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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
These supplemented foods provide plant-based protein, fibre and fatty acids that have been shown to have health benefits related to chronic disease.
Seven Oaks Hospital Chronic Disease Innovation Centre
Winnipeg, Manitoba, Canada
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.
Time frame: End of Study (Week 16)
Changes in Body Weight
Body weight will be measured in kg to the nearest 0.1 kg by an exercise professional.
Time frame: At Enrollment (Week 0) and End of Study (Week 16)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At Enrollment (Week 0) and End of Study (Week 16)
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