Mobile Integrated Care for Childhood Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 6
- 主要终点
- Change in Child Adiposity
研究概览
简要总结
The goal of this clinical trial is to evaluate a new way of providing healthcare to children with an unhealthy weight.
Families who participate will be assigned by chance to one of two groups. One group will see their child's primary care provider to talk about healthy lifestyles for 6 months.
The other group will be in our Healthy Lifestyle program for 6 months. This will include:
- Check-ins with lifestyle specialists and community health workers,
- A mobile app to help support a healthy lifestyle, and
- Access to community programs and activities.
The main questions the study aims to answer are:
- Do children in the Healthy Lifestyle program have better weight outcomes?
- Do more families in the Healthy Lifestyle program stay in the study?
- Does the Healthy Lifestyle program work better for families from certain communities?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child 4-12 years of age
- •Child is a patient of the Nemours Children's Health primary care clinics in Milford, Seaford, and Millsboro
- •Child has a BMI ≥ 95% for age and sex
- •Child is from a clinic serving rural neighborhoods (RUCA ≥ 4)
排除标准
- •Caregiver not child's legal guardian
- •Caregiver not proficient in English or Spanish
- •Caregiver does not have a device and reliable internet
- •Child has a genetic syndrome or endocrine disorder that predisposes to obesity
- •Child is on a medication that impacts weight
- •Child is already enrolled in a weight management program
结局指标
主要结局
Change in Child Adiposity
时间窗: 6 months
Change in BMI percentile (above the 95th percentile) for age and sex. Height and weight measurements will be used to calculate BMI percentile above the 95th percentile based on CDC algorithms.
Visit Adherence
时间窗: 6 months
Lost to follow-up (attrition) from study as documented in the electronic health record.
次要结局
- Differences in Change in Child Adiposity Based on Child Sociodemographic Characteristics(6 months)
- Differences in Visit Adherence Based on Child Sociodemographic Characteristics(6 months)
研究者
Thao-Ly Phan
Associate Professor of Pediatrics
Nemours Children's Health System