Feasibility and Acceptability of a Community-based Weight Loss Program Among African American Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Number of Women Who Attended the Information Session and Joined the TOPS Program
研究概览
简要总结
For women diagnosed with breast cancer, dietary, weight loss, and physical activity have been linked with clinically significant weight loss; decreased risk of death; reduced risk of breast cancer recurrence; fewer cardiovascular events; and improved physical function. The objectives of these aims are to a) determine if the TOPS materials and format are possible and accepted by overweight and obese African American breast cancer survivors; b) gather data for sample size calculations for a larger future study.
To meet these aims, we will collect data to see if participants enjoyed the TOPS program and suggestions for changes to the program to make it fit their needs. Other methods will measure recruitment, retention, and weight change.
Aim 1: Examine the feasibility and acceptability of a national, low-cost, community-based, peer-led, weight loss program (Take Off Pounds Sensibly, TOPS) for overweight and obese African American breast cancer survivors in the local chapter of a national African American breast cancer support group (Sisters Network Triangle North Carolina, SNTNC).
Aim 2: Assess the weight change of overweight and obese African American breast cancer survivors after 6 months in the TOPS program to gather data for sample size calculations for a future RCT (randomized controlled trial).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women diagnosed with breast cancer with BMI ≥ 25 kg/m after completion of primary 2 therapy (surgery, radiation, adjuvant or neo-adjuvant chemotherapy).
排除标准
- •Women whose oncology providers do not agree with their participation in a weight loss program or those participating in another weight loss program.
结局指标
主要结局
Number of Women Who Attended the Information Session and Joined the TOPS Program
时间窗: One-time information session
Number of Women Who Remained in the Program for 24 Weeks
时间窗: up to 24 weeks
Measured by the number of women who reported to the 24-week weigh in.
Number of Invited Women Who Attended the TOPS (Take Off Pounds Sensibly) Information Session
时间窗: One-time invitation
Number of Women Who Remained in the Program for 12 Weeks
时间窗: up to 12 weeks
Measured by the number of women who reported to the 12-week weigh in.
次要结局
- Percent Change in Participants' Weight as Measured by Scale Reading(baseline, 3 months, 6 months, 12 months)