly disseminate findings makes us uniquely positioned to conduct this study.<br>* Other names: WC4K;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Hypothesis 1-1: At 2-yr follow-up, patients ages 2-8 yrs with baseline BMI ≥85th percentile who were reached in intervention clinics will show a net mean BMI decrease between 0.8 and 1.0 kg/m2 (adjusted for sex, age) compared to usual care (population effect). Hypothesis 1-2: At 2-yr follow-up, patients who received the full planned MI-dose (defined as 8 of 12 sessions) will show a net mean BMI decrease between 1.0 and 1.2 kg/m2 (adjusted for sex, age) compared to usual care (individual effect). | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate how patient characteristics such as minority or low-income background and parental obesity modify the effect of the mBMI2Kids intervention (Heterogeneity of effects). | Minority or low-income background patients need a higher MI dose than other patient groups in achieving a targeted mean BMI decrease of 1.0 kg/m2 (adjusted for sex, age). Guided by the RE-AIM framework 25, we will examine reach (based on participation), effectiveness (BMI) com-pared to usual care, MI dose-response), adoption (based on clinics and PCPs participating actively), implementation (fidelity to intervention, delayed intervention), and address maintenance and potential sustainability. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Motivational Interviewing, Wellness, Coaching