Clinical trial NCT04395430: A Novel School-clinic-community Online Model of Child Obesity Treatment in Singapore During COVID-19
Official title: Adapting the US-based Clinic-community Model of Child Obesity Treatment Into an Online Intervention Model in Singapore During COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Clinical Trial
Keywords: Exercise
Child Health
Child, Preschool
Body Mass Index
Healthy Lifestyle
Community Networks
internet-based intervention
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Duke University
name: Duke-NUS Graduate Medical School
name: Sport Singapore
name: Health Promotion Board, Singapore
First posted: 2020-05-20
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Through this trial, the investigators will address the following aims:

1. 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.
2. 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.
3. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intensity of intervention
timeFrame: 6 months
Secondary outcomes:
measure: Change in cardiorespiratory fitness
timeFrame: Baseline, 3 months and 6 months
measure: Change in quality of life
timeFrame: Baseline, 3 months and 6 months
measure: Change in BMI
timeFrame: Baseline, 3 months and 6 months
measure: Change in self-esteem
timeFrame: Baseline, 3 months and 6 months
measure: Change in eating behaviour
timeFrame: Baseline, 3 months and 6 months
measure: Change in gross motor skills
timeFrame: Baseline, 3 months and 6 months
measure: Change in caloric intake
timeFrame: Baseline, 3 months and 6 months
measure: Change in physical activity
timeFrame: Baseline, 3 months and 6 months
measure: Change in blood pressure
timeFrame: Baseline, 3 months and 6 months
measure: Change in waist circumference
timeFrame: Baseline, 3 months and 6 months
measure: Change in servings of fruits and vegetables
timeFrame: Baseline, 3 months and 6 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Elaine Chu Shan Chew, MBBS
role: PRINCIPAL_INVESTIGATOR
References: