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临床试验/NCT04097353
NCT04097353终止不适用

Harvesting Hope for Kids: Improving Diet and Physical Activity in Childhood Cancer Survivors

Cynthia Gerhardt2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2017年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
31
试验地点
2
主要终点
Change in Fruit and Vegetable Intake

研究概览

简要总结

The objective of this study is to examine the efficacy of Harvesting Hope for Kids (HH4K), a biobehavioral intervention delivered in the context of a university-based, cancer survivor garden, to increase produce intake and physical activity in survivors and caregivers.

详细描述

Advances in treatment have led to a rapidly growing population of over 388,500 survivors, with 13,500 new survivors expected annually. However, chronic or long-term side effects (e.g., secondary malignancies, metabolic syndrome, cardio-pulmonary toxicities) can reduce quality of life and lead to premature death. The investigators propose that diet and fitness are two critical factors for healthy survivorship given their broad impact on late effects like obesity, fatigue, and metabolic syndrome. Despite the promise of comprehensive lifestyle interventions for children who are overweight or obese, research with survivors is limited by small samples and inconsistent effects. Novel research supports a key role for the gastrointestinal (GI) microbiome in regulating weight and health outcomes, yet no studies have examined the "obesogenic" microbiome in the context of lifestyle interventions for survivors of childhood cancer. The objective of this RCT is to examine the efficacy of Harvesting Hope for Kids (HH4K), a biobehavioral intervention delivered in the context of a university-based, cancer survivor garden, to increase produce intake and physical activity in survivors and caregivers. Families will be randomized to participate in HH4K or enhanced usual care. Dietary patterns, physical activity, cardiometabolic indices, family outcomes, and GI microbiome will be assessed and the HH4K group will demonstrate greater improved than enhanced usual care.

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
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •8-12 years of age
  • •previously diagnosed with any type of pediatric cancer
  • •within 5 years post-treatment for pediatric cancer
  • •fluent in English, with at least 1 fluent parent
  • •living within 75 miles of the medical center

排除标准

  • •significant developmental disorder or cognitive difficulties that would interfere with children and caregivers completing questionnaires
  • •Referral to hospice or at end of life.

研究组 & 干预措施

Harvesting Hope for Kids (HH4K)

Experimental

Eight weekly, 60-minute sessions at a university-based farm with booster sessions. Learning is structured around fun activities to provide information about the impact of cancer treatment on children's health, as well as the importance of nutrition and physical activity in survivorship. Each session is manualized and devoted to education, a behavioral strategy applied toward a weekly goal, a cooking demonstration/taste testing, and harvesting produce from the survivor garden. Modules are offered in a group format with families together.

干预措施: Harvesting Hope for Kids (HH4K) (Behavioral)

Surviving Strong for Kids (SS4K)

Sham Comparator

Families assigned to enhanced usual care (SS4K) group will receive education in the form of standardized guidelines for nutrition and physical activity for survivors of childhood cancer. In a one-hour session, they will learn about the impact of cancer treatment on health and the importance of nutrition and physical activity for survivors. Families will receive websites for other educational resources. They will not have access to harvesting, remote coaching, the web portal, or behavioral training to address their child's nutrition or activity.

干预措施: Surviving Strong for Kids (SS4K) (Behavioral)

结局指标

主要结局

Change in Fruit and Vegetable Intake

时间窗: Month 0 (baseline) to Month 2 (post-intervention)

Skin carotenoid score, with total scores ranging from 10,000-89,000+ and higher scores indicating more fruit and vegetable intake

Change in Physical Activity

时间窗: Month 0 (baseline) to Month 2 (post-intervention)

Daily step count, with higher counts indicating more physical activity

次要结局

  • Change in Parent-rated Child Quality of Life(Month 0 (baseline) to Month 2 (post-intervention))
  • Change in Blood Lipids and Glucose(Month 0 (baseline) to Month 2 (post-intervention))
  • Change in Body Mass Index (BMI)(Month 0 (baseline) to Month 2 (post-intervention))
  • Change in Blood Pressure(Month 0 (baseline) to Month 2 (post-intervention))
  • Change in Child Quality of Life(Month 0 (baseline) to Month 2 (post-intervention))
  • Change in Microbial Diversity(Month 0 (baseline) to Month 2 (post-intervention))

研究者

发起方
Cynthia Gerhardt
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Cynthia Gerhardt

Associate Professor

Nationwide Children's Hospital

研究点 (2)

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