African American Cancer Survivor Health: Pilot Implementation Research (National Witness Project® Witness Role Models Use Precision Nutrition)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Rate of enrollment
研究概览
简要总结
This early phase I trial studies how well a web-based lifestyle intervention called Precision Nutrition Coaching Program works in improving health in African American cancer survivors. Participating in the web-based lifestyle intervention program reinforced with experienced lifestyle coaches and consisting of physical activity, nutritional/lifestyle habits, and educational lessons may help to improve overall health and well-being, fitness level, and quality of life in African American cancer survivors.
详细描述
PRIMARY OBJECTIVE:
I. To conduct a pilot implementation research study to determine the viability, safety, and effectiveness of the use of a 12-month, commercially available, web-based lifestyle behavioral medicine intervention program by individuals who are or have been a Witness Role Model (WRM) in the National Witness Project (NWP).
SECONDARY OBJECTIVE:
I. To examine the feasibility of this research to subsequently investigate the effects of optimal health and/or lifestyle related behavioral medicine interventions used to promote optimal health on mitigating cancer-related and overall mortality disparities in African Americans (AA), and comorbidity/ chronic disease(s) management over time. (EXPLORATORY)
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has contacted study investigators using the contact information found on recruitment materials to convey their interest in participating
- •Verbally confirmed that they now currently or in the past have functioned as a WRM for NWP
- •Body mass index (BMI) >= 23
- •Weight stable over the past year (=< 10% change)
- •Current levels of physical activity were assessed and compared to United States (US) Centers for Disease Control and Prevention (CDC) Physical Activity (PA) guidelines (150 minutes of moderately intensive weekly physical activity)
- •Cleared to participate in an exercise program via the American College of Sports Medicine Exercise Pre-participation Health Screening Guidelines
- •Has access to internet and a computer/tablet etc
- •Has access to basic fitness equipment (dumbbells, resistance bands) and/or is willing to join a fitness facility
- •Is currently under the care of and has been assessed by a primary care physician within the last 12 months
- •Understands the investigational nature of this study and completes the process of informed consent per Institutional Review Board (IRB) approved protocol
排除标准
- •Has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Is pregnant or nursing
- •Is unwilling or unable to participate
- •Has any condition which in the investigators' opinion(s) deems the subject an unsuitable candidate to participate in this study
- •Has metastatic cancer
- •Has an orthopedic disorder, neuromuscular disorder or other condition (e.g., arthritis, morbid obesity) that may significantly preclude participation in exercise or related behaviors
- •Is currently incarcerated (i.e., prisoner)
结局指标
主要结局
Rate of enrollment
时间窗: Up to 12 months
Program effectiveness
时间窗: Up to 12 months
The effects of the lifestyle intervention program will be ascertained via primarily subjective, self-reported assessments administered at pre-intervention, post-intervention, and a follow-up. Subjective data will be validated through the collection of objective data in a subset of local participants via in-person assessments. Generalized linear mixed model methods, specifically a repeated measures analysis of variance with a random participant effect, as well as fixed effects for time and interaction will be used.
Rate of refusal
时间窗: Up to 12 months
Incidence of physical activity related injuries
时间窗: Up to 12 months
Biweekly inquiries about possible injuries will be conducted.
Program retention
时间窗: Up to 12 months
Will be measured by the proportion of participants who are still participating in the study at the end of the 12-month intervention.
Program adherence rate
时间窗: Up to 12 months
Measured by participation and online tracking of activity completion (workout, habit, and lessons). An overall adherence score will be calculated by averaging the percentage of time each of the 3 activities were completed by each participant over the 12-month intervention.
次要结局
未报告次要终点