Patient-Clinic-Community Integration to Prevent Obesity Among Rural Preschool Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,040
- 试验地点
- 2
- 主要终点
- Difference in BMI Z-score, Based on WHO Growth Standards
研究概览
简要总结
The goal of this research study is to compare two enhancements to well-child visits at Geisinger designed to promote family-centered counseling for the prevention of obesity in a high-risk population of rural, lower income, preschool-aged children. Compared to the standard well-child visit, enhancements will offer advantages to obesity prevention, parent involvement in counseling, lifestyle behaviors, and food resource management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age (20-months to 59-months, 29-days old)
- •BMI-for-age and -sex >50th percentile based on WHO growth standards
- •Parent commitment to participate in 18-month study
- •Plans to attend scheduled WCV and recommended follow-up WCV in 12 months
- •No plans to move or change health systems in 2 years
- •Parent age > 18 years
- •Parent is English-speaking
- •Household is considered lower-income (i.e., eligible for or receiving Special Supplemental Nutrition Program for Women, Infants and Children [WIC], Supplemental Nutrition Assistance Program [SNAP], Temporary Assistance for Needy Families [TANF], Medicaid, or Children's Health Insurance Program [CHIP]) or screens positive for food insecurity.
排除标准
- •Another child in family is participating
- •Pre-existing medical exclusions (cancer, type 1 diabetes, major developmental delays such as autism)
- •Parents with self-reported major depression will be excluded.
结局指标
主要结局
Difference in BMI Z-score, Based on WHO Growth Standards
时间窗: 1-year
BMI values will be obtained from Geisinger clinical care visits, documented in the EHR and standardized or parent-reported. Values obtained at well child visits during the study period, ideally 12 months, 1 day apart will be utilized but values within a 9- to 18-month span of baseline to 1-year follow up may be used (e.g., 3 months pre-baseline WCV to 15 months post-baseline, baseline WCV to 18-months post-baseline, etc.) to assess the primary outcome. A z-score of 0 represents the population mean. Higher z-scores represent worse outcomes. BMI z-score over \>=1 indicates possible risk for overweight.
次要结局
- United States Household Food Security Survey Module: Six-Item Short Form(1-year)
- Modified Version of Perceived Involvement in Care Scale(1-year)
- Food Resource Management(1-year)