Healthy Families: Transforming Care for Obese Children at NYU Lutheran Family Health Centers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Stabilize Body Mass Index (BMI)
研究概览
简要总结
Childhood obesity is a contributing factor to health complications such as diabetes, heart disease, high blood pressure, cancer and asthma. It is of particular concern among Hispanic populations in the United States as that group has the fastest growing childhood obesity rate. Nearly two in five Hispanic children ages 2 to 19 are overweight or obese. This program aims to test whether it is beneficial to routinize a multi-disciplinary pediatric weight management program within the highest volume clinic (NYU-LFHC Women, Adolescents and Children), and to add a home-visit component to reinforce teaching on food selection and preparation. The intervention will include 27-hour intervention session which will be distributed into 12-session series over a 3 month period. The program will target Hispanic children between the ages of 9 and 11 with a Body Mass Index (BMI) between the 95th and 99th percentiles. To assess the effectiveness of this program, the investigators propose to conduct a general prospective study using randomized pre-test and post-test control group design with minimal risk for participants.
详细描述
The proposed intervention will engage pediatricians at NYU Lutheran Family Health Centers (NYU LFHC) and providers at the school-based clinics in referring Hispanic children ages 9-11 years with a BMI between the 95th and 99th percentile to the study. In addition, a list will be generated from NYU Lutheran's Quality Improvement department if recruitment through providers is low. Providers will refer patients who meet the above criteria through eClincialWorks (ECW). A research assistant will then randomize the referrals after acquiring informed consent forms to either the control group or the intervention group. The control group will receive standard of care by nutritionists at NYU LFHC. The intervention group will receive a 27-hour intervention session which will be split into a 12-session series. The sessions will be conducted weekly over a 3 month period. This study will include three cycles with three separate cohorts.
The Healthy Families Intervention Group will include:
- Bilingual English and Spanish group nutrition education, behavioral social support, and physical activity (e.g. kickboxing, Zumba, yoga, aerobics).
- Monthly home visits by a nutritionist for family including specific recommendations on food purchasing and preparation.
Children randomized to standard of care will attend monthly sessions with a nutritionist.
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
- 9 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient of NYU-LFHC Women's, Pediatric, and Adolescent Medicine (5610)
- •Hispanic ethnicity
- •BMI percentile between the 95th and 99th
- •Ages between 9 and 11 years old at the time the program begins
排除标准
- •Autism Spectrum Disorder (299.0)
- •Pervasive Developmental Disorder-Not Otherwise Specified (PDD NOS 299.9) and
- •Other PDD (299.8)
结局指标
主要结局
Stabilize Body Mass Index (BMI)
时间窗: 3 months
The goal is to stabilize or reduce the participant's BMI at the end of the study. The height and weight of the control group will be measured at baseline and at the end of 3 months. The height and weight of the intervention group will be measured at over 12 sessions within the 3 month time frame. The intervention will be 27 hours in total.
次要结局
- Differences in 5-2-1-0 measures between baseline and post-intervention session(3 months)
- Stabilize BMI z-score(3 months)