Randomized Trial of Telephone Interventions for Pediatric Obesity in School Age Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in diet
研究概览
简要总结
In this study, we evaluate whether dietary advice based on two healthy nutritional programs can be effectively delivered to families over one month by telephone. We hypothesize that among overweight school age children, a one-month telephone intervention will result in specific dietary changes consistent with the randomly assigned dietary intervention.
详细描述
Overweight and obesity have increasingly become problems faced by children. However, the best dietary approach for managing weight in children remains unclear and how to make dietary advice practical remains a challenge. The primary aim of the study is to evaluate the feasibility of a one-month telephone-based dietary intervention for pediatric obesity in achieving changes in the target variable (dietary glycemic load or dietary fat) of the assigned intervention. We hypothesis that among overweight school age children, a one-month telephone intervention will elicit specific dietary changes consistent with the randomly assigned prescriptions. Specifically, children counseled to reduce glycemic load will achieve a significantly greater mean reduction in glycemic load than those counseled to reduced dietary fat and, conversely, those counseled to reduce dietary fat will achieve a significantly greater mean reduction in dietary fat than those counseled to reduce glycemic load. The first ten participants enrolled will comprise a pilot study group intend to inform study design/methods and will not be included in the primary analysis.
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
- 5 Years 至 10 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI ≥ 85%ile for age and sex within the last 6 months
- •Living at home with a working telephone.
- •Subject conversant in English
- •Parent/guardian conversant and literate in English
- •Family readiness to make dietary changes
排除标准
- •Major chronic medical illness (e.g., cancer)
- •Psychiatric disorder
- •Obesity-associated genetic syndrome
- •Current participation in another obesity-related research study or a formal weight loss program
- •Family or child following a specialized diet
- •Related to or living with another child study participant
结局指标
主要结局
Change in diet
时间窗: 1 month
次要结局
未报告次要终点
