跳至主要内容
临床试验/NCT02960542
NCT02960542已完成不适用

Healthy Living Partnerships to Prevent Cancer (HELP PC) Pilot Study

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2017年6月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
2
主要终点
Retention of study participants

研究概览

简要总结

This pilot study is designed to adapt a community-based diabetes prevention program to reach adults at risk for cancer.

详细描述

The Healthy Living Partnerships to Prevent Diabetes (HELP PD) study successfully translated the Diabetes Prevention Program (DPP) weight-loss lifestyle intervention in Winston-Salem, North Carolina by delivering the intervention via a partnership between a local diabetes education program with lay community health workers. This study documented a 7% weight loss and 4 mg/dl decrease in fasting blood glucose in patients with prediabetes in 1 year at promote healthy weight loss (1-2 pounds per week). These lifestyle strategies significantly lower costs than the DPP. The HELP PD lifestyle intervention focuses on restricting calories (while improving dietary quality) and increasing physical activity to allow participants to achieve an energy deficient state to are essential to reduce risk for type 2 diabetes but also for a multitude of chronic diseases where excess body weight plays a critical role in the development and exacerbation of the disease. In light of the community-based partnership on which HELP PD was based and the relatively low costs of program administration, the HELP PD model has the potential to be a highly effective and sustainable long-term approach to cancer prevention as well. This pilot study will be the initial step to determine feasibility of implementing the Healthy Living Partnerships to Prevent Cancer (HELP PC) in the Dan River Region of Southern Virginia through a partnership between researchers and colleagues from Wake Forest Comprehensive Cancer Center, Virginia Polytechnic Institute and State University, Danville Hematology and Oncology at the Danville Regional Medical Center, Resource Center of Southern Virginia in Danville, and Danville Regional Medical Center. Wake Forest will serve as the lead site in this study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
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

入选标准

  • English Proficiency: Able to read/understand English at or above a level sufficient to comprehend recruitment and intervention materials.
  • Body Mass Index: BMI > 25 kg/m2.

排除标准

  • Weight Loss: Currently involved in a supervised program for weight loss.
  • Medications: Use of insulin or other diabetes medications that would require additional medical monitoring during weight-loss; use of medications for weight loss or that may impact weight or glucometabolic function (e.g. corticosteroids).
  • Recent History of Cardiovascular Disease: Clinical history of cardiovascular disease (CVD) occurring within the past 6 months, including myocardial infarction, angina, coronary revascularization, stroke, transient ischemic attack (TIA), carotid revascularization, peripheral arterial disease, and congestive heart failure.
  • Hypertension: Uncontrolled high blood pressure: BP > 160/
  • Persons can be re-screened after controlled.
  • Pregnancy: Pregnancy, breast feeding, or planning pregnancy within 1 year.
  • Other Chronic Conditions: Other chronic disease likely to limit lifespan to less than 2-3 years, including any cancer requiring treatment in past 5 years except non-melanoma skin cancer.

结局指标

主要结局

Retention of study participants

时间窗: 6 months

Measure retention to the HELP PC intervention (measured by number of participants attending the closeout visit after 26 weeks of intervention)

Attendance at group sessions

时间窗: 6 months

Assess participant adherence to attending the HELP PC intervention sessions (measured by community health worker documentation of session attendance)

Recruitment of 20 eligible study participants

时间窗: 6 months

Develop and evaluate a feasible referral system to facilitate participant enrollment into the HELP PC intervention (measured by number screened and enrolled)

次要结局

  • Glucose(6 months)
  • Weight(6 months)
  • Blood Pressure(6 months)
  • Insulin(6 months)
  • Cholesterol(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验