Adapting the US-based Clinic-community Model of Child Obesity Treatment Into an Online Intervention Model in Singapore During COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Intensity of intervention
研究概览
简要总结
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.
详细描述
Through this trial, the investigators will address the following aims:
- To demonstrate implementation feasibility and fidelity of the Duke community-based intervention model into an online model. The investigators hypothesise that the evidence-based implementation strategy tested in the US with Parks and Recreation will be adaptable for use at Duke-National University Singapore (NUS) with Singapore Sport, leading to online implementation within a 3-month period, and children in the intervention will receive up to 60 minutes of moderate-to-vigorous physical activity per session.
- To meet current recommendations for intensity of obesity treatment. As compared with usual care, the investigators hypothesise that children in the online intervention will be more likely to receive >25 hours over 6 months of treatment.
- To estimate the effectiveness of the online intervention. Children who participate in the online intervention, as compared with usual care, will demonstrate improvements in health outcomes at 6-months, including cardiorespiratory fitness, weight-related quality of life and stabilisation or reduction in BMI at 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Intensity of intervention
时间窗: 6 months
Measure intensity of intervention from baseline to 6 months. Intensity is measured using the number of hours of exposure to intervention.
次要结局
- Change in quality of life(Baseline, 3 months and 6 months)
- Change in servings of fruits and vegetables(Baseline, 3 months and 6 months)
- Change in BMI(Baseline, 3 months and 6 months)
- Change in self-esteem(Baseline, 3 months and 6 months)
- Change in cardiorespiratory fitness(Baseline, 3 months and 6 months)
- Change in eating behaviour(Baseline, 3 months and 6 months)
- Change in waist circumference(Baseline, 3 months and 6 months)
- Change in caloric intake(Baseline, 3 months and 6 months)
- Change in blood pressure(Baseline, 3 months and 6 months)
- Change in gross motor skills(Baseline, 3 months and 6 months)
- Change in physical activity(Baseline, 3 months and 6 months)