HELP Prevent Cancer Pilot Study

Not Applicable

Completed

• Conditions: Obesity; Cancer
• Interventions: Behavioral: HELP Prevent Cancer Intervention

• Registration Number: NCT02960542
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study First Submitted: 2016-10-31
• Study First Submitted QC: 2016-11-07
• Study First Posted: 2016-11-09
• Study Start: 2017-06-26
• Primary Completion: 2018-04-04
• Study Completion: 2018-04-04
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-18
• Last Update Posted: 2020-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lifestyle Weight Loss	HELP Prevent Cancer Intervention	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Blood Pressure	6 months	Estimate the means and standard deviations at baseline and 6 months.
Insulin	6 months	Estimate the means and standard deviations at baseline and 6 months.
Cholesterol	6 months	Estimate the means and standard deviations at baseline and 6 months.
Weight	6 months	Estimate the means and standard deviations at baseline and 6 months.
Glucose	6 months	Estimate the means and standard deviations at baseline and 6 months.

Trial Locations

Locations (1)

Danville Regional Medical Center; 🇺🇸 Danville, Virginia, United States