Healthy Kids After Cancer: A Physical Activity and Nutrition Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 6
- 主要终点
- Feasibility: Number of participants who complete 8 of 10 intervention sessions
研究概览
简要总结
This pilot study will evaluate the feasibility, acceptability, and potential efficacy of a parent-targeted, phone-based program to prevent unhealthy weight gain and improve biomarkers of oxidative stress and inflammation among childhood acute lymphoblastic leukemia survivors.
详细描述
Acute lymphoblastic leukemia (ALL) is the most common childhood cancer, accounting for 25% of all childhood malignancies. Treatment of childhood ALL has a high success rate, with long-term event-free survival of >85%. Treatment success, however, has not come without cost. Recognition of long-term health problems related to childhood cancer therapies is growing. Both during and after therapy, children treated for ALL are at risk for fatigue, reduced physical activity, poor dietary intake, and excessive weight gain, which are driven by physiological (chemotherapy-induced) changes and social (home/environmental) factors. The goals of this pilot study are to evaluate the feasibility, acceptability, and potential efficacy of a parent-targeted, phone-delivered nutrition and physical activity program to prevent unhealthy weight gain among 60 childhood ALL survivors, 4-10 years of age. Participants will be randomly assigned to either the phone-delivered parent-targeted nutrition and physical activity intervention or a standard-of-care control group. Intervention success will be benchmarked by changes in key weight-related behaviors (physical activity and dietary intake) over the 6-month trial, and initial impact of the intervention on biomarkers of inflammation and oxidative stress, fatigue, and body composition will be examined.
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
- None
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 4.0 years and < 11.0 years of age at the time of recruitment
- •Previously diagnosed of ALL and currently in remission
- •Between 1-5 years post completion of chemotherapy
- •BMI ≥ 85 percentile for age and sex (overweight or obese) OR at risk for obesity (BMI between the 50th and 85th percentile and at least one overweight parent (BMI ≥ 25 kg/m2)
排除标准
- •History of cranial radiation therapy
- •History of bone marrow transplant
- •History of relapse of ALL
- •Diagnosis of Down's Syndrome
- •Comorbidities of obesity that require immediate subspecialist referral
- •Significant pulmonary, cardiovascular, orthopedic, or musculoskeletal problems that would, in their oncologist's judgment, limit their ability to participate in physical activity
- •Significant psychiatric or neurologic disorders that would impair compliance with study protocol
- •Current participation in a weight-loss program
研究组 & 干预措施
Phone Coaching Program
Participants will receive a nutrition and physical activity phone coaching program, in addition to standard-of-care physician counseling regarding lifestyle recommendations to achieve/maintain a healthy weight trajectory after cancer treatment.
干预措施: Phone Coaching Program (Behavioral)
Standard Care Control
Participants will receive standard-of-care physician counseling regarding lifestyle recommendations to achieve/maintain a healthy weight trajectory after cancer treatment.
结局指标
主要结局
Feasibility: Number of participants who complete 8 of 10 intervention sessions
时间窗: 6 months
Measured by intervention session completion rates.
Acceptability: Number of participants who report high satisfaction with the intervention
时间窗: 6 months
Measured by parent survey of satisfaction with intervention materials and sessions.
Retention: Number of participants who complete 6-month outcome assessments
时间窗: 6 months
Measured by completion of the 6-month outcome assessment.
次要结局
- Change in children's BMI(6 months)
- Change in children's physical activity(6 months)
- Change in children's dietary intake(6 months)
- Change in children's energy level(6 months)
- Change in children's biomarker outcome measures(6 months)