跳至主要内容
临床试验/NCT05143697
NCT05143697招募中不适用

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

Kaiser Permanente2 个研究点 分布在 1 个国家目标入组 6,600 人开始时间: 2022年5月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
6,600
试验地点
2
主要终点
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.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
2 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Wellness Coaching for Families and Kids

Other

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.

干预措施: Wellness Coaching for Families and Kids (Behavioral)

结局指标

主要结局

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.

时间窗: 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).

次要结局

  • Investigate how patient characteristics such as minority or low-income background and parental obesity modify the effect of the mBMI2Kids intervention (Heterogeneity of effects).(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Corinna Koebnick

Principal Investigator

Kaiser Permanente

研究点 (2)

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