Building Lifestyle Options for Orthopedic Mobility: Preoperative Weight Loss and Impact on Health in People Living With Obesity Awaiting Orthopedic Procedure
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 58
- 主要终点
- Weight loss
研究概览
简要总结
The goal of this clinical trial is to prospectively assess the efficacy of the BLOOM program, a comprehensive weight loss dietary and lifestyle program, in a population of patients living with obesity and awaiting hip or knee surgery. The main questions it seeks to answer are:
- Can the BLOOM program support these patients to lose up to 10% of their initial body weight?
- Will patients continue to lose weight for the next six months after completing the program?
- Does the BLOOM program help patients to improve their overall quality of life?
Study participants will undergo the BLOOM program, a virtual pre-operative weight management program that spans 24 weeks and is carefully supervised by medical professionals. They will be recruited at the LEAF Clinic after being referred by their primary care physician.
During the BLOOM program, they will meet with a physician (initially, then once monthly) and a dietitian (initially, and then biweekly as part of virtual group coaching). They will have access to LEAF's online learning portal. These are normal elements of the BLOOM program.
Furthermore, as part of their participation in the research study, participants will be asked to complete the following questionnaires: the Mediterranean dietary score, the Oxford Hip and Knee Questionnaire and the EQ-D5-5L quality of life assessment. They will complete these initially, and then at completion of the program and 3 and 6 months post-program. We will also collect their height and weight at these intervals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To be eligible for the study, subjects must meet all the following criteria:
- •Age ≥ 18 years old
- •Body mass index (BMI) ≥ 35 kg/m2
- •Have being identified as a potential orthopedic surgery candidate by the Total Joint Assessment Clinic (TJAC)
- •Have a referral by their primary care practitioner
- •Ready to participate actively in the program (i.e., readiness to change scale score ≥7)
- •Acquisition of the required technology tools and skills to use the virtual platform (the BLOOM program will be conducted via virtual video conference)
- •English comprehension at a level that allows for active participation in the program
排除标准
- •Subjects who meet any of the following criteria are not eligible for the study:
- •Active eating disorder
- •Active substance use disorder
- •Active smoking
- •Currently or past enrollment in another weight loss program in the previous year prior to enrollment in the study
- •Ongoing pregnancy or breastfeeding
结局指标
主要结局
Weight loss
时间窗: Weight will be compared from beginning of program to end of program, six months after program completion, and also monthly for months 1-5.
The difference (in lbs and %) in weight between the admission visit and the end of the BLOOM program
次要结局
- Weight - BMI 35-40(Six months)
- EQ-5D-5L(At program start, at program completion (approx 6 months, 3 and 6 months post-program completion (total time: twelve months))
- Weight change(Twelve months)
- Mediterranean Diet Score(At program start, at program completion (approx 6 months, 3 and 6 months post-program completion (total time: twelve months))
- Weight - BMI 40+(Six months)
- Oxford Knee and Hip(At program start, at program completion (approx 6 months, 3 and 6 months post-program completion (total time: twelve months))
- Decision change(Twelve months)
研究者
Judy Shiau
Investigator
Ottawa Hospital Research Institute