NCT00780468已完成不适用
A Pilot Study to Evaluate a Revised Method of Assessing Food in a Commercial Weight Management Program Format
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 2
- 主要终点
- Change in bodyweight.
研究概览
简要总结
This study will provide data on two systems for assigning point values to food choices in a diet plan. The primary purpose of this study is to compare the effectiveness of the two systems with regard to changes in body weight.
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
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female 25-65 years of age inclusive
- •Body Mass Index (BMI) 27.0 -35.0 inclusive.
- •Not currently taking a prescription medication for weight loss (e.g. orlistat (Xenical), sibutramine (Meridia), phentermine).
- •Not currently taking any over-the-counter weight loss medications or supplement(s).
- •Not currently enrolled in commercial weight loss program (e.g. Jenny Craig, Weight Watchers) or self-help group (e.g. TOPS, Overeaters Anonymous).
- •Willing and able to commit to regular physical activity (e.g. walking) five days per week as required by study protocol.
- •Willing to keep and turn in a daily log/compliance book at the times required by study protocol.
- •Willingness and ability to make all scheduled appointments at MUSC as required by study protocol.
- •Willingness to make weekly meetings at MUSC.
排除标准
- •History of thyroid disease, but not taking medication, or medication dosage changed one or more times over last 6 months. History of thyroid disease and on a stable dose of prescription medication for 6 months or longer is acceptable.
- •Diagnosed with Type I or Type II diabetes or glucose intolerance, or use of anti-diabetic medications
- •History of a surgical procedure for weight loss at any time (e.g. gastroplasty, gastric by-pass, gastrectomy or partial gastrectomy, adjustable banding, gastric sleeve).
- •History of major surgery within three months of enrollment.
- •History of heart problems (e.g. angina, bypass surgery, MI, etc.) within three months prior to enrollment.
- •Presence of implanted cardiac defibrillator or pacemaker.
- •Uncontrolled hypertension/high blood pressure.
- •Orthopedic limitations that would interfere with ability to engage in regular physical activity.
- •Gastrointestinal disorders including chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, chronic diarrhea or active gallbladder disease.
- •History or presence of cancer. Persons with successfully resected basal cell carcinoma of the skin may be enrolled if treatment completed more than 6 months prior to enrollment.
- •History of clinically diagnosed eating disorders including anorexia nervosa or bulimia nervosa.
- •Women who are pregnant, lactating , trying to become pregnant or unwilling to use an effective means of birth control.
- •Participation in another clinical trial within 30 days prior to enrollment.
- •Weight loss of more than 5 pounds for any reason over the 30 days prior to enrollment.
- •Taking any psychotropic medicine known to influence weight or weight loss
结局指标
主要结局
Change in bodyweight.
时间窗: 12 weeks
次要结局
- Changes in waist circumference, blood pressure, lipids, questionnaire measures(12 weeks)
研究者
Lynne Becker
Project Manager
Medical University of South Carolina
研究点 (2)
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