Recruiting

Intervention for Obesity

Sponsor:

Kaiser Permanente

Code:

NCT05143697

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 2 - 8

Healthy Volunteers: Accepted

Interventions

Wellness Coaching for Families and Kids

Study Details

Brief summary:

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.

Conditions

Obesity

Study ID

NCT05143697

Start date

May 16, 2022

Status verified date

Aug, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 8

Healthy Volunteers: Accepted

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 Design

Enrollment

6600 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

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 outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

Kaiser Permanente Pasadena

Recruiting

Pasadena, California, United States, 91101

Contacts

Principal Investigator:

Corinna M Koebnick, PhD

More Information

Sponsor

Kaiser Permanente

Last update posted

Sep 4, 2025

Last verified

Aug, 2025

Keywords

  • Motivational Interviewing
  • Wellness
  • Coaching

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Kaiser Permanente on 2025-09-04.