Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug5030 | low-dose Wiki | 0.30 |
| drug2618 | Middle-dose Wiki | 0.30 |
| drug1912 | Higher-dose Wiki | 0.30 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1321 | Dietary program Wiki | 0.30 |
| drug3158 | Phentermine 37.5 Mg Wiki | 0.30 |
| drug4318 | Telemedicine to remote outpatient visit in bariatric patient Wiki | 0.30 |
| drug3398 | Project Health Wiki | 0.30 |
| drug1586 | Exposure to the Dutch measures due to the Covid-19 pandemic. Wiki | 0.30 |
| drug1609 | FBT+Variety Wiki | 0.30 |
| drug1608 | FBT Wiki | 0.30 |
| drug552 | Bariatric procedures Wiki | 0.30 |
| drug5109 | online KKH Sports Singapore Program with Usual Care Wiki | 0.30 |
| drug1098 | Computer Based Response Training Weight Loss Intervention Wiki | 0.30 |
| drug1505 | Enhanced Go NAPSACC Wiki | 0.30 |
| drug1782 | Generic Response Training Control Intervention Wiki | 0.30 |
| drug565 | Basic Go NAPSACC Wiki | 0.30 |
| drug3676 | Response and Attention Training Wiki | 0.30 |
| drug3348 | Pozelimab Wiki | 0.21 |
| drug1569 | Exercise program Wiki | 0.17 |
| drug4593 | Usual Care Wiki | 0.09 |
| drug3195 | Placebo Wiki | 0.01 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D063766 | Pediatric Obesity NIH | 0.37 |
| D050177 | Overweight NIH | 0.27 |
| D006963 | Hyperphagia NIH | 0.21 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D009767 | Obesity, Morbid NIH | 0.17 |
| D001068 | Feeding and Eating Disorders NIH | 0.09 |
| D016638 | Critical Illness NIH | 0.04 |
| D011024 | Pneumonia, Viral NIH | 0.03 |
| D014777 | Virus Diseases NIH | 0.03 |
| D011014 | Pneumonia NIH | 0.02 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.01 |
| D018352 | Coronavirus Infections NIH | 0.01 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0001513 | Obesity HPO | 1.00 |
| HP:0002591 | Polyphagia HPO | 0.21 |
| HP:0002090 | Pneumonia HPO | 0.02 |
Navigate: Correlations HPO
There are 11 clinical trials
This project will test whether a food response training intervention produces lasting body fat loss, use objective brain imaging to examine the mechanism of effect of this treatment and investigate the generalizability of the training to non-training foods, and examine factors that should amplify intervention effects to provide a test of the intervention theory. This novel treatment represents a bottom-up implicit training intervention that does not rely on executive control, prolonged caloric deprivation, and expensive clinicians to deliver, like behavioral weight loss treatments that have not produced lasting weight loss. If this computer-based response training intervention produces sustained body fat loss in overweight individuals, it could be easily implemented very broadly at almost no expense, addressing a leading public health problem.
Description: Change in participant's body fat percentage
Measure: Body Fat Change Time: Baseline, 1 month, 3 months, 6 months, 12 monthsDescription: Eating disorder symptoms as measured with the Eating Disorder Diagnostic Interview
Measure: Change in Eating Disorder Symptoms Time: Baseline, 1 month, 3 months, 6 months, 12 monthsDescription: Change in Dietary Restraint, Emotional Eating, and External Eating (aggregate score) as measured by the Dutch Eating Behavior Questionnaire
Measure: Dietary Restraint, Emotional Eating, and External Eating Time: Baseline, 1 month, 3 months, 6 months, 12 monthsDescription: Chang in Disinhibited Eating as measured by the Three Factor Eating Questionnaire
Measure: Change in Disinhibited Eating Behavior Time: Baseline, 1 month, 3 months, 6 months, 12 monthsDescription: Change in Eating When Not Hungry as measured by the Eating in the Absence of Hunger Questionnaire
Measure: Change in Eating in the Absence of Hunger Behavior Time: Baseline, 1 month, 3 months, 6 months, 12 monthsDescription: Change in Problematic eating patterns associated with symptoms of addictive behaviors as measured by the Yale Food Addiction Scale
Measure: Change in Food Addiction Behavior Time: Baseline, 1 month, 3 months, 6 months, 12 monthsDescription: Change in Physical Activity as measured by the Paffenberger Questionnaire
Measure: Change in Physical Activity Time: Baseline, 1 month, 3 months, 6 months, 12 monthsDescription: Change in Substance use frequency (i.e., number of times per day) for alcohol of participants as measured by the Daily Drinking Questionnaire
Measure: Change in Alcohol Use Behavior Time: Baseline, 1 month, 3 months, 6 months, 12 monthsDescription: Change in Substance use frequency (i.e., number of times per day) for common recreational drugs of participants as measured by the Daily Drug Taking Questionnaire
Measure: Change in Substance Use Behavior Time: Baseline, 1 month, 3 months, 6 months, 12 monthsDescription: Change in Participant behavioral response to food pictures, and subjective palatability rating
Measure: Change in Participant Ratings of Unhealthy Food Palatability Time: Baseline, 1 monthDescription: Change in Participant behavioral response to food pictures, and willingness to pay given dollar amounts (aggregate score) for the pictured food
Measure: Change in Participant Ratings of Food Monetary Value Time: Baseline, 1 monthDescription: Change Participant food craving behaviors as measured by the Food Craving and Liking Scale
Measure: Change in Food Craving and Liking Behavior Time: Baseline, 1 month, 3 months, 6 months, 12 monthsDescription: Change in Participant BMI using standard methods of calculation
Measure: Change in Body Mass Index Time: Baseline, 1 month, 3 months, 6 months, 12 monthsDescription: Change in mean R-Peak Amplitude measured using three-lead ECG using PowerLab 8 Diagnostic Suite
Measure: Change in mean R-Peak Amplitude Time: Baseline, 1 month, 3 months, 6 months, 12 monthsDescription: Change in Heart Rate Variability measured using three-lead ECG using PowerLab 8 Diagnostic Suite
Measure: Change in Heart Rate Variability Time: Baseline, 1 month, 3 months, 6 months, 12 monthsThis project seeks to improve the effectiveness of a novel dissonance-based obesity prevention program that has reduced future BMI gain and overweight/obesity onset by (a) experimentally testing whether implementing it in single- versus mixed-sex groups, which should increase dissonance-induction that contributes to weight gain prevention effects, and (b) experimentally testing whether adding food response and attention training, which theoretically reduces valuation of and attention for high-calorie foods, increases weight gain prevention effects. This randomized trial would be the first to experimentally manipulate these two factors in an effort to produce superior weight gain prevention effects. A brief effective obesity prevention program that can be easily, inexpensively, and broadly implemented to late adolescents at risk for excess weight gain, as has been the case with another dissonance-based prevention program, could markedly reduce the prevalence of obesity and associated morbidity and mortality.
Description: Change in percentage of body fat (Not collected during COVID-19 shelter-at-home order)
Measure: Body Fat Time: Baseline, 2 months, 8 months, 14 months, 26 months, and 38 monthsDescription: Change in BMI (Not collected during COVID-19 shelter-at-home order)
Measure: Body Mass Index (BMI) Time: Baseline, 2 months, 8 months, 14 months, 26 months, and 38 monthsDescription: Change in weight concerns. Scale scores range from 0 to 42 with higher scores being indicative of higher weight concerns.
Measure: Weight Concerns Scale from the Eating Disorder Examination Questionnaire (EDE-Q) Time: Baseline, 2 months, 8 months, 14 months, 26 months, and 38 monthsDescription: Change in depressive symptoms
Measure: Beck Depression Index (BDI) Time: Baseline, 2 months, 8 months, 14 months, 26 months, and 38 monthsDescription: Change in eating disorder symptoms
Measure: Eating Disorder Interview (EDDI) Time: Baseline, 2 months, 8 months, 14 months, 26 months, and 38 monthsThis study will compare the effectiveness and cost of Basic and Enhanced delivery models for Go NAPSACC on child care centers' use of evidence-based nutrition and physical activity practices. Technical assistance (TA) coaches from Child Care Aware of Kentucky will lead delivery. Half of the TA coaches will deliver Go NAPSACC using the Basic model and the other half will deliver the program using the Enhanced model. It is hypothesized that the Enhanced model will result in greater use of evidence-based nutrition and physical activity practices and will also be more cost effective.
Description: Each center's nutrition and physical activity environment will be assessed using the Environment and Policy Assessment and Observation- Self Report (EPAO-SR), a self-report measure filled out through online surveys by child care center directors and preschool classroom lead teachers. When directors upload a month of menus and policy handbooks, a trained staff member will fill out relevant items. If not, the directors will fill out those items. An overall nutrition and physical activity environment score will be derived with scores ranging from 0-57, where higher scores indicate better (more supportive) nutrition and physical activity environments.
Measure: Change in nutrition and physical activity environment score from baseline to 12 months Time: Measures collected 3-12 weeks prior to start of intervention and 1-8 weeks post-12-month interventionDescription: The number of participating centers will be captured by the Go NAPSACC website and extracted using the Go NAPSACC Registration Report. This Registration Report documents all child care centers that have completed registration and created a Go NAPSACC account. Creation of an account will be used to define participation/adoption.
Measure: Number of participating centers Time: Measures collected 3-12 weeks prior to start of interventionDescription: Percent of Go NAPSACC core program components completed will be captured by the Go NAPSACC website and extracted using the Detailed Activity Report. These data will serve as indicators of fidelity. The Detailed Activity report captures centers' completion of key steps in the improvement process (completion of a self-assessment, selection of goals, creation of action plans, etc.). For this study, centers will be expected to complete 2 cycles of the improvement process, including all key steps. These data will be used to calculate the percentage of steps completed.
Measure: Percent of Go NAPSACC core program components completed by centers Time: Measures collected during the 1 year intervention period.Description: Percent of Go NAPSACC core program components completed will be captured by the Go NAPSACC website and extracted using the TA Activity Report. These data will serve as indicators of fidelity. The TA Activity Report all coaches to document their implementation activities. Based on their prescribed implementation model (basic or enhanced), these data will be used to calculate the percentage of prescribed implementation activities completed.
Measure: Percent of Go NAPSACC core program components completed by TAs Time: Measures collected during the 1 year intervention period.Description: Child nutrition self-assessment scores are captured on the Go NAPSACC website each time child care centers complete a self-assessment for that module. Each self-assessment item is scored 1-4 points, where higher points indicate closer compliance with best practices. Responses are then used to calculate a total score (total points/total possible points x 100). As an indicator of maintenance, self-assessment data will be extracted using the Go NAPSACC Child Nutrition Self-Assessment Report pulled immediately post-intervention, as well as 6, 12, and 18 months post to calculate changes in scores over time. No change and/or positive change would indicate that the intervention effect was maintained.
Measure: Changes in child nutrition self-assessment scores at 6 and 12, and 18 months post-intervention Time: Measures will be collected at 6, 12, and 18 months post-interventionDescription: Physical activity self-assessment scores are captured on the Go NAPSACC website each time child care centers complete a self-assessment for that module. Each self-assessment items is scored 1-4 points, where higher points indicate closer compliance with best practices. Responses are then used to calculate a total score (total points/total possible points x 100). As an indicator of maintenance, self-assessment data will be extracted using the Go NAPSACC Physical Activity Self-Assessment Report pulled immediately post-intervention, as well as 6, 12, and 18 months post to calculate changes in scores over time. No change and/or positive change would indicate that the intervention effect was maintained.
Measure: Changes in physical activity self-assessment scores at 6, 12, and 18 months post-intervention Time: Measures will be collected at 6, 12, and 18 months post-interventionDescription: Contextual factors will be assessed using surveys completed by directors, teachers, and TA coaches. Specifically, Fernandez's CFIR Inner Setting measure will be used to assess Culture, Culture Stress, Culture Effort, Implementation Climate, Leadership Engagement, and Available Resources. Items are scored 1-5. Items within subscales will be averaged to determine the scale score. Higher scores indicate better contextual factors. These scores will be used to examine how context predicts changes in nutrition and physical activity environment scores.
Measure: Contextual factors scores- Culture, implementation climate, leadership engagement, and available resources Time: Measures collected 3-12 weeks prior to the start of interventionDescription: Contextual factors will be assessed using surveys completed by directors, teachers, and TA coaches. TCU's Organizational Readiness for Change Survey will be used to assess Networks and Communications and Access to Knowledge and Information. Items are scored 1-5 and items within subscales will be averaged to determine the scale score. Higher scores indicate better contextual scores. These scores will be used to examine how context predicts changes in nutrition and physical activity environment scores.
Measure: Contextual factors scores- Networks and communications and access to knowledge and information Time: Measures collected 3-12 weeks prior to the start of interventionDescription: Contextual factors will be assessed using surveys completed by directors, teachers, and TA coaches. Seward's Theoretical Domains Framework Questionnaire will be used to assess Knowledge, Beliefs and Consequences, and Self-Efficacy. Items are scored 1-7. Items within subscales will be averaged to determine the scale score. Higher scores indicate better contextual scores. These scores will be used to examine how context predicts changes in nutrition and physical activity environment scores.
Measure: Contextual factors scores- Knowledge, beliefs, and consequences and self-efficacy Time: Measures collected 3-12 weeks prior to the start of interventionDescription: Costs of implementation include TA coaches time and any resources required to train and support centers for 12 months. Cost tracking will use the TA Activity Log to capture TA coaches' time and TA coaches will be asked to fill out a supplemental log of additional costs (e.g., mileage, printing). These data will be combined to calculate the total cost per center for implementing Go NAPSACC. Average cost per center for basic and enhanced implementation models will also be calculated. To explore the cost-effectiveness of basic and enhanced implementation models, these data will be combined with data on the change in nutrition and physical activity environment scores to calculate the incremental cost-effectiveness ratio (average incremental cost of delivering Enhanced Go NAPSACC relative to Basic Go NAPSACC divided by the average incremental change in effectiveness from delivering Enhanced Go NAPSACC relative to Basic Go NAPSACC).
Measure: Cost of basic and enhanced implementation models Time: Measures collected throughout the 1 year intervention periodDescription: Center-level dietary intake of food served to preschool children will be assessed via the foods and beverages provided section of the EPAO-SR as filled out online by the director on 2 different days of the week. Center-level served dietary intake data will be used to calculate Healthy Eating Index 2015 (HEI2015) scores to produce a center-level estimate of children's diet quality. Scores will range from 0-100, where scores closer to 100 will indicate higher diet quality.
Measure: Change in children's diet quality served at child care from baseline to 12 months (exploratory) Time: Measures collected 3-12 weeks prior to start of intervention and 1-8 weeks post-12-month interventionDescription: A center-level score for time provided for active play for preschool children will be assessed via the daily activities section of the of the EPAO-SR as filled out online by 2 classroom teachers on 2 different days of the week. Active play time blocks will be summed each day and then averaged across the 2 days to calculate a center-level estimate, where higher scores indicate more active play time provided.
Measure: Change in time provided for physical activity for preschool children at child care from baseline to 12 months (exploratory) Time: Measures collected 3-12 weeks prior to start of intervention and 1-8 weeks post-12-month interventionThe investigators plan to implement a novel limited RED (high-energy-dense) food variety prescription within a 18-month FBT to examine its effect on 18-month body mass index (BMI). This will be the first randomized control trial to examine how habituation rate, assessed via salivary habituation, mediates reduction in RED food intake, overall energy intake, and reductions in BMI over time, as well as if baseline habituation rate is a behavioral phenotype that moderates BMI outcomes. One hundred fifty-six children aged 8 to 12 years at > 85th percentile BMI will be randomized to one of two, 18-month interventions compared in our 6-month pilot study: FBT (family-based behavioral obesity treatment) or FBT+Variety. Child and adult caregiver assessments will occur at 0, 6, 12, and 18 months on anthropometrics, dietary intake (RED food variety, energy, and diet quality), habituation, and physical activity.
Description: Child's and adult caregiver's weight will be assessed by an electronic scale and height will be measured by a stadiometer.
Measure: Child and adult body mass index Time: Change from 0 to 6, and 6 to 18 monthsDescription: To assess habituation of salivary responses to food cues, whole mouth parotid salivary flow will be measured using the Strongin-Hinsie Peck method. Two measures will be taken, one with juice and one with food.
Measure: Child and adult salivary habituation Time: Change from 0 to 6, and 6 to 18 monthsDescription: Dietary intake for both the child and adult caregiver will be assessed by 3 (2 weekdays and 1 weekend day) 24-hour dietary phone recalls, using the five-step, multiple-pass method. Variables of interest will be the variety of RED foods consumed over the three days; and the mean over the three days of daily servings and kcal from RED foods, kcal, energy density (kcal/g), and Healthy Eating Index (HEI)-2015. Adherence to the prescriptions in the two conditions will be examined. At 6, 12, and 18 months, the percentage of goals met each day will be calculated, with a mean percentage calculated. We will also provide a detailed list of snack foods to participants, and they will be asked to indicate which of the foods on the list were eaten during the previous month, regardless of quantity consumed.
Measure: Child and adult dietary Intake Time: Change from 0 to 6, and 6 to 18 monthsDescription: The wGT9x (ActiGraph, LLC, Pensacola, FL) will objectively measure time spent in MVPA (physical activity at > 3.0 metabolic equivalents units).
Measure: Child and adult physical activity via wGT3X-BT Time: Change from 0 to 6, and 6 to 18 monthsDescription: Percent overweight (%OW) will also be calculated (100*[BMI/50th percentile BMI for child age and sex]).
Measure: Child percent overweight Time: Change from 0 to 6, and 6 to 18 monthsDescription: Waist circumference (WC) will be measured using standard procedures.
Measure: Child and adult waist circumference Time: Change from 0 to 6, and 6 to 18 monthsDescription: Parent time scarcity and fatigue as barriers to planning and preparing meals will measure frequency of occurrence of these barriers.
Measure: Meal planning, preparation, and grocery shopping Time: Change from 0 to 6, and 6 to 18 monthsDescription: Child eating pathology will be assessed using the Kid's Eating Disorder Survey
Measure: Child eating pathology Time: Change from 0 to 6, and 6 to 18 monthsDescription: Self-reported inventory of foods available in the household will be assessed
Measure: Home Food Inventory Time: Change from 0 to 6, and 6 to 18 monthsDescription: Usual sleeping and waking time will be collected
Measure: Child and Adult Sleep Habits Time: Change from 0 to 6, and 6 to 18 monthsDescription: Parent-report measure of commonly occurring routines in school-aged children will measure the frequency of occurrence of routines in children.
Measure: Child Routines Time: Change from 0 to 6, and 6 to 18 monthsDescription: Total number of weekly, and type, of self-monitoring records (hard copy or electronic) completed will be assessed. Number of treatment sessions attended will be recorded.
Measure: Compliance and process data Time: 6, 12, and 18 monthsBackground: The Coronavirus 2019 (COVID-19) is an infectious disease, which was first identified in December 2019 and has then spread rapidly around the world. COVID-19 spreads mainly through respiratory droplets and causes people to experience mild to moderate respiratory illness. On 11 March 2020, the World Health Organisation (WHO) declared COVID-19 a pandemic. With the surge in cases and to contain the spread of this disease, Singapore implemented a circuit breaker to reduce movements and interactions in public and private places. People are advised to stay at home and practise social distancing. With restrictions in movements, parents and children are likely to be more sedentary in this pandemic. There is an urgent need to move face-to-face interventions to online interventions as it is important to be active in this period. Childhood obesity threatens the health of US and Singapore populations. In the US, 30% of children are overweight, 17% have obesity, and 8% have severe obesity. In Singapore, 13% of children have obesity, and approximately half of all overweight children live in Asia. In both countries the prevalence is increasing, especially amongst the lower income populations, and is associated with future cardiovascular and metabolic disease. In US, obesity is most prevalent in Black and Hispanic populations and in Singapore, obesity affects Malays and Indians disproportionately. The underlying drivers and potential solutions thus share many common factors. The current evidence shows a clear dose-response effect with increasing number of hours of treatment, with a threshold for effectiveness at > 25 hours over a 6-month period. A key gap in delivering this recommendation is meeting the intensity, and delivering comprehensive treatment that is culturally relevant, engaging to families, and integrated within the community context. The study is an online pilot randomised controlled trial among children aged 4-6 with obesity, in Singapore, to test a novel school-clinic-community online intervention, the KK Hospital (KKH) Sports Singapore program, for child obesity treatment with usual care. The primary outcome is intensity of treatment as measured by hours of exposure to intervention. The online KKH Sports Singapore program involves 3-4 weekly online sessions of physical activity and nutrition lessons for children and parents.
Description: Measure intensity of intervention from baseline to 6 months. Intensity is measured using the number of hours of exposure to intervention.
Measure: Intensity of intervention Time: 6 monthsDescription: Measure change in cardiorespiratory fitness at baseline, 3 months and 6 months using the 3 minute step test.
Measure: Change in cardiorespiratory fitness Time: Baseline, 3 months and 6 monthsDescription: Measure change in quality of life at baseline, 3 months and 6 months using the Paediatric Quality of Life Inventory (PedsQL; US version 4). PedsQL is a comprehensive and multi-dimensional construct that includes physical, emotional, and social functioning to assess quality of life in the children. It uses a 5-point Likert scale where 0= never, 1 = almost never, 2 = sometimes, 3 = often, 4 = almost always. Items will be reverse scored and linearly transformed to a 0-100 scale so that higher scores indicate better quality of life.
Measure: Change in quality of life Time: Baseline, 3 months and 6 monthsDescription: Measure the stabilisation or change in BMI at baseline, 3 months and 6 months. Body mass index (BMI) will be calculated as kg/m2.
Measure: Change in BMI Time: Baseline, 3 months and 6 monthsDescription: Measure change in self-esteem at baseline, 3 months and 6 months. Self-esteem is measured using the Behavioural Rating Scale of Presented Self-Esteem questionnaire. The first category of items consists of active displays of confidence, curiosity, initiative, exploration and independence while the second category consists of adaptive reactions to change or stress. It uses a four-point scale from 1-4 where higher scores indicate higher self-esteem.
Measure: Change in self-esteem Time: Baseline, 3 months and 6 monthsDescription: Measure change in eating behaviour at baseline, 3 months and 6 months. Eating behaviour is measured using the Child Eating Behaviour Questionnaire (CEBQ). The questionnaire consists of 35 items and measures food responsiveness, emotional over-eating, enjoyment of food, desire to drink, satiety responsiveness, slowness in eating, emotional under-eating and food fussiness using a 5-point Likert scale (1= never, 2 = rarely, 3 = sometimes, 4 = often, 5 = always). Higher scores indicate higher level of behaviour in the respective dimensions.
Measure: Change in eating behaviour Time: Baseline, 3 months and 6 monthsDescription: Measure change in gross motor skills at baseline, 3 months and 6 months. Gross motor skills is measured using the Test of Gross Motor Development (Ver. 3.0). The first subtest, Locomotor, measures the gross motor skills that require fluid coordinated movements of the body as the child moves in one direction or another. The second subtest, Ball Skills, measure the gross motor skills that demonstrate efficient throwing, striking, and catching movements.
Measure: Change in gross motor skills Time: Baseline, 3 months and 6 monthsDescription: Measure change in caloric intake using a three day food diary at baseline, 3 months and 6 months.
Measure: Change in caloric intake Time: Baseline, 3 months and 6 monthsDescription: Measure change in physical activity using results from accelerometer to assess time spent on sedentary and moderate to vigorous physical activity at baseline, 3 months and 6 months.
Measure: Change in physical activity Time: Baseline, 3 months and 6 monthsDescription: Measure change in blood pressure at baseline, 3 months and 6 months. Blood pressure will be measured in mmHg via an electronic sphygmomanometer. Both systolic and diastolic blood pressure will be measured.
Measure: Change in blood pressure Time: Baseline, 3 months and 6 monthsDescription: Measure change in waist circumference at baseline, 3 months and 6 months. Waist circumference is measured at the narrowest point between the lower costal (rib) border and the iliac crest using a non-extensible steel tape.
Measure: Change in waist circumference Time: Baseline, 3 months and 6 monthsDescription: Measure change in number of servings of fruits and vegetables using a three day food diary at baseline, 3 months and 6 months .
Measure: Change in servings of fruits and vegetables Time: Baseline, 3 months and 6 monthsBariatric patients represent a peculiar and frail subset of subjects, constantly increasing. During the novel coronavirus disease outbreak, for the lockdown of any non-urgent and non-oncological activity, the access to healthcare services was severely limited, according to the International Federation for the Surgery of Obesity and Metabolic Disorders.
Description: Telemedicine to follow-up and identify sing or symptom of alarm in patient undergoing bariatric surgery or in established bariatric patients during COVID-19 outbreak
Measure: Evaluation of feasibility of telemedicine in outpatient visit in bariatric patients Time: 2 monthsThis study aims to evaluate the impact of the COVID-19 pandemic and its measures on lifestyle in Dutch children between 4 - 18 years.
Description: Weight development of the child. Weight (in kg) will be measured using scales at home, with clear instructions.
Measure: Change in weight child Time: Every 2 weeks until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the "measures"-period, 1 follow-up moment.Description: Weight development of the parents. Weight (in kg) will be measured using scales at home, with clear instructions.
Measure: Change in weight parents Time: Every 2 weeks until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs, hereafter: "coronacrisis-period"). Three months after the "measures"-period, 1 follow-up moment.Description: eating behaviour during measures due to the coronacrisis, measured with an online questionnaire.
Measure: Eating behaviour Time: Every month until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the "measures"-period, 1 follow-up moment.Description: COVID-19 related symptoms and adherence to governmental measures, measured with an online questionnaire.
Measure: Symptoms Time: Every 2 weeks until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the "measures"-period, 1 follow-up moment.Description: Daystructure of children during the coronacrisis, measured with an online questionnaire.
Measure: Day structure Time: Every month until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the "measures"-period, 1 follow-up moment.Description: Physical activity behaviour children during the coronacrisis, measured with the Baecke questionnaire.
Measure: Physical activity Time: Every month until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the "measures"-period, 1 follow-up moment.Description: Screentime during the the coronacrisis, measured with an online questionnaire.
Measure: Screentime Time: Every month until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the "measures"-period, 1 follow-up moment.Description: Online possibilities for working on a healthy lifestyle, such as challenges regarding nutrition and physical activity, measured with an online questionnaire.
Measure: Online possibilities Time: Every month until end of the Dutch governement measures affecting children (e.g. fully opening of the schools and sportclubs). Three months after the "measures"-period, 1 follow-up moment.Description: Quality of life during the coronacrisis, measured with the Kidscreen-27.
Measure: Quality of life in children Time: Once in first month of the study and once within three months after COVID-19 measures are scaled down.Description: Parenting practices regarding eating behaviour and physical activity, measured with a questionnaire.
Measure: Parenting practices Time: Once in first month of the study and once within three months after COVID-19 measures are scaled down.Description: Qualitative data on lifestyle in children during the coronacrisis, by semi-structured interviews.
Measure: Qualitative data on lifestyle in children Time: Up to approximately 1 yearDisproportionate impact of COVID-19 in patients with obesity is now well established. Obesity is associated with severe forms of COVID-19 and may be a risk factor of intensive care unit (ICU) admission. Obesity is associated with COVID-19 related hospital death in a large United Kingdom cohort study. However, there is a gap of knowledge on assessment of outcomes such as severity of Acute Respiratory Distress syndrome (ARDS), duration of hospitalisation and mortality in ICU. Moreover, an obesity survival paradox has been observed in patients with ARDS. This raises the question whether the obesity paradox has been broken by COVID-19. The investigators aim to explore risk factors of in-ICU death for patient with COVID-19, including obesity and other chronic diseases and to describe the clinical course and outcomes, including the management of acute respiratory failure and other intensive care management.
Description: number of fatal cases
Measure: ICU mortality Time: through study completion, an average of 14 daysDescription: number of patients with invasive mechanical ventilation
Measure: Invasive mechanical ventilation Time: through study completion, an average of 14 daysDescription: number of fatal cases
Measure: In-hospital mortality Time: through study completion, an average of 21 daysThe first person-to-person Coronavirus disease (COVID-19) transmission in Italy was reported on Feb 21st, 2020, causing one of the most massive outbreak in Europe so far that stopped immediately all elective surgical procedures. Bariatric surgery represents the most effective treatment to obtain an important, long-term weight loss and comorbidities' resolution, including respiratory disorders. A sensitive decrease of epidemic has been observed lately and a gradual and progressive stop of the lockdown (phase 2-3) was planned, when the virus is supposed to be under control and protocols are guiding the restart of the elective bariatric surgery. Several questions are currently open: Laparoscopic bariatric surgery is safe in the phase 2-3? What's the expected complications rate? The actual hospital protocols are effective to minimize the risk of postoperative COVID-19 infection? Aim: to analyse results of bariatric surgery during phase 2-3 COVID-19 pandemic in Italy. Primary end point: 30 days COVID-19 infection, mortality and complications. Secondary end points: readmission rate 30 days, reoperations for any reason related to surgery. Study design: prospective multicenter observational. Setting: Italian National Health Service 8 high-volume bariatric centres. Enrollment criteria: No previous Covid-19 infection; Primary, standard IFSO approved bariatric procedures; No concomitant procedure; No previous major abdominal surgery; >18<60 years old; Compensated comorbidities; Official SICOB's surgical informed consent given, including COVID-19 addendum; Adherence to very restrictive protocols regarding: hospital admission, management of in-hospital patients and after discharge. Follow-up: scheduled outpatient visit 30th postoperative day. Data evaluation: all the cases performed during July/December 2020 will be collected in a prospective database. Patients operated during the period July/December 2019 in the same centers will be considered comparative group (control). Expected results: Transparent information to the patients, and the introduction of the COVID-19 protocol concerning patients and health-professionals protection, should guarantee a safe restart of bariatric surgery in Italy. The network of 8 high-volume centers sharing information and protocols in this "unexplored" period will be a guarantee for patients' safety. Bariatric surgery should induce a postoperative amelioration of the comorbidities reducing the risks in case of a second outbreak.
Description: Postbariatric surgery COVID-19 infection, mortality and complications
Measure: Postoperative COVID-19 infection Time: 30 postoperative daysDescription: Complications, reoperations for any reason related to bariatric surgery.
Measure: Complications related to bariatric surgery Time: 30 postoperative daysThis study has been designed as a randomized, double blinded, multi-centric, placebo controlled, and phase II dose-ranging study. The herbal drug contains bioactive ingredients from Labisia pumila plant and it is an aqueous ethanolic standardized extract (SKF7™).
Description: Percentage of subjects whose Body Weight is lowered
Measure: Change in body weight Time: 12 weeksDescription: Change in waist and hip circumference
Measure: Change in waist and hip circumferences Time: 12 weeksDescription: Change in waist-hip ratio and waist-height ratio
Measure: Change in the waist-hip and waist-height ratios Time: 12 weeksDescription: Change in BMI in kg/m^2
Measure: Change in Body Mass Index (BMI) Time: 12 weeksDescription: The change of body fat percentage
Measure: Body fat percentage Time: 12 weeksDescription: The amount of lean body mass will be calculated from body fat percentage
Measure: Lean Body Mass Time: 12 weeksDescription: Abnormality of vital signs and laboratory test results
Measure: Incidence of abnormal vital signs and of abnormal laboratory test results Time: 12 weeksDescription: The incidence and percentage of Adverse events and serious adverse events
Measure: Incidence of Adverse Events Time: 12 weeksThis study will study the effects associated with the prescription of phentermine in a virtual setting, comparing with prescription of phentermine via a standard face-to-face visit for patients with obesity or overweight.
Description: The primary endpoint is mean change in body weight (%) from baseline (visit 1) to 12 weeks (visit 4) in body weight.
Measure: Change in body weight (percentage) Time: 12 weeksDescription: Assessed as number of missed visits
Measure: Adherence to weight management program Time: 12 weeksDescription: Assessment of medication compliance
Measure: Adherence to medication use Time: 12 weeksDescription: Mean change in BMI from baseline to week 12
Measure: Change in BMI Time: 12 weeksAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 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