Motivational Wellness Coaching to Reduce Childhood Obesity in Families and Kids (WC4K)

March 14, 2024 updated by: Corinna Koebnick, Kaiser Permanente

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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 49 pediatric clinics in Kaiser Permanente Southern California (KPSC) to test the effectiveness of a modified version of BMI2 intervention in pediatric clinics (24 intervention, 25 usual care with attention control, = 6,600 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.

Study Type

Interventional

Enrollment (Estimated)

6600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Pasadena, California, United States, 91101
        • Recruiting
        • Kaiser Permanente Pasadena
        • Contact:
        • Contact:
        • Principal Investigator:
          • Corinna M Koebnick, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 months to 6 years (Child)

Accepts Healthy Volunteers

Yes

Description

24 Eligible Intervention Clinics will provide motivational interview counseling and referrals to Wellness Coaching.

Inclusion criteria:

  • Children age 2-8 years
  • Body mass index in the 85 percentile or higher

Exclusion criteria:

• Families that don't speak English or Spanish as a primary language

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Wellness Coaching for Families and Kids
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.
Behavioral: Wellness Coaching for Families and Kids
The investigators propose to conduct a cluster-randomized pragmatic trial in 49 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 24 intervention or 25 usual care + attention control (enrolling 6,600 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.
Other Names:
  • WC4K

What is the study measuring?

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.
Time Frame: 2 years

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).
Time Frame: 2 years

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Collaborators

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

Investigators

  • Principal Investigator: Corinna Koebnick, PhD, Kaiser Permanente

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2022

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

August 5, 2021

First Submitted That Met QC Criteria

November 22, 2021

First Posted (Actual)

December 3, 2021

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KPSC IRB#12607
  • 1R01DK127038-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD will be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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