Implementation of the New Pediatric Obesity Clinical Practice Guideline in Rural Families and Clinics: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,024
- 试验地点
- 4
- 主要终点
- Change from baseline to 6 months to year 4 in child body mass index (BMI)
研究概览
简要总结
The current study is a multilevel factorial design RCT with interventions at the clinic (Healthy Clinic intervention period vs. Control period) and individual patient levels (iAmHealthy vs. Newsletter).
详细描述
Obesity poses a major health risk, contributing to elevated morbidity and mortality from cancer, cardiovascular disease, and diabetes. Children living in rural areas have higher rates of obesity than their urban counterparts. Based upon our extensive prior work, the investigators propose a multilevel factorial design randomized controlled trial with interventions at the clinic and individual patient level to treat pediatric obesity among underserved rural children and families. The individual intervention is an mHealth rurally tailored pediatric obesity behavioral intervention (iAmHealthy) vs. Newsletter control while the clinic-level intervention is a cluster randomized stepped wedge (Healthy Clinic intervention) designed to improve clinics' treatment of children with overweight and obesity. The iAmHealthy intervention is a rurally tailored empirically supported family-based behavioral group program targeting the families of children who are overweight or obese and providing 26 contact hours of group and individual intervention. The Healthy Clinic intervention is designed to improve provider office processes using a bundled intervention of provider prompts, skills training and intervention tools implemented with performance feedback targeted at the implementation of the American Academy of Pediatrics 2023 Clinical Practice Guideline. This intervention is a site-level quality improvement implementation, not a participant-facing intervention.
This study will be the first to assess both clinic level and patient level pediatric obesity interventions tailored to the unique barriers in rural pediatric populations. Four states (KS, NE, OK, SC), who are members of the ECHO IDeA State Pediatric Clinical Trials Network (ISPCTN) and participated in a previous feasibility study of the iAmHealthy intervention (NCT04142034) in rural medical clinics have each recruited four medical clinics who care for rural children. In each rural clinic, investigators will recruit up to 64 caregiver/child dyads who will be randomly assigned to iAmHealthy or Newsletter, for a total of 512 child/caregiver dyads. The current proposal studies two easily disseminable multilevel interventions and their combination to address modifiable risk factors for cancer in rural populations, specifically pediatric obesity. These findings could significantly change the way medical clinics care for the 41% of rural children who are overweight or obese.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for individual participants:
- •Child is ages 6-11 years at consent
- •Child BMI %ile is ≥85th
- •Child lives in a rural area
- •Child/family speaks English or Spanish
排除标准
- •for individual participants:
- •Child has a physical limitation or injury that substantially limits physical mobility or has a planned medical treatment during the course of the trial that will substantially limit physical mobility
- •Child has a known medical issue that could affect protocol compliance (e.g., cancer)
- •Child and/or primary caregiver has a developmental delay or cognitive impairment that could affect protocol compliance
- •Child is enrolled in a weight-loss trial
- •Child has a sibling who has already consented in the trial
- •Inclusion criteria for clinics:
- •History of collaboration with site awardee in research or quality improvement projects
- •In the past year at least 300 eligible potential participants
- •The clinic must have an electronic medical records system
- •Exclusion criteria for clinics:
- •Unable to generate lists of children seen in clinic by date of visit, age, and zip code
研究组 & 干预措施
Participants: iAmHealthy
The iAmHealthy intervention is a rurally tailored empirically supported family-based behavioral group program targeting the families of children who are overweight or obese and providing 26 contact hours of group and individual intervention over six months.
干预措施: Participants: iAmHealthy (Behavioral)
Participants: Newsletter
Families will receive a monthly newsletter for six months.
干预措施: Participants: Newsletter (Behavioral)
结局指标
主要结局
Change from baseline to 6 months to year 4 in child body mass index (BMI)
时间窗: Baseline, 6 months, year 4
Height and weight will be collected remotely and used to calculate BMI, BMIz, BMI%ile and BMI%95th%ile.
Clinic: Independent clinic chart audit
时间窗: Every six months for 3.5 years
The primary outcome measure for the Healthy Clinics intervention will be a random audit of 40 medical records in each clinic every 6 months performed by highly trained research staff in each state who are fully independent of the participating medical clinic. The medical record, index visit and latest well visit (within that 6 months), will be audited for child BMI and BMI%ile, evidence of recognition of whether the patient has overweight/obesity, plan for addressing overweight/obesity, followup plan, and counseling for diet and activity. The purpose of the clinic chart audit is to assess the clinic's current activities around identification and treatment of overweight and obesity.
次要结局
- Change from baseline to 6 months to year 4 in child physical activity using the Exercise Vital Sign(Baseline, 6 months, year 4)
- Change from baseline to 6 months to year 4 in child physical activity using the "moderate to vigorous physical activity" screening measure(Baseline, 6 months, year 4)
- Change from baseline to 6 months to year 4 in child physical activity using the PROMIS Parent Proxy Physical Activity Measure(Baseline, 6 months, year 4)
- Change from baseline to 6 months to year 4 in child dietary behavior(Baseline, 6 months, year 4)
- Change from baseline to 6 months to year 4 in child sleep(Baseline, 6 months, year 4)
- Parent and child satisfaction of intervention and technology(6 months)
- Change from baseline to 6 months to year 4 in caregiver body mass index (BMI)(Baseline, 6 months, year 4)
- Clinic: Internal clinic chart audit(Every month for 6 months)