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Clinical Trials, and HPO
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There is one clinical trial.
Introduction: Obesity is a major public health problem and adopting healthy lifestyle habits, while effective, is challenging in real-world settings. Culinary coaching is a behavioral intervention that aims to improve nutrition and overall health by facilitating home cooking through an active learning process that combines culinary training and health coaching. Our goal is to evaluate whether a culinary coaching telemedicine program (twelve 30-minute sessions) will significantly improve outcomes among subjects with overweight or obesity. General hypothesis: A culinary coaching telemedicine program will result in significant weight loss, and improvement in culinary attitude and self-efficacy, nutritional intake, and metabolic outcomes. Methods: This is a two-site, 36-month randomized controlled trial in which study participants between the ages of 25 to 70, with 27.5 ≤ BMI ≤ 35 Kg/m2 will be randomly assigned to nutritional counseling combined with a structured culinary coaching program or to nutritional counseling group (18 intervention, 18 control at each site). Intervention will include a 3-month culinary coaching telemedicine program with outcome data collected periodically for 12 months. The pre-defined primary outcome is body weight loss at 6 months, and secondary outcomes include change in body weight and composition at 1 year, as well as culinary attitudes and self-efficacy through a validated questionnaire, nutritional intake, lipid profile, blood pressure, and HgA1c (glycated hemoglobin); and participants' perception of the program. Potential impact: The investigators believe that this program has a potential to be a viable tool in promoting effective and scalable home cooking interventions aimed at improved nutrition and health outcomes in overweight and obesity.
Description: 5% decrease in body weight (kg) in the intervention arm as compared to control. measured by a registered dietitian.
Measure: Body weight at 6 months Time: Six monthsDescription: Body weight (kg), measured by a registered dietitian
Measure: Body weight Time: Body weight will be obtained at baseline, after the intervention (at 3 months), 6 months after the beginning of the intervention, and 12 months after the beginning of the interventionDescription: Culinary attitudes and self-efficacy will be evaluated by the Cooking With a Chef (CWC) Instrument. This is a 22-item self-administered Likert scale questionnaire that generates three subscales: 1) the cooking techniques and meal preparation self-efficacy subscale (14 items; 1 - not al all confident; 5- extremely confident; sub-scale range 14-70), 2) the negative cooking attitudes subscale (4 items; 1 - strongly disagree; 5 - strongly agree; sub-scale range 4-20), and, 3) the self-efficacy to consume fruit and vegetables subscale (5 items; 1 - not al all confident; 5- extremely confident; sub-scale range 5-25).
Measure: Culinary attitude & self-efficacy Time: Culinary attitude & self-efficacy will be obtained at baseline, after the intervention (at 3 months), 6 months after the beginning of the intervention, and 12 months after the beginning of the interventionDescription: Nutritional intake will be evaluated by a 4-day food record. Intake will be analyzed for its caloric content (kcal), saturated fats(g), trans fats(g), legumes (g), fruits (g), red and processed meat (g), sugars(g), processed food(g), vegetables(g), soft drinks(g), fish(g), whole grain(g), refined grain(g), and monounsaturated fat-saturated fat ratio. Vegetables, legumes, fruits, nuts, whole grains, fish, monounsaturated fat-saturated fat ratio, alcohol, and meat will be aggregate to report Mediterranean index in points (1-9))
Measure: Nutritional intake Time: Nutritional intake will be obtained at baseline, after the intervention (at 3 months), 6 months after the beginning of the intervention, and 12 months after the beginning of the interventionDescription: Adherence to Mediterranean Diet will be evaluated by the validated 14 items Questionnaire of Mediterranean Diet Adherence, extracted by a dietitian from a 4-day food record (0 - low adherence; 14 - high adherence)
Measure: Adherence to Mediterranean Diet Time: Nutritional intake will be obtained at baseline, after the intervention (at 3 months), 6 months after the beginning of the intervention, and 12 months after the beginning of the interventionDescription: Consumption of ultra-processed food will be evaluated by the NOVE food classification, extracted by a dietitian from a 4-day food record (unprocessed or minimally processed foods (g), processed culinary ingredients (g), processed foods (g), ultra processed foods (g))
Measure: Consumption of ultra-processed Time: Nutritional intake will be obtained at baseline, after the intervention (at 3 months), 6 months after the beginning of the intervention, and 12 months after the beginning of the interventionDescription: blood pressure (both systolic and diastolic), measured in a seated position by a nurse using a sphygmometer
Measure: Blood pressure Time: Blood pressure will be obtained at baseline, after the intervention (at 3 months), 6 months after the beginning of the intervention, and 12 months after the beginning of the interventionDescription: Lipid profile (total cholesterol, HDL-cholesterol, LDL-cholesterol, non-HDL cholesterol and triglycerides), measured from a blood sample drawn
Measure: Lipid profile Time: Lipid profile will be obtained at baseline, after the intervention (at 3 months), 6 months after the beginning of the intervention, and 12 months after the beginning of the interventionDescription: HbA1c, measured from a blood sample drawn
Measure: HbA1c Time: HbA1c will be obtained at baseline, after the intervention (at 3 months), 6 months after the beginning of the intervention, and 12 months after the beginning of the interventionDescription: Lean body mass (g) will measured using Bone Densitometry
Measure: Lean body mass Time: Lean body mass will be obtained at baseline, and at 6 months after the beginning of the interventionDescription: Total fat mass (g, %fat) will measured using Bone Densitometry
Measure: Total fat mass Time: Total fat mass will be obtained at baseline, and at 6 months after the beginning of the interventionDescription: Trunk fat mass (g, %fat) will measured using Bone Densitometry
Measure: Trunk fat mass Time: Trunk fat mass will be obtained at baseline, and at 6 months after the beginning of the interventionDescription: Fat distribution will measured using Bone Densitometry. Measurements includes: android fat mass (g, %fat) and gynoid fat mass (g, %fat). Fat distribution will be extracted from Android/ Gynoid
Measure: Fat distribution Time: Body composition will be obtained at baseline, and at 6 months after the beginning of the interventionDescription: Stages of change in relation to home cooking as assessed by the validated University of Rod Island Change Assessment (URICA) Scale. This is a 32-item self-administered Likert scale questionnaire (1 - strongly disagree; 5 - strongly agree). Minimum score - 32, maximum score - 160
Measure: Stages of change in relation to home cooking Time: Stages of change will be obtained at baseline, after the intervention (at 3 months), 6 months after the beginning of the intervention, and 12 months after the beginning of the interventionDescription: Perceived Stress, evaluated by the validated Perceived Stress Scale. This is a 10-item self-administered Likert scale questionnaire (0 - never; 4 - very often). Minimum score - 0, maximum score - 10.
Measure: Perceived Stress Time: Perceived stress will be obtained at baseline, after the intervention (at 3 months), 6 months after the beginning of the intervention, and 12 months after the beginning of the interventionDescription: Information about subjects' experiences (e.g., feelings during the CCTP; difficulties, dilemmas, and challenges during the program) will be evaluated using a structured open-ended questionnaire.
Measure: Subject perceptions of the program Time: subjects perception of the program will be obtained using open ended questionnaires at baseline, 6 months after the beginning of the intervention, and 12 months after the beginning of the interventionDescription: Information about subjects' experiences (e.g., feelings during the CCTP; difficulties, dilemmas, and challenges during the program) will be evaluated using In-depth semi-structured interview.
Measure: Subject perceptions of the program Time: Subjects perception of the program will be obtained using in-depth interview after the intervention (at 3 months).Description: Overall resiliency to cope with the COVID-19 epidemic with be obtained through the Brief Resilient Coping Scale and copying strategies through the Brief Cope scale
Measure: Coping with Stress Time: Coping with stress will be obtain through the 2 months of the pick COVID-19 epidemicAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports