Healthy Weight Clinic: Packaging and Spreading Proven Pediatric Weight Management Interventions for Use by Low-Income Families, Childhood Obesity Research Demonstration Project (CORD) 3.0
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 191
- 试验地点
- 2
- 主要终点
- Change in Child BMI z-score at 12 months
研究概览
简要总结
The overall goal of this study is to increase access to and adoption of the Healthy Weight Clinic package in primary care settings serving low income families in the United States who have a disproportionately high prevalence of childhood obesity. Two federally-qualified health centers in Mississippi and two health centers in Massachusetts will be implementing a Healthy Weight Clinic Program. The Healthy Weight Clinic is staffed by a medical provider, a Dietitian/Nutritionist, and a Community Healthy Worker. Patients attend individual medical visits (once per month for 12 months) with the multidisciplinary team, group visits led by a member of the team (once per month for 6 months), and phone follow-up between visits. All patients who receive care at the pilot implementation sites will be exposed to the systems-level intervention. A subset of patients will be invited to participate in a research evaluation of the program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •child is age 2 through 18 years at referral
- •child's BMI meets or exceeds the 85th percentile for age and sex
- •parent can read and respond to interviews and questionnaires in English or Spanish
- •received care at one of the participating pilot sites
排除标准
- •children who do not have at least one parent who can report on their child's daily activities for 1 year
- •families who plan to leave their pediatric health center in the next year
- •children who have conditions or take medications that substantially interfere with growth, physical activity, or dietary recommendations
研究组 & 干预措施
Clinically Based: Healthy Weight Clinic
干预措施: Healthy Weight Clinic (Behavioral)
结局指标
主要结局
Change in Child BMI z-score at 12 months
时间窗: 0-12 months
Weight and height will be combined to report BMI z-score based on CDC growth curves
Change in Child BMI percent of the 95th percentile at 12 months
时间窗: 0-12 months
Weight and height will be combined to report BMI in kg/m\^2 based on CDC growth curves.
Change in Child BMI at 12 months
时间窗: 0-12 months
Weight and height will be combined to report BMI in kg/m\^2 based on CDC growth curves.
次要结局
- Change in Family Food Insecurity at 12 months based on Hunger Vital Signs Questionnaire(0-12 months)
- Change in Child Physical Activity at 12 months based on Questionnaire(0-12 months)
- Change in Child Parental Stress at 12 months based on Questionnaire(0-12 months)
- Change in Child Screen Time at 12 months based on Questionnaire(0-12 months)
- Change in Child Quality of Life at 12 months based on Sizing Them Up Questionnaire(0-12 months)
- Change in Child Binge Eating at 12 months based on Questionnaire(0-12 months)
- Change in Child Nutrition at 12 months based on Questionnaire(0-12 months)
- Change in Child Sleep at 12 months based on Questionnaire(0-12 months)
研究者
Lauren G. Fiechtner, M.D.
Director of Nutrition, Division of Gastroenterology and Pediatric Health Outcomes Research
Massachusetts General Hospital