Address Obesity to Reduce Cancer Risk and Health Disparities in Rural Ohio
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Feasibility of a 15-week Telephone-based Weight Loss Intervention
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Arm I (telephone-based intervention)
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.
Intervention: Telephone-Based Intervention (Behavioral)
Arm I (telephone-based intervention)
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.
Intervention: Dietary Counseling and Surveillance (Behavioral)
Arm I (telephone-based intervention)
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.
Intervention: Exercise Intervention (Other)
Arm I (telephone-based intervention)
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.
Intervention: Questionnaire Administration (Other)
Arm II (education brochures)
Participants receive education brochures describing the American Institute for Cancer Research physical activity and dietary guidelines.
Intervention: Informational Intervention (Other)
Arm II (education brochures)
Participants receive education brochures describing the American Institute for Cancer Research physical activity and dietary guidelines.
Intervention: Questionnaire Administration (Other)
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)