NCT02635698已完成不适用
Opti-WIN: Effectiveness of the Optifast Program Compared With a Reduced-energy Food Based Diet Plan on Body Weight
Société des Produits Nestlé (SPN)9 个研究点 分布在 1 个国家目标入组 330 人开始时间: 2015年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 330
- 试验地点
- 9
- 主要终点
- Percent weight change
研究概览
简要总结
Compare percent change in loss of body weight between the OPTIFAST program and a food-based energy-deficit program
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult males and females between 18 and 70 years
- •Obese (BMI > 30 kg/m2 and 55 kg/m2)
- •Non-smokers or smoking cessation > 6 months
- •< 14 alcoholic beverages per week
- •Willing and able to give informed consent
排除标准
- •Active participation in any weight loss program within previous 3 months
- •Weight changes of > 5% body weight within previous 3 months
- •Participated in an Optifast program within prior 5 years
- •Prior bariatric surgery or liposuction
- •Use of any medication prescribed for weight loss in the past 3 months
- •Current major disease or GI disease that is poorly controlled (Crohn's, ulcerative colitis)
- •Type 1 DM
- •Current ESRD
- •Current COPD
- •Any major or active hepatic disease requiring inpatient or outpatient treatment
- •History of acute pancreatitis in the past year
- •Active cancer treatment in the past 2 years other than non-malignant skin cancers
- •Uncontrolled hypertension (Blood pressure 160/100 or greater)
- •Hemoglobin A1c > 10%
- •Recent CV event in past 6 months
- •Pregnancy, childbirth, or nursing within prior 6 months
- •Eating Attitudes Test (EAT-26) > 30
- •Current major depressive disorder with Center for Epidemiological Studies Depression Scale-Revised (CESD-R) score > 16
- •Schizophrenia, history of bipolar disorder
- •Recent hospitalization for psychiatric illness in past 6 months
- •Dependence on alcohol or sedative-hypnotic drugs
- •Intolerance or allergy to Optifast product
- •Unable to read/speak English
- •Orthopedic limitation preventing participation in regular physical activity
- •Untreated thyroid disease, abnormal TSH, non on stable dose of hormone replacement for hyperthyroidism
- •Major surgery defined as any surgical procedure that might require prolonged convalescence or limit participation in the program in any way
- •Inability to complete the 7-day run-in satisfactorily
研究组 & 干预措施
Intervention group, Optifast
Experimental
OPTIFAST, medically supervised weight-management program
干预措施: Optifast (Other)
Control group, Low-energy, low-fat
Active Comparator
Food-based program, current standard of care for weight management
干预措施: Food-Based (Other)
结局指标
主要结局
Percent weight change
时间窗: 52 weeks
Percent change in body weight between Initial Visit/Baseline and 52 weeks
Percent weight change
时间窗: 26 weeks
Percent change in body weight between Initial Visit/Baseline and 26 weeks
次要结局
- Ability to meet weight goals(52 weeks)
- Change in anthropometrics(52 weeks)
- Change in cardiometabolic outcomes(52 weeks)
研究者
研究点 (9)
Loading locations...
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