NCT02487121已完成不适用
Improving Weight Loss Maintenance Through Alternative Schedules of Treatment
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 主要终点
- body weight (kg)
研究概览
简要总结
This project examines the effects of differing schedules of extended care contact following weight loss treatment in order to prevent weight regain following treatment.
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
- None
入排标准
- 年龄范围
- 21 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 21 years-old
- •body mass index (BMI) = 28.0 - 45.0 kg/m2
- •willing to provide informed consent and accept randomization
排除标准
- •BMI >45 kg/m2
- •Illnesses requiring medical attention and/or conditions for which weight loss and moderate physical activity would be inadvisable: diabetes not under active treatment, myocardial infarction or cerebrovascular accident within the last six months; unstable angina within the past six months; congestive heart failure; cancer requiring treatment in past five years (exception: non-melanoma skin cancer); serious infectious diseases (e.g., self-reported HIV); chronic hepatitis; cirrhosis; chronic malabsorption syndrome; chronic pancreatitis; chronic lung diseases that limit physical activity; orthopedic injuries or conditions that significantly limit physical activity.
- •Conditions or behaviors likely to affect the conduct of the trial: unwilling or unable to give informed consent; unable to read English at the 5th grade level; unwilling to accept random assignment; unwilling or unable to travel to attend intervention (due to distance from clinic, work schedule or other scheduling conflicts); likely to relocate out of the service area in next 18 months.
研究组 & 干预措施
variable interval schedule
Experimental
12 group-based extended care treatment sessions scheduled in 3, 4-week periods over a 12-month period
干预措施: variable interval schedule (Behavioral)
self-directed treatment
Active Comparator
provision of treatment materials with instruction to work through materials at participant's own pace
干预措施: self-directed treatment (Behavioral)
结局指标
主要结局
body weight (kg)
时间窗: 12 months
change in body weight (kg) between randomization and month-12 follow-up
次要结局
未报告次要终点
研究者
Gareth R. Dutton PhD
Associate Professor of Medicine
University of Alabama at Birmingham
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