[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563313":3},{"organization":4,"outcomesModule":7,"designInfo":88,"detailedDescription":96,"studyPopulation":93,"armGroups":97,"interventions":108,"overallOfficials":114,"centralContacts":118,"locations":127,"responsibleParty":146,"collaborators":149,"id":157,"slug":158,"hasResults":159,"nctId":160,"briefTitle":161,"officialTitle":161,"acronym":93,"eligibilityCriteria":162,"healthyVolunteers":159,"sex":163,"minAge":164,"maxAge":93,"enrollmentInfo":165,"targetDuration":93,"studyType":168,"phases":169,"briefSummary":171,"conditions":172,"keywords":174,"overallStatus":176,"whyStopped":93,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":186},{"fullName":5,"class":6},"University of Manitoba","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"Feasibility of incorporating the WI\u002FCDIC supplemented foods into the WI weight loss clinic.","Feasibility will be demonstrated if the following five criteria are met:\n\n1. 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.\n2. 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.\n3. Follow up of greater than 85% of participant outcomes.\n4. Adherence to the supplemented food intervention calculated by consumption of \\>75% dispensed products as documented in the Product Consumption Log\n5. 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.","End of Study (Week 16)",[14,18,21,24,27],{"measure":15,"description":16,"timeFrame":17},"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)",{"measure":19,"description":20,"timeFrame":17},"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.",{"measure":22,"description":23,"timeFrame":17},"Changes in BMI","Body Mass Index will be calculated using the formula BMI = kg\u002Fm2; where kg is the weight in kilograms and m2 is height in metres squared.",{"measure":25,"description":26,"timeFrame":17},"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.",{"measure":28,"description":29,"timeFrame":17},"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\u002Ffatigue, emotional well-being, social functioning, pain, general health, and health change. A higher score indicates greater levels of quality of life.",[31,34,37,40,43,46,49,51,54,57,60,63,66,69,72,75,78,80,82,84,86],{"measure":32,"description":33,"timeFrame":17},"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.",{"measure":35,"description":36,"timeFrame":17},"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.",{"measure":38,"description":39,"timeFrame":17},"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.",{"measure":41,"description":42,"timeFrame":17},"Changes in Physical Activity","Measured using the International Physical Activity Questionnaire - Short Form - (IPAQ-S)",{"measure":44,"description":45,"timeFrame":17},"Change in Physical Activity Behaviour Patterns","Assessed using total active minutes per day as measured by multi-directional accelerometry for 7 days. Participants will be asked to wear the accelerometer at all times.",{"measure":47,"description":48,"timeFrame":17},"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)",{"measure":47,"description":50,"timeFrame":17},"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.",{"measure":52,"description":53,"timeFrame":17},"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).",{"measure":55,"description":56,"timeFrame":17},"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).",{"measure":58,"description":59,"timeFrame":17},"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).",{"measure":61,"description":62,"timeFrame":17},"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).",{"measure":64,"description":65,"timeFrame":17},"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).",{"measure":67,"description":68,"timeFrame":17},"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).",{"measure":70,"description":71,"timeFrame":17},"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).",{"measure":73,"description":74,"timeFrame":17},"Changes in Sleep Patterns","An ActiGraph activity monitor will be used to measure sleep quality patterns for 7 days, with participants asked to wear the monitor at all times, including when they sleep.",{"measure":76,"description":77,"timeFrame":17},"Changes in Total Cholesterol","Diagnostic Services of Manitoba will collect and process the participants blood samples and measure the total cholesterol concentration in mmol\u002FL according to their established protocols.",{"measure":79,"description":77,"timeFrame":17},"Changes in High density lipoprotein cholesterol",{"measure":81,"description":77,"timeFrame":17},"Changes in Low density lipoprotein cholesterol",{"measure":83,"description":77,"timeFrame":17},"Changes in Triglycerides",{"measure":85,"description":77,"timeFrame":17},"Changes in Total Cholesterol and High-Density Lipoprotein Cholesterol Ratio",{"measure":87,"description":77,"timeFrame":17},"Changes in Hemoglobin A1C",{"allocation":89,"interventionModel":90,"interventionModelDescription":91,"primaryPurpose":92,"observationalModel":93,"timePerspective":93,"maskingInfo":94},"RANDOMIZED","PARALLEL","Mixed methods","TREATMENT",null,{"masking":95,"maskingDescription":93,"whoMasked":93},"NONE","This is a pilot evaluation of the feasibility of incorporating the WI\u002FCDIC 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.",[98,104],{"label":99,"type":100,"description":101,"interventionNames":102},"The WLC program plus supplemented food","ACTIVE_COMPARATOR","Participants in weight loss clinic program will consume one supplemented food bar each day and will record this in the product consumption log.",[103],"Dietary Supplement: Supplemented Food",{"label":105,"type":106,"description":107,"interventionNames":93},"The WLC program only","NO_INTERVENTION","Participants in the weight loss clinic only.",[109],{"type":110,"name":111,"description":112,"armGroupLabels":113,"otherNames":93},"DIETARY_SUPPLEMENT","Supplemented Food","These supplemented foods provide plant-based protein, fibre and fatty acids that have been shown to have health benefits related to chronic disease.",[99],[115],{"name":116,"affiliation":5,"role":117},"Dr Dylan MacKay, PhD","PRINCIPAL_INVESTIGATOR",[119,124],{"name":120,"role":121,"phone":122,"phoneExt":93,"email":123},"Kathy Cherepak, BSc","CONTACT","204-631-3834","kcherepak@sogh.mb.ca",{"name":116,"role":121,"phone":125,"phoneExt":93,"email":126},"204-272-3119","Dylan.Mackay@umanitoba.ca",[128],{"facility":129,"status":93,"city":130,"state":131,"zip":132,"country":133,"countryCode":134,"cosmosGeoPoint":135,"geoPoint":140,"contacts":141},"Seven Oaks Hospital Chronic Disease Innovation Centre","Winnipeg","Manitoba","R2V 3M3","Canada","CA",{"type":136,"coordinates":137},"Point",[138,139],-97.14704,49.8844,{"lat":139,"lon":138},[142,143],{"name":120,"role":121,"phone":122,"phoneExt":93,"email":123},{"name":144,"role":145,"phone":93,"phoneExt":93,"email":93},"Dr Rebecca Mollard, PhD","SUB_INVESTIGATOR",{"type":117,"investigatorFullName":147,"investigatorTitle":148,"investigatorAffiliation":5,"oldNameTitle":93,"oldOrganization":93},"Dylan MacKay","Assistant Professor",[150,152,155],{"name":129,"class":151},"NETWORK",{"name":153,"class":154},"The Wellness Institute","UNKNOWN",{"name":156,"class":154},"Government of Canada - Agriculture and Agri-Food Canada","100563313","feasibility-testing-of-plant-based-meal-replacement-products-made-with-manitoba-crop-ingredients-for-weight-loss-and-diabetes-remission-100563313",false,"NCT06614543","Feasibility Testing of Plant-Based Supplemented Food Products Made With Manitoba Crop Ingredients for Weight Loss","Inclusion Criteria:\n\n* Male or female, aged 18 years or above\n* Live within the province of MB\n* Ability to give written informed consent in English.\n* Enrolled in the Wellness Institute Weight Loss Clinic or an equivalent, approved weight loss program in Winnipeg or the surrounding area.\n\nExclusion Criteria:\n\n* Female participant who is pregnant, lactating or planning pregnancy during the course of the program.\n* Participants with known allergies to the supplemented food ingredients\n* Has an active eating disorder","ALL","18 Years",{"count":166,"type":167},40,"ESTIMATED","INTERVENTIONAL",[170],"NA","The purpose of this study is to advance the development of the WI\u002FCDIC 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:\n\n* To determine whether the incorporation of WI\u002FCDIC supplemented foods into the WI weight loss clinic design is feasible.\n* To determine whether weight loss is supported by a plant-based supplemented food.\n* 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.\n\nResearchers 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.\n\nParticipants 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.",[173],"Weight Loss",[175,111],"Weight Loss Clinic","NOT_YET_RECRUITING","2026-09-15",{"date":179,"type":180},"2026-09-21","ACTUAL",{"date":182,"type":167},"2026-11-01",{"date":184,"type":167},"2027-12-31",{"name":5,"class":6},1]