Address Obesity to Reduce Cancer Risk and Health Disparities in Rural Ohio
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Feasibility of a 15-week Telephone-based Weight Loss Intervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Feasibility of a 15-week Telephone-based Weight Loss Intervention
时间窗: Up to 15 weeks
Will be defined as the number of enrolled participants who complete the study.
次要结局
- Changes in Body Weight (KG)(Up to 15 weeks)
- Changes in Body Fat Mass(Up to 15 weeks)