Weight Loss to Reduce Breast Cancer Risk Factors
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Weight loss for one group
研究概览
简要总结
This study is investigating the changes in specific hormone levels in women age 30-45 after a 12 week weight loss intervention.
详细描述
In sum, excess body weight and inactivity have emerged as strong avoidable causes of postmenopausal breast cancer, with the greatest potential for primary prevention occurring during the premenopausal years. However, surprisingly, no study to date has examined the effects of a standard behavioral weight loss intervention on breast cancer risk markers in premenopausal women. Understanding the effects of weight loss in premenopausal women is a critical next step in existing research and will inform the development of future breast cancer primary prevention programs. The purpose of this study is to determine the feasibility of recruiting, treating, and retaining 20 overweight/obese women in a 12-week randomized control trial examining feasibility and effects of a behavioral weight loss program on breast cancer risk markers in premenopausal women. Participants will be randomly assigned to either a 12-week comprehensive behavioral weight loss program (n=10) or control condition (n=10). All women will be assessed at baseline and after 3 months of treatment.
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 (Participant)
入排标准
- 年龄范围
- 30 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Premenopausal women
- •Age 30-45
- •Current BMI of >25
- •English or Spanish speaking
- •5th grade reading level
- •Menstrual regularity, defined as menstrual cycle length of 27-31 and < 1 missed period within the past 12 months.
排除标准
- •Current use or recent (< 6 months) use of oral contraceptives, hormones, or other hormone-influencing medications
- •Pregnant, lactating or planning pregnancy in the next 12 weeks
- •Unwilling and able to location for intervention visits.
- •Serious medical condition requiring the supervision of a physician for exercise and diet
- •History of eating disorder
- •History of or current use of drugs
- •Current treatment for serious psychological disorder
- •Donation of blood within past 6 weeks.
结局指标
主要结局
Weight loss for one group
时间窗: 3 months
One group in this randomized study will be focused on weight loss during a 3 month period. The goal is to acheive a 6% weight loss during this time. Specific blood draws will be conducted pre and post weight loss to measure any hormonal changes due to this weight loss.
次要结局
- Increased physical activity(3 months)
研究者
Suzanne Phelan
Principal Investigator
California Polytechnic State University-San Luis Obispo