NCT02871388已完成不适用
Addressing Modifiable Breast Cancer Risk Factors With Project CONECT [Connect Online to Engage Change Tool]
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- feasibility-participant engagement and retention
研究概览
简要总结
The objective of this protocol is to adapt and pilot test an existing lifestyle modification intervention for weight loss for women with overweight or obesity who have had a recent false positive mammography screen. The purpose of this pilot trial is to establish feasibility of Connect Online to Engage Change Tool (CONECT) to promote weight loss through increased physical activity and diet change.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •40-65 years of age,
- •Received a negative mammography screening result in the previous four weeks
- •Moderately sedentary lifestyle (less than 120 minutes/week moderate intensity activity),
- •Answer "no" to all questions on the Physical Activity Readiness Questionnaire (PAR-Q).
- •BMI 25-40 kg/m2
- •Has access to a computer or mobile device with wireless internet
- •Able to speak and read English (language requirements are necessary because we cannot accommodate additional languages in prototype development phase.)
排除标准
- •Previous history or current diagnosis of breast cancer
- •Pregnancy or lactation
- •Involvement in a weight loss program
- •Major co-morbidities (e.g.,diabetes, hypertension, etc.)
- •History of disordered eating
- •Currently taking medication that may impact weight (e.g., synthroid, metformin)
结局指标
主要结局
feasibility-participant engagement and retention
时间窗: 12 weeks
recruitment of 30 participants with 70% retention at 12 weeks
feasibility-intervention adherence
时间窗: 12 weeks
Completion of 80% of intention components including wearing Fitbit tracker, completed of the weekly weightings, answering emails, attending intervention sessions
次要结局
- Daily caloric goals(12 and 24 weeks)
- Change in autonomous motivation(12 weeks and 24 weeks)
- Steps per day(12 and 24 weeks)
- Total minutes of weekly physical activity(12 and 24 weeks)
研究者
研究点 (2)
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