CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


Report for D063766: Pediatric Obesity NIH

(Synonyms: Pediatric Obesity)

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (13)


Name (Synonyms) Correlation
drug858 Degarelix Wiki 0.41
drug1911 Non-food Ads Wiki 0.41
drug3336 media multi-task Wiki 0.41
drug1574 Lifestyle intervention Wiki 0.41
drug1070 FBT+Variety Wiki 0.41
drug3389 online KKH Sports Singapore Program with Usual Care Wiki 0.41
drug1051 Exposure to the Dutch measures due to the Covid-19 pandemic. Wiki 0.41
drug2784 Sustained attention Wiki 0.41
drug3060 Video Wiki 0.41
drug1134 Food Ads Wiki 0.41
drug1069 FBT Wiki 0.41
drug2540 Saline Wiki 0.15
drug3029 Usual Care Wiki 0.14

Correlated MeSH Terms (4)


Name (Synonyms) Correlation
D009765 Obesity NIH 0.43
D050177 Overweight NIH 0.31
D006963 Hyperphagia NIH 0.29
D002908 Chronic Disease NIH 0.12

Correlated HPO Terms (2)


Name (Synonyms) Correlation
HP:0001513 Obesity HPO 0.43
HP:0002591 Polyphagia HPO 0.29

There are 6 clinical trials

Clinical Trials


1 Kijk op Overgewicht Bij Kinderen: Study Regarding Etiological Factors, Risk Factors and Early Stages of Chronic Disease in Different Degrees of Childhood Overweight

Children and adolescents with overweight and obesity are predisposed to significant health problems. It is known that childhood obesity can adversely affect almost every organ system, and if left untreated, the major impact of childhood overweight is likely to be felt in the next generation of adults. The aim of " Kijk op overgewicht bij kinderen" is to collect and follow-up longitudinal data from a population of different degrees of children with overweight regarding etiological factors, risk factors and early stages of chronic disease in different degrees of childhood overweight.

NCT02091544 Childhood Obesity Other: Lifestyle intervention
MeSH:Pediatric Obesity Overweight Chronic Disease

Primary Outcomes

Measure: The number of overweight or obese children

Time: approximately 10 years

2 The Relation of Genetic Factors, Food Cues, and Self-Regulation With Excess Consumption and Adiposity in Children

This study assesses the associations between genetic factors, food-cue-related neural reactivity, self-regulatory capacity, eating in the absence of hunger (EAH), and adiposity gain in children.

NCT03766191 Childhood Obesity Behavioral: Food Ads Other: Non-food Ads
MeSH:Pediatric Obesity

Primary Outcomes

Description: Activation in brain reward regions in response to food vs. non-food cues, as measured by differences in the blood-oxygen-level dependent response during fMRI scans. Investigators will examine associations between polymorphisms in FTO, MC4R, as well as a genetic risk score with the differential neural activity.

Measure: Food-cue-related neural activity

Time: Baseline

Description: Difference in kcals consumed in response to food vs. non-food cue exposure in the behavioral sessions. Investigators will examine how differential neural activity in response to food vs. non-food cues will relate to EAH. Investigators will also assess whether self-regulatory capacity diminishes this association between differential neural activity and EAH.

Measure: Food-cue-related Eating in the Absence of Hunger (EAH)

Time: Baseline, 2 weeks, 4 weeks

Description: Difference between BMI z-score according to the Center for DiseaSe Control 2000 Growth Reference Curves assessed at baseline and follow-up. Investigators will assess the associations between genetic factors (polymorphisms in FTO, MC4R; and a genetic obesity risk score), food-cue-related neural activity and EAH with change in BMI.

Measure: Change in BMI

Time: Baseline, 1-year followup

3 Media Multi-tasking and Cued Overeating: Assessing the Pathway and Piloting an Intervention Using an Attentional Network Framework

Childhood obesity is a critical public health problem in the United States. One factor known to contribute to childhood obesity is excess consumption. Importantly, excess consumption related to weight gain is not necessarily driven by hunger. For example, environmental food cues stimulate brain reward regions and lead to overeating even after a child has eaten to satiety. This type of cued eating is associated with increased attention to food cues; the amount of time a child spends looking at food cues (e.g., food advertisements) is associated with increased caloric intake. However, individual susceptibility to environmental food cues remains unknown. It is proposed that the prevalent practice of media multi-tasking—simultaneously attending to multiple electronic media sources—increases attention to peripheral food cues in the environment and thereby plays an important role in the development of obesity. It is hypothesized that multi-tasking teaches children to engage in constant task switching that makes them more responsive to peripheral cues, many of which are potentially harmful (such as those that promote overeating). The overarching hypothesis is that media multi-tasking alters the attentional networks of the brain that control attention to environmental cues. High media multi-tasking children are therefore particularly susceptible to food cues, thereby leading to increased cued eating. It is also predicted that attention modification training can provide a protective effect against detrimental attentional processing caused multi-tasking, by increasing the proficiency of the attention networks. These hypotheses will be tested by assessing the pathway between media-multitasking, attention to food cues, and cued eating. It will also be examined whether it is possible to intervene on this pathway by piloting an at-home attention modification training intervention designed to reduce attention to food cues. It is our belief that this research will lead to the development of low-cost, scalable tools that can train attention networks so that children are less influenced by peripheral food cues, a known cause of overeating. For example, having children practice attention modification intervention tasks regularly (which could be accomplished through user-friendly computer games or cell phone/tablet apps) might offset the negative attentional effects of media multi-tasking.

NCT03882957 Attention Concentration Difficulty Obesity, Childhood Behavioral: Sustained attention Behavioral: media multi-task Other: Video
MeSH:Pediatric Obesity Hyperphagia
HPO:Polyphagia

Primary Outcomes

Description: Eye-tracking will be used to measure the amount of time spent looking at static food cues while participants play a media game on the computer. The amount time spent looking at a food cue is a measure how much attention was given to the food cue. The longer the looking time, the greater amount of attention.

Measure: Amount of time spent looking at food cues while playing a media game

Time: approximately 15 minutes post-intervention

Description: The amount of kcals consumed of snack foods after participants have completed the intervention.

Measure: Amount of snack foods consumed post-intervention

Time: approximately 30 minutes post-intervention

Description: This questionnaire measures the amount of media multi-tasking in a typical hour of media use, by asking respondents to report their interaction with 12 forms of media. The 12 different media forms are print media, television, computer-based video, music, non-musical audio, video or computer games, telephone and mobile phone, instant messaging, text messaging, email, web surfing, and other computer-based applications. For each activity, respondents indicate how often they concurrently use the other 11 media forms, using a 4-point scale: never (0), a little of the time (0.33), some of the time (0.67), and most of the time (1).

Measure: Daily usual media multi-tasking

Time: approximately 10 minutes prior to the intervention

4 Families Becoming Healthy Together

The 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.

NCT04027426 Obesity Childhood Obesity Behavioral: FBT Behavioral: FBT+Variety
MeSH:Obesity Pediatric Obesity
HPO:Obesity

Primary Outcomes

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 months

Description: 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 months

Secondary Outcomes

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: Usual sleeping and waking time will be collected

Measure: Child and Adult Sleep Habits

Time: Change from 0 to 6, and 6 to 18 months

Description: 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 months

Description: 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 months

5 Adapting the US-based Clinic-community Model of Child Obesity Treatment Into an Online Intervention Model in Singapore During COVID-19

Background: 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.

NCT04395430 Pediatric Obesity Clinical Trial Behavioral: Usual Care Behavioral: online KKH Sports Singapore Program with Usual Care
MeSH:Obesity Pediatric Obesity
HPO:Obesity

Primary Outcomes

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 months

Secondary Outcomes

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 months

6 The Influence of the Covid-19 Pandemia on the Health Behaviour of Primary School Children (and Their Parents) - COVID-19, Obesity and Lifestyle in Children

This study aims to evaluate the impact of the COVID-19 pandemic and its measures on lifestyle in Dutch children between 4 - 18 years.

NCT04411511 Covid-19 Obesity, Childhood Lifestyle Lifestyle, Healthy Overweight, Childhood Children, Only Family Other: Exposure to the Dutch measures due to the Covid-19 pandemic.
MeSH:Obesity Pediatric Obesity Overweig Overweight
HPO:Obesity

Primary Outcomes

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.

Secondary Outcomes

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.

Other Outcomes

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 year


HPO Nodes