Feasibility Testing of Plant-Based Meal Replacement Products Made with Manitoba Crop Ingredients for Weight Loss and Diabetes Remission
- Conditions
- Weight LossPrediabetesDiabetes
- Interventions
- Dietary Supplement: Meal Replacement
- Registration Number
- NCT06614543
- Lead Sponsor
- University of Manitoba
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description The WLC program plus meal replacements Meal Replacement 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.
- Primary Outcome Measures
Name Time Method Feasibility of incorporating the WI meal replacements into their weight loss clinic design. 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.
- Secondary Outcome Measures
Name Time Method Changes in Body Weight At Enrollment (Week 0) and End of Study (Week 16) Body weight will be measured in kg to the nearest 0.1 kg by an exercise professional.
Changes in Waist Circumference At Enrollment (Week 0) and End of Study (Week 16) Waist circumference in cm will be measured to the nearest 0.1 cm at the umbilicus, between the last rib and iliac crest using a fibreglass tape measured by an exercise professional.
Changes in BMI At Enrollment (Week 0) and End of Study (Week 16) Body Mass Index will be calculated using the formula BMI = kg/m2; where kg is the weight in kilograms and m2 is height in metres squared.
Cardiovascular Assessment At Enrollment (Week 0) and End of Study (Week 16) Using the Framingham Risk Score, cardiovascular risk will be calculated based on age, HDL-C, total cholesterol, systolic blood pressure, smoking status, and diabetes status to determine the participant's 10-year risk of cardiovascular disease and identification of metabolic syndrome.
Changes is Quality of Life At Enrollment (Week 0) and End of Study (Week 16) Quality of life will be measured through the SF-36 quality of life questionnaire. The SF-36 measures nine areas: physical functioning, role functioning (emotional), role functioning (physical), energy/fatigue, emotional well-being, social functioning, pain, general health, and health change. A higher score indicates greater levels of quality of life.
Changes in Medication At Enrollment (Week 0) and End of Study (Week 16) Changes in medications, dose, unit and frequency will be captured to assess remission of diabetes and pre-diabetes.
Changes in HemaglobinA1C At Enrollment (Week 0) and End of Study (Week 16) Changes in hemaglobinA1C will be used to assess remission of diabetes and pre-diabetes. Diagnostic Services of Manitoba will collect and process the participants blood samples and measure the hemoglobin A1C as a percentage according to their established protocols.
Trial Locations
- Locations (1)
Seven Oaks Hospital Chronic Disease Innovation Centre
🇨🇦Winnipeg, Manitoba, Canada