A Randomized Controlled Trial, Using a Mail and Video-based Weight Loss Program for Overweight or Obese Stage I-IIIC Breast Cancer Survivors.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 205
- 试验地点
- 1
- 主要终点
- Body weight (kg)
研究概览
简要总结
Proposed is a 6-month randomized controlled trial, in 200 overweight or obese Stage I-IIIC breast cancer survivors examining 6-month changes in: 1) body weight, 2) diet, 3) physical activity, and 4)quality of life in women randomized to receive the modified LEAN intervention compared to women randomized to wait-list control (i.e., the wait-list control will receive the modified LEAN intervention after completing the 6-month study).
详细描述
The purpose of the study is to evaluate the effects of modifying the LEAN intervention (NCT02110641) to make it more cost effective by reducing or eliminating the counseling sessions. To guide the modification of the intervention one or more focus group sessions with former LEAN participants will be conducted. The purpose of these meetings will be to gain input on enhancing the LEAN book.
The LEAN book will be central to the modified intervention, but the LEAN book will be modified based on feedback from the focus group(s) and experience gained from the LEAN study. The reading level of the LEAN book will also be assessed to ensure acceptability to those with a low literacy level.
Once these changes have been finalized, the efficacy of the modified program will be tested using the methods described in the Brief Summary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Overweight individuals (BMI >= 25.0 kg/m2)
- •Breast cancer survivors who have completed chemotherapy and/or radiation therapy
- •Stage 0-III
- •The ability to be physically able to exercise (e.g. walk at a moderate pace)
- •Agree to random assignment to either group
- •Give informed consent to participate in all study activities
- •Accessible by telephone
- •Able read and communicate in English
排除标准
- •Pregnant or intending to become pregnant in the next year
- •Recent (past 6 months) stroke or myocardial infarction
- •Severe uncontrolled mental illness
研究组 & 干预措施
LEAN
Participants randomized to the weight loss program will initially receive the LEAN book, as well as a CD and flash drive with the LEAN videos (and internet link), a pedometer and the Log Book for recording their food intake and physical activity. Written instructions in the LEAN book will include recording daily diet and exercise in the logs. At the end of the study, participants will return, via a stamped addressed envelope, the logs to the study office so compliance can be assessed.
干预措施: LEAN book/videos (Behavioral)
Waitlist Control
Participants randomized to the waitlist control study arm will be mailed the six-month questionnaires, which will include reporting of weight. On return of the 6-month questionnaires each woman will be provided with the entire weight loss program packet.
结局指标
主要结局
Body weight (kg)
时间窗: 6 Months
A standard digital scale will be mailed to each participant along with the baseline packet to allow consistent measurement of weight by participants. Participants will weigh themselves. Body weight will be collected in kilograms (kg).
次要结局
- Dietary Intake(12 months)
- Body weight (kg)(12 Months)
- Quality of Life (QOL)(6 months)
- Physical Activity (Vigorous)(12 months)
- Physical Activity (Moderate)(12 months)
- Body weight (kg)(Baseline)
- Quality of Life (QOL)(Baseline)
- Dietary Intake(Baseline)
- Dietary Intake(6 months)
- Physical Activity (Moderate)(Baseline)
- Physical Activity (Moderate)(6 months)
- Physical Activity (Vigorous)(Baseline)
- Physical Activity (Vigorous)(6 months)