Weight Loss Through Mayo Clinic Diet; a Prospective Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Mayo Clinic Diet- Was It Worth It survey
研究概览
简要总结
The purpose of study is to evaluate the efficacy of the Mayo Clinic Diet in clinically significant weight loss (>5%) versus usual care. We also wish to evaluate the feasibility, barriers to completion, and sustainability of this intervention at the 24, and 52-week marks. Lastly, we aim to study the change in participants body composition and quality of life at the end of this intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females (non-pregnant) 18-64
- •BMI > or = to 25 kg/m2
- •Ability to read and understand English. (as the Mayo Clinic Diet book and app are only available in English)
排除标准
- •Have a current diagnosis of melanoma or cancer diagnosis
- •Currently breastfeeding
- •Pregnant, or planned to be pregnant within 6 months
- •Have a diagnosis of Type 1 or 2 Diabetes Mellitus
- •Had weight loss surgery within the last year
- •Currently participating in another lifestyle weight loss program or taking medications for weight loss
- •Have lost 5% or more of their weight in the last six months
- •Have a history of eating disorders
- •Have planned surgery in the next 6 months.
研究组 & 干预措施
Mayo Clinic Diet
Subjects in the Mayo Clinic Diet (MCD) arm will be provided with options including the Mayo Clinic Diet book 3rd edition or application from digital wellness or both with full subscription paid for by the Mayo Clinic Diet for the 12 week period. The Mayo Clinic Diet arm will switch to usual care after 12 weeks.
干预措施: Mayo Clinic Diet (Behavioral)
Mayo Clinic Diet
Subjects in the Mayo Clinic Diet (MCD) arm will be provided with options including the Mayo Clinic Diet book 3rd edition or application from digital wellness or both with full subscription paid for by the Mayo Clinic Diet for the 12 week period. The Mayo Clinic Diet arm will switch to usual care after 12 weeks.
干预措施: Usual Care (Behavioral)
Usual Care
Subjects in the usual care arm will be provided with two Mayo Clinic resources for lifestyle modifications: Eat Well Use the Plate hand out, and the Food, Physical Activity and Weight Tracking Apps with a list of self-monitoring tools to support a healthy lifestyle. The usual care arm will switch to the Mayo Clinic Diet after 12 weeks.
干预措施: Mayo Clinic Diet (Behavioral)
Usual Care
Subjects in the usual care arm will be provided with two Mayo Clinic resources for lifestyle modifications: Eat Well Use the Plate hand out, and the Food, Physical Activity and Weight Tracking Apps with a list of self-monitoring tools to support a healthy lifestyle. The usual care arm will switch to the Mayo Clinic Diet after 12 weeks.
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Mayo Clinic Diet- Was It Worth It survey
时间窗: 12 weeks, 24 weeks
The Mayo Clinic Diet - Was It Worth It survey consists of 6 questions to get feedback on the subjects perception of the program.
次要结局
- Mayo Clinic Diet 12-item Short Form health (SF-12) survey(Baseline, 12 weeks, 24 weeks)
研究者
Tamim I. Rajjo, M.D.
Principal Investigator
Mayo Clinic