NCT01017783已完成不适用
Randomized Controlled Trial of a Water Beverage Intervention for Promoting Modest Weight Reduction in Free Living Adults
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
- 318
- 试验地点
- 1
- 主要终点
- Weight change
研究概览
简要总结
The primary objectives of this clinical trial are to determine if replacing sugar sweetened beverages with water consumption promote weight loss over 6 months in overweight adults and if replacing sugar sweetened beverages with water consumption promote greater weight loss over 6 months relative to replacement with other non-caloric sweetened beverages or control.
The secondary objective is to identify mediators and moderators of the effect of water replacement including hydration status, glucose metabolism, anthropometrics, physical activity, dietary intake and resting metabolic rate.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-65 years of age.
- •Body mass index (BMI) between 25.0-49.9 kg/m
- •Subject consumes at least 280 calories per day from caloric beverages.
排除标准
- •Report losing >5% of current body weight in the previous 6 months.
- •Report participating in a research project involving weight loss or physical activity in the previous 6 months, as these proximal experiences may impact the results of this study. Additionally, report current participating in any other research studies whose results could be compromised by or in which participation could compromise this research study. (Participation in a research study that would not affect or be affected by this study is allowed.)
- •Report pregnancy or lactation during the previous 6 months, or planned pregnancy in the next 6 months.
- •Report taking medication that could affect metabolism or change body weight (e.g., synthroid).
- •Report hospitalization for psychiatric problems during the prior year.
- •Report major psychiatric diagnoses and organic brain syndromes.
- •Report heart problems, chest pain, cancer within the last 5 years
- •Being treated by a therapist for psychological issues or problems with psychotropic medications.
- •Report behaviors that indicate probable alcohol dependence as assessed by the Rapid Alcohol Problems Screen (RAPS4-QF) (Cherpitel CJ, 2002).
- •Unwilling to change intake of beverages during the study period.
- •Plan to move from the area during the study period, and/or unable to attend monthly group meetings.
- •Report not having adequate transportation to the study center that would allow transport of study supplies back to the subject's home.
- •Report not being able to attend group meetings on Monday or Tuesday evenings.
研究组 & 干预措施
Healthy Choices
Other
干预措施: Healthy Choices (Behavioral)
Diet Substitution A
Experimental
干预措施: Dietary substitution A (Behavioral)
Diet Substitution B
Experimental
干预措施: Dietary Substitution B (Behavioral)
结局指标
主要结局
Weight change
时间窗: 0, 3, 6 months
次要结局
- urine specific gravity(0, 3, 6 months)
- fasting glucose(0, 3, 6 months)
研究者
研究点 (1)
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