Pilot Study of the Home Weight Loss Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Body weight change
研究概览
简要总结
The goal of the project is to test a remotely delivered, standalone behavioral weight loss intervention designed to help adults initiate the important dietary, physical activity (PA) and behavioral changes necessary to achieve weight loss.
详细描述
The Weight Management Center currently offers a remotely delivered (smart phone, tablet, computer) program to assist patients with maintaining weight losses already achieved, which includes multi-channel self-monitoring and asynchronous individually recorded feedback from clinical staff. The goal of the presently proposed project is to build on this existing maintenance-focused program to create a remotely delivered, standalone behavioral weight loss intervention designed to help participants initiate the important dietary, physical activity (PA) and behavioral changes necessary to achieve weight loss. We recently developed the Home Weight Loss (HWL) program by repackaging existing clinical educational materials as instructional lifestyle change modules to be delivered remotely for participant weight loss
The aim of the proposed project are to pilot test the effects of the HWL program among a sample of overweight and obese adults (N=30). The digital platform currently used in the maintenance program will be used for the HWL program
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged 18-70 years
- •BMI = 25.0- 40 kg/m2
- •Internet access via desktop or laptop computer
- •valid email address
- •smart phone ownership
- •women of childbearing potential must agree to use effective contraception during the study
排除标准
- •currently dieting (>10-pound weight loss in past 3 months)
- •another member of the household is participating in this pilot study
- •inability to engage in physical activity
- •inability to read and speak English
- •diagnosis of diabetes (other than treated by diet alone),
- •uncontrolled thyroid condition or other endocrine disorder
- •major depressive disorder or other severe psychiatric disorder (e.g., bipolar disorder) within the past two years
- •past suicide attempt
- •current use of prescription or over-the-counter weight loss medications
- •current/planned pregnancy
- •drug and/or alcohol abuse
- •use of steroid medication for more than 10 days in the past three months *implanted electronic devices
研究组 & 干预措施
Home weight loss program
Participants will be instructed to daily monitor their body weight, minutes of activity, number of steps, and calories consumed for the duration of the pilot study, and they will receive recorded individualized feedback on this self-monitored data from Weight Management Center clinicians (registered dietitians, exercise psychologists, and behavioral specialists).
干预措施: Home weight loss program (Behavioral)
结局指标
主要结局
Body weight change
时间窗: 12 weeks
body weight change (kg) from pre-to post
次要结局
- changes in body fat percentage(12 weeks)
- program satisfaction(12 weeks)
- changes in body mass index(12 weeks)
- usability of program components(12 weeks)
- changes in scores on the power of food scale(12 weeks)
- changes in eating behavior scores(12 weeks)
- changes in body weight as a percentage of start weight(12 weeks)
- changes in waist and hip measurements(12 weeks)
研究者
Patrick O'Neil
Professor
Medical University of South Carolina