Impact of an Online Behavioral Weight Loss Program Provided With or Without a Fortified Diet Beverage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 572
- 试验地点
- 4
- 主要终点
- body weight
研究概览
简要总结
This study was designed to test the impact of a 12-week online behavioral modification program for weight loss, with or without a fortified beverage. Subjects are randomized to four conditions: 1) Online Basic Lifestyle Counseling (OBLI); 2) Online Lifestyle Counseling (OLC); 3) OBLI plus a beverage (BEV); 4) OLC + BEV. The three hypotheses were: 1)after 12 weeks, individuals in the OLC condition would lose more weight than those in OBLI; 2) after 12 weeks, the OLC + BEV condition would lose more weight than the OLC condition; and 3) after 12 weeks, the OBLI + BEV condition would lose more weight than the OBLI condition.
详细描述
This study tests the impact of an innovative combination of a fortified beverage (a diet cola containing green tea extract, soluble dextrin fiber, and caffeine) and an online support weight loss program in a multi-center randomized clinical trial. The study compares the impact of all combinations of the beverage and the online behavioral modification treatment program over 12 weeks at three treatment center in the US and EU.
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
- •Body Mass Index (BMI) of 25 to 40;
- •age 18 to 65 years;
- •blood pressure less than 140 mmHg systolic and 90 mmHg diastolic;
- •caffeine intake 100-400 mg/d; and
- •ability to participate in physical activity for a minimum of 150 min/week.
排除标准
- •pregnancy, lactation or actively trying to become pregnant;
- •medical illnesses or medications that could affect body weight;
- •cigarette smokers;
- •weight loss of 10 or more pounds in the last 3 months;
- •fasting blood glucose greater than 126mg/dl;
- •participation in a clinical research study that would conflict with the purpose of the current trial; and
- •other factors that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention protocol.
结局指标
主要结局
body weight
时间窗: 12 weeks
Body weight is assessed at baseline, 6 and 12 weeks. Body weight is determined using a calibrated scale.
次要结局
- DEXA-determined fat mass(12 weeks)
研究者
John P. Foreyt
Professor, Department of Medicine
Baylor College of Medicine