Improving Maintenance Following Very Low Calorie Diet: The Sustain Lost Weight (SLW) Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Treatment Feasibility
研究概览
简要总结
Obtain a preliminary assessment of the feasibility and acceptability of delivering the sustained lost weight (SLW) intervention in a real-world clinical setting for patients who have completed a 21-week very low calorie diet (VLCD).
Hypothesis: Intervention will be feasible to implement as evidenced by the ability to recruit and retain participants and acceptable to participants as evidenced by self-report of satisfaction with the program and adoption of weight maintenance behaviors.
Secondary Aim: Obtain a preliminary assessment of the effectiveness of the sustained lost weight (SLW) intervention for patients who have completed 21 weeks of a very low calorie diet (VLCD).
Hypothesis: Greater than 75% of participants who receive this novel approach, where maintenance behaviors are individualized based on resting metabolic rate and a physical activity factor, will regain greater or equal to 10 kg. at week 52 follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed fast and transition period of the OPTIFAST® program
- •Be able to participate fully in all aspects of the study
- •Willing to refrain from participating in additional weight loss interventions for the duration of the study
- •Willing to provide written informed consent.
排除标准
- •Myocardial infarction within 6 months
- •Unstable angina
- •Chronic steroid use
- •Active peptic ulcer disease
- •Advanced cirrhosis
- •Active hepatitis
- •Advanced renal disease
- •Active thrombophlebitis
- •Recent skeletal fractures
- •Use of lithium
- •Pancreatitis
- •Pregnancy
- •Type 1 diabetes mellitus
- •History of diabetic ketoacidosis
- •Active bulimia nervosa
- •Severe depression
- •Psychosis
- •Substance abuse
结局指标
主要结局
Treatment Feasibility
时间窗: 52 weeks
Treatment will be considered feasible if greater than 50 % of participants attend a minimum of 17 of 20 sessions. The treatment will be considered acceptable for further study if greater than 50% of participants rate the maintenance program with a mean score of 6 or higher.
次要结局
- Weight Gain Analysis(52 weeks)