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| Name | Class |
|---|---|
| Seven Oaks Hospital Chronic Disease Innovation Centre | NETWORK |
| The Wellness Institute | UNKNOWN |
| Sustainable Canadian Agricultural Partnership | UNKNOWN |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The WLC program plus meal replacements | Active Comparator | 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. |
|
| The WLC program only | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meal Replacement | Dietary Supplement | These meal replacements provide plant-based protein, fibre and fatty acids that have been shown to have health benefits related to chronic disease. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of incorporating the WI meal replacements into their weight loss clinic design. | Feasibility will be demonstrated if the following five criteria are met:
| At Enrollment (Week 0) and End of Study (Week 16) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Body Weight | Body weight will be measured in kg to the nearest 0.1 kg by an exercise professional. | At Enrollment (Week 0) and End of Study (Week 16) |
| Changes in Waist Circumference |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Systolic Blood Pressure | Systolic blood pressure in mmHg is measured in triplicate, on the non-dominant arm in a sitting position by an exercise professional using a validated oscillometric blood pressure monitor. | At Enrollment (Week 0) and End of Study (Week 16) |
| Changes in Diastolic Blood Pressure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kathy Cherepak, BSc | Contact | 204-631-3834 | kcherepak@sogh.mb.ca | |
| Dr Dylan MacKay, PhD | Contact | 204-272-3119 | Dylan.Mackay@umanitoba.ca |
| Name | Affiliation | Role |
|---|---|---|
| Dr Dylan MacKay, PhD | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seven Oaks Hospital Chronic Disease Innovation Centre | Winnipeg | Manitoba | R2V 3M3 | Canada |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D011236 | Prediabetic State |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
| At Enrollment (Week 0) and End of Study (Week 16) |
| Changes in BMI | 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. | At Enrollment (Week 0) and End of Study (Week 16) |
| Cardiovascular Assessment | 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. | At Enrollment (Week 0) and End of Study (Week 16) |
| Changes is Quality of Life | 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. | At Enrollment (Week 0) and End of Study (Week 16) |
| Changes in Medication | Changes in medications, dose, unit and frequency will be captured to assess remission of diabetes and pre-diabetes. | At Enrollment (Week 0) and End of Study (Week 16) |
| Changes in HemaglobinA1C | 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. | At Enrollment (Week 0) and End of Study (Week 16) |
Diastolic blood pressure in mmHg is measured in triplicate, on the non-dominant arm in a sitting position by an exercise professional using a validated oscillometric blood pressure monitor. |
| At Enrollment (Week 0) and End of Study (Week 16) |
| Changes in Heart Rate | Heart rate in beats per minute is measured in triplicate, on the non-dominant arm in a sitting position by an exercise professional using a validated oscillometric blood pressure monitor. | At Enrollment (Week 0) and End of Study (Week 16) |
| Changes in Physical Activity | Measured using the International Physical Activity Questionnaire - Short Form - (IPAQ-S) | At Enrollment (Week 0) and End of Study (Week 16) |
| Change in Physical Activity Behaviour Patterns | Assessed using total active minutes per day as measured by multi-directional accelerometry for 5 days. Participants will be asked to wear the accelerometer at all times. | At Enrollment (Week 0) and End of Study (Week 16) |
| Changes in Dietary Intake Behaviours | Dietary intake behaviours will be measured through The Mindful Eating Questionnaire. The Mindful Eating Questionnaire recognizing patterns of overeating or eating in response to stress, boredom, or other emotions. Scoring is based on five categories, which include Awareness (being aware of how food looks, tastes and smells); Distraction (focusing on other things while eating); Disinhibition (eating even when full); Emotional Response (eating in response to sadness or stress); and External Cues (eating in response to environmental cues, such as advertising) | At Enrollment (Week 0) and End of Study (Week 16) |
| Changes in Dietary Intake Behaviours | Changes in dietary intake behaviours will be measured through the Three Factor Eating Questionnaire which is comprised of 18 items, measuring uncontrolled eating, restrained eating and emotional eating. The higher the score represents more dependency to cognition, stress or emotion the eating patterns. | At Enrollment (Week 0) and End of Study (Week 16) |
| Changes in Dietary Intake - Number of Meals | Number of meals will be captured with a meal being defined as food intake greater than 500 kcal. Dietary intake will be captured using the RxFood app. RxFood is a type of AI-driven, image based dietary assessment tool that has already demonstrated clinical benefits in various adult and pediatric clinical settings and in research as a data collection tool. Strong correlation and strength of agreement have been illustrated between RxFood and nutrient estimates from Esha's Research Nutrition analysis software, which is an industry choice for nutritional analysis and regulatory compliance (Jefferson et al, 2020). | At Enrollment (Week 0) and End of Study (Week 16) |
| Changes in Dietary Intake - Number of Snacks | Number of snacks will be captured with a meal being defined as food intake less than 500 kcal. Dietary intake will be captured using the RxFood app. RxFood is a type of AI-driven, image based dietary assessment tool that has already demonstrated clinical benefits in various adult and pediatric clinical settings and in research as a data collection tool. Strong correlation and strength of agreement have been illustrated between RxFood and nutrient estimates from Esha's Research Nutrition analysis software, which is an industry choice for nutritional analysis and regulatory compliance (Jefferson et al, 2020). | At Enrollment (Week 0) and End of Study (Week 16) |
| Changes in Dietary Intake - Energy | Energy will be measured in kCals and will be captured using the RxFood app. RxFood is a type of AI-driven, image based dietary assessment tool that has already demonstrated clinical benefits in various adult and pediatric clinical settings and in research as a data collection tool. Strong correlation and strength of agreement have been illustrated between RxFood and nutrient estimates from Esha's Research Nutrition analysis software, which is an industry choice for nutritional analysis and regulatory compliance (Jefferson et al, 2020). | At Enrollment (Week 0) and End of Study (Week 16) |
| Changes in Dietary Intake - Protein | Protein will be measured in grams and will be captured using the RxFood app. RxFood is a type of AI-driven, image based dietary assessment tool that has already demonstrated clinical benefits in various adult and pediatric clinical settings and in research as a data collection tool. Strong correlation and strength of agreement have been illustrated between RxFood and nutrient estimates from Esha's Research Nutrition analysis software, which is an industry choice for nutritional analysis and regulatory compliance (Jefferson et al, 2020). | At Enrollment (Week 0) and End of Study (Week 16) |
| Changes in Dietary Intake - Fat | Fat will be measured in grams and will be captured using the RxFood app. RxFood is a type of AI-driven, image based dietary assessment tool that has already demonstrated clinical benefits in various adult and pediatric clinical settings and in research as a data collection tool. Strong correlation and strength of agreement have been illustrated between RxFood and nutrient estimates from Esha's Research Nutrition analysis software, which is an industry choice for nutritional analysis and regulatory compliance (Jefferson et al, 2020). | At Enrollment (Week 0) and End of Study (Week 16) |
| Changes in Dietary Intake - Available Carbohydrates | Available carbohydrates will be measured in grams and will be captured using the RxFood app. RxFood is a type of AI-driven, image based dietary assessment tool that has already demonstrated clinical benefits in various adult and pediatric clinical settings and in research as a data collection tool. Strong correlation and strength of agreement have been illustrated between RxFood and nutrient estimates from Esha's Research Nutrition analysis software, which is an industry choice for nutritional analysis and regulatory compliance (Jefferson et al, 2020). | At Enrollment (Week 0) and End of Study (Week 16) |
| Changes in Dietary Intake - Fibre | Fibre will be measured in grams and will be captured using the RxFood app. RxFood is a type of AI-driven, image based dietary assessment tool that has already demonstrated clinical benefits in various adult and pediatric clinical settings and in research as a data collection tool. Strong correlation and strength of agreement have been illustrated between RxFood and nutrient estimates from Esha's Research Nutrition analysis software, which is an industry choice for nutritional analysis and regulatory compliance (Jefferson et al, 2020). | At Enrollment (Week 0) and End of Study (Week 16) |
| Changes in Sleep Patterns | An ActiGraph activity monitor will be used to measure sleep quality patterns for 5 days, with participants asked to wear the monitor at all times, including when they sleep. | At Enrollment (Week 0) and End of Study (Week 16) |
| Changes in Total Cholesterol | Diagnostic Services of Manitoba will collect and process the participants blood samples and measure the total cholesterol concentration in mmol/L according to their established protocols. | At Enrollment (Week 0) and End of Study (Week 16) |
| Changes in High density lipoprotein cholesterol | Diagnostic Services of Manitoba will collect and process the participants blood samples and measure the total cholesterol concentration in mmol/L according to their established protocols. | At Enrollment (Week 0) and End of Study (Week 16) |
| Changes in Low density lipoprotein cholesterol | Diagnostic Services of Manitoba will collect and process the participants blood samples and measure the total cholesterol concentration in mmol/L according to their established protocols. | At Enrollment (Week 0) and End of Study (Week 16) |
| Changes in Triglycerides | Diagnostic Services of Manitoba will collect and process the participants blood samples and measure the total cholesterol concentration in mmol/L according to their established protocols. | At Enrollment (Week 0) and End of Study (Week 16) |
| Changes in Total Cholesterol and High-Density Lipoprotein Cholesterol Ratio | Diagnostic Services of Manitoba will collect and process the participants blood samples and measure the total cholesterol concentration in mmol/L according to their established protocols. | At Enrollment (Week 0) and End of Study (Week 16) |
| Changes in Hemoglobin A1C | Diagnostic Services of Manitoba will collect and process the participants blood samples and measure the total cholesterol concentration in mmol/L according to their established protocols. | At Enrollment (Week 0) and End of Study (Week 16) |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |