Feasibility Testing of Plant-Based Meal Replacement Products Made With Manitoba Crop Ingredients for Weight Loss and Diabetes Remission
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Feasibility of incorporating the WI meal replacements into their weight loss clinic design.
研究概览
简要总结
The goal of this clinical trial is to advance the development of the WI meal replacements by evaluating the acceptance and feasibility of the meal replacements within the Wellness Institute's Weight Loss Clinic program (WLC). The main questions it aims to answer are:
- To determine whether the incorporation of WI meal replacements into their weight loss clinic design is feasible.
- To determine whether weight loss is supported by a plant-based meal replacement.
- To assess efficacy of the meal replacements by measuring changes in lifestyle behaviours and risk factors for chronic disease compared to non-meal replacement weight loss program members.
- To assess remission of diabetes and pre-diabetes.
Researchers will compare the WLC program plus meal replacements to the WLC program without the meal replacements to evaluate the implementation of the meal replacements into the WLC.
Participants will follow their WLC program for 16 weeks, and those in the intervention group will begin their meal replacements. Participants will have a choice on what type of meal replacement they will consume each day (either a bar or a shake) and will record this in the product consumption log.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18 years or above
- •Live within the province of MB
- •Ability to give written informed consent in English.
- •Enrolled in the Wellness Institute Weight Loss Clinic
排除标准
- •Female participant who is pregnant, lactating or planning pregnancy during the course of the program.
- •Participants with known allergies to the meal replacement ingredients
- •Has an active eating disorder
结局指标
主要结局
Feasibility of incorporating the WI meal replacements into their weight loss clinic design.
时间窗: At Enrollment (Week 0) and End of Study (Week 16)
Feasibility will be demonstrated if the following five criteria are met: 1. Eligibility to randomization ratio is greater than 0.5, calculated as the ratio of individuals within the WI WLC program who were randomized to the trial to the number eligible to participate who were approached to participate. 2. The percentage of participants who complete the 16-week program in the meal replacement arm is equivalent (plus or minus 10%) or greater than the standard arm. 3. Follow up of greater than 85% of participant outcomes. 4. Adherence to the meal replacement intervention calculated by consumption of greater than 75% dispensed products as documented in the Product Consumption Log 5. Product Acceptability using an Exit Questionnaire consisting of a 9-point hedonic box scale to assess mean acceptability values of 6 or greater (like at least slightly) in 75% or more of the participants.
次要结局
- Changes in Body Weight(At Enrollment (Week 0) and End of Study (Week 16))
- Changes in Waist Circumference(At Enrollment (Week 0) and End of Study (Week 16))
- Changes in BMI(At Enrollment (Week 0) and End of Study (Week 16))
- Cardiovascular Assessment(At Enrollment (Week 0) and End of Study (Week 16))
- Changes is Quality of Life(At Enrollment (Week 0) and End of Study (Week 16))
- Changes in Medication(At Enrollment (Week 0) and End of Study (Week 16))
- Changes in HemaglobinA1C(At Enrollment (Week 0) and End of Study (Week 16))
研究者
Dylan MacKay
Assistant Professor
University of Manitoba