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.
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.
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
Parallel
Supplemented Food
Dietary supplementThese supplemented foods provide plant-based protein, fibre and fatty acids that have been shown to have health benefits related to chronic disease.
Feasibility of incorporating the WI/CDIC supplemented foods into the WI weight loss clinic.
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.
Changes in Body Weight
Body weight will be measured in kg to the nearest 0.1 kg by an exercise professional.
Changes in Waist Circumference
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
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
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 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.
Changes in Diastolic Blood Pressure
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.
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.
Changes in Physical Activity
Measured using the International Physical Activity Questionnaire - Short Form - (IPAQ-S)
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University of Manitoba
Lead sponsor
Seven Oaks Hospital Chronic Disease Innovation Centre
Collaborator
The Wellness Institute
Collaborator
Government of Canada - Agriculture and Agri-Food Canada
Collaborator
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