An interventional study of HELP Prevent Cancer Intervention in Obesity and Cancer, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-19.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Prevention
This pilot study is designed to adapt a community-based diabetes prevention program to reach adults at risk for cancer.
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.
Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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)
Time frame: 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)
Time frame: 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)
Time frame: 6 months
Blood Pressure
Estimate the means and standard deviations at baseline and 6 months.
Time frame: 6 months
Weight
Estimate the means and standard deviations at baseline and 6 months.
Time frame: 6 months
Glucose
Estimate the means and standard deviations at baseline and 6 months.
Time frame: 6 months
Insulin
Estimate the means and standard deviations at baseline and 6 months.
Time frame: 6 months
Cholesterol
Estimate the means and standard deviations at baseline and 6 months.
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Wake Forest University Health Sciences