Clinical trial
Motivational Wellness Coaching to Reduce Childhood Obesity in Families and Kids
Recruiting now · Not applicable · 1 countries · Registry ID NCT05143697
What this study is about
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.
Basic eligibility
Full registry criteria
Treatments and study arms
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.
Primary outcomes
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).
Study locations
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