Clinical trial NCT02960542: HELP Prevent Cancer Pilot Study
Official title: Healthy Living Partnerships to Prevent Cancer (HELP PC) Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Cancer
Keywords: lifestyle intervention
weight-loss
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Virginia Polytechnic Institute and State University
name: Danville Regional Medical Center
First posted: 2016-11-09
Enrollment: 21
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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 \> 160/100. 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.

Primary outcomes:
measure: Recruitment of 20 eligible study participants
timeFrame: 6 months
measure: Retention of study participants
timeFrame: 6 months
measure: Attendance at group sessions
timeFrame: 6 months
Secondary outcomes:
measure: Blood Pressure
timeFrame: 6 months
measure: Weight
timeFrame: 6 months
measure: Glucose
timeFrame: 6 months
measure: Insulin
timeFrame: 6 months
measure: Cholesterol
timeFrame: 6 months
Other outcomes:
Locations:
city: Danville
country: United States
facility: Danville Regional Medical Center
state: Virginia
Study officials:
affiliation: Wake Forest University Health Sciences
name: Mara Z Vitolins, DrPH MPH RDN
role: PRINCIPAL_INVESTIGATOR
References: