Feasibility Testing of Plant-Based Supplemented Food Products Made With Manitoba Crop Ingredients for Weight Loss
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Feasibility of incorporating the WI/CDIC supplemented foods into the WI weight loss clinic.
研究概览
简要总结
The purpose of this study is to advance the development of the WI/CDIC supplemented foods by evaluating the acceptance and feasibility of the supplemented food bars within the Wellness Institute's Weight Loss Clinic program (WLC) or an equivalent weight loss program in Winnipeg or the surrounding area. The main questions it aims to answer are:
- To determine whether the incorporation of WI/CDIC supplemented foods into the WI weight loss clinic design is feasible.
- To determine whether weight loss is supported by a plant-based supplemented food.
- To assess efficacy of the supplemented food by measuring changes in lifestyle behaviours and risk factors for chronic disease compared to non-supplemented food weight loss program members.
Researchers will compare the WLC program plus supplemented food to the WLC program without the supplemented food to evaluate the implementation of the supplemented foods into the WLC.
Participants will follow their WLC program for the initial 16 weeks, and those in the intervention group will begin their supplemented food. Participants will consume one supplemented food bar each day and will record this in the product consumption log.
详细描述
This is a pilot evaluation of the feasibility of incorporating the WI/CDIC supplemented food into the WI's newly designed WLC. This study will employ a mixed methods quasi-experimental approach using questionnaires and data collected over the evaluation period. Following consent, participants will be asked to fill out a set of questionnaires, to capture dietary intake, and to wear an activity monitor; to measure diet, physical activity, QOL and sleep before each study meeting. Eligible participants (n=40) will be randomized to intervention (supplemented food) or no intervention. Participants will attend two in-person study visits - one at the initiation and one at the completion of the 16-week weight loss program. Body weight, height, waist circumference, blood pressure and heart rate will be recorded at these two time points as well, as collected through the weight loss clinic program. Participants will also complete an exit questionnaire at the second visit that will include a 9-point hedonic scale to evaluate product acceptability.
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 or an equivalent, approved weight loss program in Winnipeg or the surrounding area.
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 supplemented food ingredients
- •Has an active eating disorder
研究组 & 干预措施
The WLC program only
Participants in the weight loss clinic only.
The WLC program plus supplemented food
Participants in weight loss clinic program will consume one supplemented food bar each day and will record this in the product consumption log.
干预措施: Supplemented Food (Dietary Supplement)
结局指标
主要结局
Feasibility of incorporating the WI/CDIC supplemented foods into the WI weight loss clinic.
时间窗: 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 supplemented food 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 supplemented food intervention calculated by consumption of \>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))
研究者
Dylan MacKay
Assistant Professor
University of Manitoba