Pediatric Practice-based Obesity Intervention to Support Families:FITLINE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 501
- 试验地点
- 2
- 主要终点
- Reducing BMI in overweight and obese children.
研究概览
简要总结
The goal of this study is to investigate whether eight weekly telephone coaching sessions or materials on lifestyle interventions can be beneficial for overweight and obese 8-12 year olds.
详细描述
The proposed five-year cluster randomized controlled pediatric practice-based trial will compare the effectiveness of two practice-based interventions on improving diet and physical activity and reducing BMI among overweight and obese 8-12 year olds seen in pediatric practice: (1) Fitline-Coaching, consisting of a pediatric practice-based component plus Fitline counseling and workbook, or (2) Fitline-Workbook, consisting of the same practice-based component, but only the family workbook materials mailed over 8 weeks, with no referral to Fitline coaching. Sixteen pediatric primary care practices will be randomized to either the Fitline-Coaching (N=8) or the Fitline-Materials (N=8) condition. Five hundred and twelve parents and their children ages 8-12 with a body mass index (BMI) of > 85th percentile (overweight or obese) will be recruited from the practices to achieve N=400 at 12 month follow-up.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •child BMI >= 85th percentile for age/sex,
- •participating parent and child English speaking,
- •parent has access to a telephone and is available to participate in telephone counseling sessions, and
- •referred by the child's primary care provider.
排除标准
- •planning to move out of the area during the period of study participation,
- •medical condition that precludes adherence to AAP dietary and physical activity recommendations,
- •genetic or endocrine causes of obesity,
- •prescribed medications associated with weight gain,
- •child on psychiatric medications, and/or
- •morbidly obese (> 300 pounds). -
结局指标
主要结局
Reducing BMI in overweight and obese children.
时间窗: Baseline and 6-months post-baseline
BMI will be calculated from weight (kg)/height squared (in meters) and BMI z-score for age/sex will be determined using CDC growth charts for the child. It is hypothesized that the Fitline-Coaching group compared to the Fitline-Workbook group will have greater reductions in BMI z-scores at 6-month follow-up
次要结局
- Improving the child's diet(Baseline and 12-months post-baseline)
- Effect of the Fitline-Coaching on BMI through a composite measure of Social Cognitive Theory constructs(Baseline and 12-months post-baseline)
- Improving the child's physical activity(Baseline and 12-months post-baseline)
- Cost Effectiveness(Baseline and 12-months post-baseline)
研究者
Lori Pbert
Professor
University of Massachusetts, Worcester