"Mayo Clinic Diet" Individualized Lifestyle Intervention for Obesity Management Based on Obesity Phenotypes (PHENO-Diet Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 215
- 试验地点
- 1
- 主要终点
- 12-week total body weight loss
研究概览
简要总结
The purpose of this protocol is to define an "individualized diet" approach based on obesity related phenotypes (pathophysiology obesity classification), which would increase weight loss, adherence, and weight loss maintenance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Adults with obesity (BMI >30Kg/m2); these will be otherwise healthy individuals with no unstable psychiatric disease and uncontrolled life-threatening comorbidities (i.e. unstable angina).
- •Age: 18-65 years.
- •Gender: Men or women.
排除标准
- •Weight change greater than 3% in the previous 3 months (weight stable).
- •History of bariatric surgery including lap band and bariatric endoscopy.
- •Significant untreated psychiatric dysfunction including binge eating disorders and bulimia.
- •Current use of anti-obesity pharmacotherapy, medications known to affect weight (e.g., corticosteroids) or GLP-1 agonist/analog for T2DM
- •A positive score on the AUDIT-C questionnaire as judged by an investigator.
- •Patient has a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder study adherence
研究组 & 干预措施
Standard Lifestyle Intervention
Participants in this group will be instructed to follow a standard low calorie diet, recommended to have 30 minutes of physical activity 3-5 days per week, and will be followed by a wellness couch weekly.
干预措施: Standard Lifestyle Intervention (Behavioral)
Modified Lifestyle Intervention
Participants in this group will have a tailored diet, exercise, and behavioral plan according to their obesity phenotype.
干预措施: Modified Lifestyle Intervention (Behavioral)
结局指标
主要结局
12-week total body weight loss
时间窗: 12 weeks
Change in body weight during the 12 week study
次要结局
- Calorie Intake(12 weeks)
- Waist Circumference(12 weeks)
- Gastric Emptying 2 Hours(12 weeks)
- Gastric Emptying(12 weeks)
- Adherence(12 weeks)
- Anxiety Level(12 weeks)
- Emotional Eating(12 weeks)
- Responder Rate(12 weeks)
- Fat Loss(12 weeks)
- Calories to Fullness(12 weeks)
- Resting Metabolic Rate(12 weeks)
研究者
Andres J. Acosta, M.D., Ph.D.
Principal Investigator
Mayo Clinic