- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT06614543
Feasibility Testing of Plant-Based Supplemented Food Products Made With Manitoba Crop Ingredients for Weight Loss
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Kathy Cherepak, BSc
- Número de teléfono: 204-631-3834
- Correo electrónico: kcherepak@sogh.mb.ca
Copia de seguridad de contactos de estudio
- Nombre: Dr Dylan MacKay, PhD
- Número de teléfono: 204-272-3119
- Correo electrónico: Dylan.Mackay@umanitoba.ca
Ubicaciones de estudio
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Manitoba
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Winnipeg, Manitoba, Canadá, R2V 3M3
- Seven Oaks Hospital Chronic Disease Innovation Centre
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Contacto:
- Kathy Cherepak, BSc
- Número de teléfono: 204-631-3834
- Correo electrónico: kcherepak@sogh.mb.ca
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Sub-Investigador:
- Dr Rebecca Mollard, PhD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: The WLC program plus supplemented food
Participants in weight loss clinic program will consume one supplemented food bar each day and will record this in the product consumption log. |
These supplemented foods provide plant-based protein, fibre and fatty acids that have been shown to have health benefits related to chronic disease. |
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Sin intervención: The WLC program only
Participants in the weight loss clinic only. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Feasibility of incorporating the WI/CDIC supplemented foods into the WI weight loss clinic.
Periodo de tiempo: End of Study (Week 16)
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Feasibility will be demonstrated if the following five criteria are met:
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End of Study (Week 16)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes in Body Weight
Periodo de tiempo: At Enrollment (Week 0) and End of Study (Week 16)
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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)
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Changes in Waist Circumference
Periodo de tiempo: At Enrollment (Week 0) and End of Study (Week 16)
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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)
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Changes in BMI
Periodo de tiempo: At Enrollment (Week 0) and End of Study (Week 16)
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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)
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Cardiovascular Assessment
Periodo de tiempo: At Enrollment (Week 0) and End of Study (Week 16)
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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)
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Changes is Quality of Life
Periodo de tiempo: At Enrollment (Week 0) and End of Study (Week 16)
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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)
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes in Systolic Blood Pressure
Periodo de tiempo: At Enrollment (Week 0) and End of Study (Week 16)
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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)
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Changes in Diastolic Blood Pressure
Periodo de tiempo: At Enrollment (Week 0) and End of Study (Week 16)
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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)
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Changes in Heart Rate
Periodo de tiempo: At Enrollment (Week 0) and End of Study (Week 16)
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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)
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Changes in Physical Activity
Periodo de tiempo: At Enrollment (Week 0) and End of Study (Week 16)
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Measured using the International Physical Activity Questionnaire - Short Form - (IPAQ-S) |
At Enrollment (Week 0) and End of Study (Week 16)
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Change in Physical Activity Behaviour Patterns
Periodo de tiempo: At Enrollment (Week 0) and End of Study (Week 16)
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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. |
At Enrollment (Week 0) and End of Study (Week 16)
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Changes in Dietary Intake Behaviours
Periodo de tiempo: At Enrollment (Week 0) and End of Study (Week 16)
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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)
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Changes in Dietary Intake Behaviours
Periodo de tiempo: At Enrollment (Week 0) and End of Study (Week 16)
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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)
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Changes in Dietary Intake - Number of Meals
Periodo de tiempo: At Enrollment (Week 0) and End of Study (Week 16)
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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)
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Changes in Dietary Intake - Number of Snacks
Periodo de tiempo: At Enrollment (Week 0) and End of Study (Week 16)
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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)
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Changes in Dietary Intake - Energy
Periodo de tiempo: At Enrollment (Week 0) and End of Study (Week 16)
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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)
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Changes in Dietary Intake - Protein
Periodo de tiempo: At Enrollment (Week 0) and End of Study (Week 16)
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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)
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Changes in Dietary Intake - Fat
Periodo de tiempo: At Enrollment (Week 0) and End of Study (Week 16)
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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)
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Changes in Dietary Intake - Available Carbohydrates
Periodo de tiempo: At Enrollment (Week 0) and End of Study (Week 16)
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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)
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Changes in Dietary Intake - Fibre
Periodo de tiempo: At Enrollment (Week 0) and End of Study (Week 16)
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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)
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Changes in Sleep Patterns
Periodo de tiempo: At Enrollment (Week 0) and End of Study (Week 16)
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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. |
At Enrollment (Week 0) and End of Study (Week 16)
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Changes in Total Cholesterol
Periodo de tiempo: At Enrollment (Week 0) and End of Study (Week 16)
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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)
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Changes in High density lipoprotein cholesterol
Periodo de tiempo: At Enrollment (Week 0) and End of Study (Week 16)
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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)
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Changes in Low density lipoprotein cholesterol
Periodo de tiempo: At Enrollment (Week 0) and End of Study (Week 16)
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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)
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Changes in Triglycerides
Periodo de tiempo: At Enrollment (Week 0) and End of Study (Week 16)
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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)
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Changes in Total Cholesterol and High-Density Lipoprotein Cholesterol Ratio
Periodo de tiempo: At Enrollment (Week 0) and End of Study (Week 16)
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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)
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Changes in Hemoglobin A1C
Periodo de tiempo: At Enrollment (Week 0) and End of Study (Week 16)
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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)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Dr Dylan MacKay, PhD, University of Manitoba
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HS26095 (B2023:073)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
De-identified individual participant data (IPD) may be placed in a repository if required by a journal for publication purposes. De-identified IPD may also be requested from the principle investigator.
Marco de tiempo para compartir IPD
Data will become available following the publication of the primary results manuscript.
Criterios de acceso compartido de IPD
Researchers who provide a methodologically sound proposal and whose proposed use of the data has been approved by the trial PI.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
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