Address Obesity to Reduce Cancer Risk and Health Disparities in Rural Ohio
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity-Related Malignant Neoplasm
- Sponsor
- Ohio State University Comprehensive Cancer Center
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Feasibility of a 15-week Telephone-based Weight Loss Intervention
- Status
- Completed
- Last Updated
- 10 months ago
Overview
Brief Summary
This study determines the feasibility of a telephone-based weight lost intervention in reducing cancer risk and health disparities in rural Ohio. Obesity is the leading preventable cause of cancer, and obesity-related inflammation is linked to elevated cancer risk, independent of obesity itself. Rural populations are a vulnerable population in need of increased access to tailored strategies and benefit from weight loss interventions. This study aims to see whether a telephone-based intervention may help obese people in rural area to reduce body weight, so as to prevent obesity-related cancer.
Detailed Description
PRIMARY OBJECTIVES: I. To determine the feasibility and acceptability of a 15-week telephone-based weight loss intervention among overweight/obese rural residents. II. To estimate the preliminary efficacy of the lifestyle modifications on weight loss, body composition (fat mass, percent body fat), inflammatory biomarkers (IL-6, TNF-alpha, and C-recreative protein \[CRP\]), and other disease risk factors (lipid profiles). OUTLINE: Participants are randomized to 1 of 2 arms. ARM I: Participants receive weekly telephone-based weight loss intervention for 15 weeks, including dietary recommendations tailored to their current weight and weight loss target, home-based aerobic and resistance exercise, and weekly telephone counseling session over 30-45 minutes. ARM II: Participants receive education brochures describing the American Institute for Cancer Research physical activity and dietary guidelines.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Body mass index (BMI) \>= 25 kg/m\^2
- •Age: 20-64.9 years
- •Not currently participating in any weight loss intervention or meet the physical activity recommendation (150 min/week of moderate-intensity exercise or 75 min/week of vigorous exercise)
- •The ability to walk two blocks
- •Ability to speak and read English
Exclusion Criteria
- •Prior cancer diagnosis (except non-melanoma skin cancer) or severe medical conditions such as unstable cardiovascular disease or digestive disorders that would preclude physical activity and dietary intervention
- •Pregnant or nursing women
- •Unable to give informed consent
Outcomes
Primary Outcomes
Feasibility of a 15-week Telephone-based Weight Loss Intervention
Time Frame: Up to 15 weeks
Will be defined as the number of enrolled participants who complete the study.
Secondary Outcomes
- Changes in Body Weight (KG)(Up to 15 weeks)
- Changes in Body Fat Mass(Up to 15 weeks)