Motivational Wellness Coaching to Reduce Childhood Obesity in Families and Kids

ConditionObesity

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age2-8

SponsorKaiser Permanente

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Children age 2-8 years

Body mass index in the 85 percentile or higher

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

Wellness Coaching for Families and Kids
Behavioral
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.

Treatment groups

6,600 Participants

are divided into 1 treatment group

Group A: Wellness Coaching for Families and KidsOther 1 intervention

Trial outcomes

Primary outcomes

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).

Time frame

2 years

Secondary outcomes

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.

Time frame

2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kaiser Permanente

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov

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