Pediatric Obesity Clinical Trial
Official title:
Adapting the US-based Clinic-community Model of Child Obesity Treatment Into an Online Intervention Model in Singapore During COVID-19
Verified date | March 2023 |
Source | KK Women's and Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 4-7 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 4-6 weekly online sessions of physical activity and nutrition lessons for children and parents.
Status | Completed |
Enrollment | 40 |
Est. completion date | May 12, 2022 |
Est. primary completion date | May 12, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Years to 7 Years |
Eligibility | Inclusion Criteria: Subject must meet all of the inclusion criteria to participate in this study. - Overweight as defined by BMI percentile of above 90th percentile - Age 4-7 years old in the year of referral - Ability to provide informed consent Exclusion Criteria: - Patients with secondary causes of obesity especially genetic syndromes e.g. Trisomy 21, Prader-Willi - Currently participating in a weight management program - Unable to understand and speak English sufficiently to give informed consent and complete the research assessments. |
Country | Name | City | State |
---|---|---|---|
Singapore | KK Women's and Children's Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
KK Women's and Children's Hospital | Duke University, Duke-NUS Graduate Medical School, Health Promotion Board, Singapore, Sport Singapore |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intensity of intervention | Measure intensity of intervention from baseline to 6 months. Intensity is measured using the number of hours of exposure to intervention. | 6 months | |
Secondary | Change in cardiorespiratory fitness | Measure change in cardiorespiratory fitness at baseline, 3 months and 6 months using the 3 minute step test. | Baseline, 3 months and 6 months | |
Secondary | Change in quality of life | 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. | Baseline, 3 months and 6 months | |
Secondary | Change in BMI | Measure the stabilisation or change in BMI at baseline, 3 months and 6 months. Body mass index (BMI) will be calculated as kg/m2. | Baseline, 3 months and 6 months | |
Secondary | Change in self-esteem | 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. | Baseline, 3 months and 6 months | |
Secondary | Change in eating behaviour | 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. | Baseline, 3 months and 6 months | |
Secondary | Change in gross motor skills | 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. | Baseline, 3 months and 6 months | |
Secondary | Change in caloric intake | Measure change in caloric intake using a three day food diary at baseline, 3 months and 6 months. | Baseline, 3 months and 6 months | |
Secondary | Change in physical activity | 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. | Baseline, 3 months and 6 months | |
Secondary | Change in blood pressure | 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. | Baseline, 3 months and 6 months | |
Secondary | Change in waist circumference | 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. | Baseline, 3 months and 6 months | |
Secondary | Change in servings of fruits and vegetables | Measure change in number of servings of fruits and vegetables using a three day food diary at baseline, 3 months and 6 months . | Baseline, 3 months and 6 months |
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