HELP Prevent Cancer Pilot Study (HELP PC)

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

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

Study Overview

• Status: Completed
• Conditions: Obesity; Cancer
• Intervention / Treatment: Behavioral: HELP Prevent Cancer Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Danville, Virginia, United States, 24541
      • Danville Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Lifestyle Weight Loss; The Behavioral: HELP Prevent Cancer Intervention is a lifestyle intervention consisting of 24-weekly group meetings led by a community health worker and 3 individual sessions with a nutritionist/diabetes educator

Behavioral: HELP Prevent Cancer Intervention; This Behavioral: Lifestyle Weigh Loss Intervention involves a dietary weight-loss program and an increase in caloric expenditure through moderate physical activity. The primary treatment objectives for the weight-loss component of the intervention will be to decrease caloric intake in a nutritionally sound manner so as to produce a weight-loss of .3 kg/week for a total weight loss of 5-7%. The primary objective for the physical activity component of the intervention will be to promote an increase in home-based energy expenditure to an eventual goal of 180 minutes/week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment of 20 eligible study participants	Develop and evaluate a feasible referral system to facilitate participant enrollment into the HELP PC intervention (measured by number screened and enrolled)	6 months
Retention of study participants	Measure retention to the HELP PC intervention (measured by number of participants attending the closeout visit after 26 weeks of intervention)	6 months
Attendance at group sessions	Assess participant adherence to attending the HELP PC intervention sessions (measured by community health worker documentation of session attendance)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure	Estimate the means and standard deviations at baseline and 6 months.	6 months
Weight	Estimate the means and standard deviations at baseline and 6 months.	6 months
Glucose	Estimate the means and standard deviations at baseline and 6 months.	6 months
Insulin	Estimate the means and standard deviations at baseline and 6 months.	6 months
Cholesterol	Estimate the means and standard deviations at baseline and 6 months.	6 months

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: Virginia Polytechnic Institute and State University; Danville Regional Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2017
• Primary Completion (Actual): April 4, 2018
• Study Completion (Actual): April 4, 2018

Study Registration Dates

• First Submitted: October 31, 2016
• First Submitted That Met QC Criteria: November 7, 2016
• First Posted (Estimate): November 9, 2016

Study Record Updates

• Last Update Posted (Actual): June 19, 2020
• Last Update Submitted That Met QC Criteria: June 18, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: lifestyle intervention; weight-loss
• Other Study ID Numbers: IRB00039102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No