Nutrition Intervention for Pediatric Patients With Leukemia or Lymphoma Treated With Prednisone and/or Dexamethasone
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in waist circumference
研究概览
简要总结
This trial studies how well a nutrition and physical activity intervention works in preventing excess weight gain in pediatric patients with leukemia or lymphoma treated with Treated with prednisone and/or dexamethasone. A nutrition and physical activity intervention may help develop healthier eating habits and prevent rapid excess weight gain in pediatric patients with leukemia or lymphoma who are receiving prednisone and/or dexamethasone.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate if a nutrition counseling intervention will prevent an increase in waist circumference from baseline measurements for children/adolescents diagnosed with leukemia or lymphoma and being treated with prednisone and/or dexamethasone.
SECONDARY OBJECTIVES:
I. To conduct qualitative research on diet habits, likeability of low-fat and-low sucrose foods.
II. To conduct qualitative research on exercise habits and willingness to engage in moderate walking.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Leukemia or lymphoma patient at MD Anderson Children's Cancer Hospital
- •Patients receiving prednisone and/or dexamethasone therapy at MD Anderson Children's Cancer Hospital at time of enrollment
- •Karnofsky performance status greater than or equal to 70
- •Must be cleared by treating oncologist to participate in study
- •Must live close enough to attend measurement sessions at one of the clinical centers
排除标准
- •Patients receiving nutrition counseling or weight management counseling elsewhere
- •Pediatric patients who are already receiving steroids that are not part of treatment
- •History of psychological disorders as indicated in the medical record (eg: eating disorders, depression)
结局指标
主要结局
Change in waist circumference
时间窗: through study completion an average of 1 year
Will assess the difference in waist circumferences between patients in the Arm 1 intervention group compared to patients in the Arm 1 control group. The primary analysis will use the two-sample t-tests, and will be conducted on the intent-to-treat basis. This implies that if patients in the control arm received nutrition counseling, that patient will still be labeled as control.
次要结局
未报告次要终点